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Monday, June 27 • 8:30am - 9:45am
#107: Fatal Drug Trials in Phase 1: Understanding Risk, Subject Safety, Timelines, and Cost

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Limited Capacity seats available
Component Type: Forum
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-615-L04-P; CME 1.25; IACET 1.25; RN 1.25

A recent French clinical trial resulted in one subject dead and five with severe health problems. The panel will examine how to best understand the risks in providing feedback to address participant safety, timelines, and costs.

Learning Objectives

Working with the sponsor, identify IP risks and best understand potential adverse events/serious adverse event (AE/SAE); Formulate a process to best address participant safety; Adapt to clinical information in addressing participant safety and timelines and cost of study.

Chair

William B Smith

Speaker

Panelist
Howard Greenberg, MD

Panelist
Thijs Van Iersel, MD

Panelist
Mary L. Westrick, PhD


Chair
avatar for William Smith

William Smith

President, New Orleans Center for Clinical Research
William B. Smith, MD, FACC, is a Professor of Medicine at the University of Tennessee Medical Center in Knoxville, Tennessee. Dr. Smith is board certified in Nephrology, Internal Medicine, Cardiology and Critical Care. Dr. Smith is the President of New Orleans Center for Clinical Research and Volunteer Group located within the University of Tennessee Medical Center. Dr. Smith has been involved as a Principal Investigator in over 1800 clinical... Read More →

Speakers
avatar for Howard Greenberg

Howard Greenberg

Medical Safety Officer, Janssen Pharmaceuticals, Inc.
Dr. Greenberg is a Medical Safety Officer for Janssen Pharmaceuticals R&D, and Adjunct Associate Professor in the Department of Pharmacology & Experimental Therapeutics of Thomas Jefferson University. He is a Clinical Pharmacologist with education and experience in chemical engineering, business, and clinical research. He's been an Investigator of more than 130 early phase clinical trials from ~30 sponsors, and authored 50+ papers, and has been... Read More →
avatar for Thijs Van Iersel

Thijs Van Iersel

Senior Director of Science, Early Development Services, PRA Health Sciences
Dr van Iersel is an MD with > 20 years of experience in clinical development. He is trained in Clinical Pharmacology in the UK and the Netherlands. Currently he is a Senior Director of Science at PRA. Previously he worked as Resident at Urology, and as Principal Investigator, Medical Director and Manager at Clinical Pharmacology Units of PBR and Xendo. He led the phase 1-2 clinical development of suggamadex at Organon, the Netherlands and... Read More →
avatar for Mary Westrick

Mary Westrick

Adjunct Professor, University of Wisconsin
Dr. Mary Westrick holds a BS in Chem, and MS & PhD degrees in pharmacology from Purdue University. She has held leadership positions in Global Clinical Pharmacology at Covance, Astellas and Quintiles and currently teaches Project Management and Leadership in the MS Program in Biotechnology at the University of Wisconsin-Madison. Dr. Westrick sits on the Dean's Industrial Advisory Board for the College of Pharmacy at Purdue, where she was... Read More →

Monday June 27, 2016 8:30am - 9:45am
202AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA
  Trk 04: Preclin Transl-Early Clin Dev, Forum