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Advts.indd 2 9/25/09 11:53:42 AM 1 OPEN FORUM 9/25/09 4:42:35 PM9/25/09 4:42:35 PM

GLOBAL FORUM GLOBAL ECS, Inc. Laurel, MD PharmaNet Sarah Powell Potomac, MD Potomac, omson Reuters omson Editor-in-Chief Student Member Hina Chandawat GlaxoSmithKline Th Johnson & Johnson Daiichi Sankyo, Inc Nancy D. Smith, PhD Smith, Nancy D. Qingshan Zheng, PhD Shanghai University of Shanghai University Sanjay Batra, PhD, FACC Batra,Sanjay PhD, Chinese Medicine, China Richard Chamberlain, PhD Jean H. Soul-Lawton, DPhil Eastern Michigan University Betty R. MBA Kuhnert, PhD, Beth Lowenthal, PharmD, MBA Beth PharmD, Lowenthal, Ronald D. Fitzmartin, PhD, MBA Fitzmartin, PhD, Ronald D. Andrzej Czarnecki, MD, PhD, DScAndrzej Czarnecki, PhD, MD, DIA Editorial Global Forum Board The Unpredictable Change Impact of n he biggest discoveries and he biggesth discoveries and were of humanity i inventions (eg, simple Archimedes’ r rather h t

law, the wheel, relativity theory). It theory). wheel, relativity the It l law, taken a very have might long time to understand ideas these simple and rules and formulation of their time the at they However, together. put them to clearly moved civilization our forward. Sometimes, use the of our inventions was example, not clearly understood. For steam machine of Alexandria’s Heron worked but his contemporaries well, benefit human it for until not apply could recent In more some 1600 years later. it took us about 30 years start to history, benefiting from in everyday microwaves home use. appear may from our historical It on standard relying that experience thinking, everyday beliefs, and rules time hasof the not led too to much of pace when the progress. Today, dissemination progress and information few only the individuals that is so rapid deeply who are field can involved in the keep current with changes, all of the it is important acknowledge to that of simplification only appropriate regulation, application and information, can us understand these help developments and benefit from them. notion seems This be to frequently lost in our regulated/overregulated world/ a well environment. By presumption, regulated (but not overregulated) world is being of what better allows for control done and how (following procedures and T

EDITOR-IN-CHIEF ANDRZEJ CZARNECKI ANDRZEJ OF1-Open Forum.indd 1OF1-Open Forum.indd 1 OF1-Open Forum.indd 2 2

OPEN FORUM

GLOBAL FORUM on all sides ofthe table.on allsides sectors working inpharmaceutical helping people world,national andinternational regulatory inthe ofhisprofessional career most spent the from ascientist Netherlands whopresents This month’s ofJan profile Willem derLaan van what isthere itto see for check you. please so ofinterest ofourmembership, areas chosen covering contains articles section Practices” “Best andcoverage. toreach Our global our dedication of whichispart information China, onandfrom In ourcurrent issue, the for thepopulation. global benefit ofsafetytreatment andrisk aspects important ourthinkingonthe truly shouldfocus Internet, the at all,via ingredient or ofnoqualityactive counterfeit, generic, are branded, whether they The availability ofalldrugs, areas. in their own andto diminishissuesmarket ofpharmaceuticals to morescientists appropriately control the global aidfrom their significant brainswith “merging” regulators allcountries shouldconsider from sight Notlosing ofthe latter, regions. ICH leading control undergoingissues strict inthe main three for the world’s rather population, thanminor some abiggerissue to be counterfeit appear medicines From aninternational perspective, activities. quality, andmarketing, markets andallassociated control anddevelopment, of inresearch forward to the given concept ofhowtoshould be move ofthought Therefore, level direction. agood isthe rightand morewhichcertainly global, more are area becoming inevery activities Our environment. the about new prediction realistic to orother discover tools the most 360° feedback, ofchange,throughthe consequences think tanks, to consider itiswise measures, introducing new consequences.Well ie,unknown, long-term, before human history. It istherefore to advisable avoid throughout wehave as seen infull, predicted beThe cannot frequently ofchanges impact notdeliver to “the society.does right thing” profession onthejudgement legal anddecisions ofthe andbasing understanding science proper amount them. behind Excluding ofscience a have asubstantial areas allregulated practically Similarto pure science, andperspective. language, formulae, bylegal science that override frequently areas regulated heavily inthose and specifically life, ofoureveryday inmanycriteria activities of“thinkuse tanks,” created any without exclusion ofsuchasituation,impact oneshouldconsider the To limited. severely the offset partially at least be can ideas then the dissemination ofnew the box.”outside Ifsuchthinkingissuppressed, eliminates boxes),ticking butvirtually ”thinking ■ Global Forum provides u hssto he o ut$9 today. $699 just for three of set this Buy ipyvsthttp://store.centerwatch.com. visit Simply 0 .Wsigo t,Se 301 Ste. St., Washington N. 100 lnclresearch clinical xlr h new the Explore ihu leaving without rn n D esosavailable. versions PDF and Print oroffice. your rnir in frontiers www 15 .centerwatch.com th Anniversary 1994-2009 | otn A02114 MA Boston, SM 9/25/09 4:42:37 PM A few inches that may mean the difference between winning and losing

What the regulatory authorities will consider when determining your product's efficacy – or lack thereof

Advts.indd 9 9/25/09 12:01:39 PM CONTENTS

Publishing Information DIA Global Forum Staff William Brassington 24 Acting Executive Director Andrzej Czarnecki, MD, PhD, DSc, Editor-in-Chief Lisa Zoks, Editor OPEN FORUM Fran Klass, Managing Editor Chris Slawecki, Senior Copywriter 1 Th e Unpredictable Impact of Change Andrzej Czarnecki Joe Krasowski, Marketing Communications Manager Pat Friia, Joyce Litwin Zimmerman PRESIDENT’S MESSAGE Freelance Writers Mission 6 Leading and Managing DIA to Continued Success The DIA Global Forum provides a multidisciplinary, Jeff Sherman neutral forum for communicating information related to drug development and lifecycle management on a global BEST PRACTICES basis. The Global Forum disseminates content that is relevant to members’ professional experiences, including 8 Fragile Bridge Between Strategy and Execution - international industry and regulatory updates and news Th e Clinical Manager in Drug Development of the association and its programs. The magazine is Peter Blaisdell circulated six times a year as a benefi t of DIA membership. Publishing, Subscription, and Advertising Offi ces: 11 Off shoring of Chemical and Pharmaceutical R&D Drug Information Association (DIA), 800 Enterprise Road toward Asia Suite 200, Horsham, PA 19044-3595, USA. Frank U. Floether Contact Information 14 Communicating Locally when Marketing Globally- Worldwide Advertising Sales, Steve Everly 267 893 5686 Subscription Information, Customer Service 215 442 6100 Th e Very Real Local Diff erences in Marketing Pharma Membership Services, Mike McGovern 215 442 6129 Products Around the World Senior Marketing Manager, Mike Keller 215 442 6173 Gary Muddyman The DIA Global Forum (ISSN: 1944-1991) is a publication of the PROFILE Drug Information Association. Editorial Offi ce: Drug Information Association (DIA), 800 Enterprise Road, Suite 200, Horsham, PA 17 Jan Willem van der Laan 19044-3595, USA; phone: 215 442 6100; fax 215 442 6199. Copyright © 2009, Drug Information Association. CAREER TIPS The DIA Global Forum (ISSN: 1944-1991) is published six times a year, in February, April, June, August, October, 19 Having Problems Getting Ahead? How to Recognize and December. Thirteen dollars of each member’s annual and Overcome Key Leadership Career Derailers membership fee is for a year’s subscription. Prices include postage and are subject to change without notice. Notify DIA REGIONAL REPORTS eight weeks in advance of address change with a copy of the mailing label. Back issues of most previously published issues China are available from DIA. PUBLICATIONS MAIL AGREEMENT NO. 41103506 23 Th e Status and Trends of Clinical Trials in China RETURN UNDELIVERABLE CANADIAN ADDRESSES TO Shimei Wen CIRCULATION DEPARTMENT, PO BOX 1051, FORT ERIE, ONTARIO L2A 6C7 24 On Location: Beijing-Imperial City to Modern Capital Postmaster: Send changes of address to DIA Global Forum, 800 Enterprise Road, Suite 200, Horsham, PA 19044-3595, 32 Interview with Ling Su USA. Periodical postage paid at Horsham, Pennsylvania, and additional mailing offi ces. 34 A Guide to Traditional Chinese Medicine Injections Cover photo: From istockphoto.com, ©Tan Kian Khoon Junchao Chen

4 GLOBAL FORUM

TOC.indd 4 9/26/09 12:03:36 PM 60

35 Th e Application of Electronic Clinical Data 50 Critical Role of the CRC and Site Management in China Management in Assuring Data Quality Yinghua LV in India Dr. Sauren Das 36 Changes to China’s Patent Law Take Eff ect October 1 Latin America Tony Chen and Ann Chen 52 2nd Latin American Regulatory Europe Conference (LARC) Rescheduled 40 Planning Your Monaco Meeting Experience- EuroMeeting 2010 ASSOCIATION NEWS 38 Upcoming Events 43 Aiming for a 360° Green EuroMeeting 54 Paul Pomerantz-DIA’s New Executive 44 DIA HTA Forum 2009 Director Angelika Joos and Wills Hughes-Wilson 56 Working Together to Create Better 46 Pharmaceutical Quality Forum Access to Better Medicines-46th Annual Meeting Japan 59 Nominations are Now Open 47 Annual Japan DIA Meeting 60 DIA Convenes Global Vaccine 48 13th Annual Workshop in Japan Development Symposium for CDM 62 4 New Training Courses Debuted in 2009 India 64 Tailoring an EPM Capability: How to 49 4th Annual Drug Discovery and Find the Right Fit Development Conference Matt Kiernan Fernando Quezada and Satish Tripathi 67 eClinical for Today and Tomorrow

PROGRAM NOTES 69 Industry & FDA Share SPL & eDrug 11 Listing Updates

71 PATIENT PERSPECTIVE

74 MARKETPLACE

76 MEMBERS ON THE MOVE

GLOBAL FORUM 5

TOC.indd 5 9/26/09 12:03:43 PM President's Message.indd 6 6

PRESIDENT’S MESSAGE

GLOBAL FORUM

JEFFREY W. SHERMAN building upon our vibrant andself-sustaining ourvibrant building upon offurther toward ourcommon purpose management andstaff,Chapters, team, SIACs, Councils, Advisory Directors, of Board and volunteers, ourmembers with to working together forward that helooks collaborations andIknow andrelationships, provenPaul hisability has to build ofDirectors. Board Leadership Association ofthe Center chairman forimmediate past and Surgeons ofPlastic Society American recently executive president vice ofthe as experience, most and association healthcare of 25years from gained expertise vast to DIA He bringsplan for sustainability andgrowth. implementation long-term ofourstrategic, the andlead operations our global direct Paul will aresult. candidate as suited andwell such anexperienced identifying work throughout andfor process this search for their President, hardImmediate Past Dray, byMarie committee led search I sincerely thank ourexecutive director ourassociation. andmanaging in leading efforts the strong volunteer andstaff solidify director, further 1,will December effective executive worldwide ournew as CAE, MBA, exception. The additionofPaul Pomerantz, isno The environment. changing DIA A ever inourcurrent andever- ever management than ismore important strong and culture ofleadership to ContinuedSuccess Leading andManagingDIA pharmaceutical industry and DIA initiatives andDIA industry pharmaceutical inthisthe issueabout state ofthearticles timely thatI hope you enjoy several evolve. discussions ofthe future issues youin with updates to sharing forward Ilook andexpandoutreach ourscope. extend ways wecan about ourdiscussions instrategic iscurrently engaged Directors inthis of timeofchange.Thevision Board and leadership andprovide our association, The advance contributions ofourcolleagues issue ofthe inthis elsewhere nomination processes Award. You moreboth read about can Volunteernomination for aDIA Service witha colleagues association deserving oneofyour to moments reward afew take nominated. youto Allowmeto also ask ifyouare leadership ofBoard a position in andconsider serving of ourassociation, to the help future chart colleagues qualified the take timeto nominate Please Directors. Nominations of for the 2010-2011 Board director, for ourCall wehave issued also executive ournew In additionto hiring Paul. with together to welcoming andworkingforward We volunteer association. global alllook Global Forum. Global Forum as these 9/25/09 4:46:49 PM 7 PRESIDENT’S MESSAGE 9/25/09 4:46:50 PM9/25/09 4:46:50 PM

GLOBAL FORUM GLOBAL ■ UROLOGY CARDIOLOGY IMMUNOLOGY DERMATOLOGY INFECTIOUS DISEASE INFECTIOUS www.us.astellas.com EOE/M/F/D/V A dynamic tomorrow. sets itself apartAstellas being eager the pack by from nimble and willing are We adapt. to and ready grow to change quicklyto know because we it is important and be part to exciting of a high It’s know can do it. we we performing everyone is professional, where culture a Senior QA Associate for I’m and dynamic. supportive, helping Astellas change tomorrow. and I’m R&D programs Olivia Stabile R&D Programs Associate, Senior QA we shine! Together, DIA’s collaborative reach and commitment to to reach and commitment collaborative DIA’s world. the around professionals I look forward as we further your involvement to build our leadership capabilities and management DIA. of the success continued the for DIA China DIA China st Changing tomorrow in China, we will where 1 our present Annual Meeting:Annual Drug Development in a Flat – Innovation, Regulation Globalization, & World November 1-3 in Beijing. articles These include that law patent a summary of changes China’s to took effect on October 1, clinical and trial status in China, Ling trends and an interview with Dr. Su, Chairperson of our Provisional Advisory Council of China. Our first meeting annual in China, with the presented in collaboration Pharmaceutical for International China Center & Drug Food Administration State of the Exchange of provides demonstration another (SFDA), President's Message.indd 7President's Message.indd 7 BP1_Fragile Bridges.indd 8 8

BEST PRACTICES

GLOBAL FORUM consequence. However,consequence. the because andthuspurely ofmarginal tactical as regarded this role issometimes the creation of novel medicines, toward optimizing aneye with fi development ofdrug the organization As function. butunderappreciated, an important, managersare clinical development, play roles indrug experts critical Whilemany therapy work. will ifapotential new in determining andexecution isvital design trial clinical between linkage close development, drug intricate as as for anendeavor and, particularly organizations technology-based execution iscomplicated for most Th and design between dynamic e Introduction Blaisdell Peter rms isconsidered rms function; “studyfunction; manager,” “clinical this nomenclature to describe used complication isdivergentA further challenging. the position assessing multidimensional make role can Th Role inDesignandExecution A Foot inBoth Camps: TheManager’s development eff development the overall to support better enhanced could be how the position and manager currently functions howtheunderstanding clinical by realized couldadvantage be Acompetitive drugs. to develop themselves how companies organize intothis awindow role provides examining research, inclinical steps managerisahubclinical for key e clinical manager’s eclinical ort. Th the project’s stage. developmental understudy area therapeutic and organization’s the experience with Th structure. others related to organizational specifi project some of factors, position’s onanarray depends scope the manager’s role isnarrow. Th inother fi upat night; sweep except everything virtually does the manager organizations, In some “clinical or“manager.” manager” refer will to this role as review in diff Th erent companies. thedoing essentially samething of the to attached titles individuals are justsome manager” research manager,”project and“clinical elatter include the fi e former includethe eformer rm’s and size is brief rms, c, e 9/29/09 4:52:40 PM 9 BEST PRACTICES 9/29/09 4:52:45 PM9/29/09 4:52:45 PM

ort. is should should is GLOBAL FORUM GLOBAL e clinical manager can from statisticians input cant lm script, group from a large input In parallel with designing the study, withIn parallel designing study, the most drug development companies formal process a more-or-less have assess Th to its feasibility. drug developer-sponsored trials are aggressive timelinesusually more than academicfor research. However, needswhile a study be to practical, designingclinical research based of study primarily on convenience as criticalis inappropriate, conduct aspects of assessing therapy’s a novel cacy can require complex safety and effi procedures assess. to A balance needs be to struck between design and operational ease.complexity basic expert on the input Following design and a corporate green-light to someone author must fund study, the In some organizations, protocol. the manager draftsthe with protocol the signifi and clinicians. organizations, In other a writer manager and who is not the in involvement little have who may the authors study, the conducting the study e that is risk here Th protocol. and objectivesincorporates features abstractly appealing, but not central purpose will render study’s that the to and conduct.cult enroll to it diffi of studies, cost Given the protocol the extensive have will appropriately like a organizational input. However, fi needs be to by a single coordinated eff the to bring to coherence author of soliciting input the involve an international for ces regional offi Th study. be useful in providing input orts, thanks to feasibilityto eff therapeutic knowledge and previous withexperience similar studies. is written and protocol the Once its practicality has been assessed, clinicalthe manager can turn to overseeing in conduct. study Even manager’s ne the defi that companies narrowly and minimizerole his or erent ese but is contrasts intense with the individuals supporting study the relatively manager’s include the from design involvement continuous and analysis. completion through Th episodic of most key other involvement functions. critical Given their but limited these experts will often in a study, role support several trials simultaneously, whereas clinical the manager is less likely do so.to In fact, manager can the have inputan important coordinating role specialistsfrom other and bringing a and missionsense of overall continuity team. the to reasonablyStudies progress through ned stages. Early in their defi well development, clinical the manager participate asmay part team of a larger and with external in collaborating medicalinternal experts design to a subtleties the accommodates that study of assessing new potential the therapy Th diseasein the under study. experts because essential are of their therapeutic knowledge, but they may practical of the appreciation little have aspects of industrial trial design and conduct, especially previous if their with academic is largely experience research, which has a very diff regulatory convincing goal than safety of a newaudiences therapy’s timelines for the Further, cacy. and effi orts; the the orts; ectiveness the for senior management expectationssenior management for role. manager’s of the breadth the ough clinical mangers typically Th modest org have on the authority chart, they nonetheless contribute importantly practical to trial design and delivering high-quality results on aggressive timelines. Depending organization, on the these responsibilities not be may formally assigned, but even where manager hasthe a narrow job description, function this adds value by giving informal guidance on study role e can design and conduct. Th become limited more as a function of increased organizational size, but independent of scale, manager’s the during trial designinvolvement can subtleties the odds the that improve of a therapeutic embodied area are is also practical that to in a study conduct; striking balance right the between posing sophisticated c questions and operational scientifi feasibility is critical. team eff All studies are clinical but a lone manager is anything corporate isolated amidst the hero, Eff bureaucracy. manager depends on cooperation. characteristics distinguishingHowever, clinical manythe manager from the BP1_Fragile Bridges.indd Sec1:9BP1_Fragile Bridges.indd Sec1:9 BP1_Fragile Bridges.indd Sec1:10 10

BEST PRACTICES

well as training and, if need be, revising revising be, trainingand,ifneed well as as study troubleshooting facilitates andarchitecture of the the objectives of understanding Aclear institutions. diffipractical for the medical culties bythe protocol mayrequired present anticipated, andthe procedures more diffi is often to enroll suitable subjects Identifying problematic conduct. be during can design during made sense eff best Despite features that orts, inprotocol development. participated and thereby more eff byhaving ective managerismore informed clinical institutions to conductthe the trial, medical well as as external functions internalIn workingwith and ofthe dothis. organization parts other institutions because medical with communication direct from detached be study. Inlarger fi thathand issues inexecuting a arise this allowsthem tofi understand Th institutions. ofcontact these point with akey often the manageris of concurrent trials, a smallfi number doingalimited rm, to them. In medication experimental andadminister the subjects provide institutions that training the medical the study iscommunicating and with ofcoordinating aspect Another critical laboratories andCROs. suchas providers external service may manageralso the oversee clinical the study.of performing Inaddition, aspects for thesuch groups tactical of manager orchestrates the activities organization’s the structure, clinical onthe Depending monitors. well as as specialists, and safety andregulatory lawyers, data managers, statisticians, including numerous internal experts, inconcert with managerworks clinical To development. drug the dothis, rapidly andwell iscentral to eff of conducting the study function Th ofthis position. aspect study conduct isacore managing instudy design, her participation GLOBAL FORUM ough time consuming, oughtimeconsuming, rms, the manager may the managermay rms, cult cult than originally e prosaic ective ective rst- and execution, the drug development development and execution, the drug design inboth embedded by being manager’sclinical utilityisamplifi that the simply acknowledging Beyond development. drug successful to iscritical pieces, just the individual accountability not for the overallresult, feature ofthe role, but a recognized Usually,and execute trials. this isnot the “strawas for eff boss” to design orts conceived of be can manager position Th the trial. supporting the inthe disparate organization groups of to includecoordinating the activities ifbroadened value may addmaximal for thissteps eff the ofhowto schedule and aknowledge ofstudy conduct aspects operational of entails more than asimple mastery trial aclinical managing Successfully Manager? An OptimalRolefortheClinical the original studythe de original generalist in a tapestry ofspecialists. generalist inatapestry components andiseff signifi andoperational cant design thatone ofthe rarehave jobs can both Th functions. supporting more champion articulate inmobilizing the managera makes ofatrial design inthe involved being Again, resources. for that hisorherstudiesare notstarved infl be manager can the above manager,levels the informally are the generallymadeat trial support to assigned andpersonnel budgets about decisions Whileformal projects. many with compete other for priority Th oftheir study‘sorganization importance. role inreminding the unacknowledged if animportant the manager has andongoingstudies, of planned In bigfi studies. phase of later-study the informs design manager’s the experience with current the isaniterativeresearch process, emanager’s have study will to us, a clinical manager performs managerperforms aclinical us, rms with huge catalogues withhugerms catalogues ort. Study management Study management ort. uential in ensuring uential inensuring sign. As As sign. e clinical ective by being a a bybeing ective clinical clinical ed ed the virtues of various types ofstudy. types ofvarious the virtues related statistics and basic to design trial well as management as skills on project coaching In addition,managersneed enhancing the manager’s eff inexpensive investment toward understudy andisan the disease conferences of buildsknowledge scientifiat selected c ormedical Fundingtraining regimen. attendance including awell thought-through usefulenss, this increased to support shouldconsider steps organization author’s employerorany otherparty. ofthe theviews represent necessarily oftheauthor those and donot represent Th it. optimizing thoughts about further inform will such organizations between and comparing productivity exist models forDiverse the role, experience. with validated to be manager’sthe clinical role need including structure organization grave. Recommendations about cradletowith thefrom trial the manager’sleverages involvement instudy design, participating of the manager’s role to include blurring some allowing, least However, orat encouraging, development. to drug expertise operational primarily bringing as Th perceived manageris eclinical Conclusion at [email protected]. at Amgen, Inc .You him contact can Director, Global Study Management Executive PhD,is Blaisdell, Peter e views expressed in this article in article this expressed eviews ectiveness. ectiveness. 9/29/09 4:52:45 PM ■ Frank U. Floether prospect of such a shift.1 Historically, are China and India. Th e background the pharmaceutical industry has been for off shoring, its opportunities, and Th e center of the global pharma- slower to embrace off shoring, but over risks in conducting R&D in Asia, and ceutical industry is shifting. Not the last few years this trend has begun in particular the India option, has only is Asia set to become the largest to reverse, with signifi cant movement been explored in a recent multipart pharmaceutical market in the world, to global sourcing. Unlike many other publication in Chemical Weekly by the but many Asian territories will be industries, the pharmaceuticals sector author of this article.3 powerhouses of the industry. Th e is uniquely positioned to remotely shift began as economies grew execute one of its core competencies, India, China, and Singapore are poised and low-cost manufacturing in the ie, R&D, which represents 74% of to become leading countries in the Asia region expanded. Now, companies off shored employment.2 pharmaceutical space; other territories, increasingly seek to perform site notably South Korea, Malaysia, and research, development, analytical Part of that change is the recognition Th ailand are also building strong services, and clinical trial activity that improving R&D productivity domestic pharmaceutical bases, in Asian territories. Th is refl ects is a key challenge facing the although so far only MNCs currently both increased capabilities in the biopharmaceutical industry. As a dominate these markets. region and a changed business model result, development organizations are of pharmaceutical multinational targeting the drivers of cost and value, For example, for the top ten MNCs, BEST PRACTICES companies (MNC). Th e view that aiming to increase R&D productivity total sales in China during 1999-2004 the center of the pharmaceutical through a series of lines of attack; registered a compound annual growth industry is moving away from North off shoring is one such approach. rate of 15 %. By the year 2010, China America and Europe and toward Asia will probably have leapfrogged major is shared by pharmaceutical MNCs In other words, an essential element of European markets to become the and Asia-based companies alike. Fifty retooling the R&D engine is to off shore world’s fi fth largest national market for percent of MNCs agreed with that R&D, especially to Asia. Because of pharmaceuticals, with sales likely to statement, and less than a quarter their strategic importance and market reach $ 25 billion – almost double the voiced any disagreement with the size, the Asian countries of choice current total.4 GLOBAL FORUM 11

