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Session 3: Value/Relevance of Clinical Data: Challenges of Designing Clinical Studies and Generating Clinical Data
Session Chair(s)
Julie Ann Rosenberg, MD
Development Asset Lead, Oncology Biosimilars, Pfizer Essential Health
Pfizer, Inc., United States
This session dives deep into the challenges of biosimilar clinical trial study design and implementation, as well as the challenges of generating clinical data and its contribution in supporting a claim of biosimilarity. Sponsors must conduct clinical studies that are adequately sensitive to detect clinically meaningful differences between the biosimilar product and the comparator product. There may be significant challenges in replicating the original trial population of reference product vs placebo-controlled superiority trial. Recruitment for the trial may be difficult as it may not be of interest to either academicians or patients who have access to newer therapeutic agents. Further, the market for biosimilars clinical trials is crowded, with many sponsors conducting studies with similar clinical trial designs, competing for a limited patient pool
Speaker(s)
Biosimilars: Current Considerations with Clinical Trials
Robert Melvin Rifkin, MD, FACP
US Oncology Reserach, United States
Medical Director- Biosimilars, McKesson Specialty Health
Clinical Pharmacology Studies in Support of Biosimilar Development and Approval
Jurgen Venitz, MD, PhD
Virginia Commonwealth University, United States
Professor, Dept of Pharmaceutics, Pharmacotherapy & Outcomes Sci, Dir PK/PD Lab
Operational Complexities Specific to Biosimilar Clinical Trials
Vivienne Jenkins
Pfizer Inc, United Kingdom
Clinical Operations Program Lead
An FDA Reviewer’s Thoughts on Generating Clinical Data in a Biosimilar Development Program
Steven J. Lemery, MD, MHS
FDA, United States
Acting Director, Division of Oncology 3, Office of Oncologic Diseases, OND, CDER
Relevance of Clinical Data - A European Perspective
Martina Weise, DrMed, MD
Bfarm, Germany
Head, Licensing Division 2, BfArM; German CHMP Alternate
Panel Discussion
All Session Speakers, United States