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Wednesday, June 21 • 2:00pm - 3:15pm
#343: Expanded Access and Compassionate Use

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Component Type: Forum
Level: Intermediate
CE: CME 1.25; IACET 1.25; RN 1.25

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 Objectives

Discuss case studies of patient need and access approaches prior to regulatory approval.

Chair

Ramana Sonty, PhD

Speaker

CDER Experience: Expanded Access in Drug Development and Review
Kevin Bugin, MS, RAC

Making Compassion Work: Challenges and Next Steps
Elena Gerasimov, MA, MPH

Independent Evaluation of Compassionate Use Requests to Benefit Patients: The NYU J&J CompAC
Ramana Sonty, PhD

Navigating the Regulatory Pathways of Early Access to Medicines in the EU
Grant Strachan, LLM



Moderators
avatar for Ramana Sonty

Ramana Sonty

Strategic Business Planning and Execution, Global Medical Organization, Johnson & Johnson
Dr. Sonty is a J&J leader who helped launch Janssen’s innovative pilot with NYU called CompAC (Compassionate Use Advisory Committee). The CompAC is a first-of-its-kind independent, expert body providing recommendations on compassionate use requests. The model been expanded to a... Read More →

Speakers
avatar for Kevin Bugin

Kevin Bugin

Change Management Lead, Office of New Drugs, CDER, FDA
Kevin Bugin works for the FDA in the Office of New Drugs, leading change management on various initiatives for the new drugs regulatory program. Prior to joining the FDA, Kevin Bugin worked in both industry and government in multiple areas of clinical research and development, su... Read More →
EG

Elena Gerasimov

Director, Compassionate Use Navigator Program, Kids V Cancer
Elena is Director of Programs at Kids v Cancer, a nonprofit dedicated to changing the landscape of pediatric research. She built and directs the Compassionate Use Navigator program, which assists physicians and families applying for investigational drugs. She has experience worki... Read More →
avatar for Ramana Sonty

Ramana Sonty

Strategic Business Planning and Execution, Global Medical Organization, Johnson & Johnson
Dr. Sonty is a J&J leader who helped launch Janssen’s innovative pilot with NYU called CompAC (Compassionate Use Advisory Committee). The CompAC is a first-of-its-kind independent, expert body providing recommendations on compassionate use requests. The model been expanded to a... Read More →
GS

Grant Strachan

Senior Associate, Regulatory, Bristows LLP
Grant Strachan is a Senior Associate in the IP Regulatory Practice at Bristows LLP. Grant advises on both contentious and non-contentious EU and UK regulatory law in the healthcare and life sciences sector. This includes: advising on clinical trials; transparency and clinical dat... Read More →


Wednesday June 21, 2017 2:00pm - 3:15pm
N230b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616