Phase I: From Animals to First-in-Human Studies

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Denise Myshko

NOTE: The content below contains the first few paragraphs of the printed article and the titles of the sidebars and boxes, if applicable.

The simple study designs of the past have been replaced with more complex designs with the addition of more screening and study procedures, biomarkers, and pharmacokinetic samples requirements, as well as longer study exposure periods. The trend today is conducting more rigorous, early-phase clinical research that will help biopharmaceutical companies identify and select the most promising new compounds, says Michelle Middle, MB, Ch.B., corporate VP and worldwide head of early phase at Parexel International. “The growing interest in proof-of-concept studies in targeted patient populations, which are designed to demonstrate early signals of efficacy, is helping biopharmaceutical companies to avoid costly late-stage clinical development failures,” she says. “Geographic strategies and conducting multisite studies are playing a larger part in providing rapid access in the early phases… Sidebar: Companies Terminating ­Unpromising Candidates Experts on this topic Michelle Middle, MB, Ch.B., Corporate VP and Worldwide Head of Early Phase at Parexel International Jerome Bailey, VP, Early Phase Business Center, Omnicare Clinical Research Brian Sanderson, M.D., Medical Director, Chiltern Early Phase Peter Smith, Ph.D., Senior VP, Nonclinical Development Sciences at Millennium Pharmaceuticals: The Takeda Oncology Company Jamie Dananberg, M.D., Executive Director of Clinical Pharmacology at Eli Lilly and Company Kerri Schoedel, Ph.D., Scientific Director, Clinical Pharmacology, at Kendle Murray Ducharme, Pharm.D., Chief Science Officer for Cetero Research Alan Copa, Pharm.D., President of Clinical Operations for Cetero Research Eddie Caffrey, Global Head of Phase I at Quintiles Nancy Boman, M.D., Ph.D., VP, Clinical Development and Regulatory Affairs, at Acucela

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