BP2-Offshoring_Asia.indd 11 9/29/09 4:53:29 PM BP2-Offshoring_Asia.indd 12 12

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GLOBAL FORUM business in2008. business a$48billion the USwouldbecome (includingoff outsourcing that pharmaceutical Little predicted 2004, the consulting fi Arthur D.rm In isobserved. inAsia, particularly countries, to low-cost outsourcing acost-driven toward shift perspective, From prices. this to decrease the pressure authorities byhealth than incontrast to $1billion stand upto more costs developmental factor. increased iswell known, As the cost to be and Indiawouldseem inChina investing inR&Dactivities Th R&Dactivity. with buzzing scene inChinaandIndiaisalso this commercial activity, the pharma Butalongside commercial operations. in more deeply investing ever their marketeff intensifying are No wondermany MNCs broadly, the more R&DMNCs Very ambitions. their Asian achieve for helping companies lever strategic a as elsewhere, India andChinalies R&Din of conducting pharma short-sighted view. Th value real e a be alonewill on cost advantage focusing and compliance inAsia, functions ofsupport costs rising andthe employees for highlyskilled inwages increase of the expected industry.pharmaceutical Because consideration for the the primary However, aloneare cost savings not and languages. and the eff ofdiff ects requirements, andlegal regulatory diff andsecurity, lower productivity addition to the ofpotentially impact in maintenance ofequipment, andensuring andsupplies, equipment Westernnecessary staff come relocating the can from costs Additional cut. are clear notso involved the changes by half.Infact, andoverhead rentals, cost ofwages, the West wouldreducethe to Asia from work trials andmore clinical thatexpected simply relocating lab Consequently, MNCs pharmaceutical e quick and easy justifi equickandeasy erences in technical practices, practices, erences intechnical 5

erent cultures , importing cation for shoring) shoring) in orts, orts, are inIndiaandChina. manufactured madeinEurope APIsfor drugs used and Chinaisthat 80%ofthe currently India powerhouses pharmaceutical Illustrative of the emerging their customers. proximity inclose to markets local for products ofdeveloping advantage constraints inthe West, andtaking capacity cost savings, markets, inlarge emerging growth facilitating presence ie,strategic multifactorial, are East head MNCs pharmaceutical In summary, why the reasons MNCs. pharmaceutical R&Dpresence of up astrategic in setting theenhanced dynamic further in2001)has Organization China’s into the World entry Trade in2005; patents onpharmaceuticals product full (India recognizing adapted to international standards (IPR)situation rights was property Th overseas. earned master’s degrees anddoctoral inrecentwith have years returned who ofscientists number increasing China have animpressive andsteadily Indiaand scientists, trained locally having ahuge output ofhigh-quality, Inadditionto expandable talent pool. the huge indefi andalmost aspect… important equally at least Lastly, let’s notforget another about position. their own andconsolidate markets care health help themwill to domestic shape andreputation. Th their visibility have they to increase opportunity the more conduct inIndiaandChina, in the faster development of new ofnew development in the faster just insimple butalso cost savings ofoff the value real since that itpresents, opportunities the from othermuch industries as to stands benefi pharma late came to off industry that the fact pharmaceutical Despite are to about come. thatpredict fi products drug nished It doesn’t to alotofimagination take e fact that efact the intellectual shoring lies not not lies shoring t at least as as t at least shoring, shoring, nitely is 6

the importance of newly emerging emerging ofnewly the importance world,industry, and the globalizing constraints inpharmaceutical the objective given Nevertheless, introduces extrazones complexity. andtime across multiple languages working butnotleast, Last addressed. to be need also intellectual property Naturally,delays. concerns about to problems qualityand lead with provider. Poor communication can client from to control itpasses as there ofpartial aloss isalso party) off to athird outsourcing (by shoring that itcould In have doneelsewhere. timeandopportunity crucial loses fi ismore than justa partnership addition, the cost ofanunsuccessful andexpensive liability.massive In in resulting patients, harm or even compromise can results, mistakes simple for industry-wide; error Th operations. ofoff wary to be arecorrect also But MNCs R&Dsubsidiaries. owned upwholly bysetting and increasingly partnerships, strategic companies, byacquiringlocal mostly are varied, Th in Asia. upbyMNCs set are being activities R&D end-to-end full increasingly research, process chemical as andsuchAPI-relatedcosts) activities 60 to 80% ofanNME’s development (whichare trials conducting clinical Next to on their R&D activities. In particular, are focusing MNCs attractive strategy. off making costs, R&D proliferation, andincreased patent expirations, intense generic profi pipelines, drying t margins, ofshrinking bythe realities is driven IndiaandChina.Thpowerhouses, andlow-wage huge potential markets to the inparticular towards Asia, off of the embraced advantages has Th cost savings. labor beyond Off markets. new huge compounds andinpenetrating nancial issue,since the company e global pharmaceutical industry industry pharmaceutical eglobal shoring andgeneralexpansion shoring e business models applied applied models ebusiness shoring sensitive and vital andvital sensitive shoring ere is a lowtolerance shoring shoring an shoring today goes today goes shoring is 9/29/09 4:53:33 PM 13 BEST PRACTICES 9/29/09 4:53:33 PM9/29/09 4:53:33 PM

■ GLOBAL FORUM GLOBAL [email protected]. des EG-GMP Leitfadens Teil I mit Teil Leitfadensdes EG-GMP Guideline fuer der SFDA-GMP 70 Nr. Ind. Pharm. Chinesische Firmen, 9 (2008) D.C., Washington Labour Market, (2005) Press McKinsey Global Institute 6. 6. Vergleich Schulz, und C. Prinz H. e Emerging Global Th 7. (editor), Farrel D. can PhD be PhD, Floether, U. Frank ffl contacted at 7 shoring is shoring e shore Talent in Talent shore opportunity Statistics processes. and core ce • sizeableshore of components e Boston Consulting Group, A game Plan for China (Dec 2005) out ? Pharmaceutical moving you Are & QualityFormulation (2004) Services, Washington D.C., McKinsey D.C., Washington Services, (2005) Global Institute Press Chemical Pharmaceutical R&D to Asia, April21 (part April 14 (part 1) , Weekly 2) and April 28 (part 3) (2009) Demand for Off for a global gravity shift (2007) Th PriceWaterhouseCoopers, Gearing up PriceWaterhouseCoopers, Th Rosenfeld: and J. Pascal R. 5. Arthur D. Little: S. Viswanathan, Viswanathan, S. Little: 5. Arthur D. 3. FU Floether: Off shoring of Chemical & FU Floether: Off 3. 4. expected to increase by 16% annually, expected increase to by 16% annually, driven increases by robust in the of both and relocation augmentation back-offi their operations in place. Off operations in place. their to off to References 1. 2. & Medical Writing • Clinical Research • Outcomes Research • Project Management • Scientific ts Recruitment Specialists since 1980 SAS Programming SAS Programming Permanent Placements: smithhanley.com Placements: Permanent shoring Regulatory Contract Staffing: smithhanleyconsulting.com Staffing: Contract Data Management Data Management QA/QC Auditors QA/QC Auditors shoring benefi shoring must is adaptability shoring expansion and fewt levels. major Very erences. Th erences. bridging talent is almost ere nobody left who markets, off unavoidable Asiatoward simply are processes, regardless means of the and business model employed. Delivery of off requires sustained and investment development of management the especiallyexperience, endurance cross-cultural to and adaptability diff keep capabilitieswith pace of the development in individual geographic environments. Th realized off that hasn’t amountscant of R&D, of signifi manufacturing, and core and other competencies is becomingnon-core of sustainingan integral component profi pharmaceutical do not companies pilot programs or plansalready have BP2-Offshoring_Asia.indd 13BP2-Offshoring_Asia.indd 13 BP3-Communicating Locally Marketing-R1.indd 14 14

BEST PRACTICES

GLOBAL FORUM Gary Muddyman Gary unsuccessful product launches. product unsuccessful Failure tocould doso in result materials are culturally customized. must ensure that allcommunication companies pharmaceutical markets, inforeign opportunities growth offuture advantage take successfully be worth $1.3trillion. worth be marketwill the pharmaceutical global estimates that PricewaterhouseCoopers By2020, products. pharmaceutical inthe demandfor increase substantial a there be will morewith disease, andisfaced ages, grows, population companies face when marketing companies facewhenmarketing A major challengethat pharmaceutical success. to its the key communicates audience target to its is company which apharmaceutical that means turnover the mannerin Pressure to increase cultures. and across arangeoflanguages translated andculturally customized related collateral accurately must be allproduct- andregulations, rules Toignored. comply international with Th andcultural diff language companies faceboth pharmaceutical When marketingglobally, Challenges Faced inGlobalMarketing T ese are issues which must not be whichmust are notbe issues ese he global pharmaceutical pharmaceutical he global excess of$550billion. iscurrently in worth industry 2 In order to Inorder to erences. erences. 1 As the messaging. messaging. nature, distinct require their very diffvery erent audiences by that, countries but three English-speaking Th to well doctors: as as States, to the consumerdirect inthe United Th drug. the arenurses notable to prescribe registered butunlikethe UK, doctors, the marketis so target to the public, medicine market prescription-only to illegal InAustralia, itisalso drug. onthe depending practice nurses, andperhaps generalpractitioners, be the marketthere so target may UK, to themarketed generalpublic inthe be cannot medicine prescription-only Forthe samelanguage. example, a countries that speak –even country audiencetarget may changeinevery since the otherfor industries, most than more challenging even perhaps For itis companies, pharmaceutical languages. inmultiple creating documentation which issignifi Th orprescribe. purchase suchas action, an them taking towards and steer wouldlikeyourproduct, them that they their convince raise interest, customers, to attract collateral isdesigned audience.sophisticated Marketing attention ofanever-expanding and andcapturingthe isreaching globally is in itself is a challenge, but one isachallenge,butone isinitself e same drug can be marketed marketed be can esamedrug cantly increased when when cantly increased ree ree of each target market’s target of each culture. companies haveunderstanding afull that itisvital in foreign markets, When planningmarketingactivities should be. wheel the steering a car onwhat sideof andeven business, conduct someone, andaddress greet behavior, howyoushould such as to religionand images andsocial the ofcolor from use span markets Cultural diff erences inforeign Cultural Complexities system operates. system ofhowthe care understanding health an and inpharma, and regulations, laws, local theirbut also customs, to religion, culture, language from ofthe country’s understanding target anexcellentwhich notonlyrequires cultural customization includes translation. Localization beyond goes ofmarketingmaterials Localization brand. to costly the anddamaging very prove can any mistakes country—as to country from widely vary they to—and adhered must be country specifirequirements c to the target andregulatory Alllegal sold. is to be of the inwhichthe market product understanding demonstrates aclear the audience target inaway that to presented materials must be marketing All pharmaceutical 9/29/09 4:42:16 PM 15 BEST PRACTICES 9/29/09 4:42:20 PM9/29/09 4:42:20 PM

cally GLOBAL FORUM GLOBAL use e of Brazilian If a pharmaceutical cantly. company translates a marketing translates company Madrid aimed the brochure at Mexican Spanish, itmarket into will the down not go Using well. wrong Spanish and Portuguese wrong will market in the ect of success the certainly aff marketing campaign.any are world in the Nowhere morehigh-quality translations in France. than appreciated Pharmaceutical companies takemust great care when as French, the marketing to be shrugged may mistakes that cultures will in other off certainly not be ignored in exible and fl uid, so do not expect and fl exible include spelling and theerences er signifi er e same can be Spanish, said for a European and BrazilianEuropean Portuguese. Diff use of verb tenses and terminology. Brazilian be must Portuguese used in all marketing communications aimed a Brazilian at audience, otherwise will consumers know that is not specifi communication the Th targeted them. at aimedPortuguese on communications would also a Portuguese audience at insult thebe and could unacceptable target audience. Th 400language spoken by approximately million people worldwide. Spanish has regional variations,many some of which diff translation An unprofessional France. international to can translate literally business failure. Care should be taken in selecting the channels. relevant For communication Chinese the willexample, not build via notrelationships email and tend e best of way react directto to mail. Th a pharmaceuticalpromoting product industry-related events.is by attending face-to-face meetingsIn Mexico, are letters,preferred over telephone, or and decisionsemail. Negotiations take a long time, and deadlines seen are fl as results.immediate In terms of design and layout guidelines, some languages such as German, Italian, and SpanishFrench, or longer words more require either rst name rst erences between erences cial languages spoken are basis with peoplerst-name is very ere business little A Selection of Localization Tips Seventeen offi in India. the English and Hindi are main languages, and English is widely used in business communications. When targeting an Indian audience, thecare should be that taken ensure to correct language is used target the for region. In Libya, as in all Islamic countries, marketing sending any avoid during the communications of Ramadan. Islamic holy month Th conducted during time, and this closed are companies the many for observance.religious in Brazil,When communicating pharmaceutical be must companies diff fully of the aware head may beheadmay frowned upon. Any aimedmaterials thepromotional at such an should avoid Indian market however, society, image. In Western is not an issue. this CzechIn the Republic, it is not fi use someone’s to acceptable without being invited do so, to as this is considered insulting. Czechs are on a fi rarely familyoutside or very extended their close friends. titles and In Germany, surnames most still are commonly used, and in India, titles professional should always be used. Companies should bear in mind when this direct marketingimplementing initiatives. at means, at erent patients, erent countries erent ects medicines way the markets. in foreign erences What health care e way and drug pricing lling a prescription varies widely, meanings in diff erent countries. To countries.erent To meanings in diff it isgain trust the of your audience, understand these to imperative before developing marketing collateral. cult identify to cultural can be diffi It diff in one country notis acceptable may in China, example, For be in another. red color symbolizesthe good luck blue, and black representbut white, asdeath, do clocks, storks, and cranes. Pharmaceutical should companies use of these any avoid therefore marketing and images on any colors designedcommunications the for Chinese market. In India, head the is regarded as being a child’s seat soul pat the of the and to for the average consumer, regardless consumer, average the for medicineof what is prescribed to it will same amount.them, the cost targetingMarketing materials to unlikely are doctors therefore include messages about pricing however, or value. In Australia Pharmaceutical national the ts Scheme does subsidize Benefi certain medicines, of cost but the fi depending drug. on the doctors For prescribing less to well-off is often a patient the to end cost the Marketing messagesconsideration. therefore doctorsto in Australia include some price and valuemay messaging. only conside- And these not the are phrases,rations. colors, Words, and symbols very can have diff must bemust factored every in to global pharmaceutical product launch. health care system national A country’s directly aff prescribed, are bought, and paid for. market the is “self-medicating” How easy How launching? in which you are a doctor access your target to is it for kind of relationship or GP? What does end-user the with the have medical the for Who pays profession? prescription? UK,In the NHS the sets a basic prescription fee of £7.10. Th systems in diff operate Th BP3-Communicating Locally Marketing-R1.indd 15BP3-Communicating Locally Marketing-R1.indd 15 BP3-Communicating Locally Marketing-R1.indd 16 16

BEST PRACTICES

GLOBAL FORUM for a share in a global market, for asharemarket, inaglobal companies compete pharmaceutical intensifi competition As Conclusion ofmarketingmaterials. customization complicate the creation andcultural Its further byte. many languages rather than the more common single characters doublebyte uses Chinese complex translation into Chinese. includingthe market, the Chinese inpenetrating many faced challenges to that Th ofthe US. ere are, however, China’s only is second power buying 23 percent ofthepopulation, global of1.3billioncomprising population consumerism.With growing of its a market to enter, inlight particularly anattractive becoming China isalso suchmaterial. when producing into taken mustaccount be sensitivities country. Allcultural nuances andlocal ofthe target the needs to meet customized must be trials of clinical Th recruitment. of acost-eff optioninpatient ective companies the with opportunity Th treatment. medical access to free to gain trials inclinical participate gladly who will diseases with varied Th inthe conductingUS. atrial much as for example, cost halfas in India, can trials clinical Conducting reduced. are considerably costs as India, as countries such to developing research companies to clinical outsource for example, for pharmaceutical common, It increasingly isbecoming but are their not without challenges. companies for pharma opportunities countries provide Developing Global Marketing Opportunities additional creative costs. necessary, thus notbe avoidingwill any market for each entirely design new planning early, to create the need an By inthe stages. early discrepancy companies shouldplanfor the andpharmaceutical translations, French, andSpanish Italian, German, for Englishto expected is to be Anexcessmessage. space requirement than English to convey the same is provides pharmaceutical pharmaceutical isprovides ere aremany also potential patients e initial marketing einitialmarketing es es and accurate at all times. accurate at alltimes. must be in whichitisdistributed Information andthe manner countries. channels will also diff also channels will anddistribution Sales market. each andmarketingmaterial for messaging diff companies to develop requiring nation from widely to nation, at times overcome. Th to barriers cultural andlinguistic as toand regulations comply well as with Th continue extremely to be challenging. communicating cultureswill across 1. In order to combat these challenges, Inorder to combat challenges, these 1. ere will always be diff be always ere will Pharmaceutical atPharmaceutical anInternational Source ofInformationEssential About Marketisthe Pharmaceutical Global Understanding the and Markets: Research marketingcampaign. global whenfiexperts ona rst embarking andlocalization services language with It to consult distributed. maywise be be their communication materials are to oftherequirements countries inwhich thoroughly alllocale-specifi research companies must pharmaceutical e audience will also vary eaudience vary also will er across diff ■ erent rules erent erent erent erent c [email protected]. gary. him contact can at Readers (GALA). Association Localization and oftheGlobalization member and ofConversis Managing Director and Muddyman CEO is Gary 2. PricewaterhouseCoopers, 2. PricewaterhouseCoopers, Global com/newsroom/news.html?d=121269 www.globenewswire. on Opportunities, Must Changeto Capitalize but Industry PricewaterhouseCoopers, Estimates in Value by2020, to $1.3trillion MarkettoPharmaceutical Double ai_n25431203 articles/mi_m0EIN/is_2008_May_16/ http://fi Level, ndarticles.com/p/ 9/29/09 4:42:21 PM 17 PROFILE 9/25/09 12:47:49 PM9/25/09 12:47:49 PM

GLOBAL FORUM GLOBAL people who want to begin a What adviceWhat would you give to document e background this for In 1990, I quickly became of DIA aware organization this wasand that up made of people willing discuss who were to important matters. After some initial training with the Gerhard Zbinden, I got thelate opportunity chair sessions to on testing andboth immunotoxicity carcinogenicity testing. In a Montreux meeting (1996), we started an important on immunotoxicity initiative testing, eventually which led the to ICH years S8 document later. eight Th was laid down in Montreux, and we start this with cheesecelebrated fondue in a monastery in line with the cave storiesRomans in the of Asterix and Obelix. developed of a round concept the We with discussiontable during dinner, predetermined questions involving all participants. plenary In the discussion afterwards, we could and make conclusions draw than be could put in that recommendations regulators. of the front So, able we were useto DIA important as for a source various on the wereinput topics that ongoing: testing immunotoxicity, evaluationcarcinogenic potential vaccinewith safety transgenic mice, testing, etc. career in this industry? do your job and look Just around new for opportunities. example, For by organizing a workshop. You years area,can for in this stay as ese air, and the serious and the adverse air, ects, appeared which later be to ects reported were on triazolam, that were exceptionally serious adverse exceptionally were eff high dose product the of the to related seeminglyand the paradoxical induction of withdrawal symptoms as Based well. issue, I did on this 10 years than of researchmore on benzodiazepine dependence with biochemical and behavioral techniques. Laterin 1990, I shifted on, work my nonclinical of the coordination the to assessment group, and after a few years connectionI lost academic with my this type of research. new theMy function me into brought meeting then in Party, Safety Working Brussels seafood (with delicious meals), process ICH,and the of the which had Soon I becamejust started city. a in that Group member Expert of the Working ICHof the on carcinogenicity testing, experience,which was an exciting bringing US and Japan, the me to withtogether colleagues from other areas, and leading stimulating to discussions. I learned a lot about the of working ways and the regulations regulatory other of the parties, and made friends world. from all over the I was one month, even a temporaryFor FDA.employee of the eff especially Netherlands. in the Th antidepressants arriving same the at was DSM-III expanded the time that include a broader range of diseaseto descriptions. researchA second for topic topic was issue of dependence the of benzodiazepines, because of the Halcion aff JAN WILLEMJAN VAN DER LAANVAN PROFILE OF PROFILE e group e eld. rst SSRI, rst rst step rst in your career in the training? Graduate? What wasWhat the fi What isWhat your undergraduate rst task was develop to a set pharmaceutical development arena? pharmaceutical the into entrance My goesarena back 1980, whento I started National in the work my Th Public Health. for Institute I joined connection the had a strong to Board,Medicines as Evaluation the nonclinical assessment group. My fi assessof criteria to proof-of- the of antidepressants,concept because discussionof the mode on the of action of mianserine. I became a pharmacodynamic assessor of CNS products such as antidepressants, antipsychotics, antiepileptics, and opioid analgesics. was time that It the zimeldine came in as fi the productand this was regrettably withdrawn soon after marketing. It was an important new time with many I am educated as a biochemist in bacterial membranes, and as a second I did a stage in biologicalinterest was time of the the It at psychiatry. hypothesis serotonin development of the in depression by Herman van Praag and tutors. my were Korf, who Jaap Erasmus I attended PhD, my For learn to in Rotterdam University and behavior, pharmacology, of a real mixture biochemistry, perspectives. pharmacology and From biological it is only a small psychiatry, pharmaceutical the step to fi PRO1-Jan Willem van der Laan.indd 17PRO1-Jan Willem van der Laan.indd 17 PRO1-Jan Willem vanderLaan.indd 18 18

PROFILE

GLOBAL FORUM has new lines to discover. lines new has fi the pharmaceutical in a major way to DIA. Why? Why? amajorway toDIA. in gathered thuson the far. evidence based Guideline. it, It istimeto revise inthat expressed fi paradigms Now, allcompanies work the with the same. basically became framework andthe the with same process, started However, WHO lines. years, afew after fi inthe resistance, andmany persons Testing ofVaccines. At fi there was rst, andToxicologicalPharmacological onPreclinical we wrote aguideline in1993, the European Directive fi products those under rst came When ofvaccines. testing nonclinical the change inthinkingabout was phenomenon Another inspiring i are especially along this line. ininitiatives participating I enjoyed and process, animportant this was Istillhave that afeeling to this area. to contribute are mobilized people now. Now, the clinical 20years, after S8,whichisinforce we wrote the new In2005/6 under the auspices ofICH. bysurveys followed 2002, andthis was topic in anICH Guideline. It became Dose inthe Repeated EU appendix immunotox. In2000,wewrote an on discussion auspices ofthe DIA underthe westarted (Montreux) In 1995(Arlington)and1996 Loveren. Henkwith van immunotox classical study in rats opiates andthe immune a system, immune toxicity in1989-1992on Th fi working the in whileworking witnessed eld haddiffi workingalongthese culty e last experimental study I did on study experimental Ididon elast You your in have time found Are thereany experiences job most thesingle What is professional life to contribute tocontribute life professional you have hadthat youthink youhave change amazing eld? nteresting/inspiring? nteresting/inspiring? eld always rst EU discussions that held tointhediscussions be future. preparation for the more formal in discussions, for ICH informal the forum was for meDIA So, table ofthe SWP. extremely for example, useful, onthe andthe outcomes were life” projects, ofmy were“daily part the discussions since projects, these with involved be able to fi Iwas Zurich. Munich, Amsterdam, and Noordwijk, to conferences organize inMontreux, staff DIA’s from members offi Basel staff the with ofthe advice DIA working, way of their own propose always can Furthermore, committee aprogram professional interest andimportance. that ontopics for are discussions of forum aperfect provided organization the as DIA, workingwith I enjoyed balancing act that can be handled. handled. that act be balancing can toward career,life, sometimes itisa and then the other, toward sometimes tiltingfi perfect, not always rst oneway I have found that is whilethe division twodaysher untilold.Overall, shewas to Ididnotget see inChicago, of being my “birth” agrandfather. as aresult As to were witnesses colleagues My DIA inChicago. Annual meeting the DIA granddaughter, at whenIwas born was However,too. my fi in achurch community are important, membership andanactive background Having astrong family only thing. smaller.became isnotthe Career inwhichmy years role inDIA been compounds, focusing on real concerns, concerns, onreal focusing compounds, for new times development to shorten was on carcinogenicity discussions accomplished bystarting consumers indirectly. What I Toxicology aff orothers? consumers, Th at isatough Th question. . Ihave many with worked excellent How does the job you you thejob How does How areyouabletobalance do impact patients, patients, do impact andcareer? life ects patients and patientsand ects rst grandchild, a a rst grandchild, nd the time to nd the timeto ere have ce on the market. availabilityan earlier ofcompounds in andresult the stage, development which mighttoof ashortening lead human pharmaceuticals. fi concepts inthe regulatory new Th boxes. ticking people to involve thinkers andjustnot need toxicology,students inregulatory a way. Th futureinamorein the structured near able responsibilities toonteaching take toPerhaps doso. possibility be Iwill a therehave was onwhenever taken Teaching that I isanopportunity S6 guideline. ofthe ontheprocess revision/updating inthe helpful ICH very to be proved whichhas antibodies, of monoclonal onthe placental transfer wrote areview ago,andrecently years astudent few data onthe table a theget monkey meto Students supported elements. new addimportant butalways want, Thideas. eywork you along the lines innew the andbring right questions ask studentswith isrefreshing; they a topic for them to work on.Working to fi try Ialways universities, from when there are students coming in theWhat conclusions? haveSo, been Are wedoingthe right things? years. ofwork doneoverthe evaluations Yes, Iliketo have students to do safe products. safe products. and new ofhelp indeveloping be can toxicology ways inwhichregulatory new to see environment freedom with tonow? Iwant work inastimulating fiWhere to doIwant be from ve years that werethe there. opportunities but isapath that isthe oftaking result to year, year from notplanned was I donotknow…probably My path not. Should Ihave the taken samepath? path? same ere is a need to educate new new to educate ere isaneed Is mentoring or teaching orteaching Is mentoring If you had it to do over If youhadittodoover important toyou? important again, would you take the the wouldyoutake again, ■ ere is room for ere for isroom eld of 9/25/09 12:47:55 PM nd nd 1919 CAREER TIPS 9/26/09 9:56:13 AM9/26/09 9:56:13 AM

at’s at’s GLOBAL FORUM FORUM GLOBAL GLOBAL area that’s a likely derailer or personal derailer a likely area that’s If you answered “yes” career stopper. everything,to probably you’re then not being honest with Th yourself. because do we see rarely ourselves as we admit to do do--and, rarely, others our own shortcomings or recognize be may sabotagingbehaviors that our careers. be take a just may time to It long, honest hard, look yourself. at experts reportare there Luckily, that which back on track,” “get to ways

today. This is the plus side of the plus side of the is the This today. look where at let’s equation. Now, be we might deficient. you Are a good Can you communicator? of you aware Are others? motivate others? across to how you come Do you takeoppositional an view change? Are to when it comes you a good Do listener? you with solid relationships nurture decisionthe makers? answered honestly andIf you’ve of these any to said “no” questions, you’ve then just pinpointed an

e all know at leaste all know at one person who has been pigeon-holed same in the W mid-management job for the past job the for mid-management years.twenty works gets He well, things done on time, and doesn’t make make waves, but he doesn’t progress real professional either. any preventing his upward What’s he risen a to hasn’t mobility? Why hasleadership Why his career, role? maybe even yours, stalled? face it…we positive all have Let’s attributes, strengths, and skills we are us where gotten have that CT1-Career Derailers.indd 19CT1-Career Derailers.indd 19 include soliciting input from your the speech and behavior patterns will matter more, the further up peers, direct reports, and your boss. of those around them. For instance, you move in your career, than your are Ted’s behavior and perspective technical expertise.” Peter Rosen, president of HR diff erent from Diane’s? Does he look Strategies & Solutions in Atlanta, at things in terms of productivity, For an individual to reach the top sees career stallers or derailers as while she speaks in terms of levels in an organization, John Beeson, behaviors that may limit or prevent retention? During the fi rst month in principal of Beeson Consulting and an otherwise qualifi ed person from any new position with a new team, author of “Why You Didn’t Get that succeeding. “Even a behavior that Waldroop recommends writing down Promotion: Decoding the Unwritten propelled you to where you are today what you observe about co-workers. Rules of Corporate Advancement” may need to be modifi ed once you’re “Don’t just trust this to memory,” he (June 2009, Harvard Business Review), promoted. Otherwise, it may stop you cautions. “To get the most out of your says you must possess higher order from going further--or cause you to team, you want to get to know each communication skills and be able to fail,” he says. person on it, learn what’s important to communicate a vision and a sense him or her, and discover what trigger of direction and priorities, as well as Th e salesman whose single-minded words are important to them.” engage people. He points out that “if focus and aggressive, straightforward your lack of empathy is so acute that manner, for example, helped him According to Waldroop, an you are insensitive, abrasive, missing achieve outstanding sales fi gures “empathically tone deaf” manager cues about what others are thinking may be too abrasive for his new who believes that everyone on his and feeling, and lose your team or management team. He may need team thinks and feels as he does is your audience, then that can derail to work on building a better rapport operating egocentrically. He needs your career.” with his direct reports. Suddenly, his to learn how to personalize his winning trait has become a roadblock communication style if he wants to Get Back on Track: Practice your on his path to leadership success. inspire them. It’s about knowing how communications skills on friends to read your audience and tailoring and family, get critiques from Like our salesman, a common your tone and content accordingly. close colleagues, consider getting stumbling block for many is poor Th e same holds true for written professional assistance from an communications and a lack of communications. executive coach, and work on tone interpersonal skills. It’s the key and infl ection with a speech coach. to motivating others, providing When asked what behavior sinks most direction, and getting ideas across. managers, Jack Zenger, co-author of Resistance to change is another huge Th e Inspiring Leader: Unlocking the stumbling block. Rigid thinking, Successful Leaders Are Great Secrets of How Extraordinary Leaders a strong opposition to change, an Communicators Motivate, said it’s fi rst and foremost unwillingness to learn new skills and For some individuals, communicating interpersonal incompetence. “It’s the an “it works why fi x it” attitude can via the written word is a challenge. leader’s inability to get along with other drown your potential for leadership For others, oral presentations are people, to communicate eff ectively, advancement and even jeopardize awkward or even terrifying. But the work collaboratively, and off er help your position. real problem with communication when needed, that can be devastating,” is lack of empathy, according to said Zenger. “When a leader doesn’t Successful Leaders Embrace Change James Waldroop, co-author of Th e understand the negative impact he’s “Right now, organizations have a green 12 Bad Habits Th at Hold Good having on others, and can’t see the light, because of the market economy, People Back: Overcoming the demoralizing consequences on those to cut in places they might not have Behavior Patterns that Keep You from around him, he destroys trust, hurts cut in the past,” says Justin Honaman, Getting Ahead, and developer of the morale, and ends up with an uninspired Director of Customer Intelligence Internet-based interactive career team. Sooner or later this will derail for Coca-Cola Customer Business assessment program CareerLeader®. his career.” Solutions and author of Make it “Communication is based on another Happen! Live Out Your Personal Brand. skill,” says Waldroop, “understanding Maureen Moriarty, leadership Companies often see managers who other people—not using the same development trainer and executive are not open to change, not fl exible communication style with everyone coach at Pathways to Change, agrees: and not willing to learn new things, as you talk to.” “At the end of the day, we’re dealing not a good fi t. “Th ose individuals may with people and at the end of the be great contributors,” Honaman says,

