The Innovation Challenge


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There has been a great deal of discussion related to the challenges­ ­hampering innovation to create differentiated medicines.

Never before have research and cutting-edge science been more important to ensure a steady flow of innovation.
Much has been made of the industry’s decline in R&D productivity over the last few years. While the number of new drug applications (NDAs) under review at the Food and Drug Administration declined 47% from 1995 through 2007, according to data from Parexel Consulting, there was a 22% surge in original NDA submissions during 2008.
The FDA entered 2009 with 147 pending NDAs under review, up sharply from 86 a year earlier and the highest number since 1995, according to Parexel Consulting.

Digital Exclusive Innovation: Areas For Growth

Percent of Submitted NDAs and NMEs Obtaining Priority Status, ­FY2003-FY2009*
The First-Cycle Review Imperative, 2006-2009
Pharma Success Rates

Trends in Market Exclusivity
Soundbites from the Field

Katrine Bosley is CEO, Avila Therapeutics Inc.
Michael N. Chang, Ph.D., is President and CEO of Optimer Pharmaceuticals Inc.
Karen Ferrante, M.D., is Senior VP, Clinical, at Millennium: The Takeda Oncology Company
Ed Sellers, M.D., Ph.D., FRCPC, FACP, is VP, Early Stage, Kendle
Stephen M. Simes is President and CEO, BioSante Pharmaceuticals
Tom Steinke is CEO, Minnow Medical Inc.
Daniel Zurr, Ph.D., is CEO and President of Quark ­Pharmaceuticals Inc.

Experts on this topic
Julian Adams, Ph.D. President, Research and Development and Chief Scientific Officer, Infinity Pharmaceuticals Inc., a cancer drug discovery and development company seeking to deliver best-in-class medicines for the treatment of cancer and related conditions. For more information, visit
Kenneth C. Aldrich. CEO, Chairman, and Co-Founder, International Stem Cell Corp., which develops human stem-cell lines that promise to eliminate the rejection of transplanted cells by the patient’s immune system. For more information, visit
Tim Bertram, D.V.M., Ph.D. Senior VP, Science and Technology, Tengion, a clinical-stage company with developmental products in urologic, vascular, renal, and GI regeneration. For more information, visit
Jesse Bowden
. President of Imaging Services, Biomedical Systems, a provider of innovative approaches to non-invasive diagnostic services, products, and supplies. For more information, visit
Michael N. Chang, Ph.D. President and CEO, Optimer Pharmaceuticals Inc., a biopharmaceutical company focused on discovering, developing, and commercializing innovative anti-infective products, with an initial focus on gastrointestinal infections. For more information, visit
Glen de Vries
. President, Medidata Solutions Worldwide, a global provider of hosted clinical development solutions. For more information, visit
Robert Dickinson. Client Service Officer, Life-Sciences Practice, Grail Research, a global strategic research and decision support firm. For more information, visit
Michelle Dipp, M.D., Ph.D. VP and Head of U.S., GSK’s Centre of Excellence for External Drug Discovery (CEEDD), a specialized team accountable for delivering molecules with clinical proof of concept into the GSK late-stage development organization through alliances with biotech companies. For more information, visit
Richard Eglen, Ph.D. President, Bio-Discovery, PerkinElmer, a global company focused on the health and safety of people and the ­environment. For more information, visit
Sylvia Miriyam Findlay. Programme Leader, Pharmaceutical and Biotechnology, Healthcare, Europe, Frost & Sullivan, which provides ­in-depth research coverage of various industries. For more information, visit
Paul Grayson. President and CEO, Fate Therapeutics, a biopharmaceutical company that integrates stem-cell biology to develop therapeutics based on modulating cell fate. For more information, visit
Laurie Halloran. President and CEO, ­Halloran Consulting Group, a life-sciences consulting firm specializing in enhancing the development process for biopharmaceutical and medical-device companies. For more information, visit
Michael J. Harte. Founder and President of the Harte Group, an organization that represents and manages a suite of experienced functional service providers to provide a full-service CRO alternative. For more information, visit
Simon Higginbotham. Senior VP and Chief Marketing Officer, Kendle, a global CRO providing the full range of early- to late-stage clinical development services. For more information, visit
Jason Hwang, M.D. Executive Director, Healthcare, Innosight Institute, a nonprofit think tank. For more information, visit
Alice Jacobs, M.D. CEO, IntelligentMDx, a commercial-stage molecular diagnostics company. For more information, visit
Ryo Kubota, M.D., Ph.D. Chairman, President, and CEO, Acucela Inc., a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases. For more information, visit
Alistair Macdonald. Executive VP, Global Services, INC Research, a therapeutically focused global CRO. For more information, visit
John MacPhee. President, Strativa Pharmaceuticals, an emerging specialty pharmaceutical company and the proprietary products division of Par Pharmaceutical Inc. For more information, visit
Sanjay Parikh, Ph.D. Director, Indegene, a leading provider of transformational services including scientific content, creative services, and business intelligence solutions to enhance marketing success of life-science companies worldwide. For more information, visit
Joseph P. Pieroni. President and CEO, Daiichi Sankyo Inc., the U.S. subsidiary of Tokyo-based Daiichi Sankyo Co. Ltd., whose focus is in cardiovascular disease, including therapies for dyslipidemia, hypertension, diabetes, and acute coronary syndrome. For more information, visit
Richard F. Pops. Chairman, President, and CEO, Alkermes Inc., a fully integrated biotechnology company committed to developing innovative medicines. For more information, visit
Tom Russell. General Manager of Enterprise Solutions, SciQuest Inc., which provides procurement automation and supplier enablement solutions. For more information, visit
Stephen M. Simes. President and CEO, BioSante ­Pharmaceuticals, a specialty pharmaceutical ­company focused on developing products for female sexual health, menopause, contraception, and male testosterone deficiency. For more information, visit
Scott Treiber, Ph.D. Executive VP, Clinical ­Development Solutions, inVentiv Clinical Solutions, a provider of clinical outsourcing solutions. For more information, visit
Steve Worland. President and CEO, Anadys ­Pharmaceuticals, a biopharmaceutical company ­dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C. For more information, visit