Breaking Down The Complex


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Product Description

While the U.S. Food and Drug Administration has accelerated its review and approval of new medicines, drug developers’ increased focus on complex diseases, such as cancer and neurological disorders, as well as disorders for which there are few effective therapies, has resulted in longer clinical development times. According to the Outlook 2009 report from Tufts Center for the Study of Drug Development (CSDD), the average time for the FDA to approve new drugs has declined to about 13 months in recent years; however, when coupled with a more lengthy clinical-trial process, the overall amount of time needed for drug development and approval continues to average about 8 1/2 years. Still, Tufts CSDD Director Kenneth Kaitin notes, drug developers are making progress in the effort to accelerate the clinical process, adopting strategies such as improved project management and portfolio decision-making, expanded reliance on partnerships and licensing arrangements, and increased use of surrogate endpoints and adaptive clinical trials.

Technologies for Transparency

Electronic documentation and monitoring tools have become a critical component of clinical operations management, and as they continue to evolve, these technologies have the potential to do more than improve organization and dissemination…

The CRO as Partner
Selecting a CRO
Insights From the Insiders

Thought Leaders
James R. Baker Jr., M.D. CEO, Founder, and Executive Chairman, NanoBio Corp., a privately held biopharmaceutical company focused on developing and commercializing dermatological products, anti-infective treatments, and intranasal vaccines derived from its patented NanoStat technology platform. For more information, visit
Nancy L. Boman, M.D., Ph.D. VP, Clinical Development and Regulatory Affairs, Acucela Inc., a specialty pharma company leveraging promising science in visual cycle modulation to develop new methods for treating blinding eye diseases that affect tens of millions of people worldwide. For more information, visit
Roger J. Garceau, M.D., FAAP. Senior VP and Chief Medical Officer, NPS Pharmaceuticals Inc., a biotechnology company developing new treatment options for patients with rare gastrointestinal and endocrine disorders. For more information, visit
Mitchell Katz, Ph.D. VP of Global Clinical & Business Operations, Eisai Medical Research Inc., a U.S. pharmaceutical subsidiary of Tokyo-based human healthcare company Eisai Co., Ltd. that handles the company’s global clinical development functions. For more information, visit
Christoph Schnorr. Senior VP, Global Clinical Operations, Merck Serono, a division of Merck KGaA that discovers, develops, manufactures, and markets innovative small molecules and biopharmaceuticals to help patients with unmet medical needs. For more information, visit
Luc Truyen, M.D., Ph.D. Senior VP and Head of Global Clinical Operations, Johnson & Johnson Pharmaceutical Research & Development LLC (J&JPRD), a subsidiary of global healthcare products company Johnson & Johnson. For more information, visit
Randall Whitcomb, M.D. Chief Medical Officer, Arete Therapeutics Inc., a privately-held biotechnology company dedicated to the discovery and development of first-in-class drugs to treat diabetes and inflammatory and cardiovascular diseases. For more information, visit