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Tuesday, June 28 • 4:00pm - 5:15pm
#266: Perspectives on Expanded Access to Investigational New Drugs

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Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-545-L01-P; CME 1.25; IACET 1.25; RN 1.25

Expanded access is the use of an investigational drug outside of a clinical trial or study. This forum will provide an opportunity to hear perspectives from regulators, industry, and patients on the use of expanded access in drug development.

Learning Objectives

Describe the different types of expanded access investigational new drugs; Explain why a sponsor might consider expanded access in their drug development programs; Recognize the patient's role and perspective on expanded access programs.

Chair

Kevin Bugin, MS, RAC

Speaker

Introduction and FDA Regulator Perspective
Jonathan P. Jarow, PhD

Industry Perspective on Expanded Access
Kenneth I. Moch, MBA

Patient Advocacy and Expanded Access
Robert Erwin

Industry Perspective on Expanded Access
Anne B. Cropp, PharmD



Chair
avatar for Kevin Bugin

Kevin Bugin

Chief, Project Management Staff, Office of New Drugs, CDER, FDA
Kevin Bugin works for the FDA in the Division of Gastroenterology and Inborn Errors of Metabolism Products. He serves as one of the Chiefs of Project Management Staff. Prior to joining the FDA, Kevin Bugin worked in both industry and government in multiple areas of clinical research and development, such as regulatory affairs, safety and pharmacovigilance, technology transfer, and basic molecular biology research.

Speakers
avatar for Anne Cropp

Anne Cropp

Vice President, Pfizer Inc
Anne Cropp has led the strategic planning and clinical development of several compounds in Cardiovascular and Metabolic diseases, Phases 2-4. Anne has led many business process improvements and has led several initiatives across the spectrum of clinical trial planning, design and execution efficiencies, including 10 years as global lead for protocol development. She is the global leader of the Pfizer Compassionate Access Group and led the... Read More →
avatar for Robert Erwin

Robert Erwin

President, Marti Nelson Cancer Foundation
Robert L. Erwin is co-founder and President of the Marti Nelson Cancer Foundation, a cancer patient advocacy organization with a focus on access to experimental medicine. He has served as a member of the Cancer Policy Forum of the Institute of Medicine, a member of the Research Committee of the American Society of Clinical Oncology, a member of the Data and Safety Monitoring Board of NCI’s Cancer and Leukemia Group B, and has been a clinical... Read More →
avatar for Jonathan Jarow

Jonathan Jarow

Senior Medical Advisor to the Center Director, CDER, FDA
Dr. Jonathan P. Jarow is currently the senior medical advisor to the Center Director and chair of the medical policy council in CDER at FDA. Jonathan previously served as the director of CDER’s Office of Medical Policy and as deputy director of the Office of Hematology and Oncology Products. Prior to joining the FDA he was Professor of Urology, Pathology, Radiology, and Molecular Biology & Biochemistry at Johns Hopkins University.
avatar for Kenneth Moch

Kenneth Moch

Managing Partner, Salutramed Group, LLC
Mr. Moch is Managing Partner of The Salutramed Group, a strategic/operational advisor to life science companies. He has been co-founder or CEO of 4 firms developing therapies for life-threatening diseases and most recently was CEO of Chimerix. In August 2014, Mr. Moch and Arthur Caplan co-authored "Rescue Me: The Challenge of Compassionate Use in the Social Media Era." In March 2015, Mr. Moch contributed an Op-Ed to The Wall Street Journal... Read More →


Tuesday June 28, 2016 4:00pm - 5:15pm
108A Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA