Phase II: Testing Efficacy, Planning for Marketing

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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.

Pharmaceutical companies and their partners are working to address productivity and create efficiency in Phase II development. New types of trial designs, such as adaptive trials, are being considered as solutions to these perennial issues. “There are innovative ways in which biopharmaceutical companies are currently addressing the efficiency issue, which include population pharmacokinetic/pharmaco­dynamic modeling; conducting larger and potentially lengthier Phase I studies to exclude a suspected adverse event based on preclinical data before progressing to later stage development; and/or adaptive clinical trial design, such as a Phase IIb/Phase III run-in strategy,’’ explains Howard Mayer, M.D., chief medical officer at EMD Serono. “In the latter scenario, multiple doses can be initiated in the Phase IIb portion of the program with the optimal dose selected based on prespecified statistical criteria and then continued into Phase III. We believe that taking the time to conduct more appropriate Phase I and Phase II trials… Sidebar: The Year Ahead Experts on this topic Howard Mayer, M.D., Chief Medical Officer at EMD Serono Nancy Boman, M.D., Ph.D., VP, Clinical Development and Regulatory Affairs, at Acucela Nagaraja Srivatsan, VP and Head of Life Sciences, North America, at Cognizant Martha Feller, Ph.D., Global Executive VP, Operations, at i3 Research Mario Nacinovich, Jr., Managing Director, Axon Communications Laurie Lucas, Founder and Principal at L3 Healthcare Marketing Robert Norris, Founder and President of Complete Healthcare Communications Natalie Douglas, CEO of Idis Hal Barron, Global Head, Product Development and Chief Medical Officer, at Roche

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