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DIA 2012 Collaborate to Innovate GLOBAL ggff forumJUNE 2012 VOL 4 • ISSUE 3 INFORM ADVISE REACH EDUCATE DON’T MISS!! DIA 2012 CollaboRatE to INNOVatE 48TH ANNUAL MEETING JUNE 24 – 28 PHiladELPHIA Cover, TOC and Intro articles.indd 1 6/5/12 2:57 PM Cover, TOC and Intro articles.indd 2 6/5/12 2:57 PM ggff CONTCONTEENTSNTS INFORM ADVISE REACH EDUCATE Devised to Time What we are Keeps you educate and management, doing around abreast of update you on skill the globe and all association, advances in a development, how advances membership, specific area of technology, in each region regulatory, research, drugs, software topics can have a and diagnostics or and more are worldwide legislative 3 devices. 14 examined. 30 impact. 48 news. 102 In Every Issue Open Forum 6 Andrzej Czarnecki President’s Message 8 Yves Juillet Executive Director’s Message 10 Paul Pomerantz Association News Award Winners at DIA 2012 110 Devices & Diagnostics Newest SIAC 117 Guide to New & Improved Website 119 DIA Elects 2012 Board of Directors 122 Patient Perspective From Naiveté to Understanding 126 Members on the Move 129 Marketplace 130 Cover, TOC and Intro articles.indd 3 6/5/12 2:58 PM gf GLOBAL FORUM The Global Forum (ISSN: 1944-1991) is a publication of the Drug Information Association. Editorial Office: Drug Information Association (DIA), 800 Enterprise Road, Suite 200, Horsham, PA 19044-3595, USA; phone - 215.442.6100; fax: 215.442.6199. PUBLISHING Copyright © 2012, Drug Information Association. INFORMATION The Global Forum (ISSN: 1944-1991) is published six times a year, in February, April, June, August, October, and December. Periodical postage paid at Horsham, Paul Pomerantz, Executive Director Pennsylvania, and additional mailing offices. Andrzej Czarnecki, MD, PhD, DSc, Thirteen dollars of each member’s annual Editor-in-Chief membership fee is for a year’s subscription. Global Forum Staff Prices include postage and are subject to Judy Connors, Managing Editor change without notice. Notify DIA eight weeks Chris Slawecki, Senior Copywriter in advance of address change with a copy Joe Krasowski, Marketing Communications of the mailing label. Back issues of most Manager previously published issues are available from DIA. Freelance Writers PUBLICATIONS MAIL Pat Friia AGREEMENT NO. 41103506 Joyce Litwin Zimmerman RETURN UNDELIVERABLE CANADIAN 4 Mission ADDRESSES TO CIRCULATION DEPARTMENT, The Global Forum provides a multidisciplinary, PO BOX 1051, FORT ERIE, ONTARIO L2A 6C7 neutral forum for communicating information Postmaster: Send changes of address to related to drug development and lifecycle Global Forum, 800 Enterprise Road, Suite 200, management on a global basis. The Global Horsham, PA 19044-3595, USA. VOL 4 ISSUE 3 Forum disseminates content that is relevant to members’ professional experiences, including Design: Imagevolution - 610.867.4460 international industry and regulatory updates Cover Illustration: Copyright © iphoto.com and news of the association and its programs. The magazine is circulated six times a year as a DIA is a neutral organization that does not advocate for or against any issue. The views benefit of DIA membership. expressed by the individual authors or interviewees in the Global Forum are theirs and Publishing and Subscription: do not necessarily represent the views of the Drug Information Association (DIA), Drug Information Association. 800 Enterprise Road Suite 200, Horsham, PA 19044-3595, USA. Contact Information for Advertising: Worldwide Advertising Sales, Frank Cassera - SAGE Publishing [email protected] Subscription Information, Customer Service - 215.442.6100 Membership Services, Mike McGovern - 215.442.6129 Senior Marketing Manager, Mike Keller - 215.442.6173 Cover, TOC and Intro articles.indd 4 6/5/12 2:58 PM Cover, TOC and Intro articles.indd 5 6/5/12 2:58 PM gf GLOBAL FORUM OPEN FORUM Development (R&D) in Medicine By sheer incident I attended a of a large proportion of society. short talk given by Professor Lord Another solution suggested by the Robert Winston. His contribution speaker was that young people to research and clinical work, in schools are informed about specifically in fertility, is widely the ethics, quality and need of recognised and has had a global medical research, so that they impact for many years. Touching grow up with more information 6 on research in the current times, than just that what the media he shared his views on several may provide. Once the younger important aspects in relation generation enters later stages of to drug development. In many life in any field, they will have a countries, different organisations, better awareness of the ethical VOL 4 ISSUE 3 including ‘animal rights’ activists, aspects of medical research have a clear misunderstanding and will be better prepared to of how medical research is being provide appropriate support for ANDRZEJ conducted. One of the ideas its financing and other aspects of presented by Lord Winston was this challenging work. Successful CZARNECKI that all drug packaging should development was never easy; have an inscription indicating that currently, it requires even more in order for the product it contains support from any perspective, to be safe for human use, it has including appropriate policies. been tested on animals. I liked Thus, simple solutions suggested the simplicity of this approach. by Lord Winston could have an Working with scientists in any impact in raising awareness. environment, but specifically Frequently, society influenced in medical research within the by the media tends to forget Pharmaceutical Industry, is a real that drugs, although tested on eye opener as one learns how animals, are developed for human ethical this research has always illnesses, which do not recede been. It appears that all of us with expanding populations. involved in drug development Modern diagnostic methodologies in past countless years, have increase our ability to identify and not managed to send the right treat them thanks to the same message on our research and its ethical research. ethics, judging by the perception Cover, TOC and Intro articles.indd 6 6/5/12 2:58 PM The INFORM section of this governmental, managerial, issue refers to the modern financial, patients’ associations, R&D paradigm. It is widely industry and others. One could Global Forum recognised that success in drug argue that potentially the best, development is proportionally or the only, way forward is an Editorial Board low and costly, and many appropriate consolidation of different approaches have been existing brainpower. Andrzej Czarnecki, MD, PhD, DSc tested and implemented by the Editor-in-Chief pharmaceutical industry over Our readers may remember the past 20 years to increase the profile of Mary Baker from Richard Chamberlain, PhD efficiency and the rate of success. the April issue, which provided ECS, Inc. Some of the solutions used did good examples of how patients’ Ronald D. Fitzmartin, PhD, MBA work, some worked only partially involvement may help in directing Managing Partner and most have had unanticipated drug development to success Decision Analytics, LLC costs associated with them. In and the importance of open and good cooperation between all real terms, therefore, the overall Alberto Grignolo, PhD stakeholders. Looking more than success rate did not rise, and PAREXEL predicted savings were, at times, 25 years back, it is important to problematic. It seems that after recall the spirit of the International Betty R. Kuhnert, PhD, MBA having tested so many options, Conference on Harmonization 7 the ongoing discussions on (ICH) born in the late 1980s. At Sarah Powell a different, much more open that time, and for many years Thomson Reuters and, hopefully, more productive later, it helped scientists, from cooperation, is one of the few, if all environments across the Nancy D. Smith, PhD not the only, solution that could world, to share their knowledge Potomac, MD lead to better progress in the and experience and work well future. Reading through the lead together. Let’s continue joining Jean H. Soul-Lawton, DPhil article provided for us by Section forces to achieve a better GlaxoSmithKline Chairs, Ken Kaitin and Ken Getz, result than the currently 16% J. Rick Turner, PhD (big thanks to both of them for approval rate of new drugs from Quintiles taking up the compilation of this all the ones that enter clinical development. Maybe some simple section), we get a summary of Qingshan Zheng, PhD different approaches used to ideas, similar to those presented Shanghai University of speed up and achieve better in the beginning of this article, efficiency of R& D over time. could help regulators facilitate Chinese Medicine, China However, the important message research and clinical development, is this: an open cooperation and scientists to put their minds between scientists working in together, so that in several years any environment seems to be the time, when we look back, we can next step to further progress. This say that these ideas and decisions kind of cooperation has to include have made a difference. advanced academic research potentially in conglomerates with other organisations, eg, Cover, TOC and Intro articles.indd 7 6/5/12 2:58 PM gf GLOBAL FORUM PRESIDENT’S MESSAGE Being a DIA Member: Such a Wonderful Opportunity I am honored and pleased to Exchange to 1200 participants, share with you a few ideas highlighted by opening remarks at the end of my year as DIA from the Commissioner of the President. When I was a child, State Food & Drug Administration, my grandfather taught me that and featuring updates by key a day in which you don’t learn executives from the SFDA Center something is a lost day. This has for Drug Evaluation, who also 8 guided me through all my personal answered participants’ questions circumstances and professional in their Town Hall session. Let’s positions. also consider our recent African Regulatory Conference, which DIA Thanks to DIA, I have been able to co-organized in Accra (Ghana) VOL 4 ISSUE 3 learn so much.
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