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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.


Ramana Sonty, PhD


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

avatar for Ramana Sonty

Ramana Sonty

Director, Global Medical Organization, Johnson & Johnson, United States
Dr. Sonty is a Strategy Leader in the Global Medical Organization of Janssen R&D. He is currently leading efforts to transform the Safety Organization, including implementing advances in Data Sciences, Visualization & Analytics and Automation. Previously he helped launch Janssen’s... Read More →

avatar for Kevin Bugin

Kevin Bugin

Deputy Director of Operations, Office of New Drugs, CDER, FDA, United States
Dr. Bugin is an experienced pharmaceutical professional who has made significant contributions to drug development and regulatory science. He currently serves as the Deputy Director of Operations ,in this role, he plays a key leadership role in the evaluation of new drugs and ensures... Read More →

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 working... Read More →

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 data... Read More →

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