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Thursday, June 30 • 10:45am - 12:00pm
#409: Current Status of Genetic Testing in Medical Therapies: What Regulations We May Need in a Convergent Regulatory Environment

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Limited Capacity seats available

Component Type: Session
Level: Basic
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-560-L04-P; CME 1.25; IACET 1.25; RN 1.25

In the current status of new treatment, prevention and diagnostic modalities, genetic testing in medical therapies offers promising potential, and public interest is extremely high. What regulations do we need in a convergent regulatory environment?

Learning Objectives

Recognize the huge impact of genetic testing in health care; Identify challenges and opportunities that exist in the current regulatory environment; Realize that many questions about patient rights and privacy still need to be resolved; Conceive the legal framework and the impact it has in today's health care environment.


Joseph C. Scheeren, PharmD


Patient Perspective
Sue Friedman, DVM

Industry Perspective
Morten Sogaard, PhD

Regulator Perspective
Robert Schuck, PharmD, PhD

avatar for Joseph Scheeren

Joseph Scheeren

Senior Vice President, Head Regulatory Affairs, Pharma and Consumer Health, Bayer
Joseph Scheeren, Pharm.D. is Senior Vice President, Global Head of Regulatory Affairs Pharma & Consumer Health at Bayer. He has 30+ yrs exp. as Global Regulatory Affairs professional (France, Germany, Switzerland, US & China). He is an active member of the DIA Board of Directors... Read More →


Sue Friedman

Executive Director and Founder, Facing Our Risk of Cancer Empowered (FORCE)
Dr. Friedman was a practicing veterinarian in 1996 when she was diagnosed at age 33 with breast cancer and later learned she carried a BRCA2 mutation. She founded the nonprofit organization Facing Our Risk of Cancer Empowered (FORCE) in 1999 to improve the lives of people affected... Read More →
avatar for Robert Schuck

Robert Schuck

Clinical Pharmacologist, Genomics and Targeted Therapy, OTS, CDER, FDA
Robert Schuck, Pharm.D., Ph.D. is a Clinical Pharmacologist in the Genomics and Targeted Therapy Group at the FDA. In his current position, Dr. Schuck contributes to regulatory review of investigational new drug (IND), new drug (NDA), and biologic licensing (BLA) applications to effectively... Read More →

Morten Sogaard

Vice President and Head, Enterprise Scientific Technology Operations, Pfizer Inc
Morten has been with Pfizer since 2009 and is VP, Enterprise-wide Scientific Technology Operations and a member of Pfizer’s R&D leadership team . He oversees technology investment and Pfizer’s human genetics, computational biomedicine, diagnostics and bio-banking organizations... Read More →

Thursday June 30, 2016 10:45am - 12:00pm EDT
113C Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 09: Med Devices-InVitro-CombProd, Session