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Expanded Access and Compassionate Use
Session Chair(s)
Ramana Sonty, MD, PhD
Director, Global Medical Organization
Johnson & Johnson, United States
Early access to medicines is increasingly sought by patients, physicians and legislators. Regulators and industry must work together to optimize patient access ethically and in a medically appropriate way while remaining focused on registration efforts. How to find the right balance? What are some case examples?
Learning Objective : Discuss case studies of patient need and access approaches prior to regulatory approval.
Speaker(s)
CDER Experience: Expanded Access in Drug Development and Review
Kevin Bugin, PhD, MS, RAC
FDA, United States
Deputy Director of Operations, Office of New Drugs, CDER
Making Compassion Work: Challenges and Next Steps
Elena Gerasimov, MA, MPH
Kids V Cancer, United States
Director, Compassionate Use Navigator Program
Independent Evaluation of Compassionate Use Requests to Benefit Patients: The NYU J&J CompAC
Ramana Sonty, MD, PhD
Johnson & Johnson, United States
Director, Global Medical Organization
Navigating the Regulatory Pathways of Early Access to Medicines in the EU
Grant Strachan, LLM
Brodies LLP Solicitors Capital House, United Kingdom
Senior Associate, Regulatory
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