In an era of increasingly personalized cancer therapies, 24-hour news coverage and unprecedented social media reach, high