Beyond the Conventional Paradigm: Rethinking the Necessity of Chronic Toxicity Studies for Biotherapeutics (S22)

Symposium Chair(s)

• 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

Symposium Speaker(s)

• 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.

Presentations:

• 3:45 PM - 4:05 PM CT

  Industry Perspective of Value of Chronic Toxicity in Identifying Adverse Safety Signal in Human
  

  Symposium Speaker: Payal Rana, MS, MBA, PhD – Pfizer
• 4:05 PM - 4:25 PM CT

  Tick Box or Informing Patient Safety: Case Studies on the Value of Chronic Toxicity Studies for Biotherapeutics
  

  Symposium Speaker: Robert Mader, PhD – F. Hoffmann-La Roche Ltd.
• 4:25 PM - 4:45 PM CT

  European Perspective on the Need for Chronic Safety Studies for Monoclonal Antibodies
  

  Symposium Speaker: Peter J.K. van Meer, PhD – Medicines Evaluation Board
• 4:45 PM - 5:00 PM CT

  Panel Discussion