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Tuesday, June 28 • 2:00pm - 3:15pm
#241: Disease Interception: Shifting the Paradigm from Treatment to Prevention of Disease

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Limited Capacity seats available

Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-547-L01-P; CME 1.25; IACET 1.25; RN 1.25

Disease interception focuses on the development of medicines that stop or delay disease progression for patients at risk or asymptomatic within the disease continuum. Learn as regulators and payers share perspectives in this new drug development space.

Learning Objectives

Discuss the regulatory and implementation challenges to innovation in disease interception; Propose solutions to regulatory challenges to innovation for disease interception therapies; Assess the benefit and risk framework and value of disease interception therapies.


Karin Van Baelen, PharmD


FDA Perspective
Ellis Unger, MD

EU Perspective
Hans-Georg Eichler

Payer Perspective
Sean R. Tunis, MD, MSc

avatar for Karin Van Baelen

Karin Van Baelen

Head, Global Regulatory Affairs, Janssen Pharmaceutical Companies of Johnson & Johnson
Karin is leading the Global Regulatory Affairs organization at Janssen. She facilitates the relationship between the Janssen pharmaceutical companies and global health authorities, influencing and interpreting global regulatory requirements and enabling our companies to meet those guidelines. In addition, she oversees the development of regulatory strategy for products from all therapeutic areas. Karin engages in policy development at national... Read More →

avatar for Hans-Georg Eichler

Hans-Georg Eichler

Senior Medical Officer, European Medicines Agency, European Union
Dr. Eichler is responsible for coordinating activities between the European Medicine Agency's (EMA) scientific committees and giving advice on scientific and public health issues. Prior to joining EMA, Dr. Eichler was professor and chair of clinical pharmacology and vice-rector at the Medical University of Vienna. Other positions held include President of the Vienna School of Clinical Research and co-chair of the Committee on Reimbursement of... Read More →
avatar for Sean Tunis

Sean Tunis

Founder and Chief Executive Officer, Center For Medical Technology Policy (CMPT)
Sean Tunis, MD, MSc is the Founder, President, and Chief Executive Officer of the Center for Medical Technology Policy. CMTP’s main objective is to improve the quality and relevance of clinical research by providing a neutral forum for collaboration among experts, stakeholders and decision makers. He advises a wide range of domestic and international public and private health care organizations on issues of comparative effectiveness, evidence... Read More →
avatar for Ellis Unger

Ellis Unger

Director, Office of Drug Evaluation I, OND, CDER, FDA
Ellis F. Unger is the Director, Office of Drug Evaluation-I, Office of New Drugs, Center for Drug Evaluation and Research, FDA. His Office oversees the regulation of drugs for cardiovascular, renal, neurological, and psychiatric disorders. Dr. Unger is a board-certified internist and cardiologist. Prior to coming to CDER in 2003, previous positions included director of a translational angiogenesis program at NHLBI, NIH; and Medical Officer... Read More →

Tuesday June 28, 2016 2:00pm - 3:15pm
201B Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA