THE MAGAZINE OF PHARMACEUTICAL BUSINESS AND MARKETING • MEDADNEWS.COM • JANUARY 2013 • VOLUME 32 NUMBER 1 • $25
IN THIS ISSUE: AGENDA 2013 AGENDA 2013: FUTURE OF 11 MARKETING Caution: future approaching The balancing act for 2013: optimizing multi-channel The impending components of U.S. healthcare reform, the growth of “Big Data,” an increasing marketing through a next demand for pink slips, and a drive to go beyond the pill will all shake a rapidly restructuring generation “enabled” sales force, seamless pharmaceutical industry in the coming year. digital operations, valuable content, and time-tested traditional elements. By Joshua Slatko [email protected]
hile 2012 should go into the history books as a year TOP 10 of uncertainty in the pharmaceutical world, 2013 PIPELINES is expected to clear up many mysteries. 12 With President Obama re-elected, the various tendrils of his sig- Wnature healthcare reform legislation will con- GlaxoSmithKline and tinue to move forward. Although the full Roche’s extensive and scope of the act’s impact remains un- diverse product pipelines clear, at least industry players know are recognized as leaders the rules of the new game. Down- in multiple categories within sizing, restructuring, outsourcing, this annual special report. and other euphemisms for layoff s are expected to continue in the new year, but the pace should slow as companies approach a happy medium of suitability for the new marketplace. pharmaceutical industry interfaces with “Big Data,” more a buzzword than a government, payers, patients, and health- useful tool in the past, should evolve in care providers. T ose companies who are value as marketers and their data teams fi g- able to innovate within this change will ure out new ways to take advantage of the gain enormous opportunities, and those enormous sources of information at their who don’t will lag behind, operating in fi ngertips. And the practice of going “beyond the old paradigm.” the pill” by off ering complementary services, a Rarely has any piece of legislation, at least trend that is mostly present in just a few thera- since FDA was created, changed the equation for PATIENT peutic areas and categories, will expand further pharma makers and marketers more broadly than PPAC RECRUITMENT into the marketplace as brand managers seek ways will. According to Ms. Lurker, everything from the Sunshine Law 20 to off er more value to patients, payers, and other to rebates, and eventually accountable health organizations, the ex- stakeholders. changes, formularies, electronic health medical records – all will be put into play, some in ways far outside the obvious. For instance, the The creation of online The election implementation of electronic health medical records over time will patient registries will not have a signifi cant impact on how the industry tracks prescription use only lead the way for A year ago, both the results and the impact of the and interfaces with physicians. T is ability to track use and aggregate clinical trial recruitment, but upcoming U.S. presidential and congressional elec- “big data” will off er an invaluable real-time assessment of the benefi ts for post-marketing efforts as well. tions were matters of intense speculation. T e “re- and side eff ects of pharmaceutical medicines in the community, giv- sults” bit is now out of the way, but President Obama’s re-election has not ing the industry a platform from which to better tailor medicines for diff erent ended the debate over how politics and policy will impact the pharmaceutical patients and develop better solutions to health issues. marketplace. At the forefront of this discussion, of course, is the growing infl u- With these sorts of opportunities in mind, many industry-watchers em- ence of the Patient Protection and Aff ordable Care Act, with some of the Act’s phasize that pharmaceutical executives need to prepare for a post-reform en- provisions already in eff ect and many others coming over the horizon. vironment where the focus of reimbursement is shifting to value over volume “T e biggest impact from the election is that the Patient Protection and and where customers – consumers, physicians, and payers – have signifi cantly Aff ordable Care Act will now be implemented,” says Nancy Lurker, CEO diff erent expectations of value. of PDI Inc. “PPAC is going to have an enormous impact on the healthcare “Pharmaceutical companies must reassess their strategies and work to dem- landscape, eff ecting patients, physicians, and the biopharmaceutical industry. onstrate their value by improving health outcomes and/or reducing the overall Gradually, this implementation will create a profound impact on how the bio- continued on page 6
ZBRUCH/CHIHHANG/ISTOCKPHOTO.COM T is month on
WEBCAST: Specialty Pharmacy, Benefi t Investigation and Copay Programs - February 13th, 12:00pm ET Benefi t investigation and reimbursement activity has become a marketing requirement for many new drugs in addition to various FDA requirements that can include limited distribution through specialty pharmacies. Purchasers in the commercial market don’t understand the complexity or clinical issues associated with specialty products, but have more awareness of benefi t design and coverage considerations since they pay for health care. As a result, current reimbursement hub solutions are necessary, but require signifi cant resources, are driven by manual and ineffi cient processes, lack transparency and require cumbersome workfl ows from patients and physicians or other providers.
magentablackcyanyellow ES177651_MAN0113_001.pgs 01.12.2013 06:27 UBM FRESH THINKING IS HARD TO CONTAIN.
And when you let it loose, something extraordinary happens. You create an uncommonly collaborative and creative environment.
We applied a healthy coat of imagination to the old agency model. The result—an independent, employee-owned group of experienced and talented people with the drive to create something original.
Curious? Call Ed Mitzen 518.488.8304 fingerpaintmarketing.com
magentablackcyanyellow ES177316_MAN0113_002_FP.pgs 01.11.2013 23:15 UBM MedAdNews
CEO Sally Shankland tothepoint [email protected] BRAND DIRECTOR Daniel Becker By Christiane Truelove [email protected] [email protected] DIRECTOR OF CONTENT Christiane Truelove Happy New Year. I can’t believe it’s 2013, but not for the obvious doomsday [email protected] reasons. Despite the endless speculations about the “Mayan prophecy,” Dec. 21, 2012, MANAGING EDITOR, SPECIAL REPORTS Andrew Humphreys was not the end of the world; for me, though it did mark the end of my Christmas [email protected]
shopping and cookie baking, and my kitchen did look like an apocalypse hit it (the MANAGING EDITOR, MED AD NEWS Joshua Slatko aftermath of baking reminds me why I rarely do it – the product is delicious, but [email protected] scrubbing cookie sheets is tedious and tiring). EDITOR AT LARGE With the new year comes change and new resolutions, and speculation of what is to Ed Silverman come. In Agenda 2013, our cover story, Managing Editor Joshua Slatko asked editorial [email protected] board members and other industry experts what they think the future holds for the LEAD ART DIRECTOR Marco Aguilera pharmaceutical and healthcare advertising industries. One of our favorite comments “Somewhere along the way, [email protected] came from Denise DeMan, chairman and CEO of the executive search company Bench we’re forgetting that men and ASSOCIATE ART DIRECTOR International. Renny Jose Balaswamy woman who create products, [email protected] Ms. DeMan says 2013 needs to be a time of corporate soul-searching in the develop training programs, PRODUCTION MANAGER pharmaceutical industry; although the number of workers shed was fewer in 2012 than in and design the services of next- Venkatraman Jayaraman previous years, the hits were particularly deep on the R&D side. generation pharma companies [email protected] “I fear that leaders, once again, have failed to consider the toll that these predictable must themselves feel honored, SENIOR ACCOUNT MANAGER protected, and viable.” Dave Huisman waves of layoff s, cresting every Christmas, corporate emotional intelligence, complete [email protected]
absent of institutional courage and conviction,” she writes. “What becomes of bravery, SENIOR ACCOUNT MANAGER and the will to invest in new medicines? ‘Merry Christmas. We are having a big layoff . Now the rest of you who dodged the Andrew McSherry [email protected] bullet be prepared to start the New Year refreshed, revitalized, and excited to take on the challenges of the New Year.’” MARKETING MANAGER As one pharmaceutical executive put it to Ms. DeMan, “Our raison d’être is to make people well, yet we are made to feel Joanna Siddiqui vulnerable, insignifi cant, and physically ill in the process.” [email protected] Ms. DeMan argues that the industry is forgetting the human beings that populate it. “How can we focus on the patient, ONLINE MANAGING EDITOR Barbara Lempert create important products, and get them to sick/hurt individuals if our companies are populated with fearful, sick, insecure [email protected]
people?” she says. “Somewhere along the way, we’re forgetting that men and women who create products, develop training ASSOCIATE WEB EDITOR programs, and design the services of next-generation pharma companies must themselves feel honored, protected, and viable.” Mia Burns [email protected] I would say that feeling of being honored, protected, and viable is missing from a lot of industries, not just the DATA SPECIALIST pharmaceutical industry. Artists have felt like that for decades – and being asked to perform for free is fl attering, but doesn’t Silvia Arriola pay the bills or put food on the table. Journalists who have spent years honing their craft and going from regional paper to [email protected] regional paper fi nd those regional papers are disappearing and the practice of news reporting has been replaced by people on DATA SPECIALIST Diane Strohm the street Tweeting out iPhone videos or Websites where “content” is provided by aggregators who pay anonymous stringers [email protected] $5 per article. And then there is the sad story of the book giant Barnes & Noble, which is closing locations down in major cities – HOW TO CONTACT US some experts are saying the company will be out of business in two to three years. T e company that crowded independent EDITORIAL Send all press releases to editorial@ booksellers out of business by undercutting prices will now be leaving those markets without any book stores at all, reducing pharmalive.com. Please note that we prefer all the options for authors to share their works. I’ve seen stats that say B&N holds 80 percent of the print book market, so if you press releases and other documents to be sent to us in electronic format, via the e-mail system know any aspiring authors, you might want to help them rethink their career paths. to [email protected]. All visuals, So, we’re coming to a world where no one values books – and authors and editors – because people won’t really see any of photographs, illustrations, and images should be submitted to [email protected] in them. As Dennis Johnson says on the publisher Melville House’s blog, “In short, B&N’s scorched earth policy of the 1990s .JPG, .TIF, or .PDF format at 300 dpi or higher. has ultimately left us with, well, scorched earth. If the book is going to survive it, it’s going to take some real revolutionary We do not accept press releases through the post or through facsimile. All press releases activity, indeed.” will be posted on our electronic-information And if there is going to be a viable pharmaceutical industry, it will also take some revolutionary activity. Companies’ resource at pharmalive.com. Appropriate press releases will be published in various fi xation on the bottom line has led to the cuts that have disheartened everyone from the scientists to the sales reps. T e time departments in Med Ad News. Although is now to take the steps that truly prove the value of new medicines, by embracing Big Data eff orts (see my story on page 20) we welcome article ideas, please note that we do not accept articles or manuscripts for and the building of relationships with patients from clinical trial recruitment to post-marketing studies. Hopefully, this can publication. For general inquiries, call 609- also improve pipelines (see Managing Editor Andrew Humphreys’ evaluations of the top 10 pharma/biotech pipelines on page 759-7680, or e-mail Director of Content Chris Truelove at [email protected]. 12). And perhaps if the focus shifts away from the bottom line to the people, everyone will feel like what they do matters. SUBSCRIPTIONS For new subscriptions, renewals, payments, address changes, and back issues, call 877- EDITORIAL ADVISORY BOARD 361-2911, or e-mail [email protected]. REPRINTS AND PERMISSIONS To order reprints of articles, or for permission to Med Ad News ELIZABETH IZARD APELLES CEO, SANDER A. FLAUM Principal, Flaum Navigators; Chairman, MIKE MYERS President, Palio copy or reuse material from , call Greater Than One Inc. Fordham Leadership Forum, Fordham Graduate School of Wright’s Media at 877-652-5295, or e-mail Business LESLIE C. NORTH VP, Marketing, Women’s Healthcare, [email protected]. JAY APPEL Marketing Director, Physician Relationship Bayer HealthCare Pharmaceuticals Inc. Management, Amgen Inc. JOSH FRANKLIN VP, Sales and Marketing, Cornerstone Therapeutics Inc. LINDA PALCZUK VP, Sales and Marketing, CHERYL BUXTON Global Managing Director AstraZeneca Pharmaceuticals Pharmaceuticals and R&D, Korn/Ferry International DIANE KRUSKO Former director, Pfi zer Inc. PETER PITTS President, co-founder, Center for Medicine in JAY CARTER Senior VP, Director of Strategy Services, ANGELA MICCOLI President, the Public Interest AbelsonTaylor Cegedim Relationship Management MICHAEL E. THYEN Director, Marketing and Sales FOR EDITORIAL TO BE POSTED DENISE CLEMONS Senior Director, Marketing STEVEN MICHAELSON Founder and CEO, Global Procurement, Eli Lilly and Co. ON PHARMALIVE.COM Operations, Takeda Pharmaceuticals U.S.A. Inc. Calcium Call Barbara Lempert, 609-759-7663, DENNIS URBANIAK VP, U.S. Diabetes, Sanofi US or e-mail [email protected] CHRIS ESPOSITO Managing Director, General MANNY MONTALVO VP, Comm Operations, Shionogi Send press releases for posting on PharmaLive. Medicines Portfolio, Eastern PA, Novartis Pharmaceuticals com to [email protected].
JANUARY 2013 MED AD NEWS • 3
magentablackcyanyellow ES177904_MAN0113_003.pgs 01.15.2013 03:06 UBM inside Med Ad News Insider is a blog providing up-to-the-minute news, opinion, and commentary from the editors of Med Ad News magazine, ON THE COVER with the same editorial focus on pharmaceutical business and product marketing you have come to AGENDA 2013 • CAUTION: FUTURE AHEAD trust from our print publication. The impending components of U.S. healthcare reform, the growth of “Big Data,” an increasing demand for pink slips, and a drive to go beyond the pill will all shake a rapidly restructuring pharmaceutical industry in the coming year.
FEATURES
Searchable online database of pharma and biotech 11 AGENDA 2013 • THE SHAPE OF MARKETING TO COME companies, their pipelines, The balancing act for 2013: optimizing multi-channel marketing through a next generation fi nancials, brands, and “enabled” sales force, seamless digital operations, valuable content, and time-tested traditional more. elements. Learn more at PharmaLive.com/ neweKB. Contact Sandra Martin at 310-445-4251 or e-mail [email protected]. 12 TOP 10 PIPELINES GlaxoSmithKline and Roche’s extensive and diverse product pipelines are recognized as leaders in multiple categories within this annual special report.
WEBCASTS 20 PATIENT RECRUITMENT • GETTING NETWORKED The creation of online patient registries will not only lead the way for clinical trial recruitment, Specialty Pharmacy, Benefi t but for post-marketing efforts as well. Investigation and Copay Programs
February 13th,12:00pm ET
The growth in biologics and specialty pharmacy products has evolved new business practices, benefi t coverage issues, and DEPARTMENTS cost offsetting programs related to health product marketing, especially pharmaceuticals and some medical devices. 22 SALES & MARKETING Benefi t investigation and A journey approach to treatment flow modeling can provide actionable insights, resulting in more insightful, better-informed reimbursement activity has strategic decisions for marketing pharmaceutical products. become a marketing requirement for many new drugs in addition to various FDA requirements that can include limited distribution through 24 INTERACTIVE AND DIGITAL MARKETING specialty pharmacies. Purchasers in the commercial market don’t The wait for guidance on social media from FDA may be coming to an end, thanks to a little-noticed provision in the FDA understand the complexity or reform bill passed last summer. clinical issues associated with specialty products, but have more awareness of benefi t design and coverage considerations since 26 AD AGENCY UPDATE they pay for health care. As Publicis Healthcare Communications Group has announced the creation of Publicis Health Media, a new offering which a result, current reimbursement aims to fuse media into a specialized health and wellness practice. hub solutions are necessary, but require signifi cant resources, are driven by manual and ineffi cient processes, lack transparency and require cumbersome workfl ows 28 PEOPLE ON THE MOVE from patients and physicians or Endo Health Solutions Inc. has announced that David P. Holveck, the company’s president and CEO since 2008, will retire other providers. in 2013.
What you will learn:
Market impacts that were 30 THE LAST WORD: LOOKING FOR A NEW JOB? STIMULUS SPENDING WON’T HELP – BUT INNOVATION WILL! intended or unintended Whatever the talking heads of the political world might say, the fact remains that jobs are created in response to innovations consequences of specialty that open up opportunities that didn’t exist before, writes Sander Flaum. pharmacy drug marketing.
Contemporary issues and insights on copay card programs with plans or PBMs.
Value on innovation and automation in Reimbursement Hub benefi t verifi cation related activities. Med Ad News (ISSN 1067-733X) is published monthly by UBM Canon, 2901 28th St., Ste. 100. Santa Monica, CA 90405, United States. Periodicals postage is paid at Santa Monica, CA, and additional mailing offices. POSTMASTER: Send address changes to Med Ad News, PO Box 5060, Brentwood, TN 37024, United States. The U.S. subscription rate is $285 for one year; the Canadian subscription rate is $325 for one year; and the subscription rate for the rest of the world is $425 for one year. Advertising and editorial offices are located at 300 American Metro Blvd., Suite 125, Hamilton, NJ 08619, United States; telephone: 609-759-7600. For advertising, call extension 7674; for editorial, call extension 7680; facsimile: 609-759-7676. http://bit.ly/13iRLji © 2013. UBM Canon. All rights reserved. No portion of this publication may be reproduced in any form without the written consent of the publisher. Printed in the United States.
4 • MED AD NEWS JANUARY 2013
magentablackcyanyellow ES177900_MAN0113_004.pgs 01.15.2013 03:06 UBM contents|interactive&digitalmarketing WHAT’S ONLINE WHAT’S IN PRINT WEBCAST: SPECIALTY PHARMACY, BENEFIT INVESTIGATION, AGENDA 2013: BIG DATA AND COPAY PROGRAMS Inasmuch as marketing has a responsibility to communicate the value February 13th at 12:00pm ET of the medicine, “Big Data” is likely to make life more difficult for The growth in biologics and specialty pharmacy products has marketers. evolved new business practices, benefit coverage issues, and cost Go to page 8 offsetting programs related to health product marketing, especially pharmaceuticals and some medical devices. AGENDA 2013: “DIGITAL MARKETING” BECOMES “MARKETING” Benefit investigation and reimbursement activity has become a Bill Drummy of Heartbeat Ideas predicts that the distinction between marketing requirement for many new drugs in addition to various what’s digital and what’s not will disappear in the marketing world in FDA requirements that can include limited distribution through specialty pharmacies. Purchasers in the commercial market don’t the coming year. understand the complexity or clinical issues associated with specialty Go to page 10 products, but have more awareness of benefit design and coverage considerations since they pay for health care. As a result, current reimbursement hub solutions are necessary, but require significant AGENDA 2013: THE SHAPE OF MARKETING TO COME resources, are driven by manual and inefficient processes, lack As channels evolve to keep pace with tech innovations, 2013 will transparency and require cumbersome workflows from patients and see some companies adapt and leverage these dynamic tools to their physicians or other providers. competitive advantage over those that don’t. What you will learn: Go to page 11 - Market impacts that were intended or unintended consequences of specialty pharmacy drug marketing. - Contemporary issues and insights on copay card programs with plans PATIENT RECRUITMENT: GETTING NETWORKED or PBMs. The creation of online patient registries will not only lead the way for - Value on innovation and automation in Reimbursement Hub benefit clinical trial recruitment, but for post-marketing efforts as well. verification related activities. Go to page 20
Go to http://bit.ly/13iRLji to register for this Webcast
24
Thursday, April 25, 2013 at Pier Sixty, New York 13
Honor the best agencies in pharmaceutical advertising at this celebratory annual gala event.
Med Ad News will present the industry’s most respected awards and continue to honor the Advertising Person of the Year.
To reserve your company’s table or seats, visit MannyAwards.com or contact: Joanna Siddiqui at 973-808-8847, [email protected]
For sponsorship information, contact: Daniel Becker at 973-808-1191, [email protected]
magentablackcyanyellow ES177803_MAN0113_005.pgs 01.14.2013 22:47 UBM continued from page 1 more fi nancially rigorous, with increased for policy-watchers in 2013, though. T e partner and leader of the global health accountability and transparency,” says Rob ongoing “fi scal cliff ” discussions, however practice, Booz & Company. “However, we cost of care, an economic outcome,” says Rebak, CEO, QualityHealth. “Spending they are resolved, have the potential to add should be wary of looking to the past as Todd Evans, director, pharmaceutical and in areas like marketing, long supported by another variable to the industry’s equa- a guide to a future model. Certainly there life sciences practice, PwC. “When health- analysis but often determined by the dis- tions, especially in the pricing area. have been individual successes, especially care providers are paid for the quality of cretion of the brand team, will be tied to “T e outcomes of fi scal cliff discus- where we have seen platforms that help care they deliver, they’ll apply the same the outcome of the marketing activity. I am sions will impact pharma more immedi- patients engage in their disease more pro- criterion to the therapies they prescribe. encouraged that this will accelerate a larger ately,” says Ganesh Vedarajan, principal ductively. T is includes past eff orts like T at means payers will only pay a pre- scale shift to performance-based marketing and leader of the oncology and specialty patient support services to enable adher- mium for medicines that off set or reduce services, which I have been evangelizing therapeutics practice, ZS Associates. “If ence during the rough start-up of drugs in costs from elsewhere in the care pathway. for several years now.” Medicare payments are cut dramatically in MS, as well as more recent examples using Pharmaceutical companies must be able From a sales strategy perspective, the 2013, then this will trigger increased pric- gamifi cation, to engage groups of patients to develop products that are clinically and long coat tails of PPAC may well exacer- ing pressures and cause pharma to adjust to better understand their disease implica- economically superior to what already ex- bate one of the industry’s long-standing its pricing and discounting strategies for tions and treatment requirements. At the ists, and they must be able to prove it to challenges – the availability, or lack there- buy-and-bill products.” same time, though, a lot of money has payers, providers, and patients with hard, of, of physicians for personal promotion. been spent on ‘beyond the pill’ off erings real world data expressed as outcomes. In But this too, like most of the act’s eff ects, that do not add value, nor do they enhance essence, if there is no outcome, then there could be an opportunity disguised as a BEYOND THE PILL the fi nancial results of the drug brand.” is no income.” challenge. T e key to getting this right, Edmunds Because of this, Evans expects pharma- “T e combination of an infl ux of newly One of the key marketing stories of 2012 believes, is an end-to-end, multi-stake- ceutical companies to regard the values of covered patients in the market for health- was how pharma brand managers have holder (patient, physician, payer, et cetera) their candidate assets in development us- care as a result of Aff ordable Care Act pro- been pushing “beyond the pill” by adding view of the clinical, economic, and experi- ing outcome valuation logic and reset their visions and a lower percentage of new phy- complementary services to their brands to ential pain points each stakeholder faces as net present values. “We can also expect sicians going into family practice or GP try to play a larger role in the entire patient the patient progresses through the disease. that as the various economic implications specialization will exacerbate fi eld sales’ care continuum. Although a few product T is understanding will provide the insight of the ACA take hold, pharmaceutical challenges to reach HCPs for personal pro- categories experienced this trend full-force to assess whether adherence services, educa- companies will refocus and recast the logic motion during offi ce hours,” says Karen in the past year, the new year is expected to tional apps, e-diagnostic services, in-home of their global planning for both mature Lichtig, senior VP, alliance management send it broader and deeper into the mar- delivery, or other such services will make a and growth markets, since the overall rates and partner enablement, CMI/Compas. ketplace. But as with most hot marketing diff erence. “Digital technology holds great of growth and margins earned from U.S. “To help balance the patient load, NPs trends, brand managers should be wary promise in providing these solutions, and sales is now responding to a very diff erent and PAs will need to be prepared to ad- not to fall in love before they know a bit in the New Year we will be supporting the drumbeat,” he says. dress a wider range of indications to sup- more about their intended. creation of breakthrough digital platforms Calculating those new values, though – port a busy FP/GP offi ce. T is off ers us an “T ere is no question this is a trend we to greatly enhance ‘beyond the pill’ off er- and, more broadly, fi guring out what will opportunity – non-personal promotion see with our clients, and one we expect ings,” he says. work and what won’t in the new PPAC en- strategy (especially point of practice and to continue,” says Rick Edmunds, senior Implementation of successful “beyond vironment – is still a matter of some doubt, digital channels) will become even more if well past the burning entrails phase. T e important to reach and inform this in- center of gravity for the discussion all along creasingly infl uential audience as well as The leader of an executive product for another, and doesn’t get at the has been payers and providers, and as those capture whatever still remains of the physi- search company offers her heart of the word “reformation.” Why? Because cians’ share of mind. I predict that in 2013 perspective on “behind the companies really need to think about leverag- we will see both a dramatically increased pill” ing the assets they have by being so narrowly “Pharma will need to shift eff ort to reach out to NPs and PAs, and product focused. Brand focus is their tip of the its go-to-market model from we will enhance our measurement tools to tip of their iceberg. share-of-voice promotion to capture the impact of this group.” he popularity of the catchphrase “beyond I don’t dispute that medication non-adher- Another existing trend that may be the pill” tells us that large numbers of ence is a problem for patients and for phar- one centered on meaningful pushed along further by the impact of Tpeople recognize the need for change maceutical companies. The U.S. drug industry dialogues with institutions PPAC is demand for health information in our industry. Among other signs, there is the loses $188 billion a year because patients fail through easily accessible digital sources. transformation of the traditional sales force, to fi ll or refi ll their prescriptions, according to about meeting their overall care “Looking forward, more people will marked by role consolidation as pharma slashes Capgemini consulting. I guess it’s encouraging and cost objectives.” have access to healthcare coverage,” says sales and marketing staff. As head of Bench to see drug companies developing health-relat- Marc Weiner, managing partner, Ogilvy International, an executive recruitment company ed apps to keep patients compliant. At a site stakeholders strive to improve outcomes CommonHealth Worldwide. “T at means focused on life sciences, I’ve seen the birth of a called Pocket.MD, you can click on any pharma and reduce costs, both challenges and op- more patients competing to see a fi nite new skill set. Call it the super MSL (medical sci- company and call up lists of their smartphone portunities for pharma will arise. number of healthcare professionals. Quite ence liaison). The core competency is the ability offerings. And it’s not just about prescription “On the challenge side, we expect an in- simply, it’s getting harder to schedule a to represent a product across a broader swath adherence. Digital health apps, which now creased portion of consumers to opt-in to visit with a physician. of the medical community. That may entail number more than 17,000 according to Frost & low price products with less benefi ts and “Patients are already turning to the web reframing the product, not just to physicians but Sullivan, are becoming a new drug-marketing choice than are typical in most employer for more information, but we believe they to patients, advocacy groups and insurers. Indi- channel. My point is that commentators who are plans,” says Greg Rotz, partner and lead want more than text. Patients at all levels viduals who possess these skills, many of them huge fans of mobile e-health may be missing the of the North American life sciences sector, respond to video-based learning, and we M.D.s and Ph.D.s, must confi dently represent or point – at least in reference to the drug industry. Booz & Company. “On the opportunity anticipate that the need for video will con- advocate for patients in a disease state as well The revolution we want to see in healthcare side, the fact that many drugs can reduce, tinue to increase. as for the pharma and device sector seeking the isn’t the discovery of new marketing channels, or avoid altogether, higher-cost events is “Doctors will have less time to train privilege of serving them. The idea is not brand with or without sexy devices and software. It’s more important than ever. T e question is (and retrain) patients to participate in their new, but the tide in this direction is noteworthy. fi nding better, more effective ways of putting the which drugs will be favored in this envi- own health and wellness. As such, patients From the vantage of attracting and retaining patient fi rst. ronment, and what’s required to succeed? are likely to ‘fi ll in the gap’ by watching talented leaders, the human asset in most A model leader of a pharma company who Generics will be a natural benefi ciary. videos that answer questions exactly when demand is no longer the detailers’ direct sell to thinks well beyond pharma is Clive Meanwell, Branded pharma will need to enhance its they need answers.” physicians. It’s the deep scientifi c, medical, or M.D., the chairman and CEO of The Medicines eff orts around comparative eff ectiveness, A well-produced video, Weiner believes, procedural knowledge base offered to pharma Company. Clive, at his core, is a futurist as well build real-world evidence capabilities, ag- can demonstrate a technique that tran- and device industry “clients,” be they providers, as a hands-on businessman. Meanwell tackled gressively pursue personalized medicine scends educational, cultural, and language payers or patients. The conversation truly has the puzzle of why critical care units of some hos- strategies, and collaborate with stakehold- barriers. A busy caregiver may want to ac- moved beyond conventional sales and market- pitals experience different patient outcomes who ers to drive value versus just driving drug cess a longer, more detailed video series ing. We’re talking about signifi cant technical have experienced the exact same illnesses and utilization. And to deliver on this, pharma from a desktop. Later, that same caregiver achievement and skill, provided to pharma by a procedures. Beyond devising and marketing will need to shift its go-to-market model may need a quick refresher from an iP- smaller pool of executives than in the past. They heart medicines, he set about raising the overall from share-of-voice promotion to one hone, if he or she is on vacation. enter at a higher pay grade, and they also may level of patient care in CCUs. In a recruitment centered on meaningful dialogues with in- “We’re seeing increased queries about prove to be harder to retain. This is a reforma- context, I’m struck by Meanwell’s ability to stitutions about meeting their overall care scalable video projects,” Weiner says. “Spe- tion in the skill set necessary at the pulse, where turn these ideas into core values for attracting and cost objectives.” cifi cally, brands want to create one asset the product is delivered and consumed. “thinking and doing differently talent.” You don’t T ose dialogues will have to justify that can be leveraged across markets, trans- There is a second nuance to the phrase get hired at the Medicines Company unless you themselves too, just like the drugs will. lated into multiple languages, and format- “beyond the pill.” It describes a trend in which know that it is your responsibility is to improve With the force of momentum behind it, ted for multiple digital channels. Look for healthcare companies – drugmakers among the life of patients’ lives. outcome-based decisionmaking may well more videos being distributed across public them – devising apps for iPhones or Android spread beyond actual product choice into platforms like YouTube, but also through devices that remind patients to take their meds. - Denise DeMan, chairman and CEO, Bench other places, such as marketing itself. private channels like physician portals.” To me, this is simply substituting one type of International “Pharma will fi nd itself having to be far PPAC isn’t quite the end of the story
6 • MED AD NEWS JANUARY 2013
magentablackcyanyellow ES177590_MAN0113_006.pgs 01.12.2013 06:13 UBM the pill” off erings so far has been spotty, coordinate patient management while on Geisenger Health System, which looks at only be a modest bounce given concentrat- with most of the notable successes coming therapy,” Evans says. “T is type of packag- innovative ways to drive shared decision ed customer bases. Operating at a lower from high-price brands like oncology and ing and the reimbursement of an outcome making and adherence to treatment plans. cost at headquarters, however, will become large molecules, as well as chronic areas like also implies that these are not subsidized Another example is the partnership be- the long-term norm, since this trend is also diabetes and multiple sclerosis. According extras, but in fact are required parts that tween Boehringer Ingelheim and Healthra- driven by strong payer pressure on profi ts, to Pratap Khedkar, managing principal drive an outcome solution with a very dif- geous to develop a pilot program targeting emerging markets’ needs, and centraliza- and leader of the global pharmaceuticals ferent price to value than the traditional lifestyle and behavior modifi cation in pa- tion of services. practice at ZS Associates, brands like this unit based sale.” tients with type 2 diabetes.” “We expect more companies to out- come with a built-in related services advan- In 2013, Evans expects remote monitor- With the story having barely started, source multiple aspects of commercial tage because the patient so obviously needs ing via mobile devices to support patient signifi cant room seems to exist for beyond- operations, sales, and even marketing,” assistance dealing with the complexities of adherence and to better understand the ef- the-pill initiatives to become even more Khedkar says. “T is is true of big pharma both the drug and their condition. Small fects of a particular remedy on a particu- valuable than they are today. “Many pro- as it tries to cut costs and emerging small molecule brands have been another matter, lar patient will continue to grow, as will grams, whether initiated at the brand or pharma as it tries to contain costs. In addi- but their day may be coming. the data that can be added to the EHR. corporate level, are still very product or dis- tion, the combination of specialization and “Many pharma companies have added Pharma will also continue to move more ease centric, addressing just one aspect of scale helps third parties deliver supporting related services for staff and patients (e.g., aggressively into the health management patient care,” Ms. Brueggeman says. “T is services at lower costs and higher quality. reimbursement services, patient tools, space, with compliance programs, nutri- limits their ability to be embedded broadly T is, in turn, enables pharma to focus on nurse educators, et cetera),” Khedkar says. tional advice, wellness promotion, health as real world solutions. In the future, we its core competency of molecule develop- “Most oncology and specialty [large mol- screening and other such services, with a anticipate that pharma companies will go ment and customer promotion.” ecule] companies do this often and well, broad range of partners in order to forge beyond an external focus and partnerships. Ms. Lurker agrees with Khedkar’s esti- largely because the customer clearly needs closer relationships with the patients who T ey’ll take on the more diffi cult task of mate of the coming pace of restructuring. help. Small molecule brands have struggled use their products and services and to cre- looking inward at their own capabilities, “We have absolutely not reached a ‘happy to create complementary services, and have ate outcomes that align with their provider not just for the ability to generate insights medium’ in headcount reduction and con- largely created alternate channels to deliver and payer incentives. to market products eff ectively, but to re- tinued outsourcing,” she says. “As we look traditional value propositions, including “We believe a golden era lies ahead for ally examine and build the internal skills, forward, we see patent cliff s continuing to information and patient resources. T ese pharma, but pharma companies have to processes and priorities to eff ectively and roll on in 2013 and beyond. As a result, will fi nd more traction in 2013-2015 as decide to thrive in it,” Evans says. “T ose broadly impact patient outcomes.” restructuring with continue, but not at the companies harmonize the channels and the that do will have to face the crucial need One dangerous temptation for market- same pace as in prior years. Becoming more roles. T is will be a scaling – not a change to marry the pipeline with the new market ers may be wanting to tack on services later effi cient is not something new. We are sim- in value. New value-add will come from defi nition of value. T e industry has spent along in a brand’s lifespan when the idea of ply following trends set by other industries in-home devices and monitoring to direct- billions to develop new drugs, but it con- an integrated approach should have been before us, such as fi nance and retail. And ly address the patient, but pharma may not tinues to focus on ‘me-too’ or small popu- built in from the beginning. Cavan Red- like other industries, we are beginning to have a monopoly on this.” lation, high-price specialty treatments, mond, the CEO of WebMD and a former embrace technology trends. Leveraging Khedkar and his colleagues at ZS also our ability to reach patients and physi- expect a bump in the use of companion “First and foremost the biggest challenge for pharma cians through technology, coupled with diagnostics. enormous cost pressures will continue. T e “Companion diagnostics associated with companies in moving beyond the pill is avoiding the ability to deleverage and create fl exible or- the use of a product are not very prevalent; impulse to simply ‘add on’ services.” ganizations will be the industry’s model of 1 percent of brands have one today,” he the future.” says. “But clinical trial pipelines indicate even though outcome demand and cus- top leader at Pfi zer, cautions against this In the rush to “right size,” though, phar- that 30 percent to 50 percent of treatments tomer expectations around chronic disease sort of short-term thinking. ma organizations may be tossing away a will need biomarkers in the coming years. and population management are changing “First and foremost the biggest challenge good deal of what has made them innova- As more products launch with a biomarker dramatically. Pharma companies need to for pharma companies in moving beyond tive in the fi rst place, not to mention the diagnostic, the ‘dual’ launch will be more shift from a mass-market, one-size-fi ts-all the pill is avoiding the impulse to simply morale of their own employees. Denise complex, as companies are not experienced approach to a targeted, segment specifi c ‘add on’ services,” Redmond told Med Ad DeMan of the executive search company in this.” value delivery approach that aligns with News. “T e industry should seek to off er Bench International believes that this in- Beyond that, companies are off ering or and responds to the new incentives and truly integrated approaches to the health- creasing pressure to shed numbers is mak- considering an array of products, including business models that their customers are care experience that brings value all along ing the beginning of 2013 a critical time pills, devices, and services, to serve the full adopting.” the spectrum. Embedding holistic, innova- for corporate soul searching. needs of the customer, typically within a According to Will Reese of the ad agen- tive thinking from the beginning is essen- “On the one hand, drug companies disease area or for a specialty. T is, Khed- cy Cadient Group, the most impressive tial. T erefore, the best opportunity of suc- shed workers at a slower pace in 2012 than kar says, may include services far removed complementary services pharma compa- cess is likely to be seen in those products the year before,” Ms. DeMan says. “Our from a drug product (e.g., practice manage- nies have added to their brands so far have seeking approval where, from the very out- industry lost a little under 13,000 jobs in ment). But customer-centric solutions by been in the multiple sclerosis and diabetes set, there has been a device or companion the January-November period, compared pharma companies have not realized their categories. diagnostic integrated into the continuum to more than 20,000 in the same period potential so far, due to compliance con- “Providing the ability to connect with to improve the overall health benefi ts.” of 2011, according to employment consul- cerns, margin dilution, and the inability to nurses and diabetes educators and receive tants Challenger, Gray & Christmas. On merge silos between product divisions. greater peer social support has become an the other hand, these layoff numbers are Another barrier to going beyond the important diff erentiator and driver of con- RESTRUCTURING still very high, with a weighting in critical pill has been a lack of payer support and sideration in chronic disease categories,” R&D activities, and with a devastating im- complex reimbursement, especially when Mr. Reese says. “T e most successful brands Uneasy has lain the head that wears any job pact on the social ecology pharma and the it comes to adding companion diagnostics have balanced their investments in specifi c in pharma over the past year, for fear of device sectors.” or owning multiple solutions in a disease services with the eff orts needed to ensure receiving a pink slip. Companies big and Ms. DeMan fears that the industry’s area. “Payers, with their siloed budgets and the services are integrated across marketing small alike have busied themselves with leaders have failed to consider the toll that focus on cost, have not supported such eff orts, including professional, and easily resizing, outsourcing, and all the other eu- these waves of layoff s are taking on their linkages,” Khedkar says. “As reform creates accessible across customer channels.” phemisms for letting people go. With the companies. ACOs and providers willing to focus on One recommendation Reese has for age of the traditional blockbuster nearly “What becomes of bravery, and the outcomes, this may change, but it is still a prospective beyond-the-pill adherents is over, the viability of large research organi- will to invest in new medicines?” she says. few years away.” to look outside. “Successful organizations zations prominently in question, and sales “Merry Christmas. We are having a big lay- Coordinating a solution that connects will partner with strong, well-established strategies shifting away from the face to off . Now the rest of you who dodged the disparate parts of the delivery system with patient service groups and build valuable face approach, this trend shows no sign of bullet be prepared to start the new year re- a treatment package that can prevent or programs versus building their own ser- ending in 2013, though the pace may slow freshed, revitalized, and excited to take on substantially delay increasingly intense lev- vices from the ground up,” he says. somewhat. the challenges of the new year. I’ll never els of patient care, reduces incidences of Jessica Brueggeman, VP of the health “Sales forces and corporate expenses forget what I was told by one of my clients, redundant care, and reduces total costs of behavior group at the ad agency Micro- have been cut at a furious pace driven a senior executive in pharma. ‘Our raison care to the risk bearing entity seems like Mass Communications, has observed this largely by the patent cliff ,” Khedkar says. d’être is to make people well,’ he said, ‘yet it should become a winning combination; very development in the marketplace. “While 2012 saw the most signifi cant drop we are made to feel vulnerable, insignifi - doing so, however, far exceeds the tradi- “We’ve seen the development of initia- in patent coverage, the next two years will cant, and physically ill in the process.’” tional label indication and will require tives and formalized partnerships at the see more restructuring as additional prod- It is true, Ms. DeMan believes, that some rewiring, both in the minds of mar- corporate-level that combine pharma’s ex- ucts go off patent. After a 45 percent re- the industry lived too long with bloated keters and marketees. pertise with unique products and services duction in sales personnel over the last few payrolls, under the doctrine that bigger is “Pharma companies are going beyond from external partners (e.g., integrated years, however, we expect restructuring to better. “We now know that better is better the pill, adding complementary services delivery networks, advocacy groups, tech- occur at a slower pace before we turn the and size does matter, though not the way to their brands to assist in patient com- nology products),” Ms. Brueggeman says. corner in 2014-2015.” we thought. T e lesson, for some manag- pliance, disease management, nutritional “Examples of this trend include Merck’s Hiring will bounce back as pipelines ers, is to shrink and become more nimble. habits, and other services that serve to patient engagement collaboration with pick up, Khedkar expects, although it will Yet slash-and-burn cuts into the soul of the
JANUARY 2013 MED AD NEWS • 7
magentablackcyanyellow ES177903_MAN0113_007.pgs 01.15.2013 03:06 UBM organization, the values, the belief system, on the patient, create important products, and the sense of trust and connection.” and get them to sick/hurt individuals if our Top 10 of 2013 formation if providers were able to access it on T e sense of vulnerability created by companies are populated with fearful, sick, PwC’s Health Research Institute has their mobile devices. According to PwC, only this approach can lead to retention breach. insecure people? Somewhere along the way, identifi ed ten issues as the top focus for 46 percent of hospitals have a security strategy “Consider an employee who has proven we’re forgetting that men and women who the health industry in the year ahead. to regulate the use of mobile devices. critical to a business and has been ad- create products, develop training programs, vanced quickly,” Ms. DeMan says. “We see and design the services of next-generation 1. States on the frontlines of Affordable Care 6. Goodbye cost reduction, hello transformation that these very employees start to falter, to pharma companies must themselves feel Act implementation With reimbursement resetting under the ACA deliver less, or to make errors in judgment. honored, protected, and viable.” Over the next year, state offi cials must decide and pressure from the federal budget crisis Companies must ask themselves if they how to run insurance exchanges, whether to and price-conscious consumers, hospitals are have caused the burn-out or disenfran- expand Medicaid coverage, and what type of scrambling to further reduce their costs. HRI chised key human assets.” BIG DATA insurance market regulation is needed. The big- research found that 40 percent of consumers T e question for rapidly resizing com- gest challenge states may face in 2013 will be postponed care in 2012 because of the costs. panies is how to avoid these scenarios, “Big Data” may well have been the information technology. Designing infrastructure Having already plucked low-hanging fruit with though Ms. DeMan is reluctant to answer, buzzword(s) of the year for pharma tech- to create a single, seamless entry point to the labor productivity and supply cost reductions, since doing so would be against her own nologists in 2012. Marketers seem to have exchange will require some states to undergo a more hospitals in 2013 will embark on full-scale business interest. “How does a company no trouble at all collecting mountains of major overhaul of existing Medicaid eligibility transformation efforts to redesign how they protect the health and well-being of the data on whatever topic or audience they systems. deliver care. talent that’s developing the products on wish – or, at least, talking about the moun- which they depend?” she asks. “It’s im- tains of data they plan to collect and how 2. Consumer revolution in health coverage 7. Customer ratings hit the pocketbooks of portant to add that this vulnerability is a it all will help them reach some heretofore Consumers’ rising voice on how they spend healthcare companies clarion call to recruiters. Headhunters win unattainable level of targeting nirvana – their healthcare dollars, coupled with state Paying for performance will take on new mean- by listening to the pain, by recognizing but actually processing and responding to insurance exchanges, is prompting the health ing in 2013 as consumer reviews generate pen- the unresponsive workplace, by hearing all this information is another matter. industry to compete on attributes similar to the alties and bonuses for hospitals and insurers. the questions valued staff quietly pose to “Access to more data doesn’t necessarily retail industry: convenience, price and transpar- This could mean a bonus payout of more than themselves. Maslow kicks in and their dis- result in better insight,” says Stephen Wray, ency. HRI found signs that consumers already $3 billion for insurers and a hold back of $850 enfranchisement leaves the employer vul- president and CEO of the Cadient Group. are warming up to new ways of purchasing million for providers in 2013. Healthcare com- nerable because talent will be stolen from “T e value of ‘Big Data’ will remain mar- insurance: nearly one-quarter (23 percent) of panies will need to invest in consumer research under their noses.” ginalized until we focus upon making it consumers surveyed said they are likely to buy and education in order to take full advantage of Resizing without irreversible trauma in actionable, by aggregating the most essen- health insurance from non-traditional sources the new payments. an era of increasing cost pressure will re- tial fi ndings, visualizing key strategic in- such as a retail store, up from 18 percent in quire complementary thinking; trying to sights, and making those insights portable 2011. 8. Meeting the new expectations of pharma cut costs while at the same time keeping across various levels of strategic stakehold- value the company’s best minds happy and pre- ers within organizations. Unless we focus 3. Medtech industry braces for excise tax Physicians, once the primary arbiters of pharma paring for future growth. T e consultants on converting big data into a more user- impact value, now have less say in payment decisions at Booz & Company call this approach “Fit friendly information fl ow, the pain points A 2.3 percent excise tax on medical device than insurers and large providers. The fi nal for Growth” – “A more strategic approach that have handicapped the industry’s ana- companies takes effect on January 1, 2013, hurdle in the long, expensive path to drug and representing potentially $29.1 billion to the device development is not regulatory approval, “We’re forgetting that men and women who create federal government over the next 10 years. The but rather reimbursement. Though pharma- products, develop training programs, and design the $380 billion global medical device industry ceutical and medical device companies play a is unlikely to be able to pass the tax on to its pivotal role in health outcomes, they will have to services of next-generation pharma companies must customers, but could look to its suppliers to prove it to earn it by demonstrating their value themselves feel honored, protected, and viable.” share in the burden. Some companies could and comparative effectiveness. owe more in taxes than they generate in profi ts, to costs that helps companies save but still lytics process will only be exacerbated by making them less attractive to investors but more 9. Bigger than benefi ts: employers rethink their prepare to grow,” Rotz says. “To borrow the increasing volumes of data available for enticing to larger companies looking to expand role in healthcare an analogy, the idea is to move from ‘crash analysis.” their portfolio. The tax impact should kick start For nearly 70 years, employer-based coverage diet’ cost saving initiatives – e.g., restruc- In order to do this, Wray suggests that new innovation, industry consolidation and has been a cornerstone of U.S. healthcare - but turing to address a wave of patent losses companies should begin to look to take ad- operational recalibration in the medtech sector. healthcare and employers may not be insepa- – to an ongoing cost fi tness regimen where vantage of advanced business intelligence rable. With the Supreme Court ruling to uphold you can build muscle and lose weight at tools that will allow them to access numer- 4. Caring for the nation’s most vulnerable: dual the ACA and the re-election of the President, em- the same time.” ous data sources simultaneously, mash up eligibles ployers have an opportunity to re-examine their Before any signifi cant decisions about data from numerous channels, and visual- Dual eligibles – people who qualify for both long term role in providing healthcare coverage resizing are made, Rotz suggests that com- ize the data in a user-friendly manner. Per- Medicare and Medicaid – make up many of the and explore alternative approaches provided panies should address two prior questions: formance indexing and competitive analy- 16 million people the ACA will add to Medic- by state and/or private exchanges. In 2013, “Where should we grow?” and “What are sis must also be enabled in one integrated aid rolls by 2019. The cost of care for duals is CEOs will ask tough questions about how and the few truly diff erence-making capabili- process. skyrocketing – much of it wasted due to a lack why so many resources are going to something ties we need?” Even the best tools, though, won’t nec- of care coordination between the two programs that is not core to the business. The answers will “Armed with answers to these questions, essarily help separate the useful from the – and 70 percent of state Medicaid spend- vary by company, some of which are likely to executives are well-equipped to align re- rest; that is a judgment that real people ing on duals goes to long-term care support transition away from healthcare coverage while sources, including how to reduce spend- need to make. Adam Budish, senior VP of services, such as nursing homes. Cash-strapped others will redesign their benefi t strategies. ing on capabilities, and headcount, outside sales at Epocrates and a decided “Big Data” states are increasingly turning to the expertise of those areas deemed to be ‘diff erence-mak- skeptic, calls this Real Data. managed care companies to better coordinate 10. The building blocks of population health ing,’” he says. “It also presses executives to “‘Big Data’ may have been a hot topic care, and they are seeking innovative solutions, management determine where business model changes – for 2012, but it didn’t generate much ac- such as from the technology sector, to better sup- Medicare’s accountable care organization and and the capabilities required to deliver on tion,” Budish says. “Focusing on the port home-based care and caregivers. patient-centered medical home initiatives laid them – can deliver more substantial pro- amount of data is counterintuitive to what a foundation for improving population health, ductivity compared to current eff orts that actually needs to be done with quality 5. Bring your own mobile device: convenience but other collaborations are fueling growth in try doing the same thing with less.” data. We should be drilling down to the at a cost population health management. In 2013, more Whatever strategy companies choose, precise moment that a physician is mak- Doctors and nurses are bringing their own companies are likely to form partnerships to Ms. DeMan believes that the year 2013 ing a life-saving decision and focusing on mobile devices to work, but many hospitals do build their population health IT infrastructures could be a turning point in pharma’s grand the information they need at that point in not yet have a secure enough environment to and to share responsibility for patient outcomes eff ort to fi gure out what human resources time. Real Data will tell you what they are protect sensitive patient information. Sixty-nine and satisfaction, data collection and analysis, it really needs and how they should be looking up and what information would percent of consumers surveyed said they are member education and engagement, with a cared for – the time for the industry to be relevant to be delivered to them.” concerned about the privacy of their medical in- focus on at-risk populations. get away from slash and burn and back to Embracing Real Data, Budish believes fundamental principles. Otherwise com- will help pharma companies gain a bet- panies may pay a high price for their lack ter understanding of physicians’needs and generating – another Budish catchphrase – follow suit.” of vision. behaviors while helping them see which Real ROI. T e leaders at Veeva Systems, a com- “It’s a time to learn that those of us who resources may be most benefi cial to which “Currently, in the absence of market pany that plays with data all day long, have chosen a life path of human health, audience at what time and on which chan- standards for data evaluation and shar- take a similar view, meanwhile warning of either attempting to manifest it, or to be nel. ing, it’s on the companies to ask for Real the dangers of that old business bugbear a service company supporting them, we T is will enable pharma marketers to Data versus a large pile of ‘Big Data,’” of balkanization. “New technologies have are all servant leaders, we are servants of a provide more targeted and dynamic con- Budish says. “Making the distinction will certainly made it much easier for pharma- population that wouldn’t turn to us if they tent to their target audiences based on Real lead to better decision-making and opti- ceutical companies, marketers in particu- weren’t sick,” she says. “How can we focus Data and real world scenarios, ultimately mized campaigns, and proven ROI will lar, to collect mountains of data from vari-
8 • MED AD NEWS JANUARY 2013
magentablackcyanyellow ES177902_MAN0113_008.pgs 01.15.2013 03:06 UBM magentablackcyanyellow ES177315_MAN0113_009_FP.pgs 01.11.2013 23:16 UBM ous channels – all promising huge insight,” And fi nally, better data relationships. Three new predictions for signifi cantly erode iPad’s market share dominance says Paul Shawah, Veeva’s VP of multi- Healthcare is arguably the most complicat- pharma marketers in 2013 (in Q3 2012, iPad shipments accounted for 55 channel CRM. “T is is good, but collect- ed topic in the world. T e inter-relationship percent of the tablet market, down 14 points from ing relevant data is better. However, many of genetics, personal history, medication, By Bill Drummy Q2 2012), in pharma, it’s pretty much an all-iPad marketing organizations are struggling to and lifestyle, among other factors, means game, and likely to remain so with the Q4 intro- realize the benefi ts of big data due to the that each person’s health is individualized Nate Silver of the New York Times astounded duction of the more labcoat-friendly iPad Mini. diffi culty in integrating data from multiple to an impressive degree. the political world by predicting the results of the The news here is that pharma companies will channels, all siloed. At best, cross-channel “T e movement toward the integration 2012 elections with uncanny accuracy, while now make the platform much more impactful in interaction data is stitched together after of all the data into longitudinal patient- many so-called experts, including the revered 2013, in terms of both salesforce productivity and the fact, but that is often delayed and only centric relational databases is paramount and/or feared Karl Rove (who George W. sales detail creativity. From the productivity point a partial view. At worst, it is not captured to developing the right solutions for each Bush referred to as the “architect” of his 2004 of view, by integrating the devices more deeply at all. T e marketing team, therefore, never patient,” Nesbitt says. “Insights gained re-election) were dramatically, historically, and into closed-loop marketing systems, companies gets a complete perspective of the physi- from proper use of ‘Big Data’ will help embarrassingly wrong. will achieve signifi cant savings and greater clarity cian across all channels and the process is physicians and pharmacists better match This brings to mind the promise and peril about salesforce effectiveness. grossly ineffi cient.” and fi ne tune regimens to specifi c patient of the prediction business. I have been making Many companies that took halting, conserva- In 2013, Shawah suggests that the phar- needs, leading to improved patient out- predictions about the future of pharma marketing tive fi rst steps with tablets in the name of expedi- ma technologist’s focus is going to turn from comes and reduced healthcare costs.” for more than a decade; sometimes I’ve come out ency and risk-avoidance are realizing just how “Big Data” to Relevant Data – “In other One potential source of insight that looking like a svelte and psychic Silver; other times much of the value of the device as a sales tool they words, how can pharma capture and con- some companies may be overlooking in I resembled a rotund and retrograde Rove. And have been avoiding as well. (Throwing a PDF of solidate data from all of the interactions that their rush to all the data that comes from yet here I go again. a sales aid onto an iPad has not impressed many a physician has with the company through electronic health records in hospitals, in- For 2013, I foresee three major developments doctors.) Now we are seeing clients looking to use all channels AND put it into context. surers’ claims and cost data, pharmaceuti- that will have dramatic impact on how pharma the full power of the device to make a deeper im- “Also, how do you simplify this analytics cal clinical trials, health risk assessments, marketers plan and execute their marketing pression on HCPs. That means taking advantage process for marketing teams? New technolo- and the rest is that which comes with an- campaigns, with those on top of the trends enjoy- of the iPad’s GPS functionality, accelerometers, gies will emerge to enable both consolida- other of the industry’s buzzwords: social ing superior results and burnished careers. This and built-in cameras, as well as design principles tion of interaction data and orchestration of media. year, the trends are not so much revolutionary as that are tablet-centric. The result in 2013 should sales and marketing tactics from across all “Social media is a rich source of data and evolutionary: crystallizations of strategies that have be breakthroughs in sales effectiveness for those channels. T e result will be better, real-time an opportunity for health organizations to emerged over the last several years, and refi ne- companies that deploy these devices to full effect. customer insight and a more orchestrated interact with communities of both con- ments of platforms that are no longer new. customer engagement approach across chan- sumers and clinicians,” says Andrew Gunn, Filling the gap between patient and HCP nels. Marketing will be able to answer the director, pharmaceutical and life sciences Digital marketing becomes “Marketing” With all the focus on the HCP-sales rep relation- question, ‘How do I spend my limited bud- advisory, PwC. “A recent PwC Health I am old enough (as my partners regularly tell ship, the most intriguing opportunity for pharma get for maximum return?’” Research Institute survey found that one- me) to remember lots of things that nobody else marketers may well lay in another space entirely Asking the question is easier than an- third of consumers are using social media does. When I was a kid, the TV networks used to – the dialogue between HCPs and their patients. swering. One industry analytics specialist for health-related matters. Yet social media announce that popular shows like Bonanza were Of course, pharma can’t practice medicine or do off ers the industry-perplexed three poten- has largely been used in healthcare as a tool “brought to you in living color.” They eventu- anything that violates the sanctity of the patient/ tial areas of focus. for one way education and promotional ac- ally stopped doing that, long after it seemed HCP relationship. But marketers can (and should) “‘Big Data’ enables evidence-based rea- tivity, which represents unique challenges superfl uous, even to an 8-year-old. Well, we enable that critical dialogue – by providing tools have reached that point with digital marketing. that will help the HCP better understand a particu- “Inasmuch as marketing has a responsibility to Virtually all marketing is now (or will be by next lar condition, and better inform the patient of how to best manage that condition, including how to communicate the value of the medicine, ‘Big Data’ is likely season) “digital” in some sense, whether it’s detail aids on iPads, targeted campaigns driven by best use their drugs. This is such a rich place to to make life more diffi cult.” “Big Data” insights, or HCP programs that reach play that the possibilities appear almost as broad clinicians at the moment of care through mobile as your imagination as a marketer. soning on a broader and deeper scale, with for pharmaceutical companies.” devices. Digital, digital, digital. So in 2013, smart Here are just a few non-imaginary examples: more data being analyzed and brought to As marketers become more sophisticat- marketers will not be asking, “What is my digital • An app that visualizes an algorithm for bear in clinical, behavioral, and marketing ed in their use of data, Gunn suggests that marketing strategy?” but, “How should my entire oncologists to help them understand which patients decisions,” says Scott Nesbitt, executive social media will become a more valuable marketing strategy be digitally enabled?” Artifi cial are right for a particular treatment – based on VP, analytics, insight, and strategy, Patient- source of actionable business intelligence distinctions will disappear. Everyone knows that industry-accepted guidelines – made functional, Point. “To better manage the information, about consumer preferences, expectations Bonanza will be broadcast in color. impactful and user-friendly by a clear-thinking marketers need to focus on three areas: and behavior, prescription adherence, But this is more than just a change in nomen- pharma company. fi rst, a move toward actionable insight; product performance-quality and safety is- clature. In a more signifi cant way, it signifi es that • An app that helps both patients and doctors second, expanded personnel skillset; and sues, unmet clinical needs, and emerging marketers need to change their orientation to mar- see how the patient is progressing between offi ce third, better data relationships.” health concerns as well as sources for clini- keting. The fundamentals don’t change: you still visits, that critical time when the effect of a drug Regarding Nesbitt’s fi rst area, the fi eld of cal trial participation. build campaigns based on audience insights, and starts to become apparent, but remains invis- data analytics is continuing to evolve from Whatever the source, though, marketers you still need to conceive a strategy with differenti- ible simply because the doctor does not see the the reporting of data to the interpretation should prepare themselves for many sleep- ating creative. But no longer should you think in a patient’s progress fi rst-hand. The app allows the and understanding of data. “Just spewing less nights of fi guring out the implications pigeon-holed way about marketing “channels.” physician to follow the patient’s progress remotely, out data in reports, charts, and tables is no of all the data they were so overjoyed to Rather, you maximize the power of all your thus increasing the HCP’s confi dence in the treat- longer the end point for the pharma tech- access. In an inversion of the usual cliche, marketing by using digital as a tool for deriving ment regimen, and the patient’s willingness to nologist,” he says. “T e challenge is to pro- “Big Data” may well be a challenge dis- key customer insights, and then by deploying adhere to the therapy. vide actionable insight. T e industry needs guised as an opportunity. assets strategically to reach your targets most effi - • A web appliance that makes it easy for doc- to convert ‘Big Data’ into ‘Big Insight.’ For “Inasmuch as marketing has a respon- ciently and effectively. To be clear: I am not saying tors to see whether a particular drug is covered by example, it is not enough to know that ‘we sibility to communicate the value of the that every tactic will be or should be digital. There the patient’s insurance plan, and which pharmacy need to improve adherence.’ T e insight medicine, ‘Big Data’ is likely to make life are still good reasons for slim-jims, TV spots, and in the area is currently stocking the product. is that ‘we can improve adherence by pro- more diffi cult,” Rotz says. “Whereas his- print ads. But the prism through which one peers Simple, useful, incredibly valuable to the doctor, actively analyzing and identifying patterns torically the manufacturer had good con- into marketing strategy must be a digital one, and patient and pharma company. Win-win-win. leading to non-adherence and suggest regi- trol and visibility of the clinical trial data every component of the strategy should include I could go on. (We have seen, and built, many men changes that lead to better adherence that underpins the product’s value propo- measurement that is, inherently, digital. Think of of these apps in the last 18 months.) This is per- and improved outcomes.’” sition, the rise of ‘Big Data’ – and specifi - it as making all your assets intelligent, in the way haps the most exciting territory of the new pharma Next up, the expanded personnel skillset. cally real-world data on the products – will that they can smartly interact with their audiences, marketing, a place where marketers can do real A new hybrid of data analyst has evolved, make shaping the value story much more and in how they can tell you about themselves, in good for customers, for patients, for their brands, one that is in high demand and short sup- diffi cult. A signifi cant implication of Big other words, how they can become, in a sense, and indeed or the industry’s reputation. In 2013, ply. T is analyst can decipher the data and Data is that pharma companies will need “self-aware” and thus much more relevant to the I predict that at least six such apps produced by think like a business person. to create a forward-looking real-world audience and illuminating to the marketer. pharma marketers will make a measurable impact “Because of the complexity of ‘Big Data’ evidence capability, which is inherently So my prediction is this: Marketers who take in the marketplace. and the millions of paths down which it a cross-functional undertaking spanning a digital-centric approach will be signifi cantly So will you see me in December wearing a can lead, a need now exists for an empow- commercial and medical. While control of more successful in 2013 than their old-fashioned wide smile as you honor my perspicacity, or will ered analyst as thought/business leader,” the ‘value message’ for the product is just competitors (who may still be watching Bonanza you instead be grinning at my gaffes? Time will Nesbitt says. “Analysts no longer simply one implication, more generally, we need in black and white). tell, but I am far surer about these predictions than report the data and ‘pull crosstabs’ for the to remember ‘Big Data’ itself does not cre- I was about the 2012 election, which turned out marketing department. Instead they need ate wisdom or insight. Given all of the pos- The iPad dives deeper into sales not to be very close, after all. to understand and learn all aspects of the sibilities, pharma marketers will need to be The entire industry has gone gaga over the tablet business and focus on providing both ac- even sharper on the questions they want to platform. And even though Android tablets from Bill Drummy is the founder and CEO of Heartbeat tionable insights and business solutions – answer and how they will use those answers Samsung, Google, and Amazon have begun to Ideas and Heartbeat West. not just data.” to drive performance.”
10 • MED AD NEWS JANUARY 2013
magentablackcyanyellow ES177899_MAN0113_010.pgs 01.15.2013 03:06 UBM THE SHAPE OF MARKETING TO COME
The balancing act for 2013: optimizing multi-channel marketing through a next generation “enabled” sales force, seamless digital operations, valuable content and time-tested traditional elements.
By Christopher Wooden, Cegedim Strategic Data
he new year will bring exciting oppor- “no-see” doctors, the traditional one-on-one panies need to objectively tunities and challenges for pharmaceuti- marketing approach is no longer sustainable. evaluate web conference Tcal marketing. An expanding audience Nevertheless, face-to-face sales meetings will usability and fi nd provid- of physicians, payers and patients is more con- remain an essential part of the marketing chan- ers that alleviate confusion nected and online than ever – and more sub- nel mix. Indeed, a fi eld user must be equipped with reservations, dial-in ject to information overload than ever. Value- to rapidly stimulate further engagement, tying numbers and access codes. creating marketing strategies in 2013 depend the HCP into other valuable resources. Ideally, Especially important for on the performance of each engagement chan- these will be available through a near seamless smaller practices, select nel in a company’s network of touchpoints multi-channel off ering. Serving as the lead-in technology that relies less with healthcare professionals (HCPs) on fl ashy interfaces and more on sim- proached social media with caution due to reg- as well as patients and other stake- ple capabilities to eliminate compat- ulatory scrutiny and potential public relations holders. ibility issues for physicians with older missteps. Yet, success with social media is pos- Currently, the multi-channel strat- hardware. sible in terms of building brand awareness and egy encompasses all personal promo- Extremely relevant for the e-detail- generating good PR – and several big pharma tion, e-detailing, social media, print ing channel, webinars and webcasts – have demonstrated this admirably. But this is advertising, digital promotion, email when done right – can off er clear value not accomplished quickly or without invest- campaigns and integrated telephone in terms of time saved and features of- ment. Broadly speaking, those companies that interactions. As channels evolve to fered. T ese interactions build on an have invested in well designed, content rich keep pace with tech innovations, existing, trusted relationship between and accessible websites have also performed 2013 will see some companies adapt a sales rep and physician – and ideally well in integrating new social media tools. and leverage these dynamic tools off er value which augments conven- Some processes in this context should “go to their competitive advantage over tional sales calls. During a successful without saying” but incredibly, something as those that don’t. e-detailing session, reps can better basic as making sure that social posts off er a T e United States is well aware manage the fl ow of information, and, well-planned click-though pathway begs to be of this transition. According to Cegedim Re- and human side to the multi-channel environ- because the interaction is based on a physician’s mentioned. For example, if a physician clicks lationship Management’s 2012 US Pharma ment, sales reps must be enabled to maintain schedule, can last signifi cantly longer than tra- on a link from a company’s Twitter feed for a Insights Report, 74 percent of survey respon- high-level effi ciency. Improved fi eld practices ditional meetings. page that highlights clinical results on a given dents ranked the changing commercial busi- will most likely come through upgrading tab- Most importantly, streamlining digital com- drug, does that very same web page logically ness model as a priority. Organizations are let capabilities – cited as most companies’ tool munications can empower Life Sciences orga- provide additional contacts and resources by coming to the awareness that doctors, patients of choice (80 percent) according to Cegedim’s nizations with a clear, up-to-date voice in the phone, video and email? Some companies are and other stakeholders view drug purchases in 2012 U.S. Pharma Insights Report. current healthcare discussion. By integrating truly “best practice” in this regard, whereas much the same way they might shop for con- Instant-on capabilities and simple yet in- these channels, reps and other service providers others clearly have room to improve. sumer goods and services tuitive dashboards can save users precious mo- within an organization can be easily reached if Consistently left out of the multi-channel Transformations in conventional market- buzz, paper mail and print journals will never- ing underscore the need for diversifi ed strate- theless generate value and provide a means of gies. Pharma sales rep “detailing,” face-to-face increasing brand awareness. With many online with individual HCPs continues a downward As channels evolve to keep pace with tech innovations, 2013 will publications featuring distracting, animated trend everywhere except emerging markets. advertisements and less than relevant, in-your- Yet, this development may not be suffi cient to see some companies adapt and leverage these dynamic tools to face videos, gleaning useful information can be provoke action. T e fl ood of new technology their competitive advantage over those that don’t. frustrating for many users. In this context, the comes with the associated potential for costly now underused and it’s-so-traditional-its-old- IT investments. In addition, any suggestion of fashioned channel of print could see a come- “holistic” operational change may create ap- back. Perhaps ironically, print may off er a prehension as to revamping an existing multi- ments in front of doctors with a waiting room a doctor, patient or hospital administrator has “new” opportunity to diff erentiate a brand and channel approach. full of patients. Further, enhancing reps’ mo- a specifi c question about a disease, conference, increase visibility. However, a strategic approach does not bile toolkits can allow administrators to easily referral, treatment or cost-benefi t issue. Indeed, Of course, the content, services and inter- necessarily equate to a wholesale business rein- track performance, execute/modify activities, the right multi-channel strategy can allow action off ered should always be of the highest vention, but merely a more intelligent merger and quickly adapt to market transitions and pharmaceutical, medical device and biotech quality and signifi cance to the targeted stake- of tools and practices that are already in play: specifi c budgets. Eventually, by enriching these companies to quickly become more visible and holders. Consider the century-old Merck Man- personal interactions; traditional media; a channels with the fruits gleaned from “big accessible. ual as a resource archetype that has successfully comprehensive digital presence; operational data” from the right healthcare sources, com- integrated with digital channels. Now very ac- excellence; and next generation technology. panies will bring HCPs even more value. tive on social media, this paradigm could be Building a more logical presence applied in a product-specifi c format for com- with resource-driven content panies to generate more meaningful feedback Altered models: A condensed, more Smooth out the digital interchange loops with all targets in a similar fashion. effective sales force In the rush to boost their digital presence, Best practices in 2013 will be a hybrid of Once a rep has aced the sales meeting and the many pharma company initiatives lack stra- old and new. Undoubtedly, companies that Facing numerous blockbuster patent expira- physician accesses digital resources, or picks up tegic planning and, in some cases, coherence. achieve cohesion between perfecting the basics, tions, current pharma industry pipelines will the phone to close the loop, the rest is downhill Best practice online depends on a logical, or- empowering fi eld users, and streamlining their not yield the revenue to displace losses. Reduc- – right? It is hard to believe, but many doctors derly and aesthetically consistent relationship digital channels will deliver value to stakehold- ing sales force and budgets are unavoidable agree that this channel is still far from a painless of working parts. ers and shareholders alike. facts in this context. Accordingly, companies experience. Any use of social media for marketing are forced to achieve more with less. Moreover, Blurry web conference meetings and acces- and PR purposes requires a cohesive strategy. Christopher Wooden is the VP for global sales with one in fi ve U.S. physicians now listed as sibility issues act as powerful deterrents. Com- Understandably, the pharma industry has ap- at Cegedim Strategic Data.
JANUARY 2013 MED AD NEWS • 11
magentablackcyanyellow ES177601_MAN0113_011.pgs 01.12.2013 06:14 UBM SPECIAL REPORT
of $9.08 billion. T ose analysts projected BEST BIOTECHNOLOGY PIPELINE global 2018 sales of $3.4 billion for the drug. ROCHE PEGylated Interferon beta-1a is a chemically modifi ed version of interferon beta-1a, and BEST CNS PIPELINE Top 10 pipelines is designed to increase half-life and systemic BIOGEN IDEC exposure of the protein. Biogen Idec is BEST DIABETES PIPELINE GlaxoSmithKline and Roche’s extensive and diverse product developing the drug candidate in Phase III NOVO NORDISK pipelines are recognized as leaders in multiple categories. trials for relapsing forms of multiple sclerosis. PEGylation extends the half-life of BEST INFECTIOUS DISEASE PIPELINE Interferon beta-1a, potentially enabling dosing By Andrew Humphreys [email protected] every two or four weeks instead of the once- GILEAD SCIENCES weekly administration of intramuscular IFN BEST LATE-STAGE PIPELINE beta-1a. PEG-IFN beta-1a is anticipated to off er effi cacy at least equivalent to that GLAXOSMITHKLINE his annual special feature iden- Canada, and Switzerland for treating relapsing- of intramuscular Interferon beta-1a 30 μg. BEST MID-STAGE/EARLY-STAGE PIPELINE tifi es and profi les 10 therapeutic pipeline remitting multiple sclerosis. Dimethyl fumarate Because PEG-IFN beta-1a may help address PFIZER categories covering pharma, biopharma- is the only known investigational compound unmet patient needs, U.S. regulators granted T BEST ONCOLOGY PIPELINE ceutical and biotech companies as chosen by for treating RRMS that has experimentally this product candidate Fast Track designation. Med Ad News editors. Winners in each category shown activation of the Nrf-2 pathway. T e investigational, once-monthly ROCHE were selected based on pipeline depth, diversity, In October 2012, Biogen Idec announced subcutaneous therapy daclizumab high-yield BEST RESPIRATORY PIPELINE innovation, and commercial potential. In de- that FDA extended the initial PDUFA date process (DAC HYP) is being developed by GLAXOSMITHKLINE termining the winners, with the exception of for its review of the new drug application Biogen Idec in Phase III for treating relapsing- the Best Mid-Stage/Early-Stage Pipeline selec- for dimethyl fumarate. T e three-month remitting multiple sclerosis. A humanized BEST VACCINE PIPELINE tion, a special emphasis was placed on late-stage extension – a standard extension time line – antibody specifi c for the interleukin-2 GLAXOSMITHKLINE products with blockbuster potential because so was needed to allow extra time for review of receptor, daclizumab is being developed under MOST INNOVATIVE PIPELINE many mid-stage and early-stage candidates do the application. a collaboration with Abbott Biotherapeutics. NOVARTIS not reach the marketplace. T e information for In other October 2012 news, a pre-specifi ed T e drug is believed to work by selectively this special report was gathered from company analysis of integrated data from the Phase III binding to and inhibiting the high-affi nity and industry sources as well as internal resourc- DEFINE and CONFIRM trials for dimethyl IL-2 receptor on activated T cells (immune companies are developing antisense products es of Med Ad News. T e pipeline reviews are fumarate demonstrated statistically signifi cant cells) without resulting in T-cell depletion. to treat spinal muscular atrophy and myotonic listed in alphabetical order by company. Ocrelizumab is in Phase II trials for dystrophy type 1 under previously established relapsing-remitting multiple sclerosis. T is collaborations. humanized anti-CD20 mAb is being developed Biogen Idec has several development BEST CNS PIPELINE: in a collaboration with Genentech, a wholly programs for amytrophic lateral sclerosis BIOGEN IDEC owned member of Roche. For more details, (ALS). T e company in 2012 entered into a please see the Roche Best Biotechnology research collaboration with Duke University iogen Idec discovers, develops and Pipeline entry. and HudsonAlpha Institute to sequence the Bdelivers innovative medicines for neuro- Anti-LINGO 1 is a monoclonal antibody genomes of up to 1,000 people with ALS during degenerative diseases, hemophilia and auto- and clinically relevant eff ects in reducing MS in Phase II trials. Data from animal models the next fi ve years to gain a better understanding immune disorders to patients globally. Estab- relapses and progression of disability, as well as have demonstrated that the product candidate about the fundamental genetic causes of the lished during 1978, Biogen Idec is the world’s reductions in MRI measures of disease activity. promotes remyelination and axon survival. disease. Biogen Idec also established a research oldest independent biotech entity. Worldwide, Interim safety data from a Phase III extension Proof-of-concept studies in optic neuritis were consortium in collaboration with several top patients benefi t from the Weston, Mass.-based trial indicate that continued exposure to anticipated to begin in fourth-quarter 2012, academic research centers to identify new company’s leading multiple sclerosis therapies: dimethyl fumarate did not lead to any new or and in second-half 2013 for multiple sclerosis. approaches to treating ALS. T e company has the blockbuster brands Avonex and Tysabri. worsening safety signals. Alo, the drug’s safety Biogen Idec struck a deal with Isis dedicated signifi cant funds to the University of Dimethyl fumarate (product code BG-12) and tolerability profi les were consistent with Pharmaceuticals during December 2012 on a Massachusetts Medical School ALS Champion represents the next promising MS treatment previous studies. worldwide collaboration. Biogen Idec and Isis Fund to spur awareness of amytrophic lateral and anticipated mega-brand for Biogen Idec. In a June 2012 report, EvaluatePharma plan to discover and develop antisense drugs sclerosis, and support basic and clinical science T e immunomodulator is awaiting approval in cited BG-12 as the second most valuable R&D against three undisclosed targets for treating research into potential treatments for ALS and the United States, European Union, Australia, project in the industry with a net present value neurological or neuromuscular disorders. T e other neurodegenerative diseases.
BEST INFECTIOUS DISEASE also marketed for treating HIV infection in “boosting” agent to raise blood levels and infection for treatment-naïve adults. Stribild patients 2 years of age and older in combination enable once-daily dosing for certain HIV joins together four compounds in one daily PIPELINE: GILEAD SCIENCES with other antiretroviral agents. medicines, including elvitegravir. Cobicistat is tablet: the integrase inhibitor elvitegravir; the ilead Sciences of Foster City, Calif., Gilead’s R&D program is at its largest being investigated as a boosting agent for other pharmacoenhancing agent cobicistat; and Gis a research-based biopharma company capacity ever. T e company has over 75 Phase antiretrovirals, in particular, protease inhibitors. emtricitabine and tenofovir. that discovers, develops and commercializes II and III clinical studies evaluating compounds T e drug candidate is in Phase III trials. FDA’s approval of Stribild is supported innovative medicines in fi elds of unmet medi- with the potential to become the next generation As a novel prodrug of tenofovir, the active by 48-week data from two pivotal Phase III cal need. T erapeutic areas of concentration of innovative therapies for HIV; hepatitis; agent in Viread, GS-7340 has the potential studies in which the single-tablet regimen met include HIV/AIDS; hepatitis; serious respira- serious respiratory, cardiovascular and metabolic to provide greater antiviral effi cacy at a dose its primary objective of non-inferiority versus tory, cardiovascular, and metabolic conditions; conditions; cancer; and infl ammation. T rough 10 times lower than Viread. GS-7340 is being Atripla and to a regimen containing ritonavir- cancer; and infl ammation. the fi rst nine months of 2012, Gilead spent studied in Phase II for treating HIV infection. boosted atazanavir plus Truvada (Study 103). Gilead’s portfolio of 15 marketed products $1.32 billion on R&D compared to $826.9 Gilead has a host of new product candidates EvaluatePharma analysts have projected includes various category fi rsts, including the only million during the corresponding January- Stribild global sales of $2.79 billion for 2018. complete treatment regimens for HIV infection September 2011 period. Anticipated to be even a larger market available in a once-daily single pill – Atripla, Elvitegravir is one of the fi rst candidates presence than Stribild is Gilead’s sofosbuvir/ cleared for marketing in 2006; Complera, in a new class of HIV drugs called integrase GS-7977. Sofosbuvir is a once-per-day approved during 2011; and Stribild, which was inhibitors. Unlike other classes of antiretroviral nucleotide analog polymerase inhibitor for approved during 2012. Additionally in 2012, agents, integrase inhibitors interfere with HIV HCV infection treatment. T e drug candidate Truvada became the fi rst agent approved in replication by blocking the virus’ ability to is being studied as part of multiple therapeutic combination with safer-sex practices to reduce integrate into human cells’ genetic material. One regimens, including in combination with RBV the risk of HIV-1 in high-risk uninfected adults, of the active ingredients in Stribild, elvitegravir being developed for liver disease. In its World and peg-IFN. Sofosbuvir is being evaluated as a strategy known as pre-exposure prophylaxis is also undergoing Phase III trials on its own. Preview 2018 report published during June a once-daily fi xed-dose combo consisting of (PrEP). Atripla and Truvada generate billions of Elvitegravir was licensed by Gilead from 2012, EvaluatePharma rated the industry’s sofosbuvir and the NS5A inhibitor GS-5885. dollars in annual global sales. Japan Tobacco (JT) in March 2005. Gilead has top 20 most valuable R&D projects. Gilead For this combination product, the added goal With annual sales exceeding $700 million, exclusive rights to develop and commercialize accounted for two of those top 20 pipeline is creating a potent, tolerable and convenient Gilead’s leading hepatitis drug is Viread. T e elvitegravir in all countries globally except projects that are anticipated to be mega-brands all-oral treatment for genotype 1 infected HCV once-daily oral NtRTI treats chronic hepatitis Japan, where JT retains rights. Gilead fi led a by 2018: GS-7977 and “Quad.” patients that may eliminate the necessity for B virus infection in adults with compensated New Drug Application to U.S. regulators for Since that report was issued, “Quad” was interferon and/or RBV. and decompensated liver disease and pediatric elvitegravir on June 27, 2012. FDA-approved in August 2012 under the In late November 2012, Gilead revealed patients 12 years and older. Initially approved Cobicistat is an investigational compound brand name Stribild. T e product is a complete top-line results from the Phase III POSITRON by U.S. and EU regulators in 2008, Viread is being studied as a pharmacoenhancing or once-daily single-tablet regimen for HIV-1 study examining a 12-week course of once-
12 • MED AD NEWS JANUARY 2013
magentablackcyanyellow ES177778_MAN0113_012.pgs 01.14.2013 22:40 UBM daily sofosbuvir plus ribavirin in patients are evaluating sofosbuvir therapy in HCV Certain industry analysts believe that “T is product boasts impressive 2018 with genotype 2 or 3 chronic hepatitis C genotype 2 or 3 infected patient populations. Gilead appears to have a lead on its rivals in forecasts of $5.4bn, which the product will virus infection who are not candidates to Positive clinical-trial results are expected to the development of a new hepatitis C drug need to achieve in order to justify the $11.2bn take interferon. T e clinical trial found that support initial regulatory submissions during that could compete in a potential $20 billion Gilead paid for Pharmasset in order to obtain 78 percent of patients remained HCV RNA mid-2013 for an all-oral therapy with sofosbuvir market. Sofosbuvir is anticipated to thrive in the candidate,” according to the analysts in its undetectable 12 weeks after completing plus RBV among genotype 2 or 3 treatment- the marketplace due to its impressive effi cacy World Preview 2018 report. therapy. T e safety profi le of sofosbuvir was naïve, treatment-experienced and interferon- as a single pill taken once a day compared to Gilead completed the acquisition of similar to that evident in previous trials, and intolerant patients, and for sofosbuvir in multi-drug combinations. Pharmasset in January 2012. A clinical-stage there were few treatment discontinuations combination with RBV and peg-IFN among EvaluatePharma ranked the hepatitis C pharma company, Pharmasset was dedicated to because of adverse events. POSITRON is the treatment-naïve patients with HCV genotypes polymerase inhibitor sofosbuvir as its No. 1 discovering, developing and commercializing fi rst of three completed Phase III trials that 1, 4, 5 and 6. R&D industry project as of June 2012. novel drugs to treat viral infections.
BEST LATE-STAGE PIPELINE: the MEK inhibitor trametinib. T e European investigational biological, injectable form HCl to ERT to primarily support worldwide application requests that dabrafenib be approved of human glucagon-like peptide-1. GLP-1 market clearance. GLAXOSMITHKLINE for treating adult patients with unresectable acts throughout the body to help maintain For patients receiving enzyme replacement or metastatic melanoma with a BRAF V600 normal blood-sugar levels and control appetite. therapy for Fabry disease, migalastat HCl in s a science-led worldwide healthcare mutation. T e U.S. submissions for dabrafenib Typically, GLP-1 levels increase during a meal combination with that therapy may improve Acompany, GlaxoSmithKline researches and and trametinib are for the treatment of patients to help the body use and control the elevation ERT outcomes by keeping the infused alpha- develops a wide array of innovative medicines with unresectable or metastatic melanoma in blood sugar levels. However, GLP-1 is rapidly Gal A enzyme in its properly folded and and brands. T e company’s three main business with BRAF V600 mutations as detected by an degraded, leading to its short duration of action. active form. Migalastat HCl co-administered areas are pharmaceuticals, vaccines and con- FDA-approved test. T e regulatory fi ling for In individuals with type 2 diabetes, GLP-1 with ERT is in a Phase II trial (Study 013). sumer healthcare. According to GSK, its com- trametinib with the EMA is expected soon. secretion in response to a meal is reduced. Migalastat HCl co-formulated with JCR mercial success depends on creating innovative An orally bioavailable inhibitor of the Albiglutide fuses human GLP-1 to human Pharmaceuticals’ proprietary investigational new products and making them accessible to as BRAF protein, dabrafenib was discovered and albumin. T e drug is designed to extend the ERT JR-051, a recombinant human alpha- many people who need them as possible. developed by GSK. An orally bioavailable action of GLP-1, and has the potential to enable Gal A enzyme, is undergoing preclinical Research is vitally signifi cant to the success inhibitor of the MEK protein, trametinib was weekly injections. GSK is developing a once- development. of GlaxoSmithKline’s business. T e company discovered by Japan Tobacco and in-licensed by weekly injection of albiglutide using a fi ne gauge T rough a collaboration with Janssen spent £4.01 billion ($6.43 billion) in 2011 and GlaxoSmithKline during 2006. needle for reconstitution and subcutaneous Biologics (Ireland), GlaxoSmithKline is £2.83 billion ($4.54 billion) during January- In vitro diagnostics leader bioMérieux during administration by the patient. evaluating sirukumab (product code CNTO September 2012 to research to develop new 2010 developed a molecular T e Phase III development 136) in Phase III development. T e human medicines, vaccines and innovating consumer theranostic test to detect BRAF program for albiglutide consists anti-interleukin (IL)-6 monoclonal antibody products. GSK is one of the few healthcare V600 (V600E and V600K) of eight individual trials involving is being developed for treating patients with companies researching medicines and vaccines gene mutations located in several 5,000 patients, known as Harmony. moderately to severely active rheumatoid for the World Health Organization’s three cancers, including melanoma. T e program is investigating the arthritis. Sirukumab targets the cytokine priority diseases – HIV/AIDS, tuberculosis T e French company submitted effi cacy, tolerability and safety of interleukin (IL)-6, a naturally occurring and malaria. GSK’s pharma business researches, for FDA Pre-Market Approval of albiglutide as monotherapy and protein believed to have a role in autoimmune develops and makes available medicines for the test, and it is being used in the add-on therapy in patients with conditions such as RA. treating an array of serious and chronic diseases. Phase III trametinib-dabrafenib combination type 2 diabetes. A majority of the trials include GlaxoSmithKline and Janssen Biologics Medicines available or in development by the program to identify appropriate patients. active comparators, including a sulfonylurea, during December 2011 agreed to jointly develop company include these areas: infectious diseases, T e investigational integrase inhibitor a thiazolidinedione, insulin, and a dipeptidyl and commercialize sirukumab for rheumatoid cancer, epilepsy, heart disease, asthma and dolutegravir is awaiting regulatory clearance peptidase four inhibitor. arthritis. Before this deal, Janssen Research & chronic obstructive pulmonary disease, as well from health authorities in the United States, In collaboration with the biopharma company Development was developing sirukumab for as HIV/AIDS. European Union, and Canada. T e product’s Amicus T erapeutics, GlaxoSmithKline is rheumatoid arthritis. Phase III programs were completed for six application fi lings were announced during developing the investigational pharmacological GlaxoSmithKline is developing the novel medicines during the fi rst 10 months December 2012 by ViiV Healthcare. chaperone migalastat HCl for treating Fabry antisense oligonucleotide drisapersen (also of 2012, with worldwide regulatory fi lings ViiV is a worldwide specialist HIV company disease. Amicus holds commercial rights to all known under the product code 2402968) for initiated for several potential new products. that was established in November 2009 by Fabry products in the United States and GSK the rare disease Duchenne muscular dystrophy. “Progress in our late stage pipeline this year has GSK and Pfi zer. Shionogi became a 10 percent has commercial rights to all of these products Recruitment into the Phase III studies was been exceptional with output better than in any shareholder in October 2012. T e aim of ViiV in the rest of the world. As a monotherapy, completed as of third-quarter 2012. T e previous period for the company,” noted GSK is to take a deeper and broader interest in HIV/ migalastat HCl is designed to bind to and product came from Prosensa, a privately held in its fi nancial report based on the fi rst three AIDS than any other company and take an stabilize, or “chaperone” a patient’s own alpha- biopharma company that concentrates on quarters of 2012. innovative approach to deliver eff ective and new galactosidase A enzyme in individuals with RNA-modulating therapeutics for rare diseases T e company held an analyst seminar in HIV drugs. genetic mutations amenable to this chaperone with high unmet need. December 2012 detailing GlaxoSmithKline’s Known by the product code S/GSK1349572, in a cell-based assay. In 2012, GlaxoSmithKline also commenced late-stage pipeline. GSK says its pipeline has the dolutegravir is intended for treating HIV Oral migalastat HCl monotherapy is regulatory submissions for various respiratory potential for about 15 product launches in the infection in adults and adolescents. T e undergoing Phase III trials for Fabry patients medicines as well as vaccines that are regarded next three years. regulatory submissions are for the treatment of with amenable mutations. as promising late-stage assets. For details During August 2012, GSK announced U.S. HIV infection in adults and children 12 years Study 011 is a placebo-controlled trial about those products and others, please see and EU regulatory fi lings for single-agent use of and older. intended mainly to support an FDA submission. the following two GlaxoSmithKline pipeline the company’s BRAF inhibitor dabrafenib and GlaxoSmithKline’s albiglutide is an Study 012 is comparing open-label migalastat sections.
BEST RESPIRATORY furoate is the active ingredient in GSK’s pulmonary disease. maintenance bronchodilator treatment of marketed allergy medicine Veramyst/Avamyst. T eravance is a biopharma company with airfl ow obstruction in patients with COPD, PIPELINE: GLAXOSMITHKLINE T e U.S. and EU fi lings were submitted a pipeline of internally discovered product including chronic bronchitis and emphysema. during July 2012. FF/VI is awaiting approval candidates and strategic collaborations with T e EU regulatory submission for Anoro laxoSmithKline generates more in the European Union under the brand name pharma companies. T eravance is concentrated was announced in January 2013. Filings in Gsales from its respiratory portfolio than any Relvar for asthma and chronic obstructive on the discovery, development and other countries are expected during 2013. other therapeutic category. Respiratory products pulmonary disease. T e drug has been commercialization of small-molecule medicines GlaxoSmithKline also plans to commence produced 2011 sales of £7.3 billion ($11.71 submitted for market clearance in the United across respiratory disease, bacterial infections, worldwide regulatory fi lings for UMEC billion), accounting for nearly one-third of all States under the trade name Breo. T e intended and CNS/pain. monotherapy in the Ellipta inhaler for COPD GSK Pharmaceutical sales for that year. Lead- indication for Breo is for the long-term once- GSK and T eravance announced during patients during 2013. ing the charge with sales of £5.06 billion ($8.12 daily maintenance treatment of airfl ow December 2012 the U.S. regulatory fi ling Phase III trials were under way as of October billion) was the asthma and COPD product obstruction in patients with COPD, including for UMEC/VI. T e investigational once- 2012 for the IL-5 antagonist mepolizumab Advair/Seretide, which is one of the industry’s chronic bronchitis and/or emphysema and to daily LAMA/LABA combination medicine as adjunctive therapy in severe uncontrolled best-selling prescription pharmaceuticals ever. reduce exacerbations of COPD in patients with is intended for patients with COPD. refractory asthma. Mepolizumab is a fully For the fi rst nine months of 2012, GSK’s global a history of exacerbations. For asthma, GSK UMEC/VI joins together two investigational humanized IgG monoclonal antibody specifi c respiratory sales totaled £5.39 billion ($8.64 bil- and T eravance are reviewing the strategy for bronchodilator molecules – the long-acting for interleukin 5 (IL-5). T e product is being lion), with Advair/Seretide contributing £3.74 an eventual FDA submission of Breo. Relvar muscarinic antagonist (LAMA) GSK573719 developed for severe refractory asthma in billion ($6 billion). and Breo are administered via a new dry powder or umeclidinium bromide (UMEC), and the patients who worsen despite high-dose inhaled GSK’s respiratory development portfolio inhaler called Ellipta. long-acting beta2 agonist (LABA) vilanterol corticosteroids or oral corticosteroids and long- includes several late-stage assets. T e once-daily FF is also being developed in Phase III trials (VI). T e proposed trade name for UMEC/ acting beta-2 agonist use. investigational medicine fl uticasone furoate/ by GSK as a monotherapy for treating asthma. VI in the United States is Anoro. T e medicine T e cytokine IL-5 regulates the growth, vilanterol is awaiting U.S. and EU regulatory Vilanterol on its own is undergoing Phase III is administered via the Ellipta inhaler and activation and survival of eosinophils (white clearance. Vilanterol is an NME and fl uticasone studies for the treatment of chronic obstructive is intended for the long-term once-daily blood cells). IL-5 provides an essential signal
JANUARY 2013 MED AD NEWS • 13
magentablackcyanyellow ES177772_MAN0113_013.pgs 01.14.2013 22:40 UBM for the movement of eosinophils from the bone new product candidate is undergoing Phase II inhaled muscarinic antagonists and inhaled develop a product with greater effi cacy than marrow into the lung. Mepolizumab binds to trials for COPD. beta2 agonists, either in two separate inhalers single mechanism bronchodilators and with human IL-5, preventing it from binding to its When inhaled into the lungs, muscarinic or through a product that joins together short- equal or better tolerability. T is bifunctional receptor on the surface of eosinophils. Inhibiting antagonists and beta2 agonists result in acting agents from the two drug classes. bronchodilator could potentially then IL-5 binding in this manner reduces blood, bronchodilation, but through diff erent GSK and T eravance are developing a serve as a basis for improved combination tissue and sputum eosinophil levels, which in mechanisms of action. Each class of drug long-acting inhaled bronchodilator that is therapy via joint delivery with an inhaled turn reduces the amount of exacerbations. has non-bronchodilator eff ects that can be bifunctional, thus it is one molecule with corticosteroid. T e medicine could deliver GSK and T eravance are developing the complementary and benefi cial in patients muscarinic antagonist and beta2 agonist three complementary therapeutic eff ects in muscarinic antagonist and beta2 agonist MABA, with COPD and perhaps in individuals activities. By uniting bifunctional activity and one product for patients with respiratory known by the product code GSK961081. T e with severe asthma. Many patients are using high lung selectivity, the companies plan to disease.
BEST VACCINE PIPELINE: To enroll in the clinical trial, industry also known by its scientifi c name RTS,S, which immunization against pneumonia caused GLAXOSMITHKLINE analysts say a patient’s tumor must express represents its composition. RTS,S aims to trigger by Streptococcus pneumoniae in infants and MAGE-A3 as demonstrated by a molecular the immune system to combat Plasmodium children from 6 weeks through 5 years old. SK produces over 30 prescribed vac- diagnostic test being developed by Abbott. falciparum malaria parasite when it fi rst enters Synfl orix is already marketed in the European Gcines around the globe to prevent po- T e NSCLC study is evaluating MAGE-A3 the human host’s bloodstream and/or when the Union and 90 other countries for active tentially life-threatening or crippling illnesses. as adjuvant therapy in 2,000-plus MAGE- parasite infects liver cells. RTS,S is designed to immunization against invasive disease and T ese illnesses include hepatitis A, hepatitis B, A3 positive post-surgical lung cancer patients, prevent the parasite from infecting, maturing, acute otitis media caused by S. pneumoniae in diphtheria, tetanus, whooping cough, measles, reportedly the largest Phase III study ever and multiplying in the liver, after which time infants and children aged 6 weeks through 5 mumps, rubella, polio, typhoid, infl uenza and performed in lung cancer. the parasite would re-enter the bloodstream years old. T e pneumonia indication has been bacterial meningitis. GSK’s billion-dollar fran- GSK’s H5N1 adjuvanted infl uenza vaccine and infect red blood cells, resulting in disease approved in at least 67 countries. T e vaccine chises in this area include the Infanrix and candidate is awaiting marketing clearance from symptoms. In a Phase III effi cacy study, the is not FDA-approved. Pediarix line, as well as the company’s hepati- U.S. regulators. In November 2012, FDA’s vaccine is administered in three doses, one Nimenrix was cleared for marketing by tis vaccine family. For the fi rst nine months of Vaccines and Related Biological Products month apart. A booster dose administered 18 the European Medicines Agency in April 2012, GSK’s vaccine sales amounted to £2.46 Advisory Committee voted unanimously 14-0 months after the third dose is additionally being 2012 for active immunization against invasive billion ($3.95 billion). that the safety and immunogenicity data of the investigated in the study. meningococcal disease caused by Neisseria Based in Belgium, GSK Vaccines has 14 vaccine supports its licensure. T e vaccine is Results from a pivotal, large-scale Phase meningitides serogroups A,C, W-135 and Y. manufacturing sites strategically positioned intended for the active immunization for the III study published online during November Launches were under way in the latter part of worldwide. Of the 1.1 billion doses of GSK prevention of disease in persons 18 years of age 2012 in the New England Journal of Medicine 2012 in several countries throughout Europe, vaccines distributed during 2011, more than 80 and older who are at increased risk of exposure demonstrate that Mosquirix can help protect including the United Kingdom, Germany and percent were distributed in developing countries, to the infl uenza A virus H5N1 subtype African infants against malaria. When the Netherlands. T e vaccine is undergoing including the least developed, low-income and contained in the vaccine. T e regulatory compared to immunization with a control U.S. Phase II studies for the prevention of N. middle-income countries. submission was announced during March vaccine, infants (aged 6-12 weeks at fi rst meningitidis groups A, C, W and Y diseases. A potential blockbuster vaccine in the GSK 2012. vaccination) vaccinated with RTS,S had one- Nimenrix is the fi rst quadrivalent conjugate pipeline is MAGE-A3. T e antigen-specifi c T e two-component vaccine consists of third fewer episodes of clinical and severe vaccine to become available in Europe for active cancer immunotherapy is undergoing U.S. and a monovalent, inactivated, split A/H5N1 malaria and similar reactions to the injection. immunization of individuals from 12 months EU Phase III trials for the adjuvant treatment infl uenza virus antigen and the AS03 adjuvant RTS,S showed an acceptable safety and old against invasive meningococcal disease of melanoma and non-small cell lung cancer. system. T e H5N1 infl uenza vaccine candidate tolerability profi le. resulting from N. meningitidis serogroups A, MAGE-A3 belongs to a novel class of vaccines is manufactured in Québec and is already A herpes zoster vaccine is being developed C, W -135 and Y. A highly contagious disease, designed to encourage a patient’s own body marketed in Europe as Pumarix. T e vaccine by GSK for the prevention of shingles. T e N. meningitidis represents potentially disabling to recognize and eliminate cancer cells by program was supported by a development recombinant vaccine is undergoing U.S. and consequences including deafness, epilepsy and stimulating their immune system. MAGE-A3 contract with the Biomedical Advanced EU Phase III clinical development. other neurological disorders; in severe cases unites tumor antigens with GSK’s proprietary Development and Research Authority of the An EU regulatory submission was fi led in the disease can be life-threatening. T e highest adjuvant system, which unites immune- U.S. Department of Health and Human September 2012 for a new indication for the risk of contracting N. meningitidis is in infants stimulating compounds designed to increase Services. pediatric pneumococcal vaccine Synfl orix. and toddlers during the fi rst four years of their antitumor immune response. T e malaria vaccine candidate Mosquirix is T e additional indication is for the active lives, with another peak in adolescents.
MOST INNOVATIVE PIPELINE: In November 2012, Novartis provided an another 11 pivotal trials read-out, 11 fi lings and Data demonstrate that patients receiving an NOVARTIS update touting its strong and diversifi ed pipeline 10 regulatory decisions. infusion of serelaxin had short-term and long- containing more than 73 new compounds. Novartis has a proven track record of bringing term benefi ts. In the short term, patients treated ovartis has one of the industry’s Novartis says its industry-leading pipeline innovative products to market as evidenced by with the drug candidate had improved heart Ndeepest and most productive pipelines will provide the basis for continued growth the recent introductions of the cancer medicine failure symptoms including dyspnea (shortness with about 140 projects, including many new through 2017. T e company reportedly said its Afi nitor, the COPD treatment Seebri of breath) and edema, in addition to having a molecular entities. According to Novartis, it cre- pharma division could generate 14 or more new Breezhaler, the myelofi brosis product Jakavi, shorter hospital stay. T e long-term benefi ts led ates innovative medicines and prioritizes work blockbusters by 2017 through pipeline projects and the Cushing’s disease drug Signifor. to a statistically signifi cant 37 percent reduction based on unmet medical need and strong sci- in areas such as oncology, heart and respiratory. Novartis Oncology in 2012 gained in cardiovascular mortality and all-cause entifi c understanding of disease – not the size of T ese promising medicines include the heart regulatory clearance for six indications, mortality. Fewer patients treated with RLX030 the potential commercial market. failure drugs serelaxin (RLX030) and LCZ696. including two NMEs, as of early November. had heart failure worsening as measured on day Novartis researchers are mapping complex Another exciting drug prospect is AIN457 for Continued growth is expected for the next fi ve 5 and day 14 after treatment. Based on these protein signaling networks called molecular psoriasis and multiple sclerosis. Novartis also years. According to Novartis, one of the major fi ndings of the RELAX-AHF study, Novartis signaling pathways inside of cells. Novartis says has a comprehensive early-stage and late-stage growth drivers is Afi nitor. T e medicine has expects to initiate U.S. and EU regulatory these molecular pathways are highly controlled pipeline of novel oncology compounds. received approval for fi ve indications and has submissions for RLX030 during early 2013. and interconnected signal-relay systems – the potential to top $2 billion in sales for breast T e company is making progress on its similar to communication networks – and are cancer alone by 2017. Launches of Jakavi and the comprehensive clinical program in respiratory responsible for normal cell function. When a planned introductions of pipeline projects such to address the needs of patients with chronic pathway protein does not properly function, as BKM120 for various tumors and LDK378 obstructive pulmonary disease. QVA149 has abnormal signaling and disease can occur. in lung cancer have the potential to contribute the potential to establish a new standard of Novartis Institutes for BioMedical Research According to Novartis, since 2007 through more than $1 billion in sales by 2017. care for patients with COPD, preventing scientists develop small-molecule drugs or early November 2012 the Group led the Novartis has launched a broad-scale clinical- exacerbations and demonstrating improvement antibodies to target key nodes within pathways industry with 56 new approvals in the United development program called PRISM for its in bronchodilation versus placebo and current that, when defective, result in disease. NIBR is States, Europe, Japan and China. As of Nov. 8, leading PI3K inhibitor BKM120 across multiple standard of care. Across numerous clinical trials, dedicated to discovering innovative medicines 2012, the Pharmaceuticals division had gained indications. T e drug compound is being QVA149 allows for the limited use of ICS as that treat disease and advance human health. nine approvals or positive recommendations for studied as a single agent and in combination rescue medications as recommended by the By concentrating on patients and following 2012. with other therapeutic agents in diff erent breast GOLD treatment guidelines for COPD. the science, Novartis has discovered innovative Novartis Pharmaceuticals has established a cancer settings, as well as other indications. Positive clinical data has been established treatments for disorders varying from cancer strong foundation for the company’s continuing Novartis started pivotal studies during for the highly eff ective novel IL-17 inhibitor to degenerative disease. NIBR’s research areas growth based on already-marketed products. December 2012 for LDK378, an ALK AIN457 across various disease areas including include autoimmunity, transplantation & For the 12-month period starting in November inhibitor that has demonstrated potent activity psoriasis, ankylosing spondylitis, rheumatoid infl ammatory diseases; cardiovascular and 2012, the Pharmaceuticals group anticipated in patients with ALK+ non-small cell lung arthritis and multiple sclerosis. In Phase II trials, metabolic diseases; gastrointestinal disease; data read-out on 13 pivotal studies, nine cancer (NSCLC) as well as activity on brain AIN457 has demonstrated rapid improvement infectious diseases; musculoskeletal diseases; submissions and seven regulatory decisions. For metastases. Other clinical trials are set for 2013 of psoriasis signs and symptoms in patients neuroscience; oncology; ophthalmology; and the following 13 to 24 months, strong pipeline and regulatory submissions are anticipated to be with moderate to severe psoriasis. Phase III respiratory diseases. news fl ow is anticipated to continue with initiated during 2014 if studies are successful. trials in this setting continue with regulatory
14 • MED AD NEWS JANUARY 2013
magentablackcyanyellow ES177920_MAN0113_014.pgs 01.15.2013 03:07 UBM submissions planned to begin during late 2013. until recent scientifi c developments. Bexsero the unique leadership position of Novartis 2 months and older. Upon regulatory clearance, Novartis is exploring AIN457 across multiple was developed using an award-winning in the worldwide fi ght against devastating Bexsero will be the fi rst licensed broad coverage indications such as multiple sclerosis. scientifi c approach that consisted of decoding meningococcal disease. T e two vaccines vaccine that can help protect all age groups Bexsero represents an innovative and the genetic makeup (genome sequence) of together help to protect against all fi ve main against MenB disease, including infants, the age potentially successful market opportunity for MenB. Novartis says this innovative method serogroups of meningococcal bacteria (A, B, group at the greatest infection risk. Novartis. T e Meningococcal Group B Vaccine provides the foundation for a new generation C, W-135 and Y) that result in the majority of Bexsero is expected to be a blockbuster by is the result of 20-plus years of pioneering of vaccines that can help prevent other diseases cases globally. 2018 according to EvaluatePharma, which research. MenB has been an especially with an important diversity of disease-causing During November 2012, Novartis ranked the vaccine at the industry’s No. 9 challenging target because the outer coating of strains. announced the Committee for Medicinal most valuable R&D project as of June 2012. A the bacteria is not well recognized as an antigen Following the market clearance of Menveo Products for Human Use (CHMP) of the Bernstein Research report issued in November by the immune system, making it particularly during 2010, the expected approval of the European Medicines Agency (EMA) adopted a 2012 projected that Bexsero will have 2016 sales diffi cult to develop a broadly eff ective vaccine groundbreaking vaccine Bexsero underscores positive opinion for Bexsero for use in individuals of $390 million.
BEST DIABETES PIPELINE: NOVO NORDISK and Ryzodeg was cleared in that country during Along with results from DUAL I, for which December 2012. Tresiba and Ryzodeg received headline data were revealed during August enmark-based Novo Nordisk is T e company discovered and is developing positive CHMP opinions in October 2012, 2012, DUAL II reconfi rms the competitive Da leading force in the diabetes product insulin degludec as a once-daily new- clearing the way for approval in Europe. An profi les of Tresiba and Victoza. T e studies arena. T e worldwide healthcare company has generation basal insulin analog, with an ultra- FDA advisory committee during November demonstrate that patients can realize benefi ts about 90 years of innovation and leadership long duration of action. T e drug has a distinct 2012 recommended approval of the medicines from each component in the combination in diabetes care. More than 371 million indi- slow absorption that provides a fl at and stable despite safety questions. As a result, Novo product. Pending marketing authorization viduals worldwide – including over 26 million action profi le. Insulin degludec has been Nordisk reportedly is expecting a fi rst-half of Tresiba, Novo Nordisk intends to submit Americans – have diabetes, and that total is studied in a large-scale clinical-trial program 2013 U.S. approval for Tresiba. U.S. and EU regulatory fi lings for IDegLira projected to exceed 556 million by 2030. known as BEGIN, examining its impact T e Phase IIIa program for IDegLira in2013. According to EvaluatePharma’s World on glucose control, hypoglycemia and the (product code NN9068) was announced by Additionally announced by Novo Nordisk Preview 2018 report published in June 2012, possibility to fl exibly adjust insulin degludec Novo Nordisk as completed during December in December 2012 was the decision to begin diabetes will be the No. 2 therapy area in dosing time to meet patient needs. Insulin 2012. IDegLira is a fi xed-ratio combination Phase III development for FIAsp (product worldwide Rx and OTC sales during 2018 at of Tresiba, a once-daily new-generation basal code NN1218), a faster-acting version of $58.2 billion, trailing only oncology ($104.1 insulin analog with an ultra-long duration of NovoRapid. billion). From 2011 to 2018, diabetes is action, and once-daily Victoza. Phase I proof–of-concept studies for forecasted to have one of the highest CAGRs DUAL II was the second and fi nal Phase IIIa FIAsp have been fi nalized. In these, the among leading therapy areas at 9.1 percent. trial with IDegLira for treating patients with pharmacokinetic and pharmacodynamic Novo Nordisk markets several blockbuster type 2 diabetes. T rough the 400-person study, properties of insulin aspart in various diff erent diabetes brands. Containing insulin aspart, patients previously inadequately controlled on formulations have been analyzed in patients NovoLog/NovoRapid is the world’s most basal insulin in combination with one or two with type 1 and type 2 diabetes to identify widely used rapid-acting insulin for use oral anti-diabetic agents were randomized to 26 the form with the most attractive profi le at mealtimes. Levemir is a soluble, long- weeks of double-blinded treatment with either with regard to speed of onset of appearance, acting modern insulin for once-per-day degludec is being branded in major markets IDegLira or Tresiba, in addition to metformin. as well as stability. T e new form of insulin use for type 1 and 2 diabetes; the product under the trade name Tresiba. In agreement with regulatory requirements, aspart chosen for Phase III development has provides glucose control with a favorable Novo Nordisk is developing a combo the maximum dose of Tresiba in the study was a faster onset of appearance than NovoLog/ weight profi le. Composed of biphasic insulin product containing insulin degludec in a fi xed in each treatment arm to investigate the NovoRapid and mimics the endogenous aspart, NovoLog Mix 70/30 and NovoMix formulation with a bolus boost of insulin aspart. additional eff ect of the liraglutide component insulin secretory response in a non-diabetic 70/30 represent another successful diabetes T is represents the fi rst soluble insulin combo of the IDegLira product on glucose control. individual more closely. T is potentially allows franchise for Novo Nordisk. Used to either of insulin degludec and the most prescribed After 26 weeks, patients randomized to the for more fl exible insulin administration in initiate or intensify insulin therapy, this dual- rapid-acting insulin (NovoLog/NovoRapid), Tresiba arm – with a fi xed maximum dose – connection with meals, as well as improved release modern insulin covers mealtime and providing fasting and post-prandial glucose achieved blood glucose control as anticipated post-prandial glucose control. basal requirements. Victoza, composed of control. T e brand name for insulin degludec/ from the fi ndings in the Phase IIIa program In the proof-of-concept studies, no liraglutide, represents Novo Nordisk’s fastest- insulin aspart is Ryzodeg. BEGIN. Patients randomized to IDegLira apparent diff erences between NovoRapid and growing sales generator. Victoza is the only Tresiba and Ryzodeg were fi led for FDA experienced HbA1c reduction of 1.9 percent the new forms of insulin aspart were observed human glucagon-like peptide-1 analog that and EMA regulatory review in September from baseline. T e variation in HbA1c pertaining to adverse events and standard safety is 97 percent similar to endogenous human 2011. Applications also have been submitted reduction between the treatment groups was parameters. Novo Nordisk plans to begin the GLP-1. for regulatory clearance in Canada, Switzerland statistically signifi cant, and the study met its Phase III program called Onset – anticipated Novo Nordisk’s next blockbuster diabetes and other countries. Tresiba was approved for primary endpoint of achieving superiority to include about 3,000 people with type 1 or medicine is anticipated to be insulin degludec. marketing in Japan during September 2012, versus stand-alone therapy with Tresiba. type 2 diabetes – near year-end 2013.
BEST MID-STAGE/EARLY-STAGE PIPELINE: PFIZER kinases that allow tumor cell progression during Pfi zer is developing PF-04449913, an oral phase G1 to phase S in the cell cycle. T is inhibitor of SMO, as one of the key components fi zer is prioritizing the company’s randomized Phase II data that demonstrated progression is required for DNA replication and of the Hedgehog signaling pathway. T e Phase PR&D eff orts in fi elds with the greatest sci- PD-0332991 (or PD-991) in combination with cell division. Inhibition of CDK 4 and 6 has I trial is evaluating the eff ectiveness of the entifi c and commercial promise: immunology letrozole signifi cantly extended progression-free been demonstrated to prevent the deactivation drug compound across multiple hematologic and infl ammation; oncology; cardiovascular survival (PFS) versus letrozole alone in post- cancers, including CML, AML, myelodysplatic and metabolic diseases; neuroscience and pain; menopausal patients with estrogen receptor syndrome, and myelofi brosis. and vaccines. T e New York-based biopharma positive (ER+), human epidermal growth factor Abnormal activation of the Hedgehog entity is carrying out major research eff orts receptor 2 negative (HER2-) locally advanced pathway has been linked to various human across multiple modalities, including small mol- or metastatic breast cancer. For patients treated cancers. Recent data suggest that disruption ecules, biologics and vaccines. Pfi zer also is gear- with the combination of PD-991 and letrozole, of the hedgehog pathway or inhibition of its ing specialized eff orts toward biosimilars as well median PFS was 26.1 months, a statistically activity may provide a new strategy for treating as orphan and genetic diseases to develop and signifi cant improvement versus the median PFS of retinoblastoma, a tumor suppressor protein, hematologic disorders such as multiple myeloma, deliver innovative medicines and vaccines for in women who received letrozole alone, which and interfere with tumor cell progression. In lymphoma, and myeloid malignancies. patients around the globe. was 7.5 months. Letrozole is marketed as Femara pre-clinical studies, the drug candidate was PF-04856884 (also known as CVX 060), an As of November 2012, slightly more than by Novartis and Chugai Pharmaceutical. demonstrated to be an inhibitor of cell growth intravenous humanized monoclonal CovX body two-thirds of Pfi zer’s 78 pipeline projects – “T ese results are especially important and a suppressor of DNA replication by inhibiting angiopoietin 2 (ang-2) with sunitinib, consisting of 59 NMEs, 17 new indications and because of the magnitude of clinical eff ect preventing cells from entering S phase. is undergoing Phase II studies. Sunitinib is the two biosimilars – were in Phase I (25) or Phase observed and the fact that PD-991 represents Besides breast cancer, PD-991 is being active chemical in Pfi zer’s blockbuster cancer II (28) clinical trials. a potential fi rst-in-class compound,” noted evaluated via Pfi zer-sponsored and investigator- drug Sutent. Pfi zer is making progress with a Phase II Dr. Mace Rothenberg, senior VP of clinical initiated research in other cancers. T ese include Pharmacokinetic modeling and simulation study of the CDK 4 inhibitor PD-0332991 in development and medical aff airs for Pfi zer’s liposarcoma, non-small cell lung cancer, liver supported dose escalation of Pfi zer’s PF- CDK4-amplifi ed liposarcoma. T ere is another Oncology Business Unit. “Based on these cancer, ovarian cancer, glioblastoma, refractory 03446962 in patients with solid tumors. Phase II trial of this investigational compound positive Phase II data, Pfi zer is planning to open solid tumors, multiple myeloma, and mantle T e monoclonal antibody (mAb) against exploring its potential for treating patients with a randomized Phase III study of PD-991 in this cell lymphoma. If approved for marketing, activin receptor-like kinase 1 is in Phase I estrogen-receptor positive, HER2-negative patient population in 2013.” various industry trackers forecast annual multi- development. advanced breast cancer in combination with PD-991 represents an investigational, oral billion dollar sales for PD-991. T e biologic PF-04950615 (additionally standard of care anti-estrogens. and selective inhibitor of the CDK 4 and 6 Pfi zer has touted new pathways with new known as RN316) is undergoing Phase II In December 2012, Pfi zer revealed kinases. CDK 4 and 6 are two closely related promise in the company’s early-stage pipeline. development for hypercholesterolemia. RN-316
JANUARY 2013 MED AD NEWS • 15
magentablackcyanyellow ES177919_MAN0113_015.pgs 01.15.2013 03:07 UBM magentablackcyanyellow ES177323_MAN0113_016_FP.pgs 01.11.2013 23:22 UBM Burned-Out Pancreas Tubby Triglyceride Group Support by NEWACTOS.™ pioglitazone HCl
Sensitivity training for insulin-resistant cells. Hyperactive Hungry Liver • Insulin resistance represents a core defect in type 2 diabetes, leading to metabolic abnormalities, Muscle including increased cardiovascular risk.2 • ACTOS reduces insulin resistance by increasing peripheral glucose uptake and decreasing hepatic glucose output.1
Confronts challenges and concerns in type 2 diabetes.
• ACTOS provides impressive improvements in glycemic control:1 • The only insulin sensitizer indicated for use alone and in combination with sulfonylureas, metformin, or insulin.1,3,4 • ACTOS positively impacts mean triglycerides and mean HDL cholesterol (HDL-C), with no consistent mean changes in LDL and total cholesterol (total-C) levels.1 • ACTOS addresses common treatment concerns regarding the kidneys and stomach:1
Impaired • Does not cause stomach upset or lactic acidosis. Depressed Kidney HDL • In addition, ACTOS provides:
Upset • No evidence of drug-induced hepatotoxicity or serum transaminase (ALT) elevations in 1 Stomach clinical trials. • No stimulation of pancreatic insulin secretion.1
As an adjunct to diet and exercise, ACTOS may be used as monotherapy to lower blood glucose in patients with type 2 diabetes. ACTOS may also be used as combination therapy with sulfonylureas, metformin, or insulin when diet plus the single agent does not result in adequate glycemic control. ACTOS should not be used in type 1 diabetes or for the treatment of diabetic ketoacidosis. Management of type 2 diabetes should also include nutritional counseling, weight reduction as needed, and exercise.1
Please see brief summary of Prescribing Information on the last page of this advertisement.
Neck options let you outfit your patients with a personalized hip fit
Simply select the neck to correct— Intraoperative flexibility spans 3 dimensions through the application Multiple Femoral head For more information about the science of Kinectiv of Kinectiv® Technology in total hip replacement. An innovative system neck Key to simplicity is the Technology, contact your Zimmer a modular neck system lets you options exclusive use of +0 mm representative to arrange a visit. Or visit of neck provisionals mimics the template of femoral head centers. heads for truly independent independently adjust leg length, Head center www.kinectiv.zimmer.com. Use the trial provisionals to assess the trial fit. Then implant the neck adjustment of leg length, offset, and version to uniquely fit adjustments are offset, and version after that matches the patient’s anatomy. No stem orientation adjustment, accomplished stem implantation M/L Taper Hip with the hip to the patient solely by choosing no leg length discrepancy, no compromise. Only improved operative ® from an array of necks Tapered stem flow and a fit that’s personalized 3 ways. Such exacting standards. Kinectiv to precisely match the Achieve version with a slim Branding more doctors Only from Zimmer. How fitting. patient’s anatomy wedge-shape design Technology recall seeing.
Brand Recognition
50 47%
+47% NEW Combination of amlodipine and olmesartan medoxomil 40 Cut hypertension The power of two working as one AZOR 10/40 mg gives AZOR 10/40 mg (n=161) reduced BP by a mean of 30/19 mm Hg (placebo [n=160]: 5/3 mm Hg)1 patients 30 mm Hg AZOR 5/40 mg (n=157) reduced BP by a mean of 25/16 mm Hg mean reductions in (placebo [n=160]: 5/3 mm Hg)1 systolic blood pressure In a clinical trial of 1940 patients: —Cough occurred in only 1 AZOR-treated and 1 placebo-treated patient1 1 (placebo: 5 mm Hg) —2.6% of AZOR-treated patients (n=970) discontinued due to drug-related adverse events1 —The only adverse reaction that occurred in greater than or equal to 3% of patients and more frequently than placebo was edema. The placebo-subtracted incidence was 5.7% (5/20 mg), 6.2% (5/40 mg), 13.3% (10/20 mg), and 11.2% (10/40 mg). The edema incidence for placebo was 12.3%1 32% (For additional information on adverse reactions, see the following page.) Simple, convenient dosing with one tablet, once a day
USE IN PREGNANCY When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, AZOR should be discontinued as soon as possible. See WARNINGS AND PRECAUTIONS, Fetal/Neonatal Morbidity and Mortality.
AZOR is indicated for the treatment of hypertension, alone or with other antihypertensive agents. AZOR is not indicated for the initial therapy of hypertension.
Please see following page for important safety information. 30 Please see brief summary of prescribing information for AZOR.
20
Deliver 5-ASA all the way down the intestinal tract.
Only PENTASA reliably delivers mesalamine throughout both the small and large intestine.1,2
t PENTASA is the only 5-ASA that has a unique moisture activation delivery system.1 t PENTASA dispersion is not dependent on intestinal pH or bacteria.1,2 t The dispersion of PENTASA is not significantly affected 10 by accelerated transit time during diarrhea flare-ups.1-3 PENTASA is generally well tolerated—most common adverse events reported in clinical trials were diarrhea (3.4%), headache (2.0%), nausea (1.8%), abdominal pain (1.7%), dyspepsia (1.6%), vomiting (1.5%), anorexia (1.1%), and rash (1.0%).4 Exercise caution in patients with impaired hepatic or renal function; monitor patients with pre-existing renal disease, increased BUN or serum creatinine, or proteinuria.
References: 1. Data on file, Shire US Inc. 2. Wilding IR. A scintigraphic study to evaluate what happens to Pentasa® and Asacol® in the human gut. Pract Gastroenterol. 1999(Nov suppl):1-8. 3. Rijk MCM, Van Schaik A, Van Tongeren JHM. Disposition of mesalazine-delivering drugs in patients with inflammatory bowel disease, with and without diarrhoea. Scand J Gastroenterol. 1992;27:863-868. 4. Pentasa prescribing information, Shire US Inc., 1999.
Please see references above and full prescribing information on adjacent page.
SHIRE US Inc. 1-800-828-2088 PENTASA® is a registered trademark of Ferring A/S Corporation. 0 ©2003 Shire US Inc., Newport, Kentucky 41071 February 2003 PEJA306 AbelsonTaylor Other Agencies n=76 ads n=206 ads
KAPIDEX is the first and only PPI with a Dual Delayed Release™ (DDR) formulation, which provides a second release of drug
Mean plasma concentration (in healthy subjects; day 5; ng/mL)1
1200
1000
800
600 KAPIDEX WORKS A 400 KAPIDEX 60 mg 200 KAPIDEX 30 mg
0 0 6 12 18 24 SECOND SHIFT Time (h) s KAPIDEX 30 mg provided full 24-hour heartburn relief in a majority of symptomatic TO HELP SHUT DOWN ACID PUMPS non-erosive gastroesophageal reflux disease patients at week 41 s KAPIDEX 60 mg provided consistently high erosive esophagitis healing rates at week 81 s KAPIDEX offers a safety and tolerability profile similar to lansoprazole1 s KAPIDEX can be taken without regard to food1 KAPIDEX should be swallowed whole. Alternatively, capsules can be opened, sprinkled on 1 tablespoon of applesauce, and swallowed immediately. While KAPIDEX can be taken without regard to food, some patients may benefit from administering the dose prior to a meal if post-meal symptoms do not resolve under post-fed conditions. Conclusions of comparative efficacy cannot be drawn from this information. Indications KAPIDEX is indicated for healing all grades of erosive esophagitis (EE) for up to 8 weeks, maintaining healing of EE for up to 6 months, and treating heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for 4 weeks. Important Safety Information Can one agency’s communications provide than those of other agencies—giving those KAPIDEX is contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity and anaphylaxis have been reported with KAPIDEX use. Symptomatic response with KAPIDEX does not preclude the presence of gastric malignancy. Most commonly reported treatment-emergent adverse reactions ( 2%): diarrhea (4.8%), abdominal pain (4.0%), nausea (2.9%), upper respiratory tract infection (1.9%), vomiting (1.6%), and flatulence (1.6%). Do not co-administer atazanavir with KAPIDEX because atazanavir systemic concentrations may be substantially decreased. KAPIDEX may interfere with absorption of drugs for which gastric pH is important for bioavailability (e.g., ampicillin esters, digoxin, iron salts, ketoconazole). Patients taking concomitant warfarin may require monitoring for increases in international normalized ratio (INR) and prothrombin time. Increases in INR and prothrombin time may lead to abnormal bleeding, which can lead to serious consequences. Please see adjacent brief summary of prescribing information for KAPIDEX. a proven advantage over another’s? That’s products a recognizable advantage in the
the question Kantar Health investigated market. To get a glimpse of your brand’s
first and only estradiol transdermal spray Relief in a mist with regard to product recognition. And the potential and see what we can do for you, Give her convenient relief of moderate-to-severe vasomotor symptoms with low-dose Evamist™
: Reduces the frequency and severity of hot flashes1 : Flexible dosing with 1, 2, or 3 sprays – 69% reduction in frequency once daily1 (vs 38% with placebo)* – Precision-metered spray delivers – 41% reduction in severity consistent and accurate dosing (vs 10% with placebo)† : Convenient spray delivery to the – Sustained estrogen delivery inner forearm dries in a median of : Low dose of plant-based 67 seconds‡2 17β-estradiol2
*At Week 12, mean change of –8.10 from baseline 11.81 hot flashes with 1 spray/day vs mean change of –4.76 from baseline 12.41 hot flashes with placebo (P=0.0004). †At Week 12, mean change of –1.04 from baseline score 2.53 with 1 spray/day vs mean change of –0.26 from baseline score 2.55 with placebo (P<0.0001). results were eye-popping. Physicians could call Dale Taylor at 312.894.5657 or visit ‡Patients should wait at least 2 minutes after applying Evamist before dressing.1 Evamistª is indicated for the treatment of moderate-to-severe vasomotor symptoms The WomenÕs Health Initiative Memory Study (WHIMS), a substudy of the WHI, reported increased risk of developing due to menopause. probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE 0.625 mg alone and during 4 years of treatment with daily CE 0.625 mg combined with MPA 2.5 mg, relative WARNING—ENDOMETRIAL CANCER, CARDIOVASCULAR, AND OTHER RISKS to placebo. It is unknown whether this finding applies to younger postmenopausal women. ENDOMETRIAL CANCER Adequate diagnostic measures, including endometrial sampling when indicated, In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal and other combinations and dosage forms of estrogens and progestins. Because of these risks, estrogens with vaginal bleeding. or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent CARDIOVASCULAR AND OTHER RISKS Estrogens with or without progestins should not be used for the with treatment goals and risks for the individual woman. prevention of cardiovascular disease or dementia. The WomenÕs Health Initiative (WHI) estrogen-alone Evamist should not be used in women with undiagnosed abnormal genital bleeding; known, suspected, substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women or history of breast cancer; known or suspected estrogen-dependent neoplasia; active deep vein thrombosis, (50 to 79 years of age) during 6.8 years and 7.1 years, respectively, of treatment with daily oral conjugated pulmonary embolism, or history of these conditions; active or recent arterial thromboembolic disease; liver estrogens (CE 0.625 mg), relative to placebo. dysfunction or disease; or known or suspected pregnancy. The estrogen plus progestin WHI substudy reported increased risk of myocardial infarction, stroke, invasive In a clinical trial with Evamist, the most common side effects were headache, breast tenderness, breast cancer, pulmonary emboli, and DVT in postmenopausal women (50 to 79 years of age) during 5.6 years nasopharyngitis, nipple pain, back pain, nausea, and arthralgia. of treatment with daily oral CE 0.625 mg combined with medroxyprogesterone acetate (MPA 2.5 mg), relative Please see brief summary of prescribing information on adjacent pages. to placebo. For more information about Evamistª, visit www.evamist.com or call 877-567-7676. identify AbelsonTaylor’s brands 47% more abelsontaylor.com. Marketed by Ther-Rx Corporation, St. Louis, MO 63044 © 2008 Ther-Rx Corporation 11-014 02/08
No other porous metal material so closely resembles the structure, function, and physiology of trabecular bone1,2
For implant stability, nothing compares to tUnrivaled product availability— For more information about the full line of Trabecular Metall Technology. includes hip, knee, shoulder, spine, Trabecular Metall Products, contact your Zimmer and trauma implants t11 years of clinical experience—longest record representative or visit www.tm.zimmer.com. of published, peer-reviewed data3
tExceptional initial fixation and stability— References: 1. J Bone Joint Surg Br. 1999;81-B:907-914. 2. Bobyn JD, et al. Characterization of a new porous tantalum 0.98 coefficient of friction for nonmachined biomaterial for reconstructive orthopaedics. Scientific Exhibit, 4 Trabecular surfaces reduces risk of early implant motion Proc AAOS, Anaheim, Calif, 1999. 3. J Bone Joint Surg Br. 2006;88-B:304-309. 4. J Musculoskel Res. 1999;3:245-251. ™ tMaximized bone and soft-tissue ingrowth 5. Medlin DJ, et al. Metallurgical characterization of a porous and vascularization—highest volume porosity, tantalum biomaterial (Trabecular Metal™) for orthopaedic Metal Bone ingrowth and vascularization implant applications. Presentation, Materials & Processes for up to 80%1,2,5 in Trabecular Metal Material Medical Devices Conference, Anaheim, Calif, 2003.
©2009 Zimmer, Inc.
NEW Therapeutic advance in second-line NSCLC Proven to prolong your patientÕs lifeline
Tarceva is a HER1/EGFR-targeted therapyÑthe first and only one proven to significantly prolong survival in second-line NSCLC 1
Tarceva has been shown to target HER1/EGFR and inhibit Tyrosine Kinase (TK) phosphorylation. EGFR is expressed on normal cells and cancer cells. TarcevaÕs mechanism of clinical antitumor action has not been fully characterized.1
Tarceva 15 0 mg once daily 731 patients with Outcome measures: (N=488) stage IIIB/IV NSCLC Double-blind; Overall survival randomized after failure of ≥1 Progression-free survival 2:1 Placebo chemotherapy regimens Tumor response (N=243)
Tarceva met the primary endpoint in the single-agent Phase III clinical trialÑa 33% increase in overall survival.1,2
Tarceva significantly prolonged overall survival: increased median survival by 42.5% and 1-year survival by 45% 1,2
100 42.5% Hazard ratio 0.73 improvement (95% CI=0.61Ð0.86; P<0.001)
75 } indicates a 27% reduction in risk of death for patients who received Tarceva.1,2
50
Survival rate (%) 45% improvement Tarceva (N= 488) 25 } Median survival 6.7 months 1-Year survival 31.2% Placebo (N=243) Median survival 4.7 months 1-Year survival 21.5% 0 6 12 18 24 Survival time (months)
Tarceva met all secondary endpoints in the analysis, NEW including progression-free survival.1, 2 Progression-free survival hazard ratio of 0.59 (95% CI =0.50Ð 0.70; P<0.001) indicates a 41% reduction in risk of death or disease progression for patients who received Tarceva.1 tablets
Safety and effectiveness have not See following important safety information and Power to prolong survival been studied in pediatric patients. brief summary of full prescribing information.
magentablackcyanyellow ES177324_MAN0113_017_FP.pgs 01.11.2013 23:22 UBM reportedly cut bad cholesterol by 80% in clinical remove that area to activate the enzyme. T e majority of Roche’s diagnostic tests Ocrelizumab researchers say the B cells appear trials, with some patients’ LDL levels so low that PCSK9 has medical importance because it acts are biotech-based. Enzymes produced to induce the T cells to attack. T e Phase II they did not qualify for a second injection. Some in cholesterol synthesis. Medicines that block biotechnologically are used in many tests for study demonstrated that if one is blocked, the industry analysts believe a drug that can stand PCSK9 can reduce cholesterol, and studies are blood and urine components such as cholesterol other may be stopped. in the way of the PCSK9 protein that interferes investigating whether they can improve heart- and glucose. Roche produces hundreds of T e humanized monoclonal antibody is with the ability of the liver to remove LDL from disease outcomes. enzymes and antibodies for industrial, scientifi c undergoing Phase III studies for primary- the blood could generate billions in annual Upon completing its acquisition of San and medical diagnostic uses. progressive multiple sclerosis and relapsing sales. Diego-based Excaliard Pharmaceuticals in Roche’s leading therapeutic area is oncology. multiple sclerosis. Regulatory fi ling of Proprotein convertase subtilisin/kexin type December 2011, with it came the Phase II drug Some of the company’s most promising ocrelizumab is projected in 2015 as Phase III 9 is a human enzyme encoded by the PCSK9 EXC 001 for treating excessive skin scarring. biotech compounds for oncology are T-DM1, recruitment has been slower than expected due gene. Similar genes (orthologs) are located T e privately owned biopharma company had onartuzumab, and obinutuzumab. For more to the various MS studies under way. across many species. Many enzymes are inactive concentrated on developing novel drugs for details about these products, please see the Roche and Genentech are developing a novel when they are initially synthesized, because treating skin fi brosis, more commonly known Roche oncology profi le following this section. humanized monoclonal antibody for severe they have a section of peptide chains that as skin scarring. T ere is no FDA-approved In other therapeutic areas, aleglitazar is being asthma. Lebrikizumab is designed to specifi cally blocks their activity. Proprotein convertases treatment for excessive skin scarring. developed by Roche as a treatment to reduce block the action of the interleukin-13 cytokine major cardiovascular events (cardiovascular and reduce airway infl ammation, which is a key mortality, heart attack, or stroke) in patients who asthma feature. T e IL-13 cytokine is a signalling BEST BIOTECHNOLOGY of approaches and joining together the cutting- have experienced an acute coronary syndrome protein that acts as a messenger between cells PIPELINE: ROCHE edge research of Roche and Genentech, as well as and have type 2 diabetes or patients with stable that is increased in some asthma patients. Chugai. As part of the 2009 merger, Genentech’s cardiovascular disease and type 2 diabetes/pre- “Compared with other asthma drugs in the oche generates more product sales Research and Early Development (Phase I and diabetes. Aleglitazar is additionally being studied pipeline, lebrikizumab has progressed rapidly Rfrom biotechnology than any other com- Phase II) organizations were reformed as a as a general type 2 diabetes glucose regulator. through clinical trials,” stated Dr. Laura Runkel, pany worldwide. Roche’s 2011 biotech sales single independent center for discovery research T is oral, small molecule is designed to associate director of Autoimmune/Infl ammation totaled $25.7 billion. EvaluatePharma projects and early clinical development. Genentech provide balanced dual peroxisome proliferator- for Citeline, which provides comprehensive real- that the total will reach $32.6 billion in 2018. Research and Early Development concentrates activated receptor (PPAR) activation. T e time R&D intelligence to the pharma industry. Roche is one of the industry’s pipeline leaders on continuing the pioneering biotech work and drug compound’s impact on peripheral insulin “Further setting lebrikizumab apart from its with 72 NMEs as of September 2012. T e tradition established more than 30 years ago, sensitivity associated with PPAR activation and competitors is the fact that Roche is the only company’s 19 late-stage clinical trials at that time and includes therapeutic antibodies, antibody- dyslipidemia is being studied. sponsor currently employing a companion included 12 NMEs, expected to read out within drug conjugates, and small molecules. Aleglitazar is being evaluated as part of a diagnostic in its asthma trials.” According to an 18-month period. Genentech’s R&D activities are concentrated comprehensive clinical program, including Citeline, the use of a validated companion Roche spent SFr.8.33 billion ($9.4 billion) on applying excellent science to discover and the completed Phase II trials SESTA-R, diagnostic could provide the key advantage on R&D in 2011. T e company plans to develop potential new medicines intended SYNCHRONY and AleNephro as well as the in choosing the subset of patients most likely keep its R&D budget stable by implementing to represent fi rst-in-class or best-in-class Phase III studies AleCardio, AlePrevent and to benefi t from IL-13 antagonism. Although continued productivity improvements as well as AleGlucose. T e large, long-term, event-driven companion diagnostics are rarely used in asthma rigorous portfolio prioritization. Phase III outcomes trial AleCardio is under studies, Citeline’s Pipeline product shows that Roche acquired a majority holding in long- way to evaluate whether aleglitazar may reduce their use overall is increasing and is tracking 82 time biotech leader Genentech during 1990, major cardiovascular events in patients who companion diagnostics intended for approval and by 1999 had obtained all the company’s have experienced acute coronary syndromes with specifi c medicines. shares. T en in March 2009, Genentech became and have type 2 diabetes. AlePrevent is a second During third-quarter 2012, Roche identifi ed a wholly owned member of the Roche Group. cardiovascular outcomes study in patients with the necessity to optimize the manufacturing for Established in 1976, South San Francisco-based stable cardiovascular disease and type 2 diabetes lebrikizumab. As a result, regulatory submission Genentech is regarded as the founder of the or pre-diabetes. AleGlucose is a set of glycemic is expected to take place after 2016. modern biotechnology industry. T e revamped therapeutics. T e company’s Research and Early control studies to further characterise the eff ect For schizophrenia, Roche and Genentech organization of Roche and Genentech as of Development pipeline has more than 30 NMEs of aleglitazar on glycemic control in type 2 are developing the potential fi rst-in-class drug 2009 leverages the combined strength of both undergoing active clinical development. diabetes patients. candidate bitopertin. T e oral, small-molecule companies while maintaining the diversity of In parallel, Pharma Research and Early For multiple sclerosis, Roche/Genentech glycine reuptake inhibitor is designed to enhance approaches essential for successful innovation. Development unites the worldwide early is developing an innovative medicine with a N-methyl-D-aspartate receptor activity. T is is T e merger during 2002 between Nippon development and research organizations that mechanism of action fundamentally diff erent believed to be a signifi cant pathway in psychiatric Roche, Roche’s Japanese subsidiary, and Chugai existed within Roche, with a concentration on than other existing therapies for the disease. disorders, particularly schizophrenia. Pharmaceutical resulted in the establishment of creating value from a deep understanding of life MS drugs work by targeting a person’s immune A worldwide Phase III program of six trials Japan’s fi fth-largest pharma entity and largest sciences. pRED is committed to the translation system, but they target fundamentally various is exploring two indications for bitopertin. T e biotechnology company. Chugai functions as and understanding of disease biology in the parts. Traditionally, industry R&D has Phase III program is designed to optimize data an independent member of the Roche Group clinical setting, and providing novel therapeutics concentrated on targeting one component of quality by carrying out three studies for negative and is listed separately on the stock exchange. to the specifi c patient populations in fi ve disease the immune system – the T cells – which attack symptoms and three other for sub-optimally Chugai is responsible for the sale of all Roche categories. nerve fi bers in the brain, resulting in lesions and controlled symptoms in schizophrenia in products in Japan and benefi ts from the Group’s Roche provides biopharmaceuticals for use ultimately MS symptoms. Ocrelizumab, on the parallel at the same clinical sites. A companion global sales network. Roche holds licensee rights in the following areas: leukemia, breast cancer, other hand, targets the CD20 molecule located diagnostics assay is being developed by Roche to all Chugai products marketed outside of lymphoma, intestinal cancer, lung cancer, on the surface of B cells, a diff erent component to validate the hypothesis for an exploratory Japan or South Korea. renal cancer, skin cancer, rheumatoid arthritis, of the immune system. CD20-positive biomarker predicting response to therapy with T e Roche Group ensures continued transplant rejection prevention, renal anemia, B-cells are implicated in the infl ammatory bitopertin. Clinical data are expected to be research innovation by maintaining a diversity hepatitis, and cystic fi brosis (mucoviscidosis). and neurodegenerative processes of MS. available in late 2013.
BEST ONCOLOGY PIPELINE: T e company is leading the industry charge third-line non-small cell lung cancer. Clinical lymphocytic leukemia and non-Hodgkin’s ROCHE in developing antibody–drug conjugates results from this program are anticipated for lymphoma. T e drug is being developed in (ADCs) that unite the specifi city of antibodies 2014. T e fi rst-in-class monoclonal monovalent collaboration with Biogen Idec. Obinutuzumab with the power of chemotherapy. T ese ADCs antibody is designed to inhibit Met signaling is the fi rst type II, glycoengineered, humanized oche, with help from Genentech may lead to improved effi cacy and fewer adverse in cancer cells by binding to the extracellular anti-CD20 MAb. T e drug is designed Rand Chugai, leads the oncology drug events. domain of Met, and in turn blocks HGF- to enhance direct cell death and ADCC market behind long-established billion-dollar Regarded as a potential market-leader mediated activation. HGF/Met signaling is mechanisms when binding to CD20-positive brands such as Avastin, Herceptin, Rituxan/ successor to Herceptin when that drug loses activated through over expression of HGF and/ malignant B cells. CD20 is a B-cell surface MabT era, Xeloda, and Tarceva. According patent protection, trastuzumab-DM1 (T-DM1) or Met in tumors and via activating mutations protein expressed on malignancies of B-cell to the Roche, they represent an unprecedented has produced positive results in clinical trials in Met. Met signaling activation spurs precursors and mature B cells. fi ve innovative cancer products that are proven for HER2 positive breast cancer. T is ADC tumor growth, and has been linked to tumor By virtue of its type II antibody characteristics, to provide survival benefi t in six diff erent major contains the unique stable linker trastuzumab angiogenesis and metastatic potential. obinutuzumab results in higher direct cell death tumor indications. and the potent cytotoxic agent DM1. T e drug RG3638 is also undergoing Phase II induction of cancer cells and lower complement Roche continues to seek out new oncology candidate is designed to bind to the HER2 development for fi rst-line non-squamous non- recruitment versus type I anti-CD20 compounds, and spends nearly 50 percent of its receptor on the surface of cancer cells and small cell lung cancer, fi rst-line squamous non- antibodies. Afucosylation of the Fc region of total R&D each year on oncology products. selectively kill cancer cells while minimizing small cell lung cancer, Avastin-naïve recurrent obinutuzumab (GlycoMAb technology) has led Besides the innovative portfolio of cancer cytotoxic eff ects on normal tissue. glioblastoma, metastatic gastric cancer, metastatic to stronger FcgRIIIa binding, which translates to medicines, Roche is developing new diagnostic T-DM1 was submitted for regulatory colorectal cancer, and triple-negative metastatic enhanced ADCC. Preclinical studies show that tests that will have an important eff ect on disease clearance in the European Union and United breast cancer. A companion diagnostic test to obinutuzumab induces greater B-cell depletion management for cancer patients in the future. States during August 2012. identify individuals with MET-positive tumors in peripheral blood and in lymphoid tissue Roche’s oncology pipeline contains 23 T e antibody onartuzumab (RG3638) is undergoing development. versus other available monoclonal antibodies. NMEs, including fi ve undergoing late-stage is undergoing Phase III development in Obinutuzumab, or RG7159, is another T e drug candidate additionally mediates high development. combination with Tarceva for second-line and antibody in Phase III studies, for chronic antitumor activity in NHL xenograft models.
18 • MED AD NEWS JANUARY 2013
magentablackcyanyellow ES177931_MAN0113_018.pgs 01.15.2013 03:21 UBM Thursday, April 25, 2013 at Pier Sixty, New York
Honor the best agencies in pharmaceutical advertising at this celebratory annual gala event. Med Ad News will present the industry’s most respected awards and continue to honor the Advertising Person of the Year.
To reserve your company’s table or seats, visit MannyAwards.com or contact: Joanna Siddiqui at 973-808-8847, [email protected]
For sponsorship information, contact: Daniel Becker at 973-808-1191, [email protected]
magentablackcyanyellow ES177545_MAN0113_019_FP.pgs 01.12.2013 05:24 UBM blast out information to patients, and hope they would come directly to a physician’s offi ce,” Mr. Coman says. “T ere’s very little interaction or intervention along that continuum. It was GETTING networked really a one-way push, and the vehicle that they pushed all their communications out through was typical mass advertis- ing.” When hearing a typical radio spot for clinical trials, Mr. The creation of online patient registries will not only lead the way for clinical trial recruitment, but for Coman, who came from the telecom industry 10 years ago post-marketing efforts as well. and used to do direct-to-consumer marketing, said he used to by Christiane Truelove ([email protected]) ask himself, “Why in the world are they doing that?” “I know from my past that radio is the least effi cient me- s pharmaceutical companies continue to explore the It was with these sorts of statistics in mind that Pfi zer an- dium to deliver a message and to get a consumer to respond,” social media world, it’s not only marketing eff orts nounced an eff ort in June 2011 to let patients use social media he says, adding that the pharma industry’s reliance on radio Athat would benefi t from interactive outreach. Clinical to participate in a clinical trial. Called the “clinical trial in a spots for clinical trial recruitment fascinated him. trial recruitment, always diffi cult and growing even more so, box,” the eff ort would allow patients enrolled in a trial for the He acknowledges that the industry has evolved and has could be revolutionized by the use of online registries to gather overactive bladder drug Detrol to participate from home, us- begun to fi gure out how patients are engaging and thinking, potential participants – rather than just reaching out blindly ing smartphones and computers, instead of having to go to and how the industry can best interact with patients. In 2007, through social media sites. And in the era of Big Data, the the doctor’s offi ce. Patients were to be recruited through In- Quintiles started iGuard.org, now MediGuard.org. Founded value of the communities created by these registries will go far ternet ads and prospects would visit a Website that explained by Dr. Hugo Stephenson, the site allows those who register beyond clinical trials, to marketing and post-marketing stud- the trial and permit enrollment process. All materials – the to monitor the safety of the prescription medicines, over the ies that can track side eff ects, use, and clinical eff ectiveness in blinded study drug and a mobile app for electronic patient- counter medicines, and healthcare supplements that they are the real world – information that will be invaluable for payer reported outcomes – were sent to participants at home, with taking. Patients can leave information and “rate” the drugs decisions. blood drawn at a local clinic or during home visits. they are taking, and the site provides patients with rapid alerts Clinical trial recruitment can certainly use some kind of Unfortunately, in June 2012, Pfi zer made headlines again, in the event one of their medications is the subject of a recall, serious boost. According to the Center for Information & for shutting down the eff ort. T e company had problems re- or was found to have an interaction with another drug they Study on Clinical Research Participation, the delays in patient cruiting patients. Craig Lipset, head of clinical innovation at are taking. T ere now are more than two million patients reg- recruitment for clinical trials account for an average of 4.6 Pfi zer, told Pharmalot that though the company used a lot istered on MediGuard. months lost per trial. When calculated, this is an annual cu- of diff erent methods to recruit patients – Craigslist, Google Mr. Coman says when it fi rst started, MediGuard was seen mulative loss of 26 years, on average, for each company. Each searching, Facebook, online patient communities – that drove as “a pure experiment, to see if you could speak with patients day a drug is delayed from market, sponsors lose up to $8 mil- thousands of patients to the recruitment Website, actual con- in a diff erent manner, and try to create a community, more lion, and the average cost of clinical trials has risen to nearly 60 version rates were low. than a social network of patients looking for all the same type percent of total development costs, compared to just over 30 “T at said, we didn’t expect each patient who learns about of information.” percent in the 1980s. this on their own and online to raise their hand and say they “I would say it’s more of a two-way, we’re providing infor- What’s more, less than one third of people who come in want to do that,” Mr. Lipset said. “If you put out Google ads, mation, and they’re providing a little information back,” he for a screening end up completing a clinical trial. Some par- you’ll drive traffi c but not necessarily the type of patient who’s says. “We post data, we provide a service, and 95 percent, give ticipants never pass the eligibility criteria, and others drop out. ready to participate, compared with already formed commu- or take a percentage point, of the patients that we have in that Overall, one out of every four patients stick with a study until nities where patients are actively engaged. T ose are lower in community are pretty explicit in saying that they’d be willing its completion, and most participants drop out during Phases number, but they are an enriched group of patients.” to take part in health research.” II and III. Additionally, patients overall are still largely unaware of In 2009, Quintiles created a second patient community, Out of all of the research sites in the United States, less clinical trials and participation. Mr. Lipset said there were clinicalresearch.com, which allows patients to search registries than one third contain 70 percent of the valuable subjects. some success stories in Pfi zer’s eff ort, but “there are nuances we of clinical trials, get e-mail notifi cations about new clinical tri- T is means 70 percent of the research sites under-perform, need to capture and learn from.” als in their area, read health news, and watch videos, among and between 15 percent and 20 percent never even enroll a Although the trial in a box concept was not successful, Pfi zer other things. About 250,000 patients are registered in that single patient. Fifty percent of clinical research sites enroll one is still using social media channels to recruit patients for more community. Unlike the patients enrolled in MediGuard, the or no patients in their studies. In an analysis of 25,855 study conventional clinical trials. Other drugmakers have their own patients of clinicalresearch.com are actively seeking to get in- volunteers in the United States, 73.2 percent of participants digital recruitment eff orts. For example, Quintiles’ Digital Pa- volved in clinical trials. completed Phase I through Phase IV of clinical trials, 75.4 per- tient Unit created a Website and is assisting with supplemental Quintiles created its Digital Patient Unit in January last cent completed Phase I clinical trials, 69.7 percent completed patient recruitment for AstraZeneca’s AZD6765, which is be- year, formed around the concept of how the company can best Phase II/III clinical trials, and 93.8 percent completed Phase ing developed for the treatment of major depressive disorder. mobilize patients directly into clinical research, observational IV clinical trials. But studies show that enrollment rates have Quintiles’ site, majordepressionstudy.com, asks patients, studies, and disease management programs. Mr. Coman says dropped from 75 percent in 2000 to 59 percent in 2006 and “Is your major depressive disorder a daily challenge? Have you the driving idea is patient engagement, not patient recruit- retention rates have fallen from 69 percent to 48 percent dur- tried medications for your depression in the past which didn’t ment. ing same period. seem to help? Are you currently taking an antidepressant but ‘It’s about how you interact with patients in a manner in According to a 2006 CISCRP survey, the public’s percep- still feel low, tired, and depressed? If so, you may be eligible to which they get a real, clear benefi t, and the sponsor gets a re- tion regarding why people choose to participate in clinical tri- participate in this clinical research study.” Patients can choose ally clear benefi t,” he says. “I often say here that the Digital als is because they are “very sick without any other options” or to complete a questionnaire to see if they would be eligible Patient Unit is often like the eHarmony of healthcare, but the they are “looking to make money.” Sadly, also in this study, 34 for the study, called Pursuit. T e site also explains the Pursuit reality of it, the things that we do are very similar. We’re mar- percent of Americans said that they “do not admire” people study, major depressive disorder, and how Quintiles will pro- rying a pharma sponsor to a patient – those patients are really who volunteer for clinical trials. Another study showed that tect patient privacy. actively engaged in trying to resolve their health questions or less than fi ve percent of Americans know where to fi nd in- Dave Coman, the head of Quintiles Digital Patient Unit, health issues. And the pharmaceutical industry is even more formation about relevant clinical trials. On the positive side, says the organization is capitalizing on the evolution in patient needy, in terms of trying to fi nd patients to participate in clini- more than 70 percent of those who have participated in clini- communication over the last several decades. cal research or to fi nd information they need for observational cal trials are likely to do so again. “We used to have as a mentality, we as an industry, would studies to improve the economic value of a drug or to manage safety surveillance studies they have, or even engage with those patients in ad- herence or product adoption in the com- mercial side of the life cycle.” Pharma companies have to start en- gaging with patients in all areas that they can, because patients are far more involved with their health than ever be- fore. “T is is the age of the digital patient,” Mr. Coman says. “We have to match the demand with the supply – and that is to help those patients fi nd studies and the opportunities that can help them im- prove their own health and the health of others than have those same condi- tions.” Since 2007, Quintiles has engaged with more than three million patients through online means, Mr. Coman says. Quintiles’ Digital Patient Unit created this recruitment Website for AstraZeneca. The site The Genetics Alliance created this patient registry as part of its entry for the Collabo- “We’ve tried and failed, and tried and is for supplemental recruitment for a study of AstraZeneca’s depression drug AZD6765. rate/Active Innovation Challenge sponsored by Sanofi . failed, and tried and succeeded,” he says.
20 • MED AD NEWS JANUARY 2013
magentablackcyanyellow ES177594_MAN0113_020.pgs 01.12.2013 06:13 UBM “And in that process, we’ve discovered how stretching across seemingly unrelated diseases,” and need, this shapes the company’s research T e challenge is a way of bringing ideas to- best to interact with a patient in a manner she says. “Finally and most importantly, shar- model, and allows more collaboration with gether, and the enthusiastic response speaks to that’s going to drive the appropriate behav- ing data broadly will transform the competi- the R&D team, Mr. Greissing says. the desire of these groups to collaborate with ior.” tive paradigm. T is will provide an opportu- As Registries for All Diseases moves for- a pharma company. What’s more, everyone And according to Mr. Coman, recruiting nity for any interested party to apply his or her ward, it will provide access to information for seems to be aware of the same problems, Mr. patients digitally, rather than through tradi- skills to the problems at hand – think about a the patients and understanding. T e eff ort Greissing says. “You would be surprised in tional outreach, is more economical and ef- math and engineering high school student, or initially looked at creating registries for 1,000 conversations with them, how many themes fective. For the money spent on traditional retired database analyst – sunshine on the data diseases, but as time went on, Mr. Greissing start popping up, you hear it from one group outreach to get one patient into a clinical trial, will cause an explosion in new discoveries.” says the consortium decided to target 13,000 and you hear it from another, and they’ve nev- Quintiles can spend on digital outreach to get Edward Greissing, senior VP and U.S. diseases. er been in touch with each other,” he says. 100 patients. head of corporate aff airs, global services, and Mr. Greissing stresses that though the In- Mr. Greissing hopes the challenge will set In addition to lowered costs comes greater Partners for Patient Health for Sanofi , says novation Challenge and Registries for All Dis- a new example in the pharma industry of speed. Recently, Quintiles had to recruit 500 the innovation challenge and the company’s eases will have a benefi cial impact on Sanofi , how companies and patient groups can work patients into a trial that was studying patient patient initiatives are part of an eff ort to “leap- “We didn’t [start the challenge] for Sanofi . We together to truly solve patient needs, as well behavior relative to patient outcomes. Setting frog the current landscape and get out there did it for the learnings that would come and as change the way patient groups look at the up the recruitment in a traditional manner and do things that are more important to the the partnerships and the collaboration that industry. (For statstics on how pharma execu- and getting the fi rst patient in would have future of the patient and patient needs.” would develop with these groups. We had 280 tives view online patient recruiting, see page 24). taken six months, with the recruitment pro- By understanding what patients want groups submitting 128 applications.” cess taking another six months to complete. “We were able to recruit the fi rst patient in literally six minutes,” Mr. Coman says. “T e completion of the recruitment process was lit- erally six business days.” By setting up communities of patients, through registries or other means, Quintiles Join us at: can set up long-term relationships with pa- tients that can extend through clinical trials and beyond. Patients can be notifi ed through- out the clinical trial about drug successes and failures, and Quintiles does not have to duplicate its eff orts to fi nd patients for post- marketing initiatives. “From a commercial perspective, if you March 12, 2013 are trying to accelerate your adoption curve, Hamilton Park Hotel & Conference Center you’ve got a patient community who have al- ready been through the process, who are go- Florham Park, NJ ing to be the fi rst adopters, your early adopt- Early-Bird ers, and they’re also going to be your advocates Special ends 2/15 upon launch as well,” Mr. Coman says. “So Get experience-tested solutions to tackle it’s how do you start leveraging those patient ONLY $395 relationships in all aspects of the product life your toughest patient adherence challenges. cycle.”
Innovating for patient needs INVEST JUST A DAY AT RxADHERENCE and return to 75% of adults fail to Not every pharmaceutical company wants to the offi ce with new ideas, strategic solutions, and best practices to “adhere to, or comply with get directly involved in building long-term pa- implement into your marketing campaign. physician prescribed tient registries, because of the eff ort and main- tenance involved. Sanofi has found a way to These are challenging times for the pharmaceutical, biotech, and medical treatment regimens. actively support others in building these reg- device industries. Budgets have been cut to the quick and require industry -PhRMA,” 2011 istries. In December, the company awarded to employ innovative approaches to optimize health outcomes. $300,000 to a consortium of advocacy groups WHO SHOULD ATTEND? to build a diseases registry in its 2012 Col- » Brand Management Join your colleagues at the RxAdherence conference to gain critical insight » laborate/Activate Innovation Challenge. and information necessary to turn these challenges into opportunities. Pharmaceutical Industry Sales Registries for All Diseases is a collabora- & Marketing Executives tion between more than a thousand disease » Patient Compliance and Persistency advocacy organizations, including Genetic » Packaging Engineers Alliance, CFIDS Association of America, Na- KEY BENEFITS OF ATTENDING: » Packaging Professionals » Product Management tional Psoriasis Foundation, and the Infl am- t Presentations from infl uential patient adherence organizations including » matory Breast Cancer Research Foundation. Council for Aff ordable Health Coverage, NEHI, NCPIE, CapGemini, HealthPrize Business Development » Advertising Agency Professionals T ese groups have come together to create Technologies, AndersonBrecon, Xcenda and many more a platform for individuals to store and share » Promotions Management t their medical data and biological samples. Hear strategies to improve patient adherence from the perspective of the » Disease Management Registries for All Diseases will comprise physician, patient, industry, media, and analyst » Managed Care » Strategy Analysis three parts: A gamifi ed survey to engage peo- t Get experience tested strategies for facilitating dialogue with patients and » Pharmacists ple in sharing clinical information, through health care practitioners » Healthcare Providers Disease InfoSearch (diseaseinfosearch.org); a t virtual research network, asking individuals Hear how to maintain a competitive advantage by building trust and » Anyone interested in the role to respond to a couple of hundred clinical consumer loyalty with packaging solutions that better packaging can play in improving pharmaceutical questions to characterize them for potential t Analyze major trends and data related to patient adherence and improved adherence and safety! research; and a detailed questionnaire created health outcomes. by a disease advocacy organization with the t Network, Network, Network! opportunity to bank biological samples. According to Sharon Terry, president and The economic impact CEO of Genetic Alliance, Registries for All “of non-adherence is Diseases will allow individuals to participate estimated to cost $100 in their health, and gives disease advocacy Cosponsored by: organizations a valuable tool in the quest for billion annually. therapies. Registries for All Diseases is ex- ”-PhRMA, 2011 pected to accelerate translational research by linking clinical information and samples in a registry that allows recontact in a trusted envi- ronment. “Because Registries for All Diseases REGISTER NOW! breaks down the silos between diseases, it al- lows for advanced research into comorbidities RxAdherenceConference.com Promo Code: MAN
24428_MA13
magentablackcyanyellow ES177589_MAN0113_021.pgs 01.12.2013 06:13 UBM treatment options, through fi rst- tions may evolve over time. T is is only made line therapy, second-line therapy, possible by considering alternative research Sales&Marketing and so on. Next, the patient’s com- approaches, such as ethnographic studies, in pliance and persistence is outlined which observers enter the offi ce setting to watch By Joshua Slatko [email protected] with her assigned course of thera- fi rsthand the interactions patients have with py, followed by product fulfi llment, physicians, nurses, and other offi ce personnel. with payers playing an increasing A trained ethnographer observes underlying at- The patient journey: An evolved role in most therapeutic areas. titudes, thoughts, and feelings of key stakehold- Traditional treatment fl ow ers. Although often considered expensive, this approach to treatment fl ow modeling models tend to be more physician- can provide powerful insight to help marketers By Yesim Ilkin and Rohit Sood centric, failing to take into account uncover unmet needs, as well as drivers of and all of the key stakeholders aff ecting barriers to product adoption. he treatment fl ow model, also from origination through evaluation, diagnosis, a brand, including payers and other non-tra- Understanding how patients interact with known as the buying process, is one of the therapy, brand choice, fulfi llment, and compli- ditional stakeholders such as advocacy groups, the full range of stakeholders is important, but Tfoundational elements of pharmaceutical ance. It may begin with a patient displaying nurses, hospitals, pharmacists, and offi ce man- it is also necessary to understand how these marketing strategy. Marketers develop treat- symptoms of a particular condition, spurring a agers. In addition, the interactions between key stakeholders inte ract with each other. For ment fl ow algorithms to better understand the visit to her primary care physician. If the pri- these key stakeholders are usually not repre- example, advocacy groups and payers have in- patient-physician interaction for their product. mary care physician determines the condition sented by traditional treatment fl ow models. creasing infl uence on the prescribing decisions Once developed, these models can reveal the warrants further investigation, the patient may In the evolved approach to treatment fl ow of doctors. Sometimes the extent of the infl u- leakage and leverage points that can help inform be referred to a specialist. T e treatment fl ow models, marketers consider the full range of ence is overlooked. By mapping these relation- strategies and tactics to maximize the uptake of model then summarizes the course of various stakeholder interactions and how those interac- ships, marketers can now place these new stake- a drug. holders on their radars and develop strategies to Several gaps exist in the traditional physi- potentially infl uence behaviors over time. cian-centric approach to treatment fl ow mod- eling, however, which has limited the strategic Quantify the patient journey usefulness of the tool. T e increasing infl uence After identifying key stakeholders and map- of new and existing stakeholders, coupled with ping out the patient journey, it’s important to the challenges of directing limited resources to gauge the impact various stakeholders have and the right areas to shape the market, are driving to translate their impact into tangible numbers. this need for an evolved approach to treatment Treatment fl ow models are often qualitative, fl ow modeling that focuses on the true journey broadly indicating, for example, whether pa- a patient takes through the healthcare system. tients went to a primary care physician versus a T e journey approach to treatment fl ow model- radiologist. Too often, these traditional models ing can provide actionable insights, resulting in will not reveal what number of patients visited more insightful, better-informed strategic deci- one type of healthcare provider over another. sions for marketing pharmaceutical products. T ey lack the quantifi cation that may enable T is approach diverges from the traditional more advanced analysis. method in four key ways that make the practice Instead, primary and secondary research a far more eff ective tool. should be used to quantify the patient journey. If the data is simply not readily available, resources Map all stakeholders should be invested to conduct the appropriate At a high level, the traditional treatment fl ow research to gain the most complete informa- model is designed to capture the fl ow of a pa- tion possible. Chart audit data, for example, can tient population through the healthcare system provide powerful insights on the distribution of the patient fl ow. T is enables deeper insight into the movement of patients through the health- care system at a manageable cost and helps the marketer prioritize where the marketing team should focus its eff orts to make the biggest im- ANTIVIRALS 11.9% pact in the marketplace. he most-recognized antiviral brand in North America is Valtrex. Quantifi able data from the treatment fl ow TThe brand was most recognized by 11.9 percent of physicians in a survey 11.3% will show marketers where to direct dollars in conducted by Brand Institute Inc. in third-quarter 2012. Valtrex, comprising 8.2% order to drive product utilization. Knowing valacyclovir, is marketed by GlaxoSmithKline (gsk.com). The drug was fi rst where the most impactful leverage points are in approved by FDA in June 1995 as a treatment for shingles and has since received 4.3% the treatment fl ow allows marketers to prioritize additional indications for the treatment of genital herpes, cold sores, and the treat- their strategies and tactics in ways that maximize 1.7% ment of chickenpox in pediatric patients two years old to 18 years old. return on investment. Zovirax is the second most-recognized antiviral brand in North America. 1.4% About 11.3 percent of physicians recognize this brand the most. Comprising acy- Take a futuristic view
clovir, Zovirax is also marketed by GlaxoSmithKline. The drug was fi rst approved 1.3% The 10 Most Traditionally, treatment fl ow models off er a stat- Recognized by FDA in March 1982 and has received indications for the treatment of initial Anti-infective ic representation of the marketplace, providing a 1.3% and recurrent mucosal and cutaneous herpes simplex in immunocompromised BrandsIN snapshot that captures the market landscape in in North America NORTH AMERICA patients, chickenpox, herpes simplex encephalitis, genital herpes, neonatal herpes 1.2% one moment in time. infection, shingles, and cold sores. Marketers should consider developing an The third most-recognized antiviral brand in North America is Tamifl u. 1.0% evolving treatment fl ow that captures key trends About 8.2 percent of physicians recognize this brand the most. Tamifl u, compris- over time and models the expected impact of ing oseltamivir, is marketed by Genentech Inc. (gene.com), a subsidiary of future events and scenarios in the marketplace. Roche (roche.com). The product was fi rst approved by FDA in October 1999 In tandem and as necessary, marketers should to treat uncomplicated acute illness due to infl uenza infection in adults who have 15.1% develop alternative models that look ahead and been symptomatic for no more than two days. In November 2000, Tamifl u was 8.1% predict what the patient journey will evolve to approved for use by adolescents 13 years and older; the following month, a once their product launches. Meanwhile mar- liquid suspension for children 1 year and older was also approved. The prod- 5.5% ket disruptors, such as the launch of competing uct’s most recent approval by FDA was for infants two weeks of age or older, in products, changes in payer attitudes, or the im- 3.3% December 2012. plementation of healthcare reform provisions,
The most-recognized antiviral brand in Europe is Zovirax. This brand was most 1.9% should also be considered in the treatment fl ow. recognized by 15.1 percent of physicians. T is will help to shape product development Tamifl u is the second most-recognized antiviral brand in Europe. About 8.1 1.5% from a clinical perspective and develop appro- percent of physicians recognize this brand the most. priate counter-strategies. 1.5% The 10 Most The third most-recognized antiviral brand in Europe is Valtrex. About 5.5 Recognized Ideally, the treatment fl ow is mapped out for Anti-infective percent of physicians recognize this brand the most. 0.9% the fi rst time before Phase II of commercial de- BrandsIN Brand Institute (brandinstitute.com) surveyed more than 2,000 physicians and in Europe velopment. Marketers should review and refi ne NORTH AMERICA hospital and retail pharmacists in North America and Europe to determine the 0.8% the patient journey as the product transitions most-recognizable brands in the category of antivirals. Brandpoll is a marketing from Phase III and launch, and refl ect any addi- tool designed to help clients monitor the competitive marketplace and identify the 0.8% tional changes in the marketplace, such as policy potential strengths and weaknesses of their brands. changes or guideline revisions.
22 • MED AD NEWS JANUARY 2013
magentablackcyanyellow ES177640_MAN0113_022.pgs 01.12.2013 06:16 UBM SALES&MARKETING
implemented along the way to validate and quantify the treatment fl ow, including techniques such as inter- While nearly two thirds of Americans believe Sales of cancer pain therapies will increase views, ethnographic research, Medicare needs to undergo some form of to $5.2 billion in 2021 in the United States, and Web-based surveys. change, respondents were not in agreement on France, Germany, Italy, Spain, the United With the patient journey the nature of the reform, according to the Truven Kingdom, and Japan, according to projections established, the evolved ap- Health Analytics Health Poll. by Decision Resources. Over the next decade, proach to treatment fl ow The survey, which asked respondents about several premium-priced agents are expected modeling goes one step fur- their attitudes regarding the Medicare system, to enter the market, taking signifi cant patient ther, using the fi ndings to re- found that 65 percent of Americans believe share from low-cost drugs and spurring growth. fi ne the commercial strategy changes need to be made. That fi gure consisted Decision Resources analysts believe that further of the brand. During this of 71 percent of Republicans and 58 percent growth will be restricted by the enduring presence phase, the brand team iden- of Democrats. The highest rate (80 percent) of of generic opioids, which will continue to play a tifi es key leverage points on respondents who said they would favor changes major role in cancer pain treatment, and by the the patient journey map. Ap- to the Medicare system was among those who onset of generic erosion in other drug classes, Make it a strategic tool propriate value propositions make over $100,000 per year. most notably the bisphosphonates. are subsequently developed for the respective When asked if Medicare would benefi t by Based on convincing results from numerous Marketers do not always leverage treatment fl ow customer groups. encouraging competition within the program, half Phase III clinical trials in bone metastases and models as the strong strategic tools they can be. Figure A shows a fi ctional example based on of respondents (50 percent) said they believe bone loss due to ablation therapy in prostate T e patient journey model should be used as a rheumatoid arthritis (RA). T e stars in the fi g- that would be the case. Sixty nine percent cancer patients, Decision Resources forecasts that standardized framework for the development of ure represent leverage points that should ideally of Republicans and 31 percent of Democrats denosumab (Amgen/GlaxoSmithKline/Daiichi strategies and tactics based on key stakeholder- be validated by a cross-functional team, includ- said changes to encourage competition were Sankyo’s Xgeva/Ranmark) will gain blockbuster prioritized behavioral objectives. ing Marketing, Clinical, and Managed Care necessary. status in the cancer pain market by 2016. De- While ultimately the patient journey develop- functions. As seen in Figure B, these leverage A proposed voucher plan was not well nosumab is expected to derive the majority of its ment framework will be unique for each product, points may be consolidated based on the type received overall. When a voucher plan similar to market share from the rapidly-eroding bisphos- typical development usually begins with mapping of decision aff ected, the type of stakeholder the one Congressman Paul Ryan proposed prior phonate class. the patient engagement process. T is usually takes targeted, and/or the type of eff ort required to to the Presidential election was described for Decision Resources analysts also believe that into account trends in drug usage, trends in man- aff ect the decision point. High-impact lever- respondents, just 35 percent agreed it would one of the greatest commercial opportunities in aged care, promotional activity, trends in patient age points are now converted into behavioral be the right way to reform Medicare. Slightly over cancer pain is for effective products that lack the and prescription data, and launch analyses. From objectives, which outline the desired target be- half of Republicans (52 percent) and one-in-fi ve gastrointestinal and central nervous system side this secondary research, a hypothetical patient haviors that stakeholders exhibit in favor of the Democrats (19 percent) agreed with Medicare effects of opioid analgesics. journey can be mapped out that includes the key brand. Based on these prioritized behavioral being turned into a voucher program. “Experts we interviewed are skeptical that the stakeholders aff ecting brand uptake. Depend- objectives, it is then possible to develop an ac- “The fi rst step in any change process is to real- goal of greatly improved safety and tolerability ing on the stability of the brand’s future market tionable and realistic strategic and tactical plan ize that change is needed,” says Raymond Fa- will be achieved in the next ten years,” says Deci- scenario, key trends and competitive events may designed to encourage these behaviors. bius, M.D., chief medical offi cer at Truven Health sion Resources (decisionresources.com) analyst be modelled to refl ect changes and their respec- Analytics (truvenhealth.com). “With two-thirds of Natalie Taylor, Ph.D. “This is because the majority tive aff ects over time. T is makes the develop- Yesim Ilkin is an engagement manager with the public agreeing on the need for Medicare of development activity has focused on reformula- ment of strategies and counter strategies easier to Campbell Alliance. Rohit Sood is a VP with reform, the nation can now focus on solutions.” tions of existing opioids.” identify. Customized primary market research is Campbell Alliance.
Well-acclaimed, sought-after, and often-referenced.
is your source for extensive key performance metrics and analytical reporting. Respond today and SAVE 15%! Visit www.PharmaLive.com/specialoff ers and enter code MNB20101 Get exclusive online access to statistics and analysis of key performance indicators found in Med Ad News, including:
Top Biotechnology Companies Top Medicines Top Pharmaceutical Companies
t&YQFSUTBOBMZ[FUIF t.FEJDJOFPGUIF:FBSBOE t5PQQIBSNBDPNQBOJFTBSF DVSSFOUTUBUFPGUIF PUIFSMFBEJOHESVHTBSF SBOLFECZIFBMUIDBSFSFWFOVF JOEVTUSZ DIBMMFOHFT BOBMZ[FECBTFEPOLFZ 3%FYQFOEJUVSF BOEPUIFS BOEFYQFDUFEPVUDPNFT QFSGPSNBODFNFUSJDT QFSGPSNBODFEFUBJMT
t5PQCJPUFDIDPNQBOJFTBSF t5IFUPQQSFTDSJQUJPO t"OBMZ[FTUIFTUSBUFHJD SBOLFECZSFWFOVF 3% NFEJDJOFTBSFSBOLFECZTBMFT CVTJOFTTBDUJPOTBOE FYQFOEJUVSF BOEPUIFS SFTVMUJOHQFSGPSNBODFPG QFSGPSNBODFEBUB UIFUPQDPNQBOJFT
Subscribe now to access this data found in Med Ad News and other valuable content on PharmaLive.com. Your paid subscription gives you access to: tDownloadable charts and tables with fi nancial, pipeline, and brand data tMarket analysis and data on newly approved drugs and specialty pharma companies from PharmaLive Special Reports t4FBSDIBCMFJOEVTUSZOFXTSFMFBTFBOENBHB[JOFBSDIJWFTEBUJOHCBDLUP t%JTDPVOUTPOPUIFSPharmaLive.comQSPEVDUT JODMVEJOHPVSFYUFOTJWFMJCSBSZPGNBSLFUSFTFBSDISFQPSUT
21315_MA11 /FFEBTTJTUBODF $POUBDU4VCTDSJCFS4FSWJDFTBU PS1-TVCT!TVOCFMUGTDPN
magentablackcyanyellow ES177887_MAN0113_023.pgs 01.15.2013 01:59 UBM Interactive&DigitalMarketing More than six in 10 (62 percent) of By Joshua Slatko [email protected] primary care physicians use an iPhone or iPod Touch as their primary mobile device platform, according to an Octo- ber 2012 survey by Epocrates. Another FDA really will issue social media rules 20 percent use an Android device, while 4 percent use tablets and 3 By Brian Reid percent use a Blackberry. More than one in four PCPs use a tablet in their practice. Of these, 39 Two years ago, FDA watchers were atwitter: the agency had an- watch as the FDA’s thinking gets probed — successfully or other- percent use the tablet as a supplement nounced it would, in less than four months’ time, issue long- wise — by our elected representatives. And that will be illuminat- to other devices, while 27 percent use awaited guidelines on how companies could use social media to ing, one way or another. it equally with other devices and 19 promote their products and educate the public. Speculation was But it’s the third possibility that is the most likely and the most percent use it as the primary device rampant about how the FDA would deal with a world of “likes” interesting: the FDA spends the next 18 months rolling out small with other devices as supplements. and 140-character Twitter missives. rule changes that fold in new communication methods into all Another 13 percent rarely use their T e deadline came and went, though the agency told reporters manner of FDA rules, integrating rather than segregating social tablet, and 3 percent use a tablet only, that the new rules were among its “highest priorities.” But that high media. T is may have already begun; the FDA published guide- with no other device as a supplement. priority didn’t get tackled in 2011, and – with a new year looming lines on off -label promotion almost a year ago that explicitly speaks Of the tablets being used by PCPs, – it looks like won’t be tackled in 2012, either. As a consequence, about social media. But that document, rather than the fi rst of nearly four in five, or 79 percent, are marketers have largely given up on the FDA. Companies have ei- many, remains the only FDA guidance to use the words “Twitter” Apple iPads. Another 9 percent use ther decided to forgo social media altogether or move ahead with a or “YouTube.” T at’s likely to change. Android OS, 5 percent use Windows play-it-safe strategy unlikely to raise the hackles of the agency. T at doesn’t mean that current practices will change radically. OS, and 7 percent use some other But the wait for guidance may be coming to an end, thanks to a New guidance documents may only codify existing rules, impair- OS. 22 percent of respondents to the little-noticed provision in the FDA reform bill passed last summer. ing companies from providing much in the way of branded infor- ePocrates survey plan to purchase the In the legislation, the agency is directed to come up with social mation. But having rules will only encourage more experimenta- iPad Mini. media rules by the summer of 2014 or face congressional scorn. tion. One in four PCPs recommend an T e date you can circle on your calendar is July 9, 2014. And that change will be welcome. In the next month, Google app to patients at least once a week. T is opens up three possibilities, any of which would bring estimates that Americans will type “cholesterol” into the search bar Categories of apps recommended to some clarity to those wishing to use Twitter, Facebook or any one more than a million times. A quarter-million searches for “statin” patients include patient education (72 of the dozens of other platforms available. will be served. And 165,000 searches will explicitly ask “how to percent), lifestyle change tools (68 T e fi rst possibility is that the FDA develops a giant, compre- lower cholesterol.” And few of those searches will bring consumers percent), chronic disease management hensive guidance document that drops sometime before the dead- to the social properties of the companies that have invested billions (32 percent), prescription drug info line, capturing the agency’s thinking on everything from online in understanding heart disease. (23 percent), medical adherence (22 video to how you shoehorn risk information into a tweet. It won’t T at’s not to say that the pharma industry should be the only percent), and EHR patient portals (17 be a Rosetta Stone, but an eff ort to create a comprehensive site of voice trying to provide information on social media. But it prob- percent). rules would provide the green light to many companies nervous ably makes sense to make sure they’re not the only voice excluded Four in 10 (40 percent) pf physi- about operating without explicit guidelines. from doing so. cians who recommend apps to patients T e second possibility is that the agency simply blows the dead- learn about those apps from a friend or line and gets hauled before Congress. And then we’ll all get to Brian Reid is a director at the integrated communications agency WCG. colleague. Another 38 percent recom- mend apps they use themselves, and 37 percent find apps to recommend in an Strategic use of social media in patient recruitment use in recruitment. The fi rst is regulatory ambiguity. Recruitment pro- app store, while 34 percent find apps fessionals are, perhaps understandably, being cautious in their with an Internet search engine and 20 With a billion people, or one in every seven on the planet, already approach to social media because they don’t want the rug pulled out percent find them at a conference or using Facebook, it is no wonder that clinical development profes- from under them by regulatory bodies who later issue guidance for tradeshow. sionals are increasingly dipping their toes in the social media waters its use. Of respondents in ISR’s survey, 66 percent percent said their More than three in four (76 percent) for patient or subject recruitment needs. Those who respond to organization does not have policies in place regarding the use of of PCPs still use the good old telephone the online study stimuli are certainly interested and motivated; but social media for patient recruitment. as their primary method of communica- social media channels do not yet make up a large percentage of the The second main issue are anecdotes of underperformance. ISR’s tion with patients. Another 10 percent industry’s patient recruitment strategies. According to a recent report data show that drug development professionals are skeptical of the use patient portals as their primary by Industry Standard Research, though, that is about to change, and effectiveness of social media in recruitment. Several tell stories of communication method, 9 percent use change quickly. over-promising and under-delivering. Most commonly, this comes in direct mail, and 5 percent use email. “With sixty-two percent of world-wide population somehow the form of a severe drop-off rate in the number recruited through About 1 percent each use SMS mes- engaged in social media, there’s no surprise pharma is eager to take web-based channels that express interest in the study and ultimately sages and video chat. advantage of the pool of potential subjects for their clinical trials,” convert into a randomized subject. Partly to blame for this underper- As for communications with each says Kevin Olson, CEO of ISR (isrreports.com). “Patient recruitment formance is a “lack of internal expertise to execute on strategy” -- the other, 46 percent of PCPs still use the professionals we spoke to feel the use of social media will grow organizational barrier most commonly mentioned by patient recruit- telephone as their primary method of drastically between now and 2015.” ment professionals. To deal with these issues, ISR’s recommendation communication with colleagues, while Social media tools are becoming increasingly smart in their abil- is to give these channels some time. Companies should develop 22 percent use email as their primary ity to target users with appropriate content. But ISR’s researchers a body of knowledge by testing strategies in a portion of studies; method, 15 percent use an EHR sys- found two main issues working against the growth of social media understand the strengths and limitations of these tools; learn to speak tem, and 11 percent use SMS. Another the language of social media users; and share best practices. The 4 percent use secure messaging, and opportunity, ISR’s team says, is too enticing to discard. 2 percent use direct mail. None of According to ISR’s research, present use of social media in the respondents to the ePocrates survey recruitment is mixed. Seventeen percent of respondent companies listed video chat as their primary method to ISR’s survey are either “avoiding” social media or have “aban- of communication with colleagues. doned” it after having tried it, while another 17 percent report their companies are quite aggressive, describing social media as “well entrenched” or that their company is “rolling the strategy out into many clinical trials.” Much more commonly, though, 67 percent of respondents report their companies are either “evaluating” or “test- ing” the strategy. ISR’s report, “Social media: Best practices and strategic use in patient recruitment,” is based on data compiled from a survey of 104 patient recruitment professionals. The report profi les the “ideal trial” for recruitment via social media; quantifi es pharma’s use of social media and other Web-based channels; and discusses barri- ers to adoption, the use of and satisfaction with third-party service providers, and industry best practices. According to ISR’s survey, the use of social media for patient recruit- (For the reasons why pharma companies need to engage in social ment has been mixed so far. media for patient recruiting, please see page 20) Source: “Social Media: Best Practices and Strategic Use in Patient Recruitment,” Industry Standard Research (isrreports.com).
24 • MED AD NEWS JANUARY 2013
magentablackcyanyellow ES177534_MAN0113_024.pgs 01.12.2013 05:06 UBM Now your marketing solutions will always be... Within Reach
www.PharmaLive.com 23509_MA12
magentablackcyanyellow ES177546_MAN0113_025_FP.pgs 01.12.2013 05:24 UBM AdAgencyUpdate By Joshua Slatko [email protected] Publicis launches Health Media unit Publicis Healthcare Communications Group business unit for PHCG. He will be respon- duced some of the most innovative programs has announced the creation of Publicis Health sible for media strategy, planning, buying, in the sector today. He truly has the vision to “We created this integrated offering to provide all Media, a new off ering which aims to fuse content distribution, and search across all take this model to the world stage.” of our clients with unique thinking that blurs the line media into a specialized health and wellness PHCG agency brands worldwide, including According to Mr. McNally, the market de- between content and context, while meeting each practice. PHM, its leaders say, will be a new Digitas Health, Saatchi & Saatchi Health, and mands a media company that is dedicated to client’s needs through tailored service by the local business unit within PHCG that will address Publicis Life Brands. Mr. McNally launched the health and wellness industry. T e sector agency teams who best know and understand the marketplace’s ever-changing media land- and led the media divisions of Digitas Health has been changing dramatically with consum- their markets and their clients,” says Matt McNally, scape by helping pharma, health, and wellness and Razorfi sh Health since 2004. His career ers, physicians, and providers seeking informa- president of the new Publicis Health Media. clients to connect with their audiences with spans more than 15 years; he has partnered tion, support, and treatments from a variety relevant, engaging experiences. with world-class brands in the pharmaceutical, of sources and across media platforms. Health markets and their clients,” Mr. McNally says. T e distinction of this off ering, network OTC, medical device, managed care, and well- and wellness requires a unique skillset; there “Many health and wellness brands want a executives believe, is the integration of media ness spaces. Mr. McNally helped launch the is a fundamental diff erence between searching global partner to deliver innovative cross- at all agencies within PHCG. Not only is this media practice at Insight Interactive Group, for “the best Italian restaurant in New York,” channel media thinking. Because PHM is model new for PHCG, network leaders say it and led health media at one of the fi rst digital and “what chemo agent is best for my moth- derived from the integrated media off erings is unique for the healthcare category because it agencies in the United States er.” Because of this, clients need partners who at Digitas Health and Razorfi sh Healthware, unites media and creative thinking while de- “PHCG is the only network capable of de- understand today’s health consumer and can we have the experience to think about and livering time and cost effi ciencies for clients. livering a fully integrated, strategic media and help create engaging experiences, not the latest deliver solutions across a holistic media eco- PHCG can now help its clients navigate the planning off ering in the health and wellness ad campaign. system – paid, earned owned, digital, and entire paid-owned and earned media eco- space, giving us a strong advantage over our “We created this integrated off ering to traditional. Most importantly, PHM will help system through brokering partnerships with competitors,” says Nick Colucci, president and provide all of our clients with unique think- clients abandon common practices of selling global publishers for the co-creation and syn- CEO of Publicis Healthcare Communications ing that blurs the line between content and what they hope to push into the market and dication of content across platforms. Group. “We are thrilled to have Matt head the context, while meeting each client’s needs focus on building their brands and businesses Matt McNally has been named president, introduction of Publicis Health Media. Matt through tailored service by the local agency by helping reach their consumers in meaning- Publicis Health Media, and will lead the new is a well-known leader in media and has intro- teams who best know and understand their ful and engaging ways.”
■ AbelsonTaylor Health Communications, where she was lead and publication plan- Eric Densmore and Mark Finn are pro- writer for a new pediatric vaccine. ning. Brian Whalen,
moted to VP, AbelsonTaylor (abelsontaylor.com). Ph.D., will lead all of J. LEWIS
Mr. Densmore and Mr. Finn were both account C. SEARLS ■ Cambridge BioMarketing Evoke’s medical and directors. Amando Navar is promoted Maureen Franco is promoted to partner scientifi c activity. Dr.
to copywriter. Mr. Navar was an associate Z. GWARNICKI and CEO, Cambridge BioMarketing (cam- Whalen has been copywriter. Cassandra Searls is promoted bridgebmg.com). Ms. Franco takes over from translating his experi- from clinical research founder and former CEO and creative offi cer ence in biomedical associate to associate Steve West. Mr. West becomes chairman research at Harvard copywriter. Meredith relations offi cer. Zofi a of the agency, while Mike Hodgson, a ten and Columbia Universities to pharmaceutical Matthews is named Gwarnicki becomes year veteran of the agency, is appointed chief industry promotion, where he has focused on medical proofreader. clinical research as- creative offi cer. peer-to-peer medical education and advertis- Ms. Matthews joins sociate. Ms. Gwarnicki Prior to joining Cambridge BioMarketing, ing for the past seven years. E. DENSMORE AbelsonTaylor from the recently received her Ms. Franco spent 12 years at Genzyme,where American Medical As- Masters of Biotechnol- she held a number of executive leadership ■ FingerPaint Marketing
sociation in Chicago, ogy from the Robert R. M. MATTHEWS roles in commercial development, product Julie Anne Lewis and Joe Acee have where she was media McCormick School of marketing, global brand management, and joined FingerPaint Marketing (fi ngerpaintmar- Engineering at North- product promotions. keting.com). Ms. Lewis western University. most recently worked ■ Evoke Interaction as a senior copywriter
■ Cadient Group Heather Coyle becomes executive VP, HCP at AbelsonTaylor. Mr. J. ACEE M. FINN
A. NAVAR Stacey Davis is named creative director, marketing, Evoke Interaction (evokeinterac- Acee has worked at a copy, Cadient Group (cadient.com). Ms Davis tion.com). Ms. Coyle has 20 years of global number of agencies, has worked as a freelance creative director, healthcare communications experience, with including Publicis/ copywriter and marketing consultant for the past a leadership background in pharmaceutical ARC Worldwide, decade. Linda Bailey becomes senior copy- sales, HCP, DTC, and DTP marketing, digital Designframe NYC, writer. Ms. Bailey joins the agency from InVentiv strategy, payor strategy, medical education, and Palio.
clients. Ogilvy Common- entiate the group from the Ogilvy Healthworld “This decision to rebrand Ogilvy rebrands wellness, Health Wellness Market- Marketing Analytics & Consulting team in the these two groups is a ing will continue to serve New York offi ce, whose name refl ects its exper- result of our ongoing behavioral groups as a full service consumer tise in back-end quantitative business analytics. determination to provide agency with an added Ogilvy CommonHealth Worldwide (ogil- clarity and focus in all Ogilvy CommonHealth Worldwide, the focus on both health and wellness. Its name vychww.com) is a WPP company. T e organi- our business efforts,” health behavior experts of Ogilvy & Mather, change further highlights the group’s increased zation houses and maintains individual Ogilvy says Matt Giegerich, has announced that Ogilvy CommonHealth focus on helping brands become an integral CommonHealth and Ogilvy Healthworld chairman and CEO of Consumer Care and Ogilvy CommonHealth part of consumers’ and patients’ lives for health- brand identities within the marketplace. Brad Ogilvy CommonHealth Insights & Analytics will be rebranded as Ogil- ier living, particularly as they fi nd themselves Davidson is the general manager of Ogilvy Worldwide. “We believe vy CommonHealth Wellness Marketing and more and more responsible for managing their CommonHealth Behavioral Insights, and Neil this better refl ects the service offerings at each unit.” Ogilvy CommonHealth Behavioral Insights, own health and well-being. Ogilvy Common- Contess is the president of Ogilvy Common- respectively. Health Behavioral Insights’ focus is on obser- Health Wellness Marketing. eff orts,” says Matt Giegerich, chairman and Both groups were relaunched on Jan. 1, vational research, linguistic and ethnographic, “T is decision to rebrand these two groups CEO of Ogilvy CommonHealth Worldwide. with the intention of having the new names relating to health and healthcare behaviors. T e is a result of our ongoing determination to “We believe this better refl ects the service off er- better refl ect the services that each group off ers name change is also intended to further diff er- provide clarity and focus in all our business ings at each unit.”
26 • MED AD NEWS JANUARY 2013
magentablackcyanyellow ES177901_MAN0113_026.pgs 01.15.2013 03:06 UBM Now your marketing solutions will always be... Within Reach
www.PharmaLive.com
magentablackcyanyellow ES177547_MAN0113_027_FP.pgs 01.12.2013 05:24 UBM PeopleontheMove By Joshua Slatko [email protected] Endo announces CEO transition HOLVECK DAVID
Endo Health Solutions Inc. has announced success, and I will do all I can to contribute bott Laboratories. Mr. Holveck is a member that David P. Holveck, 67, the company’s to a smooth leadership transition.” of the board of trustees for T e Fund for president and CEO, will retire in 2013. Mr. Before joining Endo in April 2008, Mr. West Chester University, as well as the board Holveck will continue to serve in his present Holveck was president of Johnson & John- of directors of the Pharmaceutical Research positions until the earlier of his successor be- son Development Corporation and VP, cor- & Manufacturers of America (PhRMA), ing in place or the May 2013 annual meet- porate development of Johnson & Johnson the University City Science Center, and the ing of Endo shareholders. Mr. Holveck will since 2004. He joined Johnson & Johnson Kimmel Center. also leave the board at that time. as a company group chairman in 1999, fol- “Dave Holveck has done an excellent job Endo’s board is conducting a search for lowing the acquisition of Centocor Inc., a in his fi ve years as CEO,” says Roger Kim- the company’s next CEO and will consider biotechnology company, by Johnson & mel, chairman of the board, Endo Health David Holveck will retire in 2013 after fi ve years as both external and internal candidates with Johnson. Mr. Holveck was CEO of Cento- Solutions (endo.com). “Endo has made sig- Endo’s CEO. the assistance of Korn/Ferry, an executive cor Inc. at the time of the acquisition. He nifi cant progress in a number of important landscape. As we transition to new leader- search company. joined Centocor in 1983 and progressed areas during his tenure, including diversify- ship, the board is sharply focused on achiev- “I have had the opportunity to work with through various executive positions. In ing the business, reducing our dependence ing Endo’s full potential for the benefi t of many talented and dedicated colleagues at 1992, he assumed the role of president and on Lidoderm, and laying the foundation our shareholders and on the execution and Endo, and I am proud of all that we have chief operating offi cer and later that year was for future growth, including by building a continued integration of our four main accomplished together over the past fi ve named president and CEO. Before joining robust R&D pipeline. My fellow directors businesses. We are moving quickly and have years,” Mr. Holveck says. “I believe Endo Centocor, he had held positions at General and I appreciate his creative vision and his already begun a comprehensive search for is well positioned for the next chapter of its Electric Co., Corning Glass Works, and Ab- early recognition of the changing healthcare our next CEO.”
BIOPHARMA Industries Ltd, where he had served since maceuticals Inc. Mr. Madison joins AMAG rology, and various other U.S. functions 2008 as director of business development from Genzyme Corp., where he spent the including managed care and distribution, ■ Hans Christian Rohde is appointed chief at the Global Branded Products division. past 12 years in various commercial roles eff ective Feb. 1, 2013. Mr. Kornwasser was commercial offi cer, uniQuire B.V. Mr. Rohde OphthaliX (ophthalix.com) is an advanced in the renal division, most recently as the a senior executive at Medco Health before joins the company from Basilea Pharmaceuti- clinical stage biopharmaceutical company division’s VP and general manager. AMAG its acquisition by Express Scripts. Valeant ca, where from 2007 focused on developing therapeutic products (amagpharma.com) is a specialty pharma- (valeant.com) is a multinational specialty he was chief commer- for the treatment of ophthalmic disorders. ceutical company that manufactures and pharmaceutical company that develops, cial offi cer. uniQure ■ Randy Milby is promoted to CEO, Cor- markets Feraheme (ferumoxytol) Injection manufactures, and markets a broad range develops human gene Medix Inc. Mr. Milby previously served as for Intravenous use in the United States. of pharmaceutical products primarily in based therapies; the chief operating offi cer. Richard M. Cohen ■ Jason Levin is named chief business of- the areas of neurology, dermatology, and company’s product M. IWICKI will serve as chief fi nancial offi cer and will fi cer, Sorbent T erapeutics Inc. Before join- branded generics. Glybera, a gene ther- continue as executive chairman and direc- ing Sorbent, Mr. Levin was chief business ■ Joel Schaedler is named VP of market apy for the treatment tor of CorMedix. Mr. Cohen was previously offi cer at BrainCells Inc. Sorbent (sorbent. access and Daniel Martin becomes VP of of lipoprotein lipase interim chief fi nancial offi cer and interim com) is a private biopharmaceutical compa- marketing, A.P. Pharma Inc. Mr. Schaedler defi ciency, has been CEO. Antony E. Pfaffl e, M.D., a director ny developing therapies for patients requir- was most recently senior VP of business de- approved in the Eu- on the CorMedix board, joins the executive ing targeted cation and fl uid removal from velopment at P4 Healthcare. Mr. Martin ropean Union, and is the fi rst approved gene team as acting chief scientifi c offi cer. Mark the body. was most recently the head of U.S. market- therapy in the Western world. Klausner, M.D., current chief medical of- ■ Bryan M. Reasons is appointed senior ing at Dendreon. A.P. Pharma (appharma. ■ Jonathan P. Mow is named chief business fi cer, will depart CorMedix eff ective Feb- VP and chief fi nancial offi cer, Impax Lab- com) is a specialty pharmaceutical company offi cer, PhaseBio Pharmaceuticals Inc. Before ruary 28, 2012 upon the expiration of his oratories Inc. Mr. Reasons joined Impax developing products using its proprietary joining PhaseBio, Mr. Mow was VP, business employment agreement with the company. in January 2012 as VP, fi nance, and has Biochronomer polymer-based drug delivery development for Amylin Pharmaceuticals. CorMedix (cormedix.com) is a pharmaceu- served as acting chief fi nancial offi cer since platform. PhaseBio (phasebio.com) is a clinical stage tical company that seeks to in-license, de- June 2012. Impax (impaxlabs.com) is a biopharmaceutical company developing velop, and commercialize therapeutic prod- technology-based specialty pharmaceutical SERVICE SUPPLIERS novel drugs to treat diabetes, metabolic, and ucts for the prevention and treatment of company applying its formulation expertise cardiovascular disease. cardiac and renal dysfunction, also known and drug delivery technology to the devel- ■ Siva Narayanan is appointed senior VP, ■ Daniel J. O’Connor becomes senior VP, as cardiorenal disease. opment of controlled-release and specialty Ipsos Healthcare, charged with leading the chief legal and business development offi cer, ■ Mark Iwicki is named president, CEO, generics in addition to the development of company’s evidence generation, value and Advaxis Inc. Mr. O’Connor has 15 years of and a member of the board of directors, branded products. access portfolio. Mr. Narayanan was previ- executive, legal, and regulatory experience Blend T erapeutics Inc. Mr. Iwicki most ■ Kristine M. Ball becomes senior VP and ous a senior VP at TNS, leading the global in the biopharmaceutical industry with Im- recently served as CEO of Sunovion Phar- chief fi nancial offi cer, Relypsa Inc. Most re- treatment performance optimization/ Clone Systems, PharmaNet, and Bracco Di- maceuticals and chief commercial offi cer cently, Ms. Ball was senior VP and chief fi - HEOR business unit. Ipsos (ipsos.com) is agnostics. Advaxis (advaxis.com) is a clinical- of Sepracor. Blend T erapeutics (blendtx. nancial offi cer of KAI Pharmaceuticals Inc. an independent market research company stage biotechnology company developing the com) is a biopharmaceutical company dis- Relypsa (relypsa.com) is a late clinical stage controlled and managed by research profes- next generation of immunotherapies for can- covering new classes of medicines that have pharmaceutical company discovering and sionals. cer and infectious diseases. unique modes of action to result in drugs developing novel non-absorbed polymeric ■ Daniel Malloy becomes senior VP, ■ Brian Wiley is named VP of business de- with diff erentiated therapeutic properties. drugs for important applications in cardio- QuantiaMD. Mr. Malloy was a VP at IMS velopment, NewLink Genetics Corp. Mr ■ Alison Lawton is appointed chief oper- vascular and renal diseases. Health within the Wiley has had management responsibilities at ating offi cer, OvaScience. In conjunction ■ Fred M. Powell is appointed chief fi nan- IMS Payer Solu- Celgene Corp., Gloucester Pharmaceuticals, with this appointment, the company’s cur- cial offi cer, Celator Pharmaceuticals. Mr. tions business in Millennium Pharmaceuticals, and Aventis rent chief operating offi cer, Christopher Powell joins Celator from OraPharma Inc., the United States. Pharmaceuticals. NewLink (linkp.com) is a Bleck, will assume the role of chief com- where he was also chief fi nancial offi cer. In addition, current biopharmaceutical company focused on dis- mercial offi cer, leading sales and marketing. Celator (celatorpharma.com) is a privately QuantiaMD pres- covering, developing, and commercializing Ms. Lawton joins OvaScience from Sanofi held pharmaceutical company developing D. MALLOY dient Mike Coyne novel immunotherapeutic products to im- Biosurgery (formerly Genzyme Biosurgery), new and more eff ective therapies to treat has been appointed prove treatment options for cancer patients. where she was senior VP and general man- cancer. CEO, and the com- ager. OvaScience (ovascience.com) is a life ■ Laizer D. Kornwasser is named to Valeant pany’s founder and SPECIALTY sciences company focused on the discovery, Pharmaceuticals International Inc.’s execu- previous CEO, Eric development, and commercialization of tive management team and will assume the Schultz, has been named executive chair- ■ Gil Ben-Menachem, Ph.D., is named new treatments for infertility. role of executive VP/company group chair- man. QuantiaMD is a free online commu- CEO, OphthaliX Inc. Dr. Ben-Menachem ■ Greg Madison becomes executive VP man, where he will be responsible for the nity where practicing physicians can share joins OphthaliX from Teva Pharmaceutical and chief commercial offi cer, AMAG Phar- company’s operations in Canada, U.S. Neu- practical medicine. 0 MEDADNEWS
28 • MED AD NEWS JANUARY 2013
magentablackcyanyellow ES177535_MAN0113_028.pgs 01.12.2013 05:06 UBM Get the day’s top pharma news stories delivered to your inbox... ABSOLUTELY FREE
Our editors compile the day’s most impactful news — providing you with quick-to-read news briefi ngs.
Sign up for your daily news fi x at: www.PharmaLive.com/enewsletters
magentablackcyanyellow ES177556_MAN0113_029_FP.pgs 01.12.2013 05:24 UBM THELASTWORD Looking for a new job? Stimulus spending won’t help – but innovation will! By Sander A. Flaum, Principal, Flaum Navigators, Chairman, Fordham Leadership Forum, Fordham University Graduate School of Business Administration
If the U.S. Treasury had a dollar for every time to encourage ideas and nurture those with the If you hear (or worse, fi nd yourself think- Turn over, head upstream, and take charge. “jobs” were mentioned in the November elec- most promise. If a dream ends up as a dud, ing) “we can’t do it that way…we tried it be- And as you move forward, you’ll be helping tion, I’d be less worried about the defi cit. Yet then simply move on – without blame or fi n- fore and it didn’t work” or “let me play devil’s create new opportunities (and jobs) for others for all the focus on jobs, it’s remarkable how ger pointing. Can you think of a new business advocate,” think of a mackerel, belly up and in your wake. And that’s something awesome! little sense it all made. It’s simple: when the that didn’t look like a gamble at the start? headed out to sea. It’s not too late. (to quote my granddaughter). 0 MEDADNEWS economy shrinks, as it periodically does, jobs are lost. T ey’re the jobs employers fi nd easiest to shed – positions marginalized by new tech- nology, new competitors, or even new fash- ions. T e illusion is that when the economy MedAdNews recovers, the jobs will come back, like obedi- ent sheep. Well, some will; others won’t. You’ll Reach 16,000+ high-quality, loyal decision makers with your ad in this Classifi ed section. never see newspaper “Want” ads for typists Contact: Daniel Becker at 973-808-1191, or [email protected] again. You may not see as many newspapers or magazines in print form either. Dave Huisman at 310-740-9080, or [email protected] In the last election, we heard two schools Andrew McSherry at 781-869-7979, or [email protected] of thought (I won’t bother to identify the par- ties). One side insisted that if you lower taxes for “job creators,” they will suddenly start hir- ing. To do what? Fill obsolete positions? Make advertisers a company noncompetitive again? Give me a break. T e other side wanted to emulate the index 1930’s New Deal and pump money into pub- lic works. Hire people with borrowed money January 2013 to fi ll potholes. Great! Jobs are created in response to innovations that open up opportunities that didn’t exist before. T ese breakthroughs often come from Company ...... Page upstarts and dreamers who don’t need to be coddled or funded. Can you imagine Gates, AbelsonTaylor ...... 16, 17 Page, Jobs, or Bezos, or Zuckerberg waiting for taxes to drop before starting their multibil- ESSRX ...... 32 lion dollar businesses? Can you picture them burning the midnight oil applying for stimu- lus grants? No, they’re visionaries who blasted FingerPaint Marketing ...... 2 through the status quo to create new enterpris- es of a kind and on levels previously unseen. Greater Than One ...... 31 And that’s where the jobs by the thousands came from. Of course, we can’t all be innova- ICC Lowe Trio ...... 9 tors on this scale, but we can take a clue from their vision and actions. Have you heard this riddle? Which way PTN Healthcasts ...... Belly band does a dead fi sh swim? Wherever the current takes it! If your company is always reacting to events and trends and never embarking on new courses, then it’s time to think about moving your tail (fi ns). In my Leadership Forum class at Fordham University Graduate School of Business Ad- ministration, we have an innovation exercise in which the MBAs divide into teams and de- velop a full strategic plan for a new innovative product or service. After several rounds of eval- uation, the most promising ideas are referred to a panel which off ers advice, guidance, and perhaps even seed money. One recent proposal was for a smartphone “app” that allows driv- ers to locate and reserve a spot in a parking garage on the way into Manhattan close to their destination. (Just not while you’re actu- ally driving!) Innovation doesn’t need to be taught, but encouraged. Remaining open to new ideas is The MedTech Industry’s essential – especially in business. I’ll wage the Premier Awards Program Interested in Sponsoring? now-infamous sum of $10,000 that someone One Innovation at a Time within the Polaroid organization proposed Transforming Healthcare— Contact [email protected]. expanding into digital photography, and I’ll th 15 Annual MDEA Ceremony Endorsed by: bet another 10 grand that he or she got a pat When: June 19, 2013, 4:30 P.M.–6:00 P.M. on the head (or a kick in the butt) and was Where: Philadelphia Marriott Downtown told that big thinking was a job for the C-suite 24112_MDEA13 elite. I’m not saying that we all need to be inno- Presented by: MDEAwards.com vators. Some of the most successful business #MDEA13 leaders I know are those who have learned how Underwritten and Produced by: UBM Canon MedTech Group
30 • MED AD NEWS JANUARY 2013
magentablackcyanyellow ES177655_MAN0113_030.pgs 01.12.2013 06:28 UBM magentablackcyanyellow ES177331_MAN0113_031_FP.pgs 01.11.2013 23:22 UBM It’s Time to Experience Excellence in Virtual Meetings
If your goal is to ofer a high-quality virtual meeting then ESSRX is your solution. We produce cutting-edge, high-definition programming to deliver your critical message:
High-Definition (HD) Satellite Our HD webcast Our HD webcast at one of our 120 pre-installed, platform platform to iPads or private viewing suites at to laptops and other iOS devices Ruth’s Chris Steak Houses desktops WITHOUT any apps and Mitchell’s Fish Market restaurants
ESSRX Studio
Call us today to schedule a demo. It’s time to experience excellence!
Visit essrx.com for more details or ESSRX contact Howard Drazner at 973-575-4242 or [email protected] to plan your Experience Excellence satellite or webcast campaign.
magentablackcyanyellow ES177330_MAN0113_032_FP.pgs 01.11.2013 23:23 UBM