CAREER TIPS He sees leaders as “cultural day, emotional intelligence and “but, not the right ones to move into anthropologists” who need to observe interpersonal communication skills leadership roles.” 20 GLOBAL FORUM

CT1-Career Derailers.indd 20 9/26/09 9:56:28 AM 21 CAREER TIPS 9/26/09 9:56:34 AM9/26/09 9:56:34 AM

ective GLOBAL FORUM GLOBAL e bottom e e Braithewaite e ecting change can be peopleuence the outcomes toward ose individuals who see infl that I believe in? Marsha Egan, CEO Egan of the Reading,Group, agrees it’s PA, that important be to organizationally crucial is clueing “What’s savvy. and are uencers infl who the into aligning with someone is seen who in a positive light. By carefully observing you corporate culture, the not can become politically It’s astute. gather to ability the game it’s playing; opens door the that for intelligence respectful, build mutually you to willsupportive help that relationships company.” the Both women see politics as ability the useto analytical and networking skills about what information gather to motivates people and how corporate decisions made. are Th as information for others probing can takemanipulative a less self- serving by keeping approach others by sharing loop. others in the “Help be could of value things that to suggests Read. Th them,” line is to do what’s in the best in the interest do what’s line is to organization-- you’ll of the then, get ahead. those who view politics as a dirty To poses question: the game, Waldroop be“Do or eff to you want right beor do you want to both, and learn reminds some new tricks?” Waldroop about our ideas getting it’s us that adopted because they’re good ideas— ideas. not just about the having it’s moves” can Learning “chess right the be fun, and eff how you appreciate exhilarating, once systemthe works. of Th Perdue Jane SC, Charleston, Group, thinks politics about “It’s a badhas rap. gotten nurturing and building alliances power the help to have that coalitions working your ideas.you promote It’s peoplewith and through make to things happen.” rm in rm cult How How uential? skills and uence uential. uential. infl can hinder productivityexibility infl and keep you from ahead. getting BeGet willing Back to on Track: with co- share learn, and to listen, to workers. approachable yourself Make and open the by not discounting opinions of others. And, be eager to with experiment new ideas. A positive can change toward swingattitude open doors personal to growth and upward mobility within a company. your improved you’ve So, now that skills and you’re communications openmore new to ideas, your next will behurdle get to these changes come may that implemented--and If you refuse down you know. who to with relationships build genuine to decisionthe makers, your then career is doomed short stop of a to leadership role. “Once you reach the manager or you reach the “Once director continue to level, ability the riseto an organization through demands an understanding of Sherry states Read, politics,” internal principal of Read Solutions Group, and strategic coaching an executive fi consulting resource human DE. “Otherwise,Wilmington, you Read top.” get the to won’t simply believes those who choose not to build political infl a personal change to belief such as So instead, she “politics bad.” are by advisingturns things around askclients to themselves: can I become more infl What does to learn it take to Successful Leaders Build Infl uential Leaders Build Infl Successful Relationships and many politics,” Call it “playing idea. the of us shun But, if instead, you see it as a strong pulling together network of decision makers who can bringhelp about best the outcomes your organization, you arefor then moving directionin the of becoming infl more and logic work on hard who rely get boat.to ahead missing the are Still, she admits it can be diffi e ate goes and frequent Talent of Talent , co-author to approaches erent ectively, you’re not likely to not likely you’re ectively, a willingness involves It to exible. “Managing and driving change is a primary responsibility of leaders in Mike Noble, says an organization,” managing partner Boston- of the based Camden Consulting Group, speed with the and“especially technological that pace is change occurring. Being lead to your able is critical. If that organization through drive to capability got the you haven’t change eff be successful.” of us resistant so are many then Why root the is insecurity,” change? “At to Rueff Rusty says for the A New Manifesto Force: of Business Side Human “Most Glassdoor.com. to contributor in our routines comfortable of us are and when asked resist change, to often because vulnerable. we feel We change and waitignore to invitations demands it; situation the until but, by Rueff be too it may late.” then, on to explain that most bosses that explain on to realize a few can change involve misstepsthat but they and some uncertainty, generally look upon an openness to change as moving individual the and direction. right in the company the means change beingAccepting fl diff consider handling a task or solving a problem, an eagerness learn to new skills, and openness ideas the to of less experienced team members. or feel threatened “Leaders shouldn’t embarrassed come when subordinates Zenger. says up with good ideas,” “Instead they need realize to that great solutions of the 70% or more bubble up from underneath and trickle down from on high. Th don’t ective leaders recognize the most eff value of those ideas and and nurture ‘no’ say than rather them, implement them.” to your Keep in mind that, as a manager, rigidity can your team of its rob drive, squash thinking, creative and defl long run, In the your enthusiasm. CT1-Career Derailers.indd 21CT1-Career Derailers.indd 21 Get Back on Track: Watch to see who exposes you to new ideas. You come strategic planning consultant to get can help you move a new idea forward. back seeing things from a new angle— you started. Invite a decision maker to lunch. Get to and can start thinking with greater know the infl uencers in a casual, non- vision.” Your Next Move: Getting Feedback business way, fi nd out how you can help Over the past ten years, executive them, and cement long-lasting bonds. If you can’t envision where you’re going, coaching has become a widely accepted then how in the world are you going to practice. In fact, it is estimated that, Now, you’re able to communicate with get there? Strategic planning is a critical today, upwards of 90% of Fortune your team, you’re open to good ideas, force that aff ects day-to-day choices and 500 companies use coaching as an and you’ve made alliances with key helps guide the direction in which you, important tool in their executive decision makers, but your vision is too your department, and your company development kits. But, if you have a tightly focused on short-term goals. move. Without a sense of strategic willingness to change, then simply start You’re missing the big picture, fail to thinking, and the ability to project by asking your coworkers and higher- track trends, and lack insight when forward, your company won’t move ups for honest feedback. Or, as one it comes to future forecasting. Your ahead and neither will your career. executive coach tells his clients, start by failure to strategize may have your asking a trusted colleague the following career handcuff ed. Get Back on Track: Widen your question: If I want to really grow within horizons outside of work, read more, this organization, what’s one thing I need Successful Leaders Think Strategically including consumer and industry to improve? Or, get outside assistance. A look at peak performers shows a magazines, surf the Internet, and talk Most executive coaching fi rms off er a common thread: the ability to think to people. If you do, you’ll begin to see professional 360° feedback assessment strategically. Dr. Diane Kramer, trends in the making. Also, be sure to tool to help get you back on track. developer of Extraordinary Self ® set aside time each week for strategic Development Programs, suggests planning. If necessary, elicit the aid of a Good luck! ■ creating “future maps” based on observations about yourself, your organization, the global community, and external industry trends. Th ese maps allow you to step into the future from diff erent perspectives. With constant updating, with the latest real information, mapping gives you a better sense of the direction things are headed and can guide you toward making some intuitive predictions.

Th e transition from good manager to eff ective leader can be fraught with challenges. “For many, the biggest is getting out of the details and being able to look across initiatives in order to see how these things add up to the big picture,” says Honaman. “It’s being able to strategically pick and choose where you spend your time in order to add value.”

In order to start thinking strategically, executives need to step back from their day-to-day tasks and get a fresh perspective. “Most of us have the capacity to think strategically, but we simply don’t get around to it,” says Egan. She recommends going to industry conventions. “It takes you away from

CAREER TIPS everyday projects, gives you a chance to talk to others in your industry, and 22 GLOBAL FORUM

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e orts ■ t connected t GLOBAL FORUM GLOBAL Shii medications, making their enrollment intoenrollment clinical trials markedly quality and in the dent easier. Finally, China Finally, easier. has begun the embrace to economic are advantages that linked development of new the to drugs profi the to and to patent rights “blockbuster” for patent to type pharmaceuticals. Although China hasAlthough made great eff process the of clinical regulate to trials basis on the of GCP standards with some degree of success, there go before they to is still a long way achieve objective their completely. we can expect see to someHowever, in certain areas.improvements For review of the duration the example, for bea new may clinical application study expected,longer than 6 ie, longer than Th nal approval. get to fi 9 months to lack of established with laboratories good laboratory recognition practice is community international from the numbers of Also, large barrier. another experienced trained and well clinical research associates needed are to sponsoringencourage to companies be confi more integrity of the trial obtainedintegrity of the data from studies conducted in China. A report Kearney China showed that from A.T. overtake to inis likely India and Russia number of clinicalthe trials conducted it would become choice top and that the among trial multinational sites for pharmaceutical conducting companies clinical trials.international Readers can contact Shimei Wen ReadersRd Wen can contact Shimei at [email protected]. Center for Drugaluation, Clinical Ev Shanghai Medicine of Chinese University nancial outlay nancial of clinical trials expansion e current than in the western Based in the world. than on statistical data, develop to a new drug from discovery marketing would to take about 15 years and require an 1 billion US than of more investment dollars in western countries, of which costsmajority used of the the are for clinical research. In China, cost the research same drugfor on the would billion RMB 1 than more not exceed is less which required 1/6 of the Yuan, US and European in the investment populations in large countries. Secondly, not exposedChina are concomitant to numbers pharmaceutical of joint ventures, wholly owned enterprises, and researchglobalorganizations contract (CROs) established have R&D their facilities in China. Most have of them requested clinical conduct to China international to trials according standards, which has established a use the of for atmosphere favorable GCP in China. Th whichin China will no doubt continue, can be a number of widely attributed to begin with,recognized factors. To in pharmaceuticalinvesting R&D in China requires less of a fi c ese trials of great importance are in processthe of new drug hroughout the world, clinical world, the hroughout Shimei Wen Shimei improvements have led the have to improvements recognition trial of more results by the pharmaceuticalinternational number of In addition, the community. clinical trials multicenter international, conducted within China using specifi T research and development. In China, good clinical (GCP) practice was established in 1986 through academic communicationsinternational and exchanges, as as well because of the multinational of many investments pharmaceutical companies. the In 2003, and Drug Food AdministrationState began(SFDA) compulsory the of clinicalregulation trials with an on Chineseamendment GCP guidance. 335 clinical present, are there At research organizations in China, and it was reported number of clinical the that trials a has at been increasing strikingly, the Since speed each year. of 40 percent of GCPimplementation in China, the level and the breadth of clinical research as as quality of clinical well the activity, trials, been have rise. on the Th Chinese subject populations is gradually increasingincreasing. Moreover, The Status and Trends of Trends The Status and in China Clinical Trials GR7_Clinical Trials in China.indd 23GR7_Clinical Trials in China.indd 23 GR9-On Location-Beijing.indd 24 24

ON LOCATION: BEIJING

revealed in its beautiful bronze beautiful inits revealed China’s is cultural past poignant nationaltoward unity. independent and 20 invasions, centuries offoreign dynasties, succession ofImperial fascinating that time,ChinasawDuring a three and ahalfmillennia. the last accounts for only history written ago.Yethalf amillionyears China’s man’sproved presence inthe region southwest ofBeijing, (50km) miles ofPeking Man,just30discovery history to take its place inthe toits 21 take history upinrecent risen has 3500 years—it the past notonlysurvived China has andindustrious. loyal, ingenious, one fi (whoaccountinhabitants for nearly 1.5billion andits expansive plains, and rolling hills, covered mountains, C Th and worldstronghold. economic powerhouse anindustrial as century GLOBAL FORUM eremarkable 20 fth the world’sfth are population) land an endless sea ofmist- sea land anendless its andmysterious, romantic, hina’s isrich, history th century attempts attempts century th -century st

Imperial City and transmutable that residents occurrence. The large cityisso Here, changeisadailypeople. and holdsinexcess of14million more than 10,000squaremiles coversPeking), China, inNorth The city, capital (aka Beijing makeup. dramaticacrobatic actorsandboldly cacophony gongs, ofclashing acaptivating unique styleofopera: for its as arts much martial foras its Today,compasses. weadmire China andmagnetic printing techniques, clocks, mechanical crossbows, powder, gun as such innovations And,itgave the world vases. porcelain anddetailed sculptures Modern Capital to newspaper media. media. newspaper to the nation’s and radio,television, well as as anduniversities centers, research commercial enterprises, It ishometo huge and financial andculture. science, education, oftechnology,centrifuge industry, Today’s spinning isafast Beijing safe the from forces ofprogress. royalty. Even are not oldlandmarks and families generations of Beijing (hutongs) that many have housed the neighborhoods centuries-old are inarace to displaceSkyscrapers recognition. beyond altered fi who are weeks absent for just afew and he initiated the thousand-year and heinitiated the thousand-year nation underthe Ch’in (Qin) Dynasty, the thatnational language wouldunify oflaw a code and Qin established FromQin Shi-huang. 221-207BC, unifi its owes fi cation to its Th states. ofwarring collection a Chinawas to 221BC 1500BC from According writings, to historical Ancient Capital nd familiar streets and landmarks andlandmarks streets nd familiar rst Emperor, e nation 9/26/09 11:54:23 AM 25 ON LOCATION: BEIJING 9/26/09 11:54:32 AM9/26/09 11:54:32 AM

GLOBAL FORUM GLOBAL century city. st cial taxi stand and get on line. Here, Modern Beijing Modern 2008 Olympicfew stadium just a are of Beijing signsthe that has truly become a 21 Olympics, connects that via rail to light you can adventurous, If you’re city. the airport from the take an Express Train Dongto Zhi connect you’ll Men, where metro system. Otherwise, city’s the to we suggest you head directly the to offi cab rides ¥2 per are km 15 km (up to Expect afterand 50% more that). to a ¥100 ($15, £8.85) for around pay city hotel. ride a central to 45-minute ride the willKeep take in mind that price willlonger and the be steeper during rush hour. Airport buses provide a less expensive but theyalternative, only make certain scheduled stops; put up to so, have you’ll of taking both inconvenience with the a bus and a taxi It’s get your hotel. to to best take to a taxi direct airport from the also a good idea It’s door. hotel your to Getting To and Around Beijing and Getting To Beijing Capital International Airport is 16 miles (Shoudu Jichang) (25 km) northeast Beijing of central and boasts a brand new airport terminal, courtesy 2008 Summer of the e e en – in century, century, th Th Empire). e Bright cially proclaimed birth of Th the oodgates a new to based economy under Yongle, the old city was the leveled under Yongle, all vestiges remove to of Mongol rule, and construction was begun on the City. majestic Forbidden 500 years, than more during the For China experienced Qing dynasty, and tranquility prosperity, relative progress,cultural was but this frequently punctuatedby periods of attacks,foreign rebellions, internal and incursions from Western powers.colonial a mere Pu Yi, last emperor, China’s in the child, acceded throne the to early 1900s and that, along with historicalthe events followed that I, triggered an end to War World Imperial the for China and made way entry Modern the country’s into Era. Post Imperial China Post and Chinese Sun Yat-sen In 1912 Dr. revolutionariesNationalist overthrew and established Emperor the the Republic of China. was It in Tiananmen Mao ZedongSquare1949 that in offi 1976 – Deng Xiao-ping unlocked the fl thison capitalism and open trade. At time China was break free to able to become a country thriving on industry, and economic trade. Now, technology, China is 30 years than later, more seeing light-speed growth. Western fashion, fast food, luxury cars, and the People’s Republic of China. Th People’s AD), bringinggolden age forth a in China (Th many were Han accomplishments and included army building a huge revitalizingand navy, agriculture, eets the explore to sending treasure fl vast outside world China, and using moveable type books print to (prior 15 In the Guttenberg). to century, Ghenghis Khan century, th 800 years, en, for throughout set his sights on China. By 1279 Khan had succeeded the in AD, becoming ruling the of the monarch Around world. in the empire largest discovered Polo time, Marco that splendor of China,the and his tales to travelers foreign would inspire trade route along the way make their known as Silk Road, the bringing Buddhism from India,with them Christianity and the from Europe, teachings Middle of Islam from the East and carrying silk, back exotic and teas.porcelain, Chinese Han) native (the the Once the overthrew Mongol ruler, the Ming Dynasty of the Han emperors in power would remain the for (1368-1644 three centuries next construction of the Great Wall as well Wall construction Great of the as commissioned famous the terracotta warriors site. his grave for But it was Liao the Dynasty, not until Beijing that would be in 938 AD, established as a northern capital. Th Ming and Qing Yuan, Liao,the Jin, dynasties, Beijing served as the capital. central empire’s 13 In the GR9-On Location-Beijing.indd 25GR9-On Location-Beijing.indd 25 GR9-On Location-Beijing.indd 26 26

ON LOCATION: BEIJING

GLOBAL FORUM ($1.35 / 65p) and includes 2 miles (3 (3 2miles ($1.35 /65p)andincludes Th Fukang taxis. than the androomier red conditioned areair-or yellowbetter Xiandai;they the green choose ataxi, When taking 60% off onany busorsubway – used which be a¥20deposit, with purchased be can ATransportof any ofthe lines. Card stations forare asinglebetween valid for bought ¥2at thebe stations and can Singletickets transitlines. separate inmindthatKeep there are several are identifi to the the(ditie subways rapid) transit, (subway). Onmaps andat entrances orusingthe metro the cityisbytaxi Th on bicycle. diffi be can Th Getting Around theCity yourhotel accommodations. booking when to inquire shuttle about service km); after that, each km is ¥2 or ¥3 is¥2or¥3 km each that, after km); e sidewalks and streets of Beijing ofBeijing andstreets esidewalks cards. accept foreign credit they as level, at anATMcurrency onthe arrival local orget changers at the airport Visit smaller ¥10notes. money sure tosome get andbe Beijing in whilestaying think you’ll need you as exchange much currency as the leaving airport, Before TIP: after 15 km. Incidentally, 15km. after sure be when using the card on buses. whenusingthe card onbuses. your destination is written your destination iswritten cult to negotiate on foot or tocult negotiate or onfoot ed with a D in a circle. aDincircle. with ed down in Chinese or circled orcircled inChinese down e best way to get around way toaround get ebest on amap for yourdriver, e base charge is ¥10 charge is¥10 ebase who, most likely,who, most will only speak onlyspeak will his native his native drive themselves. drive rent to cannot cars residence visa a foreigners whodonot possess lunch. Incidentally,the driver a nice gesture, consider buying but youmust pay for tolls and,as the onthe day distance, depending thembargain to around ¥400for a“carhiring anddriver.” You can onesightfrom to another, consider anentirespending day hopping If you’re or goingoutoftown streets. hectic alongthe city’swalking crowded, andmarketplacesmuseums –avoid around the for wandering footsteps Andsave your enclosures. specified itupinthe sure to lock a bike,be Ifyoudorent challenging. be can for rental, around town butriding only.Chinese are available Bikes arein stops announced as buses, Avoid theuse metro andtaxis. you’llFor to want part, the most you withthis. Yourtongue. hotel concierge help can hotel concierge directions. for best your with check aguide; only as Use are printed. yourmap they as city are outofdate often soon as thatrapidly maps ofthe inBeijing demolition are so happening and construction New TIP: beds or seats. orseats. beds andoff of250km/h, speed atop reaching inChina, main cities between service frequent fast provide of2009,D-trains Station. As Railway West Station orBeijing Railway Z- Trains either from Beijing depart Westor Beijing Station. Railway Station Railway South station), Beijing Menmetro ofthejust north XiZhi Station (located Railway North Beijing Station, Railway stations –Beijing atyour ride oneofthe four railway offi ticket Visit Ztrains. aptly-named asatellite ononeofChina’s sleeper class a soft isto travelChina, through the night in travel to oneofthe in 12major cities to Another option, ifyouare looking orwww.elong.net. ctrip.com find excellent at prices www.english. you’ll convenience ofonlinebooking, fl on domestic travel agent discounts for the best or agency ticketing alocal with check China, destinations within If youplanto fl Traveling tootherCitieswithinChina because until 1911noonecould because the Forbidden named so Citywas Ancient Palace (Gugong), Museum or City” the “Imperial as known Also City” The “Forbidden consider addingto youritinerary. must-see attractions toare several hereIf yourleisure timeislimited, andcultural highlights. historical ofChina’ssome signifi most to complete be avisit without No fi would rst-time to Beijing trip Essential Beijing ce for a small fee or book ce orbook for asmallfee ights. Ifyouprefer the ights. y to other

ering ering soft cant 9/26/09 11:54:40 AM 2727 ON LOCATION: BEIJING 9/26/09 11:54:51 AM9/26/09 11:54:51 AM

GLOBAL FORUM FORUM GLOBAL GLOBAL century century th century AD. It was was It century AD. th e closest viewing is Badaling, site Qin Shi-huang (221-210 BC), (221-210 Qin Shi-huang the first ruling China and of emperor who Qin Dynasty, of the founder as as well the unified country, the walls. disparate formerly Later, Ming Dynastythe (1368-1644) embarkedemperors on large-scale construction would later of what become longest the structure in world. the from Beijing can see travel to the You served that Ming-era watchtowers not only as signal towers, but also as living quarters and storerooms. get you’ll amazing them, atop From views meandering of the wall and the terrainscenic which it bisects. Th of center just an hour from the Beijing. more are here (Facilities those to with disabilities amenable elsewherethen wall.) the along crowds, the avoid to However, a bit further travel to have you’ll less is a much which Mutianyu, to area commercialized, remote more wall.of the BC and 16 attacks, the Great Wall is actually is actually attacks, Wall Great the a seriesof walls. built were These individual by Chinese and rebuilt betweenstates 5 the nd it nd Gates Front e Qianmen or environment is somewhat austere lled daily activities with the of local The Great Wall of China Wall The Great (Changcheng) Initially constructed of stone and packed earth protect to the fromChinese nomadic Empire Located Forbidden just south of the largest Square is the Tiananmen City, fi public plaza You’ll world. in the fi residents as as well packed with curious tourists and kite vendors. was at here It entryway the Gate, the to Tiananmen Mao announced that City, Forbidden Republic People’s of the formation the building, a separate in his in 1949; now, refrigerated body is raised display for mausoleumfrom for an underground viewing twice daily. Th juxtaposesof concrete history the of modern-day China alongside back Imperial to date buildings that times. new Often, old and the the Th merge. (also known as Zhengyang Men or “Sun-facing originated Gate”) in the Ming Dynasty of site the and is today a city history museum; British- the now houses station built railway modern shops, a McDonalds, an opera café. hall and an internet Tiananmen Square Th e Great Wall at sunset at Wall Great e Th nd ect the the ect tells is complex ceremonial airs and

, for instance, male lions instance, , for hall e Hall of PreservingHarmony represent Imperial power, while Imperialrepresent power, lionessesthe with cubs symbolize Imperial fertility. made from relief an ornate features a single piece of marble weighing is beautifully that 200 tons adorned with dragon carvings. architectural elements that reveal that architectural elements important about information Chinese ancient culture. the symbolicIn the artwork that embellishes entryways the to each lacquered time pieces can be seen Hall of Clocks in the and Watches. Opulent enameled, jeweled and Th Everywhere, fi you’ll is carefully planned city within • • • “Inner Court” served as living empress, and quarters emperor, for concubines. A beautifully manicured garden served as for a private retreat emperor. the Highlights: enter the tower except royal family except tower the enter and aristocrats. Th the fascinatingthe tale Imperial of China. Originally in completed red-walled1420, the buildings and pavilions refl numerous history emperors twenty-four of the who ruled and resided here. Th a city served a dual purpose. Government aff gatherings “Outer in the took place palaces of the while the Court,” GR9-On Location-Beijing.indd 27GR9-On Location-Beijing.indd 27 GR9-On Location-Beijing.indd 28 28

ON LOCATION: BEIJING

northwest ofthenorthwest Forbidden City. and QianHai,merge; this islocated XiHai,Hou Hai where lakes, three including the ShiChaHaiarea inBeijing, areas inseveral alleyways You of these amaze visit can orhotels. homes intorenovated new have whileafew been urbanization, of aresult as destroyed have been siheyuan home.Other courtyard may nowinhabitfamilies asingle for natives although some several stillcontinuesLife abodes in these narrow pathways. winding, these formed that originally ofthesiheyuan the adjoining walls was It acentralcontained courtyard. open whichalso ofthe siheyuan), portion the main hall (usuallyinthe northern Traditionally, inhabited grandparents generations ofafamily.home to several , was residence, orsiheyuan courtyard each ago.InOldPeking, 700 years nearly , developed hutongs called Th an “old-style” neighborhood. Beijing fl the with historical imbued Become Hutongs • facts: Interesting in1860.troops byforeign destroyed when itwas oversaw renovation ofthe area (1835-1908);sheEmpress Cixi ofQingDynasty habits spending bytheenhanced extravagant greatlyThis was scenic region Beijing. ofdowntown northwest 12K located tranquil Kunming Lake Summer Palace (Yi He Yuan) and oftheEnjoy 700-acre the beauty The SummerPalace GLOBAL FORUM avor of ancient China by visiting avor ofancient Chinabyvisiting ese areas contain winding alleyways, contain alleyways, winding areas ese When Kunming Lake was was WhenKunming Lake especially tranquil. especially hillsideis the northern Pagoda; Tileof the Buddhaandthe Glazed site ofthe Tower ofthe Fragrance created theenlarged, excavated dirt

