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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)
Robert Melvin Rifkin, MD, FACP
Medical Director- Biosimilars, McKesson Specialty Health, US Oncology Reserach, United States
Biosimilars: Current Considerations with Clinical Trials
Jurgen Venitz, MD, PHD
Professor, Dept of Pharmaceutics, Pharmacotherapy & Outcomes Sci, Dir PK/PD Lab, Virginia Commonwealth University, United States
Clinical Pharmacology Studies in Support of Biosimilar Development and Approval
Vivienne Jenkins
Clinical Operations Program Lead, Pfizer Inc, United Kingdom
Operational Complexities Specific to Biosimilar Clinical Trials
Steven J. Lemery, MD, MHS
Acting Director, Division of Oncology 3, Office of Oncologic Diseases, OND, CDER, FDA, United States
An FDA Reviewer’s Thoughts on Generating Clinical Data in a Biosimilar Development Program
Martina Weise, DrMed, MD
Head, Licensing Division 2, BfArM; German CHMP Alternate, Bfarm, Germany
Relevance of Clinical Data - A European Perspective
Panel Discussion
, All Session Speakers, United States
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