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Planning for Regulatory and Commercial Success
Session Chair(s)
Julienne Vaillancourt, MPH, RPH
Rare Disease Liaison, CBER
FDA, United States
Trent A. Carrier
Chief Business Officer
Biologics Consulting Group, Inc, United States
Panel Discussion
All Session Speakers, United States
To foster regulatory and market success, clinical development of a live biotherapeutic (LBP) should focus on demonstrating safety and efficacy in the intended population for use while adhering to principles of good clinical practice (GCP) and human subject protection (HSP). Clinical trials to evaluate LBPs will vary in design, depending on the product, phase of development, and proposed indication. Clinical strategy should be outlined early in product development based on interactions with clinicians, feedback from the FDA and an understanding of key commercial factors.
Speaker(s)
Clinical Trial Design: A Regulatory Perspective
Jennifer S. Read, MD, MPH, MS
FDA, United States
Medical Officer, Division of Vaccines and Related Products Applications
Case Study: Results of LBP Phase 1 Studies in Healthy Adults
Taha Keilani, MD
Sigma-Tau Pharmaceuticals, Inc, United States
Vice President, Clinical Development
Key Factors for Market Success
Maik Klasen, PHD
Adivo Associates, United States
Managing Director
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