Longevity Hill Longevity , nowthe • China World Trade Center andyour ficompanies, the ne restaurants, multinational Foreign embassies, Th District Chaoyang e below.district just asampling ofattractions by through many We’ve centuries. listed people andculture ofits history Th astounding. Th Other SightseeingHighlights • Bridge in theSummer Palace e variety of diversions in Beijing is ofdiversionsinBeijing evariety Take onthe “marble aride Th Imperial Navy.Imperial intended to update the money with andfunded Empress Cixi onorders from constructed likemarble),which was to look boat beams andcrossbeams. beams brilliantly paintings enhance its 14,000traditionalChinese Lake; along the ofKunming shores four with pavilions walkway e isacovered Long Corridor ” (actually wood painted painted wood ” (actually ey refl ect the unique ect

• • these nearby attractions: attractions: nearby these here,hotel alongwith are located • • China’s isportrayed railsystem the having watched 2008 After Built during the Yuan Builtduring Dynasty Within the media at themedia andmulti- models by photos, andstructure. the facade eff ribbon-like spectacular a create to concrete with intertwined ofsteel constructed anddeMeuron,is Herzog bySwiss architects designed Nest nst/). Thstadium orBird’s emain (http//:en.beijing2008.cn/venues/ Stadium Olympic may the National to want visit you ontelevision, Olympics with food andother necessities. food with the city whichsupplied China, to southern Beijing connected fi very including anexample the from locomotives, ofthese some board still line ranin2006,butyoucan Th Road). Museum stars and planets, dating as far datingfar as andplanets, stars the for viewing bronze devices exploration. astronomical Large sitethe in the oldest world for Men)is (Jianguo Observatory (1271-1368), the Ancient centers studios. andart art galleries, with that isfilled neighborhood it isaSoho-like center Surrounding andacafé. arts It aperforming includes andmore. artists work oflocal the Maoistgraffiti, garde forms, centerart displaying avant- into avibrant transformed been factory, thatelectronics has andanabandoned building, 798 isa1950sBauhaus-style ) Factory www.798space.com (2–4 Jiuxianqiao Lu; , as it is often referred to, referred itisoften , as rst Chinese railline.Itrst Chinese e last passenger steam steam passenger elast (1Jiuxianqiao North 798 Art District 798 Art China Railway Railway China in person inperson ect ect for 9/26/09 11:55:03 AM

29 ON LOCATION: BEIJING 9/26/09 11:55:11 AM9/26/09 11:55:11 AM

GLOBAL FORUM GLOBAL Natural History (126 Tianqiao; (126 Tianqiao; the White Cloudsthe Temple Museum www.bmnh.org.cn). Here, models of dinosaurs skeleton animals are and prehistoric on view with along exhibits of animals, aquatic plant, and bird of caution: marine (A word life. Mystery of the museum’s The Body not Human may exhibit very the for be appropriate squeamish.) Cow) StreetOx (or Mosque originated(88 Niu Jie) a yearsthousand ago and today still serves Chinese Beijing’s Beijing’s minority. Muslim oldest mosque possesses a rare which handwritten Koran, teachings central the contains faith. (Required: of this long pants men; pants for or skirts and covered shoulders for not are women. Non-Muslims allowed entry prayer the into hall; closed Fridays.) South Cathedral or St Mary’s Church (141 Qian Men Xi largest city’s is the Dajie) functioning cathedral. Catholic first JesuitThe priest, Matteo Ricci, arrived in Beijing in 1601, was church and this founded building, in 1605. This notable itsfor splendid stained-glass windows, was and burnt its before twice last rebuilt construction in 1904. (Baiyuanguan outside of Xibian Jie, by the city’s city’s by the ancient huts and mud homes to homes huts to and mud ancient Imperialpalatial residences.

Chongwen, In can you stop Some original portions of • • • • Th e Xuanwu e District Th you can visitHere three houses of learnworship to variety about the of observancereligious in Beijing: e you’ll see u), wher jets,ghter planes and in Xuanwu (21 nd: AncientArchitecture e Beijing Zoo (131 Xi Zhi Military Chinese e Th History Lu) Museum (9 Fuxing 5000 yearswhich displays of military country’s the history, including fi tanks. also includes weapons It used in revolutionary acts, and paintings of Mao, Marx, Lenin and Stalin. Th is worth trip Dajie) the Men Wai itsfor pandas, shining but the aquarium;star is the it here an Amazon rainforest features reefs,and coral as as well dolphins and whales. Museum Dongjing L photos, objects and models of Chinese from architecture,

Visit the the Visit

ese oldest the districts are in • • • Chongwen and Xuanwu Th Beijing, arts traditional folk where shows can beand acrobatic seen. You can also: technology district, and university fi you’ll where century, are are century, th tranquil amidst the nd comfort exhibited on the museum tower. museumexhibited on the tower. back as mid-17 the grounds of the Confuciusgrounds of the (13 Guozijian Jie). Temple tabletsAncestral sage and of the inscriptions housed are inside. homage to his philosophy and homage to fi The Drum Tower and Bell and Bell Drum The Tower (northern end of Di’an Tower examples are Dajie), Men Wai throughout found of towers China which helped people keep daily routine track of their of clocks. invention before the drum originated tower This in 1420 and houses 25 drums; is the bell Bellthe in the Tower heaviest in all of China. erent, is Beijing’s Haidian

of Confucius can pay Followers Dongcheng start want to at with may a stop You shopping streetmajor a Wangfujing, district,in this add one or and then diversions.both of these interesting Replica of drums in the Drum of drums in Replica Tower • • Th e Haidian District Th mood in the something for If you’re diff GR9-On Location-Beijing.indd 29GR9-On Location-Beijing.indd 29 GR9-On Location-Beijing.indd 30 30

ON LOCATION: BEIJING

GLOBAL FORUM • • many parks. ofthe city’sare justahandful Followingplay andmusic. games exercise, dance, and picnic, paint, color.local relax, Here, Beijingers placeand aquiet tointhe take thefrom bustling crowded, streets abreak with tourists provide They solitude for religious observance. the cases, recreation and,insome tranquility, have provided Beijing Throughout history, of the parks Beijing’s NaturalBeauty

Ritan Park Builtin1530,Ritan Temple (Chaoyang; oftheSun 1860. Th and confi buildings destroyed soldiers French after remains, and British haunting beautiful are its left on Versailles. Today, what is summerretreatlavish modeled ofa theordered construction Emperor QingQianlong in the mid-eighteenth century, Here, statuary, andfrescoes. ofornate columns, ruins the andsee of the park(fee) Yuan) section inthe southern (Changchun Spring Everlasting Enter of the Garden Lake. outonthe lovelyboat Fuhai history. Take a astroll ortake combination and ofbeauty Summer Palace) isafascinating ofthe northeast District; Qinghuan XiLu inthe Haidian (on Palace Old Summer (Garden of 10,000Springs). (Garden andWanchunand Light) Yuan Yaun ofPerfection (Garden Everlasting Spring, ofthe of Garden is comprised benefi “karma.” ofgood ts on“right action”andthe focus inthis ofBuddhism form believers to orTaoism; Daoism dedicated ofworshipis house renowned Th and QingDynasties. since the Ming Men) have survived e scated artwork in artwork scated Old Summer Palace Old Summer Yuanming is world- or

Beihai Park • •

these parks. parks. these atofrites theineach altars annualconducted religious Emperors compass. the Chinese correlate the with fi of ve points others, andthree Park (below) TianTan alongwith Park, Ritan andmuch more. market, bonsai a fishponds, climbing wall, arock- teahouse, outdoor Lu 6)contains Bei anRitan corner ofthe Forbidden City) Jie; accessible at northwest Park Beihai inthenotable sights park. It’sPrayer”). oneofmany or“Hall ofAnnual Harvests” Dian (“HallofPrayer for Good for Qian hardy crops inits Emperors prayed in China. complex –oneofthe largest temple MingDynasty grand thewhich isalso site ofthe ofthis 660-acre park, greenery inthe Relax compass. Chinese ofthe point the southern builtin1430,marks District), ParkHeaven TianTan Park (Xicheng;1Wenjin (Chongwen orTemple of with asinglewith step begins miles ofathousand journey “A andremember: surroundings, andits Explore Beijing, futuregrowth. fast-paced on cityfocused forward-looking a remarkably as stands but also centuries oftraditionandsurvival, notonly represents Beijing China. of essence that beauty isthe very you’re sure to discover amajestic Forbidden to its of Beijing City, the andfrom templesmarketplaces, WondersSeven ofthe World, to its From the Great Wall, oneofThe experience. anunparalleled be itissure to do whileinBeijing, and to see youdecide Whatever Enjoy theEnchantment within agetaway.within Island isaninteresting getaway Here, Jade gardens. Chinese andexquisite bridges graceful features ponds, setting goldfish since 1925,the park’s peaceful to the publicKhan! Open byKublai once redesigned was –and athousandback years garden datingis anImperial ,” Confucius. 9/26/09 11:55:15 AM ■ 31 ON LOCATION: BEIJING

nd 9/26/09 11:55:22 AM9/26/09 11:55:22 AM

cers all cers GLOBAL FORUM GLOBAL All visitors obtain must a visa ey can be Chinese obtained any at Helpful Internet Sites www.bjta.gov.cn www.cnto.org www.thebeijingguide.com www.beijingscene.com www.chinadaily.com.cn shop ownerseven and police offi if you call for Even speak Chinese only. reservations, most you will likely reach speakinga native person.So, ask your personnel assistance for hotel whenever necessary. Visas: before www.cits.com arriving . Visit Service) or Travel (China International http://www.china-embassy.org to fi out more aboutout more obtaining a Chinese visa. Th Ministryembassy or the or consulate airs nearest your home. Aff of Foreign in person apply must or submit You an authorized through your application Chinese A valid visa passport agency. and a standard passport size are photo required. e following e is not this nd that Be bring to an sure is no tipping in China ere ve-star will hotels popular sell British brands in their lobby. British lobby. brands in their Th Tipping: discouraged.and it is strongly Communication: While well-trained ers know a number of staff hotel languages, fi you may insert city or a prepaid the card SIM for visiting. you’re province Zones: All of China operates Time is Greenwichon one time zone which (GMT) + 8 hours or EasternMean Time (EDT) + 13 hours. Or Time Daylight visit www.timeanddate.com get to the correct world. anywhere in the time for Emergency Numbers: Th emergency numbers will be of no use unless you speak Chinese. = 110; = 120; Police Ambulance = 119 Fire Medication: supply of Rxadequate and over-the- medications with you; theycounter are by in China, come to hard although some fi casethe Cab outside drivers, your hotel. e main unit of currency is FAST FACTS FAST Here’s a quick rundown things of you’ll Here’s need know when visiting to China: Money: Th yuanthe (RMB). (¥) or renminbi 1¥ = 1 RMB 100 fen = 10 jiao = Credit Cards: upscale at only Accepted tourist attractions,restaurants and large but can be Bank used of China any at local withdraw to currency. ATM Calling China: international Dial the your area code (see for access below), country code (86) followed by China’s regionaland the number or city code, Beijing (010): 00 – UK,New Ireland, Zealand 011 – US and Canada 0011 – Australia Calling Get Home: an IP Card (aipi ka) seen wherever initials IP are the instructions the and follow card on the calls. make international to A ¥50 card gives you about calling an hour of time. Mobile Phones: China uses European the GSM system; bring your own phone or one in China,buy an inexpensive then GR9-On Location-Beijing.indd 31GR9-On Location-Beijing.indd 31 GR2-Interview with LingSu.indd 32 32

CHINA

B China. Council of oftheAdvisory Chairperson the and as ofDirectors Board ontheDIA in 2000.He currently serves Award Service Outstanding of theDIA therecipient sincemember 1996, hewas An activeDIA and Asia. theUS both agency, in and theregulatory industry in thepharmaceutical experience Pacifi of Henearly 20years has c region. atWyeth fortheAsia and Development, our activities. whenweplan to DIA another aspect doubt the SFDA’s involvement provides China are industry, from mostly no so in Active volunteers for DIA does. cally may diff be erent typi- what from DIA aretheir andtoextent issues some they ment fi inthat, what know rst ofall,they andcultural environ- economic, social, it’s the be given moreinChina, so even May- critical. isalways ofDIA support involvement agencies’ and regulatory the inother countries, Like in China. to DIA’scritical success for its activities Th China? in activities to DIA helpful relationship proved working off this How has China. in erings educational ofDIA and presentation andrefiguide ne thedevelopment (SFDA) Administration tohelp Drug & Food State theChinese ship with GLOBAL FORUM erelationship withthe SFDA is Th includes a working relation- aworking includes ased in Shanghai,ased China, President, C President, Ling currently Vice PhD,is Su, e DIA framework in China China in framework eDIA linical Research Research linical and approval and simultaneous global global and approval and simultaneous review to facilitatedrug innovative it’s perspective, the how regulatory From andthe entiremanagement, area. risk andevaluated, are reported GMP,this means events howadverse important; quality andsafetyisvery the scientifi product c perspective, diffthere be will Butfrom erent items. diff about you talk It’s hard when to say justonebecause perspectives? and regulatory thescientifi from China in topics” cessful and very important. andvery cessful suc- very been this has Overall, needs. their audience andwhat their audience know they so meetings, do their own specifi about ideas good have usquite afew given Exchange, Th acenter SFDA. within for International Pharmaceutical the with ChinaCenter ing this meeting We inthe fall. meeting are co-sponsor- Th experience. the meeting enriches and alotofpeople attracts support, orhaving their for ourmeetings, Certainly, SFDA with co-sponsorship important. for example, thisers, isvery Justsystem. likeweinvite FDA speak- thefrom affiliate centers inthe SFDA SFDA –notjustfrom system butalso the from regulatory andadvisors sons, chairper- and helpsusinvite speakers, infl the SFDASecond, isvery e most recent emost example isourannual current “industry hot “industry current ofthe What aresome c topics because they also also they because c topics erent audiences, uential uential ey ey c spective organizations. Th organizations. spective orVPs intheir Directors re- Medical are allGMs or –these members around 25 Council ofChinahas thatknow the Advisory provisional For example, youprobablyDIA. dowith what about passionate they enthusiastic and very are very they involved, people But whenwedoget isrelativelyvolunteerism new. amore society. hierarchical be Active Chinatends to or cultural reasons: there Maybe are social inChina. new Th volunteer organization. of work –orinworkingthis type wherecialty –their they discipline do,eitherthe intheir work spe- they in whohave passion bypeople driven We isbeing DIA are allvolunteers. is avolunteer-driven organization. Th unique? China in experience volunteer maketheDIA environments social important part. important avery isalso development of drug Th achieved. not be thenthat, the government’s will goal to help orfacilitate are notequipped system regulations andthe regulatory over adefi ifthe oftime.So period ned products ofinnovative number certain a government have ofadvancing agoal by Major initiatives supported innovation. government issupporting the InChina, development. drug at’s DIA interesting because very industry, regulatory, and regulatory, industry, How dothesurrounding e globalization ey are very are very ey ispretty 9/25/09 1:26:19 PM 33 CHINA 9/25/09 1:26:20 PM9/25/09 1:26:20 PM

is c expertise c GLOBAL FORUM GLOBAL t patients with part this of c to activ-t from this or systematic e more

ts Chinese the patient ■ What elseWhat would you like to discuss? is really provides an opportu- es notion of global drug the t the world’s patient popula- patient world’s t the individuals is will the certainly help across the same industry, or in the eld amplifi doing in China to development we’re benefi we also meantime, needtion. In the we do in what that make sure to China benefi populations. So One, by doing the it is twofold: global drug development in China, drug we will and accelerate facilitate of the and accessibility availability new drug in China, so Chinese the can benefipatient e second aspectthe notion of Th ity. diseases are there China is that for particularly are prevalentthat in China or East Asia, such as hepatitis name two. So to by or liver cancer, in innovative R&D work doing more China, we also benefi diseases most specifi concept. the at’s Th world. the develop capacity and expertise the developto drugs take in China that advantage scientifi of the resources,in China and the from the economic and demographic points in China. of doing this Th of view, DIA is not new in China – I person- rst DIA meeting in ally organized fi the China in 1997. Th China is very into strategic expansion we ways.valuable in many One that talk a lot about is education and train- ing. how But I also mention want to important people the it is for working expo- international have in China to Th sure. get to networked them nity for with colleagues and experts same in the fi also provides people It world. in China opportunitywith the volunteering for engagedand getting in these activities. Th be in China to and also community the better prepared getand to involved in global development, and professionally personally. rst rst will ere be Could you please the explain concept behind the slogan, e second plenary session will be in China companies what is covers “In China,China for and the World”? Th tryingare do, especially to with new China has beendrug R&D. seen in pastthe decade or so as a manufac- – a lot of things world the for turer But beenhave in China.’ ‘made drugthe development area needs need to beyond move to that. We regulation are becoming regulation are and more globalizedmore and China is play- ing an increasingly important role newin this paradigm. Th workshops and a two preconference forumyoung professionals Nov. on will there main conference, 1. In the be two plenary sessions fi on the day and three concurrent tracks and three concurrent day with three sessions each on the second day. SFDA, from China’s cers Senior offi US FDA, EMEA, will be and PMDA rst plenary session. speaking fi the at Th focused on “Simultaneous global de- ” trials, and multiregional velopment a very important and contemporary track, “Innovation” the topic. Under we willdiscuss evolving the innova- tion ecology and innovation cluster in China as as well bioinformat- track,ics. “Regulation” In the good regulatory biosimilars practice, and ethical review of clinical trials will be focus. the “Globalization” In the track, developing high-quality clini- cal sites, of study implementation global GCP standards, and recent developments in biometrics in China over 50 have will be discussed. We speakers, panelists, and chairs from regulatorymajor agencies, in- the academia and and from many dustry, who willcountries and lead present discussions.the I very encour- much our colleagues age and welcome Beijing to come to world the around event. exciting participate this in to is is is ect ect c biopharm c peopleerent not who are May we ask you to pleaseMay preview some of the China- What specifiWhat industry disciplines could erings? inaugural is the is conference is takes two sides: is One, what needs are en there DIA that can focused topics planned for discussion our at upcoming 1st Annual China Conference, beginning November 1 in Beijing? Th DIA Meeting Annual in China. It “Drugis entitled Development in Innovation, Regula- World: a Flat believe I tion, and Globalization.” truly refl and contents title the the environment we are in, that is, that in, we are environment the development,drug discovery, and DIA help advance the most in China through our educational off Th needed most in China; other, the is DIAwhat good In China, at? there areas many withare a lot of demand can educationfor and training. We On the eld. name almost every fi hand, DIAother not be may good everything.at DIA can immedi- in terms of education help ately clinical,and training for regulatory, statistics, – the management data clinical development / regula-entire tory area and project management. Th further develop its expertise on, or perhaps by partnering with some- in bio-pharmaone else, more and in esetoo would be very, preclinical. Th very valuable. passionate about what theypassionate about what do, and DIA really provides an opportunity get to involved in a not- them for as they do in their so-routine way, a new experience regular jobs. It’s people. many for I get calls phone from diff members they get who say want to in- volved – they like it and they want to outside their involvement more have working environment. Th routine very unique, I think. GR2-Interview with Ling Su.indd 33GR2-Interview with Ling Su.indd 33 GR5-Chinese_Med_Injections.indd 34 34

CHINA

GLOBAL FORUM Junchao Chen T traditional Chinese medicine traditional Chinese Recently, concerning safetyissues orreactions. events adverse ofserious (SFDA) because State Administration Food andDrug bythe suspended was injections medicine ofChinese varieties several theof use years, few the past During year. them use every million people and more than 400 3 billiondollars, more than totaled injections these year,In atypical the annual of sales companies. pharmaceutical local bymore than are 400 produced they where TCM inChina, injections Currently, there are of 109kinds quite diffi reaction the source ofanadverse identifying nature make can ofthe injections Th acupuncture points. andat intravenous, subcutaneous, intramuscular, intradermal, including routes, various Th via intobody eyarethe injected prescriptions. medicinal Chinese natural or medicine, medicine, herbal inChinese liquids were based InTCM, and solutions these herbs. many diff including erent materials, concentrated liquidsmadefrom solutions of powder or ofpowder solutions are sterile (TCM) injections medicine raditional Chinese cult. cult. e complex has been prepared byClinical prepared been has The issued. guide be soon will injections medicine of Chinese to application theguide clinical a injections, these surrounding To upissues help clear injections. ofthese use correct are the qualityand points key that the believe experts medicine However,injections. Chinese most medicine ofChinese abolition were insistingontheinjections are notsuitable forin use medicinecomponents ofChinese the complex andunidentified that Those whobelieve disease. unique way oftreating clinical aand that have they become inTCM innovations of modern are the products injections these that mentioned their itwas use, forthe completely call prohibiting of their safety. to aresponse As of strengtheningthe supervision the with goal injections medicine the safetyofChinesere-evaluating the SFDAaregulation published 13,2009, On January injections. medicinewere Chinese from medicines ofChinese kinds all4000 from reactions adverse that 70%of reported been has publicconcern. Itwidespread have aroused again injections reactions will also be included. included. be also will reactions information onpotential adverse and theadministering injections forof theirInstructions use. andthe principlesinjections medicine ofChinese development lay also will outstandards for the The guide reactions. of adverse andcauses the classification as technology, wellproduction as on It focus will Department. Medical Medicine Chinese Administration ofTraditional under the auspices ofthe State Association Medicine Chinese ofChinaTraditionalCommittee ProfessionalPharmacology Medicine. Shanghai University ofChinese Research, Clinical forDrug Center [email protected]. forthe He works Junchao at contacted be Chencan 9/26/09 10:51:07 AM ■ 35 CHINA 9/26/09 10:47:04 AM9/26/09 10:47:04 AM

■ cult GLOBAL FORUM GLOBAL . Center for for . Center be interrupted easily, and the and the be interrupted easily, electronic Case Report Form ed in a timely (e-CRF) modifi fashion, especially early in the phase of a clinical trial. • can protocol An incomplete Readers can contact Yinghua LV at at LV Readers can Yinghua contact [email protected] Drug Clinical Research, Shanghai of Chiniese Medicine.University to persuade changeto to operators a paper-based management data system a paperless to one, despite the data and timely advantages in accurate hastransmission. In addition, SFDA not yet enacted legislation regulate to management electronic data the process. Such legislation would go far ensuring spread toward of the electronic clinical trials, which would participation global in the aid China’s clinical trials environment. However, the development and the However, management of data application clinicalsystems trials for in China is still in its initial stages. example, For clinical trial locations frequently lack necessarythe network and hardware support. can also be It diffi in China The Application Application The of Electronic Clinical Electronic Data Management Data a quickly produce to e ability legitimate access to the database the to access legitimate data up-to-date ensure to variety reports of study process • and accurate, Complete, •Th • A reduction in research costs • research in the An acceleration • Enhanced information-sharing of electronic clinical e application infectious diseases such as AIDS and viral hepatitis.” and Drug US Food In 1997, the issued (FDA) Administration electronic on regulations records and signatures. 2005, In April China started with the comply to Republic of China Law on “People’s As a result, Electronic Signatures.” clinical in China has study a legal in and conditions environment electronic clinical management data can be instituted and carried out. spread of the facilitate help To electronic clinical management, data training for has national held SFDA the software technology occasions on four and invited American experts share experiences astheir part training. of the Also, state-funded hospitals, which a large-scale clinicalconstitute trials requested were initiate to platform, systems.electronic management data Th in China has management data followingcreated advantages: the is rst began be to used in

computer networks andcomputer technologyinformation has ince the 1980s, the ince growth the of

ciency of clinical research. At Yinghua LV Yinghua

brought great developmental brought of electroniceld opportunities fi the to clinical management. data Over past the 10 years, development of rapid with the clinical management data international systems, large-scalecomputer many clinical adopted an trials the have electronic clinlcal management data data. manage their system to Th change has the improved greatly effi present, domestic advances in telecommunications, computer and the network technology, construction of hospital information conditionssystems provide favorable clinical for research carry to out electronic clinical management. data In 2005, electronic clinical data fi management number of users the has China. Today, grown 5% of clinical to trials. and Drug Food State The of China (SFDA) Administration advocates use of electronic the clinical management data systems, use the and encourages management of electronic data in data manage the systems to clinical than trials. more are There research20 major in platforms receive funding from China that example, government.the For has government the invested morn 60 million dollars in than of and treatment “prevention the S GR8_ECDM in China.indd 35GR8_ECDM in China.indd 35 GR6-Patent Law Changes.indd 36 36

CHINA

GLOBAL FORUM T completed in China. The Newcompleted inChina. abroad, ifthe invention was application filing inChinabefore apatent to file applicant needs patentChinese law, onlyaChinese Under currentmade inChina. patent applications for inventions to consider where file to first need they entities in China, with for collaborationarrange efforts centersresearch inChinaor up foreign companies set As First? Where toFile Patent Application companies. andpharmaceutical biotechnology patent inChinafor protection and their on potential impact brought Patent bythe New Law more signifi ofthe some highlights article suff Th consequences. er severe Patent are likelythe Law to New orcomplydo notunderstand with companies thatPharmaceutical inChina. landscape the shape futurepatentwill that andlitigation rules standards, fi patentability ling procedures, introduces profound to the changes 1, 2009.Th gointo will effLaw”) onOctober ect Tony andAnn Chen Chen (hereinafter “New Patent “New (hereinafter China’s Patent Law he third amendment to e New Patent (NPL) eNew Law cant transformations is Patentability? for Standard theNew What is to this requirement. and byinventors abroad are subject jointly made by inventors inChina isthatunderstanding inventions “completed inChina,” the for inventions definition statutory Although there isnoin China. ofpatentresult inloss rights requirement will of the review Violationcompleted in China. ofaninvention for review request a ofChina, outside to filing prior (SIPO), Office Intellectual Property toapplicants submitto the State Patent Law, however, all requires The New Patent Law does not PatentThe does Law New acquisition anduse.illegal andwhat constitutesare defined “reliance” on“genetic resources” onhow largelywill depend The provisions ofthese impact acquiredorused. were illegally such inventions resources ifgenetic that to nopatent granted shallbe PatentThe stipulates also New Law source oftheresources. genetic source andthedirect original inthe application thediscloses requirement that the applicant afor timeimposes the first Patent the Law New resources, For inventions relying ongenetic Disclosure of “Genetic Resources” by another describing an an by another describing patent application isana Under current law, a“confl Applications Confl Patent icting applications.pending patents and granted to previously maderetroactive be standard will It ifthe new isnotclear China. of atradeshow)outside (such as at apublicevent witnessed in Chinaofanother’s invention “patent hijacking,” ie,the patenting allowsstandard that occasionally a ofChina, outside or knowledge in the world butnotpublicuse considers publication anywhere novelty ofaninvention, one Under current law, inassessing the world before date. the filing in anywhere art publicly known as “prior art” one, anddefines for patentability anabsolute with novelty standardcurrent blended PatentThe replaces the New Law Heightened Novelty Standard of apatent inChina. either the denialorinvalidation tofailure comply could in result because disclosure requirement, toattention pay close need to this companiesand pharmaceutical such,biotechnology As in China. “genetic only resources”to those resources,” itlimit nordoes of“genetic adefinition provide icting” icting” identical pplication 9/26/09 9:45:52 AM 37 CHINA 9/25/09 1:33:34 PM9/25/09 1:33:34 PM

■ GLOBAL FORUM GLOBAL Ann Chen is Associate an Ann at Jones focuses and Day on (Shanghai) strategic patent and procurement can be contacted She counseling. at [email protected] Tony Chen is at Jones Day a Partner Tony focuses and on patent(Shanghai) technology and transfer. litigation can be contactedHe at tonychen@ JonesDay.com Conclusion China is becoming priority top a pharmaceutical international for revenues grow their to companies in developing countries. To business their goals in accomplish market, hyper-competitive China’s pharmaceutical must companies procurement patent their adapt strategy the to and enforcement new reality in China under the They should New Law. Patent closelyalso work with the plan to Chinese and local government industry bring to about further protection patent to improvement of pharmaceutical innovations. Law e New also expressly Patent blocked veto power default by the owner(s). joint of the Road Map for Compulsory Licenses no compulsory license date, To has ever been granted in China, even patent current the though compulsory contains license law provisions. Law New The Patent will make provisions that contains feasibleit more for and likely compulsory be licenses to granted owner fails in China if a patent without patents their exploit to good cause within a certain time period, or misuse patents his fashion. in an anti-competitive Despite voiced by foreign concerns drug companies, New the Patent Law now authorizes grant of the compulsory patented licenses for drugs “[f]or purposes the of public export and to said drugs to health” certainregions. or countries New Defenses and Exemptions New Defenses and New Law setsThe Patent forth several new defenses and patent a claim of to exemptions infringement, prior including the patent art international defense and exhaustion. Th infringement from patent exempts activities the concerning use and importmanufacture, of a drug or a medical solely apparatus purpose the for of regulatory review which currently (“Bolar Exemption”), exists as a judicial interpretation experimental useof the exception. should be although noted that It Bolar existsthe in the Exemption purpose the US for of facilitating generic drug development, it is term balanced extension with patent linkage encourage to and patent innovations. Because New the Patent Law does patent similar contain not provisions,term extension it leaves bea lot to desired by innovative companies. orts will not be orts with Chinese e New Law states that Patent As foreign companies enter into into As enter companies foreign researchjoint eff Patent Co-ownership Rights Co-ownership Patent entities, they need understand to governshow Chinese the law of jointly commercialization developed rights. and owned patent Th unless otherwise agreed upon, a ownerjoint can individually exploit the exploit to or allow another means by of a general license patent but license), (ie, a nonexclusive royalties the obtained share must owners.thereof joint with other is by all joint-owners Consent required means other (eg, for the assignment) of exploiting ownedjointly patent. Consequently, draft to should becare exercised research agreementscollaborative commercial that ensure to in ways rights arising from patent use of the research joint the eff invention and which was and which was invention previously filed but published of the filingafter the date in question and is application prior art purposes for of novelty. Law New no longer The Patent distinguishes between applications same or by the by others applicant. an applicant’s Thus, be could applications earlier-filed of its novelty used the attack to applications. later-filed will for beThis problematic unrelated, applicants having published that applications describe similar or related in inventions, which is common portfoliospatent of biotechnology and pharmaceutical companies. their audit should Applicants portfolios patent in China before October identify 1, 2009 to any filing and consider such problem Chinese prior to applications October 1, 2009. Enforcement Patent Will How Change? GR6-Patent Law Changes.indd 37GR6-Patent Law Changes.indd 37 UE1-Upcoming Events.indd 38 38

UPCOMING EVENTS

UPCOMING EVENTS GLOBAL FORUM NOVEMBER 2-4,2009 NOVEMBER 28-29,2009 OCTOBER 26-27,2009 OCTOBER Conferences In the Americas DECEMBER 8,2009 DECEMBER 17-19,2009 NOVEMBER 16-18,2009 NOVEMBER 3-5,2009 NOVEMBER 3-4,2009 NOVEMBER DIA’s 7 MD Bethesda, Making Decision ApproachesQuantitative for andSimulation:on Modeling Conference DIA/FDA/PhRMA LA Orleans, New Multinational Trials Clinical in Study Endpoints Measuring Washington, DC Sampling Spot Blood Workshop DIA/PhRMA onDried CA Diego, San Submissions Conference Th York,New NY Mining andData Detection Conference onSignal 2nd DIA Washington, DC Decisions inRegulatory Products Medicinal Benefi Assessing MD Bethesda, Perspectives and Industry NGO, Regions, Emerging EMEA, World FDA, Health Symposium: VaccineGlobal for Development CANADA Ontario, Ottawa, Th e Ottawa HotelWestin “TimeMeeting to Act” e 8 th Annual Electronic Annual Electronic th Annual Canadian ts and Risks of andRisks ts NOVEMBER 9-10,2009 NOVEMBER 9-12,2009 NOVEMBER 4-5,2009 NOVEMBER 2-4,2009 NOVEMBER 2-5,2009 NOVEMBER 26-28,2009 OCTOBER 21-23,2009 OCTOBER 19-20,2009 OCTOBER 19-21,2009 OCTOBER Training Courses DECEMBER 10-11,2009 DECEMBER Washington, DC Aff European Regulatory TX Dallas, Th Horsham, PA Metrics Management andPerformance toIntroduction Portfolio MD Baltimore, and AuditingPractices Clinical toIntroduction Good MD Baltimore, Th Th Aff Regulatory PAPhiladelphia, Management Project Clinical Horsham, PA Management ofProject Essentials Horsham, PA Management, Communication, andKnowledge Information, Project PAPhiladelphia, Th Aff Regulatory Washington, DC Management Plans ofRisk Harmonization 2 nd e Leadership Experience eLeadership Phase eCTD/NDA II: &Part eINDPhase Phase eCTD/NDA DIA Conference for DIA airs: Part I: Part airs: II: airs Part airs DECEMBER 8,2009 DECEMBER 7,2009 DECEMBER 3-4,2009 DECEMBER 2,2009 DECEMBER 17-18,2009 NOVEMBER 16-18,2009 NOVEMBER 13,2009 NOVEMBER OCTOBER 27-28,2009 OCTOBER 26,2009 OCTOBER 19-21,2009 OCTOBER Conferences Europe Horsham, PA Mining and Data Detection toIntroduction Signal Horsham, PA Inspection Safety How to Preparefor a Horsham, PA Development in Drug &ControlsManufacturing Chemistry,Utilizing Horsham, PA for the Noncomputer Professional Computer Systems Validation Horsham, PA Resource Planning Enterprise Horsham, PA ofICSR’sReporting inthe EEA EudraVigilance andElectronic MD Baltimore, Development ofDrug Overview 5 Working Party Children’sEFGCP Medicines 3 UK London, Conference onVariations Joint DIA/EMEA/CMD(h) Nice, FRANCE Forum &Exhibition 3 London, UK London, th rd rd Annual Conference, DIA Paediatric Forum Paediatric DIA Annual Clinical 9/25/09 1:34:58 PM 39 UPCOMING EVENTS 9/25/09 1:34:59 PM9/25/09 1:34:59 PM

GLOBAL FORUM GLOBAL ed) 12:00PM-2:00PM EDT 12:00PM-2:00PM Good Clinical Practices for Clinicalthe Research Professional 10:00AM-12:00PM ET 10:00AM-12:00PM Changes Approval Post European in the (Variations) on CMC Focusing Union ET 11:00AM-12:30PM Improve to eClinical Tools Using Data Quality EudraVigilance Information Day Information EudraVigilance th London, UK Product DictionaryMedicinal (EVMPD) DECEMBER 10 OCTOBER 21-23 (VIENNA, AUSTRIA) NOVEMBER 9-11 NOVEMBER 16-18 (HORSHAM, USA) PA, NOVEMBER 25-27 FRANCE)(PARIS, DECEMBER 7-9 NOVEMBER 4, 2009 7 Online Training Series Online Training NOVEMBER 9-12, 2009 EudraVigilance of Reporting Electronic ICSRs the EEA in At the EMEA, London, UK (unless otherwise specifi NOVEMBER 23, 2009 DECEMBER 3, 2009 Online eLearning MEDICAL COMMUNICATIONS eLEARNING CERTIFICATE PROGRAM CLINICAL INVESTIGATOR eLEARNING PROGRAM INFORMED CONSENT MODULE OF US DRUG HISTORY MODULE REGULATION Latin American Regulatory Annual Drug Annual Development and Regulatory Communication th nd st Clinical Development Conference New Delhi, INDIA 2 1 11:00AM-12:00PM EDT 11:00AM-12:00PM Cardiac Safety Issues in Early Drug Development EDT 11:00AM-12:30PM EDC Appropriate “Choosing the Hosting Model” 9:30AM-11:00AM ET Emerging Issues Safety and Ethical RecruitmentImpacting Patient and Retention 9:30AM-11:00AM ET Global Perspectives Sites on What Need from Sponsors and CROs 9:30-11:00AM ET Global Subject Recruitment Hall Discussion of A Town Today: Metrics and Practices Trends, Drug Development World in a Flat Beijing, CHINA Quality Pharmaceutical of Active Ingredients, University, Peking Beijing, CHINA 4 (LARC)Conference MEXICO City, Mexico Workshop Workshop JAPAN Tokyo, NOVEMBER 18-20, 2009 NOVEMBER 26, 2009 Webinars OCTOBER 21, 2009 OCTOBER 28, 2009 NOVEMBER 2, 2009 NOVEMBER 11, 2009 NOVEMBER 18, 2009 In Other Regions Conferences NOVEMBER 1-3, 2009 NOVEMBER 11-13, 2009 NOVEMBER 15-18, 2009 airs airs Annual Japan DIA Japan Annual eir Regulatory Aspects th Conference on European on European Conference th e 6 e Electronic Document & ExhibitionManagement AUSTRIA Vienna, US Regulatory Aff Basel, SWITZERLAND CTD Dossier Requirements: on EU ModuleFocus 1 and Quality Module 3, Dubai, UNITED ARAB EMIRATES Practical Guide for Pharmacovigilance: and Clinical Trials Marketing Post Paris, FRANCE RegulatoryEuropean Aff Paris, FRANCE Non-Clinical Safety Sciences and Th Lisbon, PORTUGAL Essentials of Clinical Management Study Basel, SWITZERLAND Meeting, Tokyo, JAPAN Meeting, Tokyo, Th PharmaceuticalQuality & Exhibition Forum Prague, CZECH REPUBLIC Assessment Technology Health & Exhibition Forum (HTA) Paris, FRANCE 10 Training Courses Training OCTOBER 19-22, 2009 NOVEMBER 1-3, 2009 NOVEMBER 18-20, 2009 NOVEMBER 19-20, 2009 NOVEMBER 23-27, 2009 DECEMBER 2-4, 2009 Conferences OCTOBER 22-23, 2009 Japan NOVEMBER 9-10, 2009 NOVEMBER 25-26, 2009 DECEMBER 2-4, 2009 UE1-Upcoming Events.indd 39UE1-Upcoming Events.indd 39 GR12-Planning Trip toMonaco.indd 40 40

EUROPE

GLOBAL FORUM print form during November. during print form andin org the from endofOctober available onlineatbe www.diahome. Th sessions. andavoid overlapsynergies between of advantage thatprogram take will working hard to create afocused been has Committee Program to attend. Th upto 14parallel sessions be will InMonaco, there opportunities. networking enough to maximize off Th years. inprevious the standards established Th Forum inMonaco. Advanced ThAdvanced -erapies Fostering Th eme5: the Paving Way for Athreat? opportunity? An Reality? Decision-Making: Infl andaccess approval, development, toeffi key Th 3years after Regulation oftheInitial Impact Paediatric Waytheir toPatients Th drawingpatients before conclusions. Indian society, practice and medical What about trials? shouldweallknow countries oronlyincludingpatientsin therapies to developing modern Th challenges quality, andexternal compliance, andregulations, allrules with youcomply How tomakesure Th Business: in Staying eme2: Way for Forward Pharma? the Paradigm Innovation Is anOpen Th eme1:Innovation Session Highlights T e price of globalization: Bringing Bringing epriceofglobalization: e 2010 EuroMeeting lives upto e2010EuroMeeting lives eme 4: Decision Making: Th Making: eme4:Decision on Medicines eme3:Pediatric er a range of choices, butcompact er arangeofchoices, uence ofHTA onRegulatory e meeting islarge enoughto emeeting 8-10, 2010 at the Grimaldi 8-10, 2010at the Grimaldi place March take from will he 22 cient cient and eff e advance program will will eadvanceprogram e EuroMeeting 2010 eEuroMeeting nd Annual EuroMeeting Annual EuroMeeting ective ective drug e work and where does itfi work andwhere does Qualifi it How does cation Process: Th going? andwherearewedo westand, where it, What is Medicines: Theme 7:Personalized at EULevel? Reproduced Could theBe UKModel Procedure the Centralized through Status Non-Prescription to Prescription from Switching Th CAT inthe First Experience Year medicines derived ofbiotechnology- generations new eEMEA’s Biomarker new eme 6: Challenges for eme6:Challenges Monaco Meeting Planning your Experience t? Research andClinical Health Care Connecting Th eme11: eHealth make? they will to -what patient diff proposals Information Package: Pharmaceutical Patient Theme 10:The Informed Management Initiatives inRisk Research Th Information Th Package- Pharmaceutical Forward Infrastructure Regulatory Th eme8: theEuropean Taking eme 9: Risk Management eme9:Risk e Latest erence 9/25/09 2:06:55 PM 41 EUROPE 9/25/09 2:06:59 PM9/25/09 2:06:59 PM

GLOBAL FORUM GLOBAL for network cial airline Annual EuroMeeting. Annual nd Reception on the e Tuesday ordable Lufthansa Lufthansa SWISS Air Lines International Scandinavian Airlines Spanair Portugal TAP Airlines Turkish Airlines United ANA ANA AirwaysAdria Airlines Austrian Blue1 bmi Airlines Croatia EgyptAir Airlines Polish LOT Communities (SIACs) Meet and 13:15 – Eatfrom 12:30 14:00. 13:30 – Particularly useful thosefor new EuroMeeting. the to 13:45 Presentation 13:15 – Exhibition Floors from 17:30 – 18:30 18:30 Presentation 18:00 – 15:30 09:00 – member e Star Alliance™ airlines • • • • • • • Making Your Meeting Making Your Aff Discounted Airfares Th offi the are 22 the • • • • • • • • Registered participants plus one person travelling accompanying event automatically the are to 20%, of up to granted a discount depending class on the of travel. is provided information More on the EuroMeeting website. Participating airlines include: – DIA Special Area Interest – Speed Networking from – Green Exhibitor Award – Th – Award Poster Student March 10, 2010 Wednesday, – sessions Parallel running from – closes 15:30 at Conference ee break) ee sessionsrst parallel will Monaco PressMonaco Centre Photo e fi e place from – 12:30 (including 09:00 place coff a 30-minute 13:30. Details be to confirmed. start 16:30. at Hotel: Fairmont Reception the at 20:00 18:30 – 17:30 09:00 – Monday, March 8, 2010 Monday, – tutorials will take Preconference – Th – Exhibition opens 12:30 at – opening plenary The will start at – Mediterranean Networking – Mediterranean March 9, 2010 Tuesday, – sessions Parallel running from

2010

Hot Topic Highlight Topic Hot

Stand-Alone Sessions EuroMeeting eme 12: Pharmaceutical eme 13: Handling Clinical Student and Young Professionals and Young Student Sessions RegulatoryJapanese Session SessionAgencies’ Satellite Exploratory Clinical Trials in the EU in the Exploratory Clinical Trials Th Sciences in 2020 Research Major What Activities Drive Drug DiscoveryWill and Development? Th eSubmissions and QualityTrials, Requests Emerging Standards from ICH GR12-Planning Trip to Monaco.indd 41GR12-Planning Trip to Monaco.indd 41 for free just by showing your Complimentary Airport Shuttle WIN TWO VIP TICKETS TO DIA will operate complimentary EuroMeeting badge. THE MONACO FORMULA ONE shuttle bus services between GRAND PRIX! Nice Côte d’Azur Airport and the Discounted Hotel Rooms conference hotels in Monaco from Reserve your Monaco hotels are ranked as some Sunday to Wednesday. Th ere will be hotel room of the best in the world. Now you a welcome desk at each terminal to online by do not have to break the bank to off er advice and help. December 4, stay in them, as DIA has negotiated 2009 (17:00 discounted conference rates which Further Discounted Transportation CET) and be are very competitive in comparison Off ers entered into to other major cities in Europe. DIA has negotiated discounts with a draw to win Find out more on the EuroMeeting car transfers companies. If you two VIP tickets website which provides a link to want to arrive in style, we have also for the Monaco our hotel agent. It is also possible to negotiated discounts with HeliAir Formula One book tours with our agent. Th ere are Monaco. Further information and Grand Prix (Sunday, May 24, two tours on off er: Royal Monaco a booking link will appear on the 2010). VIP tickets include seating and a Glamorous Monaco Walking EuroMeeting website later in the in a VIP private stand and a Tour. As they are exclusive to year. welcome cocktail and lunch. EuroMeeting participants, they are not only enjoyable but also a valuable Complimentary Local Bus Services networking opportunity. in Monaco However, if you want to move DIA’s conference hotels are within around in Monaco, for example, to For all the latest news and walking distance of the Grimaldi go from Monte Carlo to Le Rocher, information visit the EuroMeeting Forum, and Monaco is small. you can use local bus services 2010 website. ■ EUROPE

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GR12-Planning Trip to Monaco.indd 42 9/25/09 2:07:03 PM

A13_April Linda.indd 61 4/16/09 12:49:00 AM 43 EUROPE 9/25/09 2:09:45 PM9/25/09 2:09:45 PM

■ ere ll. Th ll. rst Green rst GLOBAL FORUM GLOBAL er. e fi e Participants of Provence. elds and we look forward a successful to partnership in 2010. Th was the presented at Exhibitor Award EuroMeeting in Berlin Rachel to King, CEO of CRF looking we are and Health, forward increased to competition win 2010 to the amongst exhibitors GreenEuroMeeting Exhibitor Award. doesAnd our commitment not just stop food to and beverage extends It there. will not use styrofoam, We supply. paper plastic or cups, plates, or cutlery. of 3,000By doing this, a conference participants such as EuroMeeting the 1,000 kilos than more ofeliminates waste being a landfi to sent will be coolers throughout water building,the reducing need the for will use We individual bottles of water. locally grown food wherever possible, toowhich should not prove challenging it is surrounded since in Monaco by the fertile fi will eat as be to low down able food the chain as possible, with some delicious vegetarian on off menus suggestions or any If you have ideascreative do on how we could pleasemore, Dermot contact Ryan, EuroMeeting Manager at [email protected]. which ed paper, t foundation, t rst Green Exhibitor Award, Rachel King, with Dray Marie Rachel King, rst Exhibitor Green Award, Protection e Climate EuroMeeting the to travelling badge), they all dietered are powered mixed with(diesel vegetable oil). We will be running complimentary shuttle d’Azur buses Côte and from Nice to Airport, reducing need the thereby for car and will transfers also a taxi- operate deskssharing our welcome system at sets airmiles the airport.in the DIA off of staff with nonprofi a Swiss – Th myclimate Partnership (www.myclimate.org), all our participantsand we encourage supportto our greening by initiative miles.setting their considering off During EuroMeeting, the we will er you an environmentally-friendly off bag when you collect yourconference badge we will (which of course, recycle meeting of the end the you return if at us). Recyclingit to the bins throughout cardboard, building will collect paper, plastic, packaging containers, glass, e meeting will be and batteries. Th paperless wherever possible, and all will publications EuroMeeting be printed FSC-certifi on theymeans sourced are from that well managed forests and recycled wood. is an with our exhibitors Working important part EuroMeeting, of the Th e winner of the fi e winner Th Brassington Berlin. in the exhibit in hall William and , 2 ushing cient fl cient

ect EuroMeeting. of the reen meetings a growing are conferences, and at trend the is at EuroMeeting DIA’s Annual EuroMeeting will EuroMeeting Annual

nd e infrastructure at is already in place

e 22 e G the Grimaldi Forum in areas Grimaldi such asthe Forum the systemuse to pumping of a seawater provide air conditioning energy the for system reduces which energy requirements by 20-30%, low-energy building, the throughout lighting and hand motion-sensitive water, taps for driers, an eco-effi and take place at the Grimaldi the Forum at take place (March in Monaco Centre Convention chosen8-10, 2010), and we have a partner shares that center convention our vision EuroMeeting. of a sustainable Th toilets.system the for Remarkably, has virtually Grimaldithe Forum zero emissions of greenhouse gases. is only 2 km Monaco Given that forefront of this movement. of this Using forefront practical, innovative, and often very measuressimple successfully reduces Greening our carbon footprint. DIA’s project EuroMeeting the began with 2009 in Berlin, EuroMeeting the and encouraged and that delighted we were 95% of participants who responded to surveyour conference positive were about measures the taken reduce the to ecological eff DIA its will Greening be the continuing EuroMeeting project 2010 Monaco for and willbe 3Rs: practicing the reduce, recycle, and reuse. Th everything is close. Most hotels of the a short are walking from distance the – and if you do wantGrimaldi Forum taketo a bus (free with your conference GR11-Monaco EuroMeeting.indd 43GR11-Monaco EuroMeeting.indd 43 Angelika Joos and Wills Hughes-Wilson

heh HTA discipline is, arguably, in its infancy. cost-effectiveness evaluation. This represents an ButB increased use of new technologies and the additional step and an additional hurdle following T avalanchea of scientific advances-coupled with Marketing Authorization, which already requires a a needd tot keep a tight hold on healthcare budgets-all product to pass a positive risk-benefit analysis by the mean it is not likely to go away. So how can we ensure regulatory authorities. that the right framework is in place to stimulate innovation and to ensure that the right treatments Th e DIA HTA Forum will bring together regulators, HTA are getting to the right patients, while being sure agencies, academia and industry to discuss potential that we are paying for value? mutual benefi ts that can be achieved by optimizing the current systems. Th e Forum will provide the opportunity Although a relatively new science compared to the to exchange ideas on best practices and to explore the EU’s regulatory frameworks, the debate in Europe boundaries, roles, and interface between regulatory around the structures, use and best methods for and health technology assessments. How far can conducting health technology assessments is these two evaluations – and the agencies that conduct constantly evolving. Hurdles for market access them – be synergistic? Th e opportunity to identify seem to increase: patients in most European commonalities and potential synergies is a crucial element Member States can only get access to innovative of streamlining the development and availability of new technologies and medicines after an HTA agency’s biopharmaceuticals for the benefi t of patients. EUROPE

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CEO, CEO, ■ GLOBAL FORUM GLOBAL ce, Postfach, Postfach, ce, Senior Director , Hughes-Wilson Wills Senior Director, PolicyHealth Genzyme,Europe, Belgium Angelika Joos, Regulatory Policy Europe, Merck Sharp & Dohme Inc.,(Europe) Belgium Germany UK zer Ltd., Switzerland AiM GmbH, Pfi Control, Slovakia Control, Medical Division, Global Safety, ii4sm, Global Safety, State Institute for Drug for Institute State Assessment in Medicine Hubertus Rosery, Research and Consulting, Evidence BasedEvidence Strategies, Aff Unit,airs Coordination Aff Program Co-Chairs Program Committee Peter Schulz, President Peter Vice Dagmar Stara, EU Head of the Clare Mc Grath, DIA Health Technology Forum DIA Health Technology November 25-26, 2009 Marriott Rive Gauche Hotel Paris, France expert speakers fromFeaturing the EMEA, Commission, European Authorities, Competent National Organizations.and Patient Registration: You can register online Registration: You www.diahome.org, by faxat via(+41 61 225 51 52), email ([email protected], or by mail (DIA Offi European 4002 Basel, Switzerland) cient cient forum will is HTA eld. Recently, regulatory Recently, eld. cover current practice and thinking, practice current cover but will also look aim to the to future and identify challenges and opportunities developing in this area. case Using studies as examples, speakers and panelists will explore between tensions the clinical agencies’ and HTA outcomes requirements. how open can and And lastly, processes be to should HTA e DIA HTA scrutiny? Th external increasing will the examine Forum drive towards transparency in the regulatory process over approval years,recent the to compared the to approach “closed” relatively fi HTA agencies and biopharmaceutical been have companies called upon opento doors their increased to Methodologies, scrutiny. external review data, information and other beenhave to increasingly available public. interested the But can the reviews and same be said of HTA decision reversals making? Recent of decisions lead could to several HTA viewthe increased that transparency is needed HTA help to – either agenciesunderstand wishes the of society society help or to understand behind HTA the rationale the agencies’ decisions. far How should we go and who should decide? will provide Forum DIAThe HTA an opportunity review to current future the practices and debate additional this direction that evaluation HTA but unavoidable should take. to investigate how biomarkers how biomarkers investigate to endpointsand surrogate could increasinglybe used the for regulatory process. approval But do such endpoints suffi – while needs regulators’ the for give – the they data agencies need? the HTA evaluations take And how will HTA of increasingly targeted account Th therapies? erent approaches erent and initiatives erent set. data erent Regulatory provide a forum assess to status their likelihoodand their or of success paradoxicalfailure in addressing this situation. questions are raisedAlso, there by c advances: of the many scientifi drug the facilitate to initiatives starteddevelopment process have Important questions table, on the should and why such as: “What is HTA we care about it?” and “What does look like in 2009 and where HTA is it set go?” will to be to explained to in order professionals non-HTA vocabularybuild a common and basic understanding methodologies of and and future current impact for their medicines development. Regulatory departments and pricing departmentsand reimbursement in separate traditionally existed have worlds. are data for But requirements but not just from regulators coming agencies. Meetingalso from HTA agencies HTA requirements for the often Authorization post-Marketing requires a diff agencies, governments, and industry forward ways will potential examine the build theseto requirements into development program and, if possible, in and delays duplication avoid to ways access,patient while still meeting the legitimate need evidence for on which baseto decisions. reimbursement number ofIn addition, a large which appearinitiatives exist to the aimed “de-fragmenting” are at assessments to approach between Member States. of these Many are level, a European happening at to betweenbridge gap the a European regulatory to approach questions and For, availability. to approach a national while a product receive an EU might it is subjectMarketing Authorization, 30 diff than more to assessingto its value following that Forum will e HTA Th Authorization. diff the examine GR3-DIA HTA Forum.indd 45GR3-DIA HTA Forum.indd 45 GR1-Pharmaceutical Quality Forum.indd 46 46

