Advanced
Practical
Payal Rana, MS, MBA, PhD
Director
Pfizer
Groton, Connecticut, United States
Michael Leach, DVM, PhD, DACVP
President and Owner
Trident Toxicology, Inc.
Shrewsbury, Massachusetts, United States
Robert Mader, PhD
Toxicology Project Leader
Pharma Research & Early Development (pRED)
F. Hoffmann-La Roche Ltd.
Basel
Peter van Meer, PhD
Senior Assessor
Medicines Evaluation Board
Utrecht, Utrecht, Netherlands
This session will explore the opportunity to reduce the use of animals in late-stage clinical development for biotherapeutics by conducting sub chronic toxicity studies instead of chronic. Both industry and health authorities will provide their perspectives on this matter. The usefulness of chronic toxicity studies for biotherapeutics is being questioned because it is believed that most anticipated toxicity findings can be identified through exaggerated pharmacology and/or immunogenicity, which should be evident in sub chronic studies. Despite this, the industry continues to conduct chronic studies due to concerns about program delays caused by potential lack of regulatory acceptance. Therefore, the question remains: are sub chronic studies sufficient to evaluate the safety of biotherapeutics? This session will present case studies from industry (Pfizer and Roche), as well as health authority (Medicines Evaluation Board), offering evidence-based justifications to determine if sub chronic toxicity studies are adequate to support late-stage clinical development and registration.
Symposium Speaker: Payal Rana, MS, MBA, PhD – Pfizer
Symposium Speaker: Robert Mader, PhD – F. Hoffmann-La Roche Ltd.
Symposium Speaker: Peter J.K. van Meer, PhD – Medicines Evaluation Board