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This webcast will provide information on FDA’s Project Optimus and its potential impacts on oncology drug development. The historical 3x3 Phase 1 study design to establish a Maximum Tolerated Dose (MTD) was developed for cytotoxic agents (eg, platins). Now, most new agents are immunotherapies and other biologics for which a more standard dose-finding Phase 1 study is more appropriate; however, the “standard” 3x3 design to establish MTD is still being used. Project Optimus is intended to address this discrepancy and drive more appropriate dose selection for new, and existing, oncology agents. We’ll discuss the immediate implications on Phase 1 dosing and design, as well as the potential implications for products already into Phase 2 and 3 of development, including modeling and simulation.
Industry personnel involved in the following roles:
Claire DyerCertara Insight
Dr. Dyer is a director of submissions and medical writer with experience in multidisciplinary clinical, academic, and corporate environments. She has 20 years of experience in clinical development, including 15 years in medical writing and experience with global marketing applications for both biologics and small molecules, as well as for Investigational New Drug (IND) and Clinical Trial Authorisation (CTA) applications. Dr. Dyer has led submission teams, including project management, writing submission level documents as well as training and mentoring of junior writers. Her experience in therapeutic areas include cardiovascular, central nervous system (CNS), dermatology, endocrinology, gastroenterology, immunology, oncology, pain management, urology, and vaccines.
Steve SibleyCertara Synchrogenix
With a career spanning more than 30 years in the pharmaceutical industry, Mr. Sibley has extensive experience across regulatory writing, consulting, and regulatory project leadership roles.
He has successfully supported projects from drug discovery through approval and life cycle management. These include significant roles in more than 75 submissions and, in several cases, leading the entire submission team and overseeing all documentation from Modules 1 through 5. Mr. Sibley drives the expansion of the company’s submission leadership and consulting capabilities in guiding clients to successful clearance of regulatory milestones.
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