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D GLOBAL FORUM Postfach, 4002 Basel, Switzerland) Postfach, 4002Basel, European Offi orbymail(DIA email, [email protected], via (+41612255152), byfax You, onlineat www.diahome.org register can How toRegister conference. control, orrelated qualityassurance, fi chemistry, and strategy, manufacturing pedigree, supplychainanddrug supply.”states inproduct Ifyouwork inregulatory/compliance into EUmember account role ofthe new important the increasingly Dr. “Th remarked, Schmitt throughout Europe. Summingupthe conference for potential attendees, professionals andindustry academics, senior Competent Authorities, Th National isEMEA, conference from the featuresspeakers many expert present.” will examples the studiesandpractical speakers the many case benefi the biggest always, andwhere are. met the As pitfalls be can challenges howthese sides both from to hear unmatched opportunity at holistically. islooked where qualityalongtheevent life Th cycle It isthe one the from issues regulators’these andindustry’s viewpoint. Th this requirement. more diffi inthepace marketplace ofchanges become ithas With requirement. is aregulatory andthe fast globalization increasing “Assuring life cycle product ofthe pharmaceutical qualityinallsteps ofthe conference, the importance UK)emphasized PAREXEL, Dr. Consultant, (Principal Schmitt chairperson Program Siegfried authoritiesandindustry. ofthe regulatory the from perspectives life cycle November 9-10,2009 QualityForum Pharmaceutical program will focus onthe ofqualitythrough assurance the focus drug will program Th Republic. Alcron Hotel Czech SAS inPrague, Radisson IA’s Pharmaceutical Quality Forum Quality Pharmaceutical e DIA Pharmaceutical Quality Forum Quality addresses Pharmaceutical eDIA is event has a strong European focus, taking taking astrong European focus, has isevent ■ elds, you will want to youwill attendelds, this will take place take at will the cult cult meeting t lies in t lies isan is ce, Liaison, Group Quality Operations, Operations, Group Quality Liaison, Christa Wirthumer-HocheChrista , Head, , FormerFritz Erni Technical Head Quality WorkingQuality EU Party, EMEA, Department of Medicines Control ofMedicines Department Novartis PharmaAG, Switzerland Novartis Unit for MarketingAuthorization Laboratory, Laboratoire NationalLaboratory, Laboratoire , Associate Research Research Smith,Associate Zena Fellow, Pfi Global, CMC Administrator CHMP/CVMP Administrator CHMP/CVMP of Medicinal Products, AGES Products, of Medicinal , Scientifi Luigetti Riccardo , Principal , Principal Schmitt Siegfried and Life-cycle Management and Life-cycle Program Committee Consultant, PAREXEL, UK PAREXEL, Consultant, Jean-Louis Rober Jean-Louis de laSanté, Luxembourg Program Chair PharmMed, Austria PharmMed, t, Head, Head, t, zer, UK c 9/25/09 2:17:45 PM 47 JAPAN 9/25/09 2:21:37 PM9/25/09 2:21:37 PM

■ GLOBAL FORUM GLOBAL -selective alpha 1a blocker used in the symptomatic blocker used symptomatic in the of benigntreatment prostatic hyperplasia). After in working clinical development and corporate development, I was appointed A Chief Executivethe Officer. decision was with merge made to Pharmaceutical Co., Ltd. Fujisawa beto better positioned global for company competition, and the is now called Astellas Pharma, Inc. talk I would like to about my experiences in clinical research and business development, and the future of Astellas Pharma.” 2009 on the information more For DIA Japan Meeting,Annual visit our homepage www.diahome.org at or view issue of August the , p33. Forum Global the Pharma Inc., Japan; Chairman of Pharma Inc., Chairman of Japan; of Pharmaceutical Federation the AssociationsManufacturers’ of will giveJapan) an address on “The of Japan-based Road Map Pharmaceutical Industry in the Takenaka Dr. Era of Globalization.” some Forum Global the gave background about his career experiences and a brief preview of his remarks, pharma- Japanese for “In order surviveceutical to companies in an era of highly competitive globalization, we need to strengthen clinical research and business development. I started career my as a pharmaco- logical researcher Yamanouchi at Forty-five Pharmaceutical Co. Ltd. years ago, I was involved in the discovery (calcium of Perdipine blocker) channel and Harna α (Tamsulosin, this field. It will offer an excellent will offer an excellent field. It this opportunity to all attendees for hear work who from professionals facedwith patients and are with realitiesthe of communicating daily. with them keynoteOne of the speakers, DVM, PhD Takenaka, Toichi (Chairman Board, of the Astellas (#09303)will (#09303)will Annual Japan Annual Japan his year’s his year’s DIA Meeting Hall, Tower be at held Funabori, Tokyo. The The Tokyo. Funabori, meeting will target the practical aspects of and issues in clinical operations with speakers who in work Annual Japan DIA Meeting DIA Japan Annual October 22-23 T GR15-Japan DIA Meeting.indd 47GR15-Japan DIA Meeting.indd 47 GR13-13th Ann. Workshop in Japan.indd 48 48

13 JAPAN for CDM in Japan Workshop

th GLOBAL FORUM A discussion within Japan. within However,discussion to havefeasible focused anarrowly itisnot globalization, growth “Furthermore, ofthe because workshop.”DIA is oneofourmajor missionsinthis above the described information as economy. that to deliver Ibelieve and considered inlight ofefficiency to be the qualitystandardneeds speaking, since fundamentally however, this islittle aggressive astrong image; has single error) a data without clinical (perfect first Traditionally inJapan, the speaking acceptable. be itwill expected, the islowerthan data errorlevel If anacceptableor with level. error asingleerror, data without clinical imagine people some assured, you say that data isquality- clinical When ofmuch discussion. subject andisthe varies, quality assurance However,assured. the concept of for whichthe qualityiswell data trial to prepareclinical idea, itisquite asimpleanother words, In data. ofclinical quality assurance to say, needless management is, a nature “The to attendees, ofdata Atsushi Tsujii, extends aninvitation Annual the 13 , Mr. Japan forCDM in s Program Chairperson of Chairperson s Program th Annual Workshop Annual diajapan.org ID #10301)oremaildiajapan@ go to www.diahome.org (meeting Forexhibits. more information, for tabletop opportunities offer will Hall Funabori inTokyo and 4-5,2010aton February Tower place take The will workshop workshop.” andtimelyto this important welcomeyou ahearfelt inperson to haveI hope the chance to offer andpresentation andparticipation, We to youractive forward look only inJapan butaround the globe. data managementon clinical not an ongoingexchange ofopinion and networking, presentations, chatting session), (CDM CCS including fora forum discussions to provide thistake opportunity platform for Japan. We to want inJapanworkshop to this provide CDM planning for the DIA Wediscussions. started originally of conduct where series wecan to aplatform provide we need “To a‘de establish standard,’ facto it isaninternational meeting.” role, as animportant has workshop Forcountries. this thatDIA reason, standard for Japan andother towe want avoid creating adouble . ■ Program Sub-chairperson Takeda Company Pharmaceutical Takeda Center BioDevelopment Daiichi Sankyo Co.,Ltd., Japan Sankyo Daiichi Quintiles TransnationalQuintiles Japan Program Chairperson Program Committee Kowa Company,Kowa Ltd., Japan UCB Japan Co.,Ltd.,UCB Japan Bristol-Myers K.K., Japan Bristol-Myers K.K., Hisashi Nomura, PhD Nomura, Hisashi CMIC Co., Ltd.,CMIC Japan , Mizumoto Mariko Makoto Yokobori SUXAC Inc., Japan Inc., SUXAC Mineko FujimotoMineko , Fumihito, Harada Ken Katayama, Atsushi Tsujii, Yumi, Sugiura Kenji Nagaya , Limited, JapanLimited, JapanLimited, K.K., Japan K.K., , , 9/26/09 10:11:51 AM 49 INDIA 9/25/09 2:26:15 PM9/25/09 2:26:15 PM

c Advisory c GLOBAL FORUM GLOBAL ions. Additional ■ gures such as Dr. M Venkateswarulu, M Venkateswarulu, gures such as Dr. fi Drugs General Controller of India; Supriya Sharma, Director Dr. General, Products Therapeutic Canada; of Health Directorate Dr. Mehul Division Mehta, Director, Dr. FDA; of Clinical Pharmacology, Gopalan Head, Biologics Narayanan, Kiran MHRA;and Biotechnology, Dr. CEO and Managing Majumdar-Shaw, Piramal, Swati Director of Biocon; Dr. Director and Dr. of Nichols Piramal Khorakiwala,Habil Chairman and Ltd. CEO of Wockhardt the Program Tripathi, Dr. to According Committee and Scientifi have Board Conference the for participationstrong on the enjoyed partfrom ofindividuals committed research and regulatory institutions agencies US, India, in the Europe, regand other upcoming on the information can beNovember 2009 conference (meeting www.diahome.org at found ID #09953). Fernando Quezada,Fernando serves MPA, as BiotechnologyExecutive Director, Center of Excellence Corporation-USA. airs. c Advisory c ducts, drug delivery, s and data management,s and data served have e conferences cials. Th cials. workshops ree will preconference bioinformatic pro combination clinical research and regulatory aff Th ered on November 15, focusing be off areason the of Registration of Drugs and Biologics in Canada, Global Medical Device Regulations, and Regulatory Policy. RAC, PhD, Tripathi, Satish Dr. President, Biomedical Consulting Inc has servedInternational, as Chairman Scientifi of the Board and Program Committee for pastthe conferences, three annual been which have in Mumbai. held seriesnotes, He conference “Our on Drug Discovery and Clinical Research in India has established an for important of excellence standard a key of scientists, audience industry representatives and government offi establishto a substantive dialogue opportunitieson the and challenges India is dealing with as country the its rise rapid globalcontinues in the Highlights biomedical marketplace.” have rst three conferences fi of the included from major presentations c and c program e conference

Annual Annual ology, development of ology, IA will be holding its 4th AnnualConference on Drug Discovery and Clinical

TH er keynote addresses and

in India in Development Development and Clinical Clinical and Discovery Discovery on Drug Drug on Conference Conference 4 Fernando Quezada,Fernando Satish Tripathi biologics and clinical trials. will presentations cover Additional pharmacovigilance, biopharmaceutics, D Development in India: Scientifi is designed on provide an update to global regulatorythe landscape and will off expert on drug presentations panel pharmacology quality, discovery, and toxic Regulatory Advances across Borders New Sheraton Delhi the Hotel, at Saket, New Delhi on November 16-18, 2009. Th Satish Tripathi GR14-Conference on Drug Discovery.indd 49GR14-Conference on Drug Discovery.indd 49 GR10-CRCs inIndia.indd 50 50

INDIA

GLOBAL FORUM Dr. Das Sauren (CRCs). The additionalsupport (CRCs). coordinators research clinical (SMOs)andtrainedorganizations bysite managementprovided isusuallyThe additionalsupport data. research generating key whichare theat places the sites, demandfor support an increasing Thisteam. situation created has pressure onthe andthe sites site tight timelinesexerts tremendous quality data generation within in workloadanddemandfor high- The increase agencies. regulatory andglobal local byboth sites at these andinspections audits inthe anincrease been also has There years. few over the past onthe rise been has sites research on clinical the focus In India, mutually exclusive. thatunderstand the two are not It that isimportant weleaders. consideredthoughtcompanies to be India andfor Indianphysicians and oftreatment lines to leading to bring ifwe are important isalso research However,physicians. clinical P focus and priority for andpriority focus continue the primary to be atient isandwill care all three stages of a clinical trial. ofaclinical stages all three Th players. SMO, sponsor, andother IRB, central laboratory, courier, CRO, Th investigator, andsite members. team andtheir family,(subjects) study participants between Th onepriority,number patient care. allows physicians ontheir to focus Close scrutiny in reviewing EC inreviewing scrutiny Close andapproval.and resolution follow up, submission, query path isECpackagethe critical Th completeness documents. ofthese in the right place andensures the fi theand siteprepares bycollecting Th high-quality data. andgeneration trial of organized and timely completion ofawell conduct thefor stage smooth sets which and preparation period Th is enrolled. much the before fi start Th at thesiteresponsibilities e Before theTrial ling the appropriate documents ey also coordinate also the with ey link forms acritical eCRC e next activity for CRC in enextfor CRC activity e key role over isspread ekey isthe planning e CRC actually actually eCRC rst patient filling are minimalatfilling with sites andconsentdocumentation form related to consent process that deficiencies observed been It has confidence ofthe subject. andbuild guidelines regulatory helps to ensure compliance with theunderstands contents. This andensureform that the subject explain the contents ofthe consent that spend “extrawill to hour” that ensures Indian sites someone Thecare. at presence ofaCRC utmost with bythe CRC managed whichis consent process, informed isthe responsibility critical Here the initialand of subjects. enrollment andactive screening with site begins for the CRC at ofthe the activity The crux During theTrial of the ofthe progress trial. to the apprise team meetings coordinates also CRC regular Th the updated. team to keep Th basis. on aregular Th CRC totrainsitestaff helps e monitoring/audit fi subsequent or abolishing helpsinminimizing documents ndings. is helps e 9/26/09 10:02:32 AM

dedicated CRC personnel. The of all randomized subjects and coordinated by the CRC, who benefit, above all, is that subjects calls the subject well in advance resolves them in the correct are much better informed. In fact, of the visit. This call confirms manner and within the deadlines. a 2008 survey of more than 900 the visit and should prevent study subjects found that subjects subjects coming late or missing Overall Site Management were remarkably well informed visits, which translates into a huge Apart from the CRC services at the considering the age of the market benefit for the sponsor. Missed site, the back offi ce support from the and the relatively low level of or delayed visits may amount to a SMO augments the generation of awareness about clinical research in protocol deviation and violation high-quality data. Th e SMO extends the general population. Specifically: and could affect the quality of the support to all the participating < 98% understood the number data generated from the trial. sites and ensures high-quality of times they would have data with consistency from across to visit the study site Luckily, the presence of the all sites. SMOs also assure the < 93% understood that the study ever-vigilant CRC avoids all such continuity of CRC services at all would carry risks and discomforts instances and leads to completion sites throughout the trial period. < 86% understood that they could of the trial with none of these quit the study at any time “abnormal visits,” guaranteeing Thus, Indian sites learn the details < 88% understood that they maximal compliance and of global clinical research and might receive a placebo, vs. retention rates. At all the visits, definitely need extensive support 77% in United States CRC devotes adequate time to from both SMOs and CRCs. This < 70% understood ICF very discuss in detail the subject’s will help them to participate in well, 27% somewhat well current condition and his or her more global research projects < 97% fi rst learned about the condition during the intervening and still manage the huge patient study through a physician period between visits. These few load at their sites. The CRC < Only 8% made the decision moments of discussion reinforce provides the essential “bridge” to participate alone, vs. the subject’s confidence and trust for a successful clinical trial. 38% in United States in both the trial and the CRC, The combination of competent again translating into better investigators, sites with large Th e vigilance of the CRC is bonding between the subject and patient pools, and trained put to the test with the start of CRC and maximal retention. CRCs from experienced SMOs recruitment and randomization of will ensure the completion of subjects. Th e CRC has to ensure The laboratory reports during the clinical trial on schedule fulfi llment of the inclusion and all the visit days are routinely with globally acceptable data exclusion criteria and the timely verified by the CRC and discussed which can withstand the and complete documentation of with the investigators and site scrutiny of any global audit this process. Th e CRC’s attention team. This has a dual benefit for or regulatory inspection. ■ to detail in subject recruitment the participant and the project; benefi ts the needs of the protocol. it helps to identify telltale signs of impending adverse events via The challenge of mulitple abnormal laboratory values and languages at Indian sites is takes care of the much-needed mitigated by the presence of a quality documentation. local CRC who is conversant with the local languages. Adequate After the Trial instructions by the CRC during The completion of all patient the first visit help subjects to visits at the site does not better understand the protocol, necessarily mean the end of the and this in turn helps in the job for the CRC. He/she has

active participation and proper to tie up all the loose ends and INDIA documentation of “home-based,” bring the project to a successful Dr. Sauren Das is Country Head & protocol-related findings/ conclusion, as projected. During Director of Operations at Excel Life readings/etc, like diary cards. this period, there is an influx Sciences. Readers can contact him The CRC tracks the schedules of data queries. These are at [email protected]. GLOBAL FORUM 51

GR10-CRCs in India.indd 51 9/26/09 10:02:36 AM GR4-LARC Rescheduled.indd 52 52

LATIN AMERICA

I the conference this organizers, eff andthe outstanding region commitment American to the Latin Withpostponed. DIA’s strong attendee itto be safety caused and concerns the about H1N1virus for May 2009,but scheduled was this momentum, the 2ndLARC in Mexico City, Mexico. Buildingon Region American the Latin in Development andDrug Research forClinical Harmonization entitled Conference (LARC), Regulatory American Latin the initial off marked inSantiago,program Chile. 2008 GLOBAL FORUM n 2001, DIA hosted the hosted n 2001,DIA Regulations in Latin America Latin in Regulations ofDrug Harmonization Regulatory Conference (LARC) Regulatory ering oftheering RESCHEDULED –held orts orts of 2nd Latin American 2nd LatinAmerican Latin American,”Latin commented inthe harmonization regulatory that theforum with drug deals constitutethey the continental since countries, in the regional disseminate the work ofthis group (PANDRH) byhelping to Harmonization Regulatory Drug Networkonof the PanAmerican the initiative to support the need identified year’sat last meeting, regulators industry andregional local from to feedback in response committee, program LARC’s “The Hotel deMexico.Plaza 18-20at the November Crown in Mexico City, Mexico, on conference held important be will evaluated. be will ofthe product lifecycle trends across theRegulatory ofharmonization. and direction barriers, onthe benefits, region highlight American the Latin willdepth interactive discussion In- region. American the Latin in anddevelopment research andfutureaccess ofmedicines the impact and howthey environments regulatory global to onacademia updates offer agency,from industry, and together international experts The conference bring will Dr. Guerrero. Sergio committeeprogram member 9/25/09 2:32:38 PM 53 LATIN AMERICA 9/25/09 2:32:41 PM9/25/09 2:32:41 PM

GLOBAL FORUM GLOBAL ■ Program Committee members Program Committee members Molzon, MSJustina Pharm, JD, USPHS (US FDA), CAPT. Paxton (PhRMA),Mark and Sergio MD (OCA Guerrero, Hospital/Monterrey International Research and DIA Center Board of Directors) recommend individuals program for this involved in clinical research and development, clinical safety and pharmacovigilance, clinical trial and project management, drug development and discovery, medical and scientific affairs, preclinical development, quality assurance, research and development, strategic sourcing/planning, regulatory affairs, and and government public policy. orts orts orts on orts on orts Introduction of IMPACT Latin American Countries Opportunities in Latin America Latin America by Globalizing Regulatory Processes Inspections Pharmacovigilance • Regulatory from Updates • Global Clinical Development: • Biotechnology Paradigm in • Access Faster Promoting • Collaborative Eff • Collaborative Eff • Collaborative Eff • Anti-Counterfeit (866) 258-2735 PHARMA, BIOTECH & MEDICAL DEVICE mednetstudy.com f technology solutions for clinical trials Americas the roughout Th Regulatory and Authorities Industry Latin for America Pan American Network for Drug Regulatory Harmonization Overview(PANDRH): and Updates Group Working (GRP): Ensuring Quality Regulatory the Throughout Process • Harmonization Initiatives Initiatives • Harmonization • for Environment Current • of the Status Current • Good Regulatory Practice Attendees will have the opportunity opportunity the will have Attendees learnto about and discuss the following: GR4-LARC Rescheduled.indd 53GR4-LARC Rescheduled.indd 53 PAUL POMERANTZ DIA’s New Executive Director

IA has hired Paul growing attention to quality, access, perform minimally invasive surgical Pomerantz, MBA, CAE, and cost of safe medications, DIA can procedures. Prior to SIR, Pomerantz D as its new worldwide increasingly play a signifi cant role served as executive director for the executive director. Paul will transition in improving healthcare worldwide,” Clinical Laboratory Management from his current position as executive explains Pomerantz. Association, assistant vice president for vice president of the American the Medical College of Pennsylvania, Society of Plastic Surgeons (ASPS) to Pomerantz brings to DIA more than executive director for Maxicare DIA worldwide executive director 25 years of healthcare experience Philadelphia, and deputy director for eff ective December 1, 2009. Pomerantz with specialized expertise in medical the U.S. Public Health Service. replaces William Brassington, MBA, society management and hospital who has served as acting executive administration. “Paul comes to DIA with a proven director since July 2008. Brassington track record of successfully leading will resume his role as worldwide As executive vice president at global member-driven associations, director of fi nance at DIA. ASPS, an association of 7,000 developing quality education reconstructive and cosmetic plastic programs, building coalitions and Pomerantz will direct DIA’s global surgeons, Pomerantz was responsible alliances, and opening doors to operations and strategic expansion for the association’s health policy new relationships,” says DIA Board and lead the implementation of the and advocacy initiatives, education of Directors President Dr. Jeff rey Board of Director’s long-term plan and research programs, membership Sherman. “Reinforcing our strong for sustainability and growth. He services, communications, and the relationships with global regulatory is eager to work with DIA’s board, fi nance, administration, human agencies, industry and academic management team, and staff to take resources, and information technology professionals, and patient groups is DIA to the next level of excellence. departments. In addition, he recently vital to our mission of optimizing served (2008-09) as chair of the board global drug development.” “Th is is a changing time for the of ASAE’s Center for Association biopharmaceutical and health care Leadership. From 1997-2002 DIA’s search committee worked community. I’m excited to work with Pomerantz was executive director with executive search fi rm Korn/ DIA members and constituents to for the Society of Interventional Ferry International to fi nd the most strengthen and expand educational Radiology (SIR), an international qualifi ed candidate to lead DIA into

ASSOCIATION NEWS ASSOCIATION programs and services and advance its society representing the specialty of the 21st century. “Th e requirements global presence and mission. With the radiology that uses image guidance to for the position of DIA worldwide 54 GLOBAL FORUM

AN5-Paul Pomerantz Profile.indd 54 9/25/09 2:36:59 PM executive director have evolved and the association’s business, while infrastructures to increase their are particularly challenging,” says holding on to the values we have global competitiveness. Companies Marie A. Dray, DIA immediate past shared during our 45-year history,” are increasingly outsourcing president and chair of the search Paul explains. “As we examine how we manufacturing to low cost committee. “Th e position requires have traditionally created educational destinations, and India and China experience as an association leader, programs and the methods and off er skilled manpower and a robust understanding of the challenges venues we have used to bring our manufacturing infrastructure. of membership building, skill in volunteer members together, we will training and educational program need to focus everyone’s energy on “We have expanded into emerging development, not to mention state- what DIA does best and to maintain markets to provide a neutral forum of-the-art knowledge of global health our high standards for excellence, where professionals from academia, care changes. Th at really is a tall order, relevance and value.” government, industry, and patient but one we’re confi dent we have fi lled organizations can share information with the hiring of Paul Pomerantz.” Moreover, the biopharmaceutical that leads to the development of safe sector continues to grow at a steady and eff ective medicines that enhance Under Paul’s leadership, DIA will pace, driven by cost pressures, health and well-being,” says Pomerantz. continue to serve professionals stringent regulatory requirements “By growing our presence in the Asian from around the world by providing and patent expiries. Th e highly market, we extend conversation and them with the training and member competitive nature of the industry information exchange globally— benefi ts to help them meet the has been driving consolidation helping emerging markets like China challenges of the ever-changing drug and companies are increasingly and India understand the regulatory development landscape. off shoring to emerging markets to environment and advance the reduce costs. As a result, players development of safe, quality research, “One of DIA’s challenges will be to in key outsourcing destinations clinical practices, regulatory compliance embrace innovative ways to conduct have been improving their and product development.” ■

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GLOBAL FORUM 55

AN5-Paul Pomerantz Profile.indd 55 9/25/09 2:37:00 PM Working Together to Create Better Access to Better Medicines 46th Annual Meeting

heh 46th DIA Annual Meeting will be held at the Walter E. Washington ConventionC Center on June 13-17. Gaby L. Danan, MD, PhD T (sanofi-aventis)( will serve as program chairperson, assisted byb a program committee composed of distinguished experts from the pharmaceutical and related industries. The program committee has selected

ASSOCIATION NEWS ASSOCIATION Working Together to Create Better Access to Better Medicines as the theme for the upcoming meeting. 56 GLOBAL FORUM

AN3-46th Ann.1. Meeting.indd 56 9/25/09 2:39:34 PM 57 ASSOCIATION NEWS 9/25/09 2:39:38 PM9/25/09 2:39:38 PM

GLOBAL FORUM GLOBAL

■ m y, June 14 from 14 from June y, s with more than 1000 speakers from 1000 speakers than s with more from granting,cate academic program in an accredited an document that theyan document enrolled are that in a degree or ecommendation fromecommendation a professor Student Poster Session on Session on Poster Student Monda 10:00am-6:00pm sessions at from 25 content-area Attendance track and regulatory, industry, worldwide academia professionals Networking with industry of with a letter application Submit completed r whoBe student or graduate an undergraduate c certifi is consistent academic whose institution, content mission of DIAwith the least at for 12 undergraduate hours annually or 9 graduate hours annually Student Forum Session on Sunday, June 13 from 13 from June Session on Sunday, Forum Student 3:00-5:00p ecial Student Rate ualified must students Clear methods Clear Conclusions ; ; ; Q ; ; opportunities on student information and more For registration instructions, email Michael.McNair@ diahome.org. ; ; Sp DIA has a strong commitment to students as the asDIA students to the has commitment a strong pharmaceutical/health future of the care industry. In keeping commitment, DIA with that 25 is inviting Annual 46th DIA’s the qualified attend to students DC, Meeting 13-17, 2010 in Washington from June a special,for full-meeting registration fee of $25 which includes: ; , DIA’s , DIA’s Journal Drug Information he cepted abstracts will be included in the ashington, DC oom and tax only) ttend the 46th DIA Annual Meeting for one DIA 46th the Meeting Annual ttend one for inal program and will be posted DIA 46th on the or a maximum of 3 days a Annual Meeting conference website MeetingAnnual conference W f 2010 issue of t listed author (r scholarly peer-reviewedscholarly which is publication, distributed all DIA to members f One complimentary meeting registration to Bona fide research project Specific objectives and hypothesis and results of actual Analysis data One, 1-year membership DIA to student trip, ticket One round airline coach to An allowance of $50.00 per day abstracts Accepted will be published July in the accommodations A maximum of 3 nights’ hotel abstracts Accepted will also be printed in the Student Poster AbstractsStudent Poster abstracts will Poster be Call Student for The abstracts the for with a due date released shortly, contact information, more of March 22, 2010. For [email protected]. Selected poster will presenters student receive ; Student Poster Session, which offers a total of $1750 Session, which offers Poster of $1750 a total Student in prize money winners based student awarded to following criteria:on the ; ; ; ; All ac ; ; ; ; ; AN3-46th Ann.1. Meeting.indd 57AN3-46th Ann.1. Meeting.indd 57 AN3-46th Ann.1. Meeting.indd 58 58

ASSOCIATION NEWS

; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; GLOBAL FORUM Bruce Binkowitz, PhD, MA (Merck & Co., Inc., US) PhD, (Merck &Co.,Inc., MA Binkowitz, Bruce US) JohnAitken, Sciences, PhD (Gilead Inc John CMarlow, Communications MD(Advanstar Ne Mpharm NV, (NautaDutilh LLM, John ALisman, (Th Leuchten Patricia PhD (GlaxoSmithKline, US) Ian Laws, Tatsuo PhD University, Kurokawa, (Chiba Japan) Cor Chin Koerner, Pharmaceuticals (Novartis MS V.Agnes Canada) Klein,DrPH,MD (Health Canada, PhD (CareFusion, Kirk, US) Cynthia L. US) IRB, Kelso (Goodwyn Ellen R. Comm John F. Kamp, PhD, for JD(Coalition Healthcare US) FDA, PhD (ONDIO, Jacobs, CDER, Abigail C. Me (European LLM Esq, Harvey-Allchurch Martin Comm William HahnJr Branding (Science R. William W. Gregory, PhD (Pfi and D PhD H.Gladson, (University ofMedicine Barbara US) Corporation, (Genzyme Fritsche, MBA David Re J. Michael Fitzmaurice, for Healthcare PhD (Agency Shantal Feltham Canada) Inc., Research (Stiris PhD, Cavagnaro, DABT,Joy A. (Access BIO, RAC US) US) FDA, PhD Brown, (CDER, Paul C. US) LLC, Consulting, (Interop, Med K.Bross Kay Bross, US) (Forest Inc., Laboratories Boerstoel-Streefl Mariette in P PhD (University Benau, ofthe Sciences Danny A. PhD GBaum, (PfiRobert US) PharmD(AmgenInc., J. Lynn Bass, US) (Wyeth MS Pharmaceuticals, Roy JBaranello, S (Celtic PharmaDevelopment MBA Babani, Solomon Cor Scientifi Teresa (Boston MA Ancukiewicz, ervices, US) ervices, search andQuality,search US) therlands) ., US) ., US) dicines Agency,dicines European Union, United Kingdom) poration, US) US) poration, US) poration, hiladelphia, US) hiladelphia, entistry of New Jersey, ofNew US) entistry unication, US) unications, US) unications,

e Avoca US) Group Inc., zer Global R&D,zer Global US)

and, PhD, MD, MBA

zer Inc, US) zer Inc, c 2010 Program Committee 2010 Program ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; Frank D. US) Sistare,PhD (Merck &Co.,Inc., t P.Christopher Milne,DVM,JD, MPH(Tufts Center for MD, Milligan, US) JD(AmgenInc., A. Sandra G PharmaAG, PhD (BayerSchering Johann Proeve, of P James EPolli, School PhD (University ofMaryland Wayne Worldwide (APCO Pines US) L. Inc., US) Inc., Pharmaceuticals (ARIAD DPettit, MBA Ross (sanofi MS Pradip KPaul, MBBS, P Ohurce,Catherine PMP (Kyowa MS, HakkoKirin W Solutions (Medidata Frances Nolan,MBA E. United (PAREXEL Kingdom) MS Consulting, Nick, Cecil Moheb MNasr, US) FDA, PhD, (CDER, MS US) Inc., (Genentech, MS Jane EMyles, Peiling US) Yang, FDA, PhD (CDER, US) FDA, Wilson,Stephen E. DrPH(CDER, P IWertheimer,Albert PharmD, (Center MBA for C A Walters,Kris PhD, (University MS ofNorth US) Inc., (Covance M.Wagman,Bruce RAC RN, MBA, P PMP Sun,PhD, (Novartis John Z. MBA, Su,PhDLing (Wyeth Co.,Ltd., Pharmaceutical China) P (AstraZeneca MS MBA, Janet KStoltenborg, Denmark) A/S, (H.Lundbeck MSc Stewart, Mary (Targacept MSc GStarrett, Raymond US) Inc., US) (FisherGreg Saltzman BioPharmaServices, (Me PhD,Matthew DRousculp, MPH US) (GenerationOne, Rosen Don D (Takeda RN Rose, and Research Pamela Global A. US) PhD Raymond, (PHTCorporation, Stephen A. (CISSP,Th Quinn omas Th US) FDA, (CDER, Kim M.Quaintance he Study of Drug Development, Tufts Development, he Study ofDrug University, US) harmaceutical Health Research, Temple Health Research, harmaceutical University, US) harma Inc., US) Inc., harma harmaceuticals Corporation, US) US) Corporation, harmaceuticals LP,harmaceuticals US)

arolina Wilmington, US) evelopment Inc., US) US) Inc., evelopment ermany) orldwide, US) US) orldwide, harmacy, US) dImmune, LLC., US) US) dImmune, LLC., e Hollis Group Inc., US) US) eHollis Group Inc., -a ventis, ventis, US) 9/25/09 2:39:41 PM 59 ASSOCIATION NEWS 9/25/09 2:42:13 PM9/25/09 2:42:13 PM

ese GLOBAL FORUM GLOBAL

of e outcome ■ is given e DIA Award Community e DIA Outstanding Service individuals have exceededindividuals expectations have activities volunteer in their with DIA. Community Award Th recognizeto a particular community has its demonstrated that ability beto instrumental in fostering growth professional the of their while also advancingconstituents mission, visionthe and overall to commitment is goals of DIA. Th is shown excellence professional variety the through of events and opportunities community the that has Th made available. these activities increases a group or development professional individual’s and global networking opportunities achievewhile working to DIA’s the mission and vision. Award, this next award level award would be next this Award, given highest with the recognition and volunteerism in the for appreciation DIA recognizes organization. It those to contributed individuals who have mission, vision of the advancement the and values DIA of the and fostered its growth their and development through dedicated and sustained volunteerism. Outstanding Service Award Th is given recognize to thoseAward through individuals who consistently, orts, made have eff volunteer their DIA the to contributions mission and vision past over the several years. Th ect in ect cant cant Nominations are Nominations Now Open 2009-2010 DIANominations for the Board of Directors Leadership and DIA Volunteer awards are now open. Please visit diahome.org and take a moment to get involved and nominate a colleague. and e breadth ective leadership ective is given recognize to is award the Service is named e Founders Award Nominations for Volunteer Awards Volunteer Nominations for 2009. 2, close on November inExcellence Volunteer Leadership Award Th individual who has demonstrated outstanding eff during dedicated their and extensive voluntary service DIA. the to For individual10 years this or more, and signifihas made consistent servicedepth of their as a leader DIA to a lasting,should have positive eff of thellment fulfi the to contributing mission and vision association. of the ServiceFounders Award Th after group of 30 professionals the who founded DIA the in 1964 with a Association the fundamental value that is member driven and fueled by the pharmaceutical industry’s need for a neutral forum. previously Having received Outstanding the Service contributions to the Association, the to notcontributions but as a volunteer- only as a volunteer, leader in various DIA roles. Some of these roles leadership should include positions following areas: in the meetings / workshops, communities, special positions, committee advisory editorialcouncil, or DIA board, author board membership. Th advancement of DIA’s mission, of DIA’s advancement vision, and values. cant cant ard on behalf of the Medical mmunity Aw cant individuals cant e Board of Directors, ations SIAC in San Diego last June. scal oversight, and William Brassington, Acting Executive Director, and Marie Brassington, Executive and William Acting Director, Past President, Immediate withDray, Rebecca A. Vermeulen, who accepted the Co Communic Nominations for Board of Directors 2009. close October 19, ServiceVolunteer Awards being are accepted Nominations Volunteer in Excellence the for Founders the Leadership Award, OutstandingService the Award, Community Service and the Award, www.diahome.org/ Visit Award. awards. Leadership Award DIA Volunteer designed are Nominations to recognize signifi in the or group accomplishments development, regulation, discovery, surveillance, or marketing of productspharmaceuticals or related recognizeand/or to signifi volunteer contributions to the the to contributions volunteer Board of Directors being are for accepted Nominations and Board Treasurer President-elect, www.diahome.org/ Visit Director. information more nominations for name of a DIA submit the and to member or colleague. e the Board of Directors are Th stewards DIA of the Mission and ey provide strategic Th Vision. planning, fi future of the leadership the for association. Th electedare by members, and set the overall strategy DIA for activities. AN2_Board Article.indd 59AN2_Board Article.indd 59 AN7-Global Vaccine.indd 60 60

ASSOCIATION NEWS

Global Vaccine Development Global Vaccine GLOBAL FORUM I Global VaccineGlobal for Development present ourfi will DIA agencies, andother regulatory global EMEA TB Vaccine Foundation, the FDA and for Health, the Global Global Aeras Ventures BIO Network, Regulatory Vaccine Countries the Developing the International Vaccines Initiative, the Bill&Melinda Gates Foundation, n collaboration withsuch the World Health Organization, as andorganizations associations DIA Convenes rst Symposium Foundation. Dr. Brennan’s “US article for TBVaccine the Global Aeras forAff Global Advisor Senior as Dr. Michael Brennan, serves who also Th 3-4. on November MD Conference Center inBethesda, Hotel Marriott North & the Bethesda (#09023)at Perspectives Industry & NGO, Regions, Emerging EMEA, World FDA, Symposium: Health is symposium is co-chaired by isco-chairedby issymposium airs airs promising products for global promising products of new, anumber organizations, nonprofi internationally focused, “Th the with ofthissymposium global importance v.6(7), the July 2009. He discussed Journal Medicine (PLoS) Science of inthe PublicLibrary published Vaccines was forDiseases” Global FDA aPathway Provides for Licensing rough the eff Global Forum. orts orts of 9/25/09 2:45:45 PM t 61 ASSOCIATION NEWS 9/25/09 4:13:33 PM9/25/09 4:13:33 PM

GLOBAL FORUM GLOBAL can be hard to spot can be hard Strategic planning from early product development product early planning from Strategic submissions and publishing (eCTD) Regulatory and EU QPPV Pharmacovigilance Appeals and Hearings ‘due diligence’ Licensing and user testing leaflet Package Local advisors in 60 countries Local advisors REGULATORY AFFAIRS & PHARMACOVIGILANCE CONSULTANTS & PHARMACOVIGILANCE AFFAIRS REGULATORY I I I I I I I qualified and enthusiastic team of consultants Our highly to help and scientific experts is ready Road Marlow House, Wessex Associates Limited, Wainwright Buckinghamshire SL8 5SP United Kingdom Bourne End, +44 (0)1628 530559 +44 (0)1628 530554 Fax: Tel: [email protected] Email: www.wainwrightassociates.co.uk Consultants with the right Consultants pedigree

■ new vaccines prevent to cally, cult sponsors for of these products. clinicalnd a regulatory the for pathway trial products of their review licensure – for and ultimately manner without compromising in a timely AND doing this Brennan. concluded Dr. product,” quality of the the Th eir taskto fi is Th diseases clinical for now testing in populations available are needthat most; them specifi diseases like tuberculosis and malaria and African meningitis, as as well drugs things like combat to drug-resistant tuberculosis and malaria, and diagnostics recognition rapid more of thesethe infectiousfor diseases,” explained. Brennan Dr. trials of these“Clinical products regulatory require review regulatory use by a national before in volunteers, authority process by a a licensing successful, through and, if proven and other So US and Europe, in the regulatory authority. resourced well like Australia,places Canada and Japan, regulatory authorities review evidence the quality the for product,of the clinical the trial protocols, data and the resulting from these trials. Experienced teams from these authorities inspect clinical the trial sites and manufacturing facilities where emerging countries as But in many well. new products global for diseases beingare tested, and need be to less licensed, are regulatory stringent there authorities, and, in some cases, no regulatory agency at all, which makes it diffi AN7-Global Vaccine.indd 61AN7-Global Vaccine.indd 61 AN6_4 NewTraining Offerings.indd 62 62

ASSOCIATION NEWS Debuted in2009 New TrainingOfferings 4

GLOBAL FORUM governmental or health authority orhealth governmental companya pharmaceutical than a for are moreFew important events Certifi Research Clinical Th off be and will 2. onDecember ered PhD, Chamberlain, Inc.), (ECS, MS L. by Richard instructed be will computer Th system. yourown ordevelop to purchase whether andhowto decide life cycle, forplan validation yoursystem’s howto applicable regulations, computerof basic validation, the details course #09459)describes computer Professional ValidationSystems fortheNon- First off inMay,ered Computer off December for headquarters worldwide DIA to in2009return debuted earlier thatinstructor-led trainingcourses Four changes. new these pace with professionals keep to help industry off educational and deliver new continues to DIA develop evolve, A is course is also part ofDIA’s iscoursepart isalso pharmaceutical industry industry pharmaceutical in the used and techniques s the technology, science, erings. is course cate Program. (training erings erings Barton L. Cobert L. Barton fi (#09467), Inspection for aSafety How toPrepare oraudit. inspection will be nomore than fi be will a recent Generally, statement. there comments in madeseveral the FDA, Commissionerof the new Hamburg, Dr. “Dr. suggests. Cobert Margaret today,” development indrug topics “Th instructor. as serve will Associates) (BLCMD , MD, FACP, Cobert L. Barton FFPM to end. beginning from inspections these prepare for andsupport 7,explains howto on December inspection fiinspection nding Form 483;after todays anFDA for response allowed rst off is is one of the most relevant relevant isoneofthe most ered inAugust ered andreturning fteen fteen business bow ofindustry,bow telling usto pay “Th publically.” washed be FDA linenwill website, allthe so dirty onthe public:It be be of this will will FDA bycompanies are fulfi to ensure that madeto the promises system FDA acloseout isdeveloping theto Finally, publichealth. protect – IMMEDIATE ifneeded –action are toimmediate able take andwilling on time.FDA that indicated also they fulfi itto be expect completelylled and they ispromised, ifaction proposals; bytheon action sender expect byindustry, and proposed actions andcomment corrective upon review other enforcement Th actions: letters and onwarning follow-up rapidly.and act FDA prioritize will coordinate will responses they health, than to Ifthere before. public isarisk international offi well as state, as andfederal), (local, inthe US partners other regulatory workingwith FDA nowbe will communication to the company. minimalor nofurther with action letter other ortake enforcement thethat, FDA issueawarning can is is basically a shot across the ashotacross isbasically cials, cials, much more lled. lled. Much ey ey will 9/26/09 12:13:47 PM 63 ASSOCIATION NEWS 9/26/09 12:13:59 PM9/26/09 12:13:59 PM

■ is fteen nd these nd nitely want nitely GLOBAL FORUM GLOBAL ultimate is is the clearer is a much ere to see that you have established see you have to a that process signal for detection and, if nd a signal, communicating for you fi regulatory appropriate the to that Th authority. perform to legislative mandate signal he concludes. detection in Europe,” regulatory within fi authorities became days. It physicians’ the and pharmaceutical organizations’ data;responsibility this submit to it was to regulators left the to or an data identify in that trends any be could underlying signal acted that upon. Generally speaking, is this how adverse event reporting worked several for decades.” 1990s and early late in the “However, 2000s, several on the drugs were that bemarket had to withdrawn. Th led introduction of concepts the to such as risk management: how can we risks the mitigate of these products after they’ve been the for approved market, and how can we assess these risks strategically their to plan for Signalmitigation? detection is a assessment the for prerequisite of a risks.product’s Th purpose of drug safety:fi to preventsignals adverse to in order events, like those from thalidomide.” Act Amendment US,“In the FDA the (FDAAA) of 2007 required companies who own is somewhat what loosely ned as a ‘risky product’ perform to defi cannot risk management. You without management’ ‘risk conduct assessment’ a ‘risk conducting and to assessment’ a ‘risk conduct you should perform signal detection and data mining. So it is not clearly although legislated US that or regulated in the performyou must signal detection, youit IS legislatively that mandated performmust risk management, and signalyou should conduct detection 9A is the point. that getto to Volume pertinent legislation if your in Europe: products sells company in Europe agency, by a European and is audited inspectorsthe would defi

c side c ered for ered c birth defects. Regulators illustratesrst time in August. It data mining and signaldata detection techniques uncovering potential for drug safety signals your and improving pharmacovigilance operations. Steve, who has worked in drug safety 1985 with a specialsince focus on signal detection mining and data pastnearly the for decade, explains and the background topic the of this training course:timeliness of this “Drug safety and pharmacovigilance originated early 1960s with in the a drugthalidomide, taken by pregnant it waswomen until it discovered that horrifi caused UK and subsequentlyin the US in the agreed was this and that unacceptable something be must that done; they established processestherefore for detecting adverse drug events after products had received marketing ese processes were authorization. Th detect to intended adverse events early prevent such horrifienough to ects from ever happening again. For eff decades, four next the drug companies ort collect, to assess, and made an eff report adverse event with a special data emphasis on serious unexpected events, be which had to reported to the the fi the On December 8, Steve Jolley, MA (SJ Pharma Consulting) will serve as instructor Introduction for to Signal Detection & Data Mining (#09468), which was also off instructed by Albert S. Yehaskel, MBA (Refuah Global Pharmaceutical Development, Inc.). Steve Jolley is is is course course is ey will ey cult, will cult, and willered be in April is is good public for rst off rst in India,ces China, and Latin important is nding occurs and that was fi attention and that inspections, and that attention always diffi which were Dr. explains now be even so,” more Cobert. “Th the monitor job to FDA’s health. It’s industry make sure to and others everyonethat – manufacturing, laboratories, clinical trials, drug job. People safety – is doing their be theynow must fully that aware will be inspected. has set FDA up offi America will amongst do, that things,other inspections outside States. United of the Th most also more conduct likely pharmacovigilance inspections. EMEA the In Europe, is already aggressively doing inspections, as Member the are States, as as well world, the around countries other a If and they talk each to other. fi critical, will word get out quickly in immediate age, forcing Internet this action and responses. critical So it’s DIAfor members and everyone industry understandin the to else new rules game: to of the How conduct, how to and prepare for, respondhow to inspections. to Th highest message the should go to because levels if company in the an inspection reaches problem that stage the of a warning letter, goesletter CEO the to of your When your CEO gets a company. very FDA from the letter unhappy in response an inspection to that CEOobviously that did not go well, he not reactwill happily,” surely concludes. On December 3-4, Utilizing Chemistry, Manufacturing & Controls in Drug Development for (#09453) outlines a roadmap CMC regulatory the navigating maze, including how compliance CMC for meetings prepare to write and how to FDA with the or assemble CMC sections of regulatory submissions. Th AN6_4 New Training Offerings.indd 63AN6_4 New Training Offerings.indd 63 AN1_Tailoring EPM Capability.indd 64 64

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GLOBALGLO FORUM BAL FO FO RUM their portfolios, projects, and studies. andstudies. projects, their portfolios, around eff challenges large companies stillfacefundamental many investments inEPM tools, Despite How are resourcesallocated? managed? andtimelines How are budgets studies. and projects, portfolio, and executes its to howacompany determine controls, plans, come together andprocesses—must people Th that contribute to aneff EPM capability.ective onallofthe elements focusing spent better isthe “best.”which tool Th be would atenergy ondebatingmuch energy anddetermining too date, far many companies have focused alone donotconstitute anEPM capability. To in executing anEPM strategy, tools these invaluable be can solutions While technology right EPM capabilities? the anddeploying designing — ensure they’re that those are smallto mid-size —particularly company?size companies And,howcan an investment for every inEPM makesense potential oftheir Does the EPM tools? full Are companies realizing persist: questions and doubts yet implemented EPM tools, “bigpharma”Most companies have initiative industry. inthe pharmaceutical For fi the last company culture. ofthe company, the needs portfolio, andthe oftheon the company, size ofthe the size depends really used of anEPM shouldbe extent to whichthe diff andwhat-if Th metrics operational analysis. suchas could consist also ofother modules and whoisavailable andwhen.AnEPM to what work whoisassigned understand to resource allocation named it could utilize or to calculate resource demandprojections resource management could algorithms use For items exist. ofthese variations example, andmany parts, orallofthese of some EPM capability consists and resources. costs, accomplished timelines, bymanaging is Delivery anddelivered. executed, controlled, andstudiesare planned, projects, ofhowaportfolio, capability consists management (EPM) project An enterprise What isanEPM? ose elements—technologies, as well as well as as elements—technologies, ose ve years, EPM has been a hot ahot been EPM has ve years, ective management of management of ective erent components 9/25/09 2:49:32 PM e 65 ASSOCIATION NEWS 9/25/09 2:49:35 PM9/25/09 2:49:35 PM

GLOBAL FORUM GLOBAL rst step in e fi e erent, and a one- State Effort Quality Current Resource ts-all strategy or solution isn’t Business need: Th your design and deployment must be a careful understanding of why your organization needs an EPM processes What will becapability. ected? questions do you What aff and how will you need answer, to

organizational structures, sets and data puts your organization — whatever its size developing — on track to an ective capability. EPM eff • Finding the Right Fit Finding can enhance your company EPM, With you perform way the strategic planning, including how you evaluate potential targets. and alliance acquisitions as Just important, you can decrease costs and cycle into insight greater times through timelines, costs, and resources. But how can you determine right the your organization? for approach EPM is diff Every company results yield the to you seek.likely In fact, it will lead wasted probably to Basedtime and money. on experience, advised well are companies carefully to assess following factors the when determining design how to and deploy capability: EPM their size-fi ned, ned Timeline Data Communication

Finance Data Organizational Structure ective R&D ective People Implementing standard tools Implementing Common data points Common data clear structurenitions create and your people Are clearectively. are crucial developingare to and an eff maintaining does How yourmetrics capability. organization use metrics? Do you a set reports of common have and metrics managing portfolio, for the project, assessing and studies and for risk? Is metrics reporting automated or manual? Data: People: Standard team role and People: defi expectations working together for eff about project teams and study defi teams? well Do you have processes?governance and approval Is your organizational structure well suited centralized to project and portfolio management? Tools: projectsfor and studies is imperative. Does your organization lack standard tools, standard tools? If you have theyare adding value project for teams, they or are cumbersome tools the fully Are and complex? integrated with your processes?

Working toward standard, well defi standard, well toward Working and well integrated processes,and well tools, • • • Reporting Strategy Interaction & Execution Technology rst, Operations answers.erent Often, patents” from expired ve diff ve

cult justify to need the for

Decision Making Decision Resource Management Data Management Resource Resource Management Process Hiring Process Processes: Standard project processes a and study are portfolio for critical foundation management. Does your organization lack processes, your processesare poorly understood, your processes or are not integrated? Is a lack of standardization impeding your report to ability on and understand position?your current

Figure 1. An Example Model of an EPM 9 Resource Management Components Are Measured on 3 Dimensions across Operations, Strategy, People, to Determine Needsand Technology Assessment • perform an honest assessment of how in anyyour organization improve could following areas:or all of the executives shocked are discover to resources allocatedthey a study to wasthought on hold or cancelled. of studies and high cost Given the projects, a mismanaged portfolio is propositionan expensive — and that’s particularly looming true of the in light cliff “revenue expected in 2012. needAs the you consider implement to fi capability, an EPM or enhance The Case for EPM diffi isn’t It ve executives from one AskEPM. fi studies and projects what company portfolio, in their are are and chances getyou’ll fi AN1_Tailoring EPM Capability.indd 65AN1_Tailoring EPM Capability.indd 65 AN1_Tailoring EPM Capability.indd 66 66

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Figure 2: A Sample EPM Assessment Template EPM Assessment 2:ASample Figure GLOBAL FORUM • •

Resource Management Process Maturity Model Component for the annual process? budgeting ifat all, used, itbe Howteams? will your the EPM capability support EPM touse them? address How will attention whilebuilding Pay close culture: Company reporting. data integration, and processes, yourEPM onoutsourcing focus ofyourR&D, most you outsource If model. yourbusiness but also ofyourorganization, only the size your EPM capability around not Fundamentally, youshouldbuild EPM application.build acustom to larger need companies often off use often companies can and mid-sized Small needs. large organization different or what from amid-size quite company be will requires benefi EPM.t from Butwhat that more can than 50employees and indevelopment project company more with than one Typically, size: Company any (also Annual Budget and Strat Resource Management Data Management Resource Organizational Structure Decision Making Decision Communication Hiring Process Timeline Data Timeline Finance Data -the-shelf -the-shelf products; Reporting Planning)

Quality State State Quality State Quality State State Quality Effort State Effort Effort Quality Effort State State Quality Effort Effort Quality Skill Quality State Quality Effort Effort Effort Dimension

Low Maturity Issues & Risks Not Fully Understood NotFully & Risks Issues Not Tied to Resources, No Scenario NoScenario Not Tied Resources, to Not Consolidated, Some Project Project Some Not Consolidated, Does Not FitBusiness Needs & Fragmented, Not Fragmented, Consolidated Milestones Known Milestones

Many FTEs Many Planning Process Ad-Hoc Project None None High High High High High Low Low Low Low Low Low N/A N/A N/A N/A N/A N/A is complete, yourorganization Once theframework modeling andoverly complex. overwhelming, Without become thecan process it, communicating andplanning. way ofthinking, astructured provides Figure 1).Modeling quality (see current state, resource eff component dimensions: three against each andassess interdependencies, map their the components, Identify it. bymodeling management –start resource management ortimeline plan to fi tackle ofEPM you aspect Whatever Model forSuccess 1

EPM capability. aminimalapproachtake to your bureaucracy, youmay to want of If you’re smallandleery culture place ondata andmetrics? your how much does emphasis For andtools. example,processes and the complexity ofyour organization’s ofgovernance level your EPM capability to your

Not Consolidated, Some Project Project Some Not Consolidated, Does Not FitBusiness Needs & Fragmented, Not Fragmented, Consolidated Understood- Many Decisions Many Understood- rst —whetherit’s Not Tied to Resources, No No Resources, Not Tiedto Issues & Risks Not Fully Many Stakeholders Many Milestones Known Milestones Scenario Planning Scenario Few FTEs Process Mediu Mediu Ad-Hoc Ad-Hoc Project High High High High High High High Low Low Low Low Low Low Low Low 2

ort, ort, and

Known Issues & Risks- Fits Business Needs & Needs Business Fits Tied to Resources, No No Tied toResources, Standard Milestones Standard Many Stakeholders Many Scenario Planning Scenario Consolidated, No No Consolidated, Few Decisions Consolidated Many FTEs Many Moderate Proactive Process Portfolio Mediu Mediu Mediu Mediu Ad-Hoc High High High High High High High Low Low Low Low Low 3

creating amo creating Perhaps importantly, most template to for use the assessment. Figurebut next, 2 provides a vary onecompanyfrom to the can need Themodel. assessment where youare inamaturity define whichwill assessment, amore detailed develop can pharmicaconsulting.com. Matt.Kiernan@ contact please Management SIAC, Project DIA If you’d like moreabout the tolearn Community. Interest Area Special Management Project of theDIA Consulting and Pharmica amember in Matt Kiernan apartner is improving qualityoflife. oryour missionofsaving lives manner, achieve youcan so timely, andcost-effective efficient, to marketinamoreproducts andbring to develop organization EPM your capability empowers “fit for purpose.” Ultimately, your that asolution istrulydevelop asse an in-depth

Fits Business Needs & Needs Business Fits Tied to Resources, No Known Issues & Risks- Known Issues Consolidated, Ad-Hoc Consolidated, Scenario Planning Scenario Key Stakeholders Key Many Decisions Many Moderate FTEs Project Plans Project Consolidated Consistent Proactive Portfolio Process Mediu Mediu Mediu Mediu Mediu Mediu Mediu Mediu Mediu Mediu Mediu Mediu High High High Low Low Low 4

del andperforming

ssment helps youssment helps

Consolidated, Standard Standard Consolidated, Known Issues & Risks- Known Issues Fits Business Needs & Needs Business Fits Tied toResources, Scenario Planning Scenario Key Stakeholders Key Many Decisions Many Project Plans Project Consolidated Consistent Few FTEs Proactive Portfolio Process High High High High High High High High High Low Low Low Low Low Low Low Low ■ High Maturity 5

9/25/09 2:49:35 PM

67 ASSOCIATION NEWS 9/26/09 12:09:54 PM9/26/09 12:09:54 PM

GLOBAL FORUM GLOBAL help advance the help advance the How canHow eClinical initiatives pharmaceutical industry’s current emphaseson transparency and drug safety? use of these the Through eClinical tools, stakeholders in clinical, (professionals data, and statistics departments, plus cansenior have management) in a more data their to access real-time better and, in theory, Data can be quickly quality way. accessed and presented a wide to variety provide to of audiences early detection in safety, of trends enrollment/recruitment, data design.quality and study These tools can be used improve to quality and lead overall data assured more study quicker, to decisions. also leads the to This transparency you suggest in your use of the question. Through eClinical tools, one can gauge integrity quality and data data because that is the most commonly because most commonly is the that recognized, and has been used longest the and most probably of eClinical tools. widely, “eClinical” and “electronic and “electronic “eClinical” If most experts agree that eClinical eClinical and and for Today for Today Tomorrow Tomorrow data capture” are related but are not synonymous terms, do they then why seem to be so often used interchangeably? but related, absolutely They are they same. EDC,not the are is one of capture, electronic data used are eClinical tools that many by clinical research to professionals clinically orientedcomplete tasks collection, monitoring, (data site payments, randomization, study drug and patient- management reported collection, name data to a few). to eClinical data allows for be collected in a less and arduous In talking about manner. manual eClinical, people EDC to often refer trials in an electronic manner. It It trials in an electronic manner. or of a thing application is the a verb things (a noun or nouns) to the (action or process) enable to of a clinical trial. management eClinical tools a noun, but their are our processes to application is a you useverb. How it within the is what’s clinical trial environment important. the linical cal rd of to the DIA linica,c.), In who l concepts continue nteer community. to emerge throughout the to emerge throughout discoverydrug and linical SIAC s eClinica ere has been much discussion but seems to be Th precious little consensus: Like the a is “eClinical” word “interface,” noun (a thing) or is it a verb (an action or process)? eClinical is a thing, or a series/ collection of things. constitutes It process of clinical the or conduct member volu and development spectrum, they become more important frequent and topics for discussion industry among professionals of every function and Andrus,discipline. MS, Jonathan CQA, CCDM (BioC serves as of the DIA Chair eC Society for Clinical Data these shared Management, thoughts on the importance of eClini the value initiatives and to industry, of the eC SIAC and also on the Boa and SIAC Jonathan AndrusJonathan A AN4-Q&A with Jonathan Andrus.indd 67AN4-Q&A with Jonathan Andrus.indd 67 AN4-Q&A withJonathan Andrus.indd 68 68

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monitors performing inaccordancemonitors performing Are mymanagement perspective? How are aquery wedoingfrom quality, transparency, andsafety. – the noun–to improve data byusingthe toolsmore effective –the process verb–muchtrial to makethe tools clinical these use word yourqueries.” you How can orthe way that youperspective astudy from things designthese ifyouwere helpful doing really be I’m itwould “While monitoring, conversely, say, can the CRA their monitoring; role during to help themperform better CRA insightshares a with orguidance matter who’s expert adata manager asubject Maybe professionals. We’re research allclinical andprocesses. tools eClinical ePRO: It’s about management or orvalidation It’s data notjustabout through eClinical! addressed safetyitems thatand drug be can examplessome ofthe transparency These are just reported? are being that events ofadverse significance and What are the type needed? isadditionaltraining reported, are terms beingAE andConMed along? Judging the from way that manner? How moving iscoding inatimelyup andaddressed cleaned being doing? Are queries trends? How are the data managers to observed address needed be trainingmightadditional/refresher are onsite? Whatdone whenthey How much getting work are they whenexpected? their site visits conducting Are they performing. are howpersonnel determine insight gain intocan the data and involved Allparties data. eClinical onall aneye to keep needed the transparency provides tools Further, reporting usingweb-based etc. changes, study design changes, data trends, for query by looking GLOBAL FORUM all the different to help affect study outcomes. to help affect know, tools eClinical use actually refresher training–yourequires it Maybe of data discrepancies? numberthrough anincreased whichwe’rethe sites, seeing thatthe study are design confusing timelines?Are ofwith there areas is a big goal of the eClinical SIAC: oftheis abiggoal eClinical more common andcohesive goal workingtoward a parties research allclinical Getting eClinical? that employ in they processes that wouldhelp to improve the share adata manager with CRA what andinturn, a can fulfilling, andmoretheir more job effective that wouldmake aCRA with What adata manager share can together?work more effectively profession research the clinical within roles specific the functional, Professional. How canResearch for practices the Clinicalof best rather embrace more ofamodel but for practices the CRA, best forpractices the data manager, or We toaway want get best from research? allofclinical across weworkHow more can effectively with? struggling industry within are Whatpeople trials? areas clinical anddeveloping designing, improve the qualityofplanning, and to helpeClinical speed standards withindo weutilize redundant How data collection? with existing to tools help reduce and interface more effectively How doweintegratediscussed: previously issues advance further to tools these andutilize deploy andhowto properly trials, clinical inthe conduct tools ofeClinical implementation of anduse relatedtopics to the successful We to tackle are looking help meet? SIAC theeClinical can community What needs of the clinical oftheclinical What needs research/drug development development research/drug [email protected] [email protected] to at contact medirectly jonathan. free feel orbrainstorm, share ideas Tonot aspectator! involved, get aparticipant, Be changes. industry of onthe cutting edge future. Be Have a say development. intheits of apart toand guidance you.Be to standardsor consortium bring for asociety,and wait association, this change.Don’t justsitback of apart andbe involved get can It to note that isimportant anyone initiatives? eClinical interest to ourassociation. ofmost be andwhat SIAC will withthisarea that bridged be can That’sjust onesinglegroup. the not allofus, thatguidance benefit and practices best developing and needs these to serving geared be shouldreally SIAC eClinical itthat way,And ifyouview this professionals. research clinical butwe’restatisticians, all“CRPs,” not notCRAs, data managers, We’re professionals. research not this enough:We’re allclinical emphasize Icannot different areas. andcovers allthese embodies “silos.” industry those eClinical of some to down break to start place is a great SIAC the eClinical strongly feel Ireally thatback. areofpushing stillkind people work more together, closely but are tools forcingeClinical usto to together. come closer These andresourcesthat need people, processes, differentthese tools, ofa“clearingis kind ofall house” isthat SIAC the eClinical eClinical drawn to Iwas One ofthe reasons cohesive conclusions. at matter to arrive experts subject together differentthat brings related to the profession inaway We totopics tackle are looking What did we not ask you that youthat What wenotask did you would like to share about about share to like would you ■ 9/26/09 12:09:58 PM 69 PROGRAM NOTES 9/25/09 3:13:49 PM9/25/09 3:13:49 PM

GLOBAL FORUM GLOBAL to contribute to the FDA Data Data FDA the to contribute to keepStandards Council to these movinginitiatives forward. contributed presenters Numerous industry the share to perspective subsequenton SPL in the session. Dragan Obradovich (AQR, Abbott) described transition from how the paper electronic to submissions opportunity not only created the clearly chart to his company for come streams that information the an electronic create to together submission, but also allowed them and remedy discover to gaps in those streams. (Bristol-Myers Fahmy Michael describedSquibb Company) new process flows, issues and how they were encountered, resolved, in transitioning from paper electronic to establishment code registration and labeler Industry & FDA Industry & Listing Updates Share SPL & eDrug Share SPL from these participants afforded opportunity with the FDA to refine systems these and input Smith validation procedures. Mr. process the updates to explained requestingfor and assigning drug DUNSestablishment numbers, resolvingfor discrepancies between 3 and posted SPL Rev. 4 versions,new and for SPL Rev. updating drug listing information or merger company due to in the topic a timely acquisition, industrycurrent environment. also describedHe eList common program submissions errors and Smith resolve Mr. to them. ways concluded by summarizing the of SPL and accomplishments electronicother listing initiatives past over the three years – for unique 4,670 than more example, SPL documents on available are DailyMed as past of this August – and encouraged attendees eDrug

eaturing vendors who eaturing vendors who

showcased technology for electronic drug F Listing & Establishment Registration: & Industry: FDA Overview & Lessons Learned on industry brought SPL and regulatory to together stakeholders future of these plan the help was initiatives. conference This on (PA) presented in Philadelphia with collaboration 11-12, in August Products Consumer Healthcare the Association, Generic the Pharmaceutical Association, the Care Products Personal Council, Pharmaceutical and the Research & America. of Manufacturers was preceded conference This by two popular optional events: Lonnie Project Smith, Manager Structured Product FDA’s for instructed Labeling & eList Team, a two-part Basics,” “SPL 101 – The overview electronic of the drug registrationestablishment and drug product listing submission process using SPL format. This primer was followed SPL by the Showcase, numerous where Vendor vendors presented demonstrations electronic available of currently tools and publication conversion and services to attendees for evaluate. opened following day The with 4 on SPL Rev. update Smith’s Mr. agencyfrom the perspective. He summarized results the pilot of the period electronic for establishment registration and drug listing (July 2009) in which more 2008 – May voluntarily 70 companies than participated. feedback The received establishment and product listing and productestablishment listing using Structured Product Labeling XML content (SPL), and related initiatives, along with agency representatives responsible the for and regulatory implementation of these initiatives,oversight PN1-eDrug ListingEstab. Reg FDA Ind.indd 69PN1-eDrug ListingEstab. Reg FDA Ind.indd 69 PN1-eDrug ListingEstab. Reg FDAInd.indd 70 70

PROGRAM NOTES

GLOBAL FORUM submissions until recently, most electronic notrequired has Center for Veterinary Medicine Animal Health), butsince the explained Garcia Carol (Alpharma JuneSPL initiative 2009, effective brought intowas the electronic industry medicine The veterinary circumstances. industry butnotuncommonother special and labeler anddistributor; final manufacturer, coater, product and the bulk as serve other locations NDA butdifferent companies in where one company holdsthe for products other companies; with inpartnership developed submissionsfor products such as “real world”various scenarios, explored Michael further requests. presentations bysummarizing Company) the concluded industry Morgan (Perrigoand Devon Consumer Healthcare R&D) Paula (GlaxoSmithKline Markert realize. submission regulations than they of compliance electronic with them more control overthe cost and implementation give will attendees thatplanning careful encouraged Carol outsourcing. ifyoupursue providers service example –andconsiderations for for outsourcing, resources vs. companies –usinginternalthese implementation alternativesfor herpresentation on She focused minimal XML/SPLexperience. companiesanimal health have conference. this concluded representatives Mr. Smith andother FDA of questions asked attendees whereAn interactive session your submissionprocess. Identifer(s),Ingredient in early party, andofyourUnique etc.), manufactured byathirdvs. manufactured vs. (imported the complexity listing ofthe drug andplanningfor of recognizing the importanceThese included drugs. for prescription listings compared to processes these anddifferences ofsimilarities andthe products, monograph counter andOTC (OTC) drugs listingofover-the-electronic encounteredissues inthe ■ 9/25/09 3:13:51 PM 71 PATIENT PERSPECTIVE 9/26/09 9:16:04 AM9/26/09 9:16:04 AM

nd a nd GLOBAL FORUM GLOBAL e story below is rom a series of articles created by CISCRP as part educational of their awareness campaign to increase public that understanding to those volunteer who participate in clinical trials genuine are Heroes.” “Medical Th Th f e prognosis was Jenna began dire. Leukemia & Lymphoma SocietyLeukemia San & Lymphoma Diego/Hawaii chapter. Fred Jenna transferred the to Cancer Research Hutchinson she was in Seattle. There Center diagnosed with myelodysplastic syndrome, in which blood that cells develop bone in the marrow are defective and die off. Th but she chemotherapy, undergoing needed a bone marrow transplant survive.to fi time to Her donor wascompatible limited, even she wasthough weekly getting blood transplants. ey basically parents my sent But the nurse told her she looked told nurse But the terrible. “When she pricked my of blood, a drop nger for it didn’t fi Jenna. had says “It even look normal,” a consistency like Kool-Aid; it was very clear.” Jenna was rushed local the to e doctors, who had little hospital. Th initially withexperience blood cancer, misdiagnosed her with aplastic anemia, body in which the a condition stops producing enough red blood cells. “Th home and said they should get my recalls Jenna, who at airs in order,” aff director the age 35 is executive for ure canure vanish in an instant. a bright, then Jenna Korb, what at’s Th from Montana, student college lively learned school the to when she went a check-up. for one day nurse Jenna hadIn 1993, then-19-year-old been and lightheaded. feeling exhausted She decided nurse college by the drop to checkup. a spur-of-the-moment for on the get a quick slap I’d “I thought sleep more not getting hand for Jenna. says and not eating better,” Jenna Korb: Back Korb: fromJenna the Brink of a promising thoughts Happy fut PP1-Back from the Brink.indd 71PP1-Back from the Brink.indd 71 PP1-Back fromthe Brink.indd 72 72

PATIENT PERSPECTIVE

I got great at tying scarves.” atI gotgreat tying sick,” “Ididn’t Jennarecalls. awig; get so my to hairandlooking lose was things “One devastating ofthe most overwhelming. experience was were inthe bigcitylife, andthe whole heredone much so we traveling yet, home. We’re Montana from andhadn’t youhave group at the whole support devastating,” “You says Jenna. lose “Itfor the treatment was period. Jenna’s to Seattle moved family pretty good,”which was says Jenna. find amatch; mefour months, ittook “Th that wouldhelp nausea.” relieve treatment Icould during take a drug “Th says. versus10or15,”one pillafterward she that wouldallowmeto take rejection for “One amedication was trials. intwo to participate Jenna decided hertowant responsible.” feel Ididn’t because make the decision the time.ButIdidn’t my let mom at“My ofattorney momhadpower usandmakerecommendations.”with throughto usandread sitwith them Th mean. what they wasn’t ere anyone andyouhave noidea documents that time.You at medical those look mentally capable at notvery “I was or two.’ it.” Andthat was youpickone ‘Here are youroptions, Th ofpaperwork. thick stack “Th Jenna. mefor the transplant,”prepped says they before mentioned the phrase “I don’t heard even think Iever trials. in clinical part taking Jennaabout approached the b to getting ready undergo shewas As Her Decision No Time Time toTh toTh ink About GLOBAL FORUM ey told me I had six months told meIhadsix to ey one marrow transplant, doctors doctors transplant, one marrow e other was a clinical trial for for trial aclinical eother was ey walked in with a very avery in with walked ey ink ink About ey ey said, from college, met and married my my andmarried college, met from “I’m 100%healthy.past. Igraduated areNow the inthe treatments andtests transplant.” marrow to bone rejection andit’sout there working, helping with that isstill Ihadtaken to something see neat really butitwas toadjustments it, later. 7years disease Th transplant after for her same drug that at thecenter given leukemia was name now, butoneof my co-workers particular drug and it has adiff andithas drug particular “Th herdisease-free. declared doctors later, years improved. Seven Jenna’s Gradually, Jenna’s condition says Jenna. many taking more,”could have been that that onepillversusthe fact I “I held ontotaking that the fact Iwas coma. putinto adrug-induced was point andat one times, intensive several care marrow.the bone Shewoundupin of herbody’s with rejection struggled Jenna as appeared challenges New Th youto wewant take.’ everything taking you’re because not drugs to allthese ‘We can’t eff Th pills. the totaking skip “Istarted says Jenna. taking,” Iwas amount ofmedication the with overwhelmed thatpoint Iwas Airfl Ihadgottenow room, to the stillinthe Laminar Iwas “When tocould infection. lead of any orpathogens impurities that the airfree keeps which essentially airfl 40 days inaLaminar smoothly. Jennaspent Afterward, Th everything.” recorded andthey the pills, taking My was centralized. responsibility didwas they “Everything Jenna recalls. Hutchinson were well organized, Th e clinical trials procedures at Fred at Fred procedures trials eclinical ey monitored me very closely.” mevery monitored ey e bone marrow transplant marrow went ebone e cool thing was I took that that Itook thing ecool was e researchers came in and said inandsaid came eresearchers ectively track your response trackyourresponse ectively ey’ve made some madesome ey’ve ow room, erent erent tracking certain neurotransmitters. neurotransmitters. certain tracking (than thefor then-current method) to fiwas expensive method nd aless Thimages. trial goal of etheclinical to camera create dye andaspecial that test aradioactive imaging uses anuclear scan, getting aSPECT 3hoursaway.was Th which University NC, inDurham, at trial Duke found aclinical Linda anonlinesearch, In 2005,after might available. be treatment new whatever and get for Parkinson’s trials clinical Disease invarious outtopart take set Linda mentioned.” been even never fl Iwas Disease. said it’s likely most IhadParkinson’s and methe week following “He phoned andthen sawMRI, aneurologist. a year, went Linda to herdoctor, hadan When the didn’t twitching improve after ” is exactly were what doing. they were continuallysynapses fi It felt likemymoving. and muscles that thigh my kept was symptom left “Th byothers. followed Th them andsaid,‘Hey, isn’t that weird?’” itto Ishowed saw my twitching. toe and to my talking twosons, and was uponthe chair propped “I hadmy feet amiss. was anything serious butdidn’t odd thought itwas think she twitching, hertoe noticed NC, andmot pharmacist Morgan, a54-year-old When Linda Control ofHer Parkinson’s Disease Disease Trying Morgan: Trying toTake to TakeLinda good,” ispretty“Life darn says Jenna. diagnosed. ofbeing 16th anniversary celebrated andtwocats her retriever year, herhusband, their golden Jenna, toDiego.” San husband, andmoved Th at at fi rst symptom in 2004 was in2004was rst symptom oored. Parkinson’soored. had her from Asheville, Asheville, her from e trial involved involved etrial e main ring, ring, which 9/26/09 9:16:09 AM is is 73 PATIENT PERSPECTIVE 9/26/09 9:16:09 AM9/26/09 9:16:09 AM 4/15/09 2:49:47 AM

GLOBAL FORUM GLOBAL

■ — a national, central IRB providing can potentially nding trials that Linda’s next clinical trial will clinical trial next will Linda’s biofeedback involve lessen to urinary “If it helps, frequency. take to medicine have I won’t then that.” for has condition progressed Linda’s her initial diagnosis.since She now has take to medication tremors, for and sometimes has with trouble speech. Still, Linda keep plans to fi She feels her condition. help clinical the trials her help that psychologically. part trials in the makes “Taking some control me feel like I have disease,” of my course over the know how Linda.says “I don’t is, realistic that but it makes me feel that way.” from from up there ight 3 Weekly Board Meetings – one2 week Electronic turnaround Tracking Options – FastTrack Web Portal and e-mail 1 Day Site Review Full AAHRPP Accreditation In Good Standing with FDA (Audited November 2008) Registered with OHRP [email protected] www.neirb.com 781-431-7577 ■ ■ ■ ■ ■ ■ timely review of Phase I – IV drug and device studies across the U.S. New England IRB Contact us to learn how we can support your clinical trials New England IRB stands for highreview quality and documentation. fl my e NIH paid for “That trial“That was was real invasive. It she says. was “I painful and scary,” real glad when it was over.” Besides pain, participating the in clinical trials involved time and takeexpense. off “I had to vacation go and use time to work my get Linda. says “I didn’t trial,” the to trials, of the any paid for although reimbursement. I had some travel Th and my stay in the hospital, in the stay so I got and my hospital food,” ‘delicious’ the have to she laughed. upside, her tests On the Linda felt helpful, directly if not probably were who had others to then her, to Disease. Additionally, Parkinson’s results the getting she appreciated of all her scans NIH. from the e ects ects e other other e is included an IV e uncomfortable. It took It e uncomfortable. NEIRB reviews studies across the United States Linda. trial says was at Th easy, and a lumbar puncture (spinal tap). tap). (spinal and a lumbar puncture A Trial with Painful and Scary Tests Tests Scary and Painful with Trial with Painful and Scary A A Trial Tests was however, A subsequent study, mor much of Institutes National the at place in Bethesda,Health Linda where MD, stayed a week. for pretty “I got stuck everywheremuch they stick could she says. Th you,” Th researchers worked her around schedule, she had no side eff and studies two e next dye. Th from the alsoLinda were fairly simple. found One involved blood getting drawn checkto genetic factors. Th involved rasagilinestudy (Adagio®), a drug used Parkinson’s treat to Disease. Linda was rasagiline in the clinical trial a year. for PP1-Back from the Brink.indd 73PP1-Back from the Brink.indd 73 President Message.indd Sec1:5 Marketplace.indd 74 74

MARKETPLACE MARKETPLACE

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GLOBAL FORUM GLOBAL Global Forum Ste. 301 CenterWatch 1 800 221-6600 1 516 354-2600 Boston, MA 02114 Fax: +1.267.893.5682 100 N. Washington St. 100 N. Washington www.centerwatch.com U.S. Office Information U.S. Office www.worldcourier.com All World Courier offices Courier offices All World email: [email protected] Outside the U.S. please call Outside the U.S. please YOUR AD HERE! YOUR Don’t miss this opportunity to be Don’t included in the DIA within the U.S. can be reached at reached within the U.S. can be Steve Everly, Phone: +1.267.893.5686 Phone: Steve Everly, Marketplace. Contact Advertising Sales: Headquarters 800.256.4625 773.632.1800 Brosnan House Brosnan 866.439.9491 Fax Chicago, IL 60631 Pi2 Solutions Ltd. 77 Hartland Street Fax: 860-727-6001 www.medfocus.com +44 1707 65 99 66 www.corptransinc.com www.Pi2solutions.com East Hartford, CT 06108 East Hartford, Darkes Lane, Potters Bar Telephone: 860-727-6000 Telephone: Corporate Translations, Inc. Corporate Translations, Hertfordshire, EN6 1BW, UK EN6 1BW, Hertfordshire, 8600 Bryn Mawr, Suite 700 South 8600 Bryn Mawr, etrials www.etrials.com Health Decisions www.neirb.com Fax:1.919.653.3620 Durham, NC 27713 Fax: 781-237-0330 www.HealthDec.com Morrisville, NC 27560 Voice:1.919.653.3400 Wellesley, MA 02481 Wellesley, Review Board (NEIRB) Review Board Phone: 781-431-7577 2510 Meridian Parkway Corporate Headquarters: New England Institutional Agile Clinical Development 4000 Aerial Center Parkway Tel: +1 919 967 1111 x133 Tel: 40 Washington Street, Suite 130 Street, 40 Washington www.Twitter.com/HealthDecisions Marketplace.indd 75Marketplace.indd 75 Page 076.indd 76 76

ASSOCIATION NEWS ; ; professional accomplishments: for theircongratulating recent members the DIA following usin join Please forums. andnetworking our educational andvolunteers through ofourmembers performance iscommitted to improving theDIA professional No stockholders Drug Information Association 19044-3595,USA Fran Klass,800EnterpriseRoad,Suite200,Horsham,PA 19044-3595,USA Andrzej Czarnecki,MD,PhD,800EnterpriseRoad,Suite200,Horsham,PA 19044-3595,USA Drug Information Association, 800EnterpriseRoad,Suite200,Horsham,PA 19044-3595,USA 800 EnterpriseRoad,Suite200,Horsham,PA 19044-3595,USA 800 EnterpriseRoad,Suite200,Horsham,PA Bi-monthly I GlobalForum DIA Medic Dr. William Chief as appointed J.Slichenmyer was Inc. PsychoGenics, Development, Off ChiefScientific Dr. as appointed was Lowe A. David X

icer and Executive Viceicer andExecutive & President ofResearch GLOBAL FORUM al Officer, AVEO Inc. Pharmaceuticals, DIA Members on theMove 19 6 osa,P 19044-3595,USA Horsham, PA 800 EnterpriseRoad,Suite200, 4 X 4 - 919/29/091991 $13 of each member’s dues $13 ofeachmember’s 1.215.442.6100 Fran Klass ■ X I GlobalForum DIA David F. Bernstein, David F. Bernstein, Outstanding Service Award. Service Outstanding its himwith presented In2003,DIA meetings. Track Annual andregional for DIA Chairperson Approval.” the CTM/CMC as Heserved also CompanyDrug -From Inception to Product New and“The Supplies” ofClinical Labeling and “Preparation, Packaging courses, DIA thefor coursetwo director was David OTC fi andand parenteral for forms prescription dosage topical, solid, consulting experience developing and ofindustrial HeMichigan. hadover30years the from University of Chemistry Pharmaceutical Columbia University andPhD andanMS in from aBSinPharmacy received Bernstein David Dr. away onAugust 18,2009. passed Bernstein David October 2009 rms and for a generic drug manufacturer. drug andfor ageneric rms In Memoriam August 2009 ■ aaigEio 9/29/09 Managing Editor 10,891 10,891 18,108 10,891 11,732 100% 841 –– –– –– –– –– –– – – PhD 16,885 12,164 11,384 11,384 11,384 100% 780 – – 9/25/09 7:30:34 PM Your Invitation to Network with Regulators Around the World

 The 6th Annual Japan DIA Meeting: Clinical Development in an Era of Globalization OCTOBER 22-23 | TOKYO, JAPAN

 1st DIA China Annual Meeting: Drug Development in a Flat World — Innovation, Regulation & Globalization NOVEMBER 1-3 | BEIJING, CHINA Co-sponsored by China Center for Pharmaceutical International Exchange (CCPIE) and DIA

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 4th Annual Drug Discovery & Clinical Development Conference in India: Scientific & Regulatory Advances Across Borders NOVEMBER 15-18 | NEW DELHI, INDIA

 2nd Latin American Regulatory Conference (LARC 2009): Harmonization for Clinical Research & Drug Development in the Latin American Region NOVEMBER 18-20 | MEXICO CITY, MEXICO Co-sponsored by AMEIFAC and DIA

For more information on these and future DIA offerings, please monitor the DIA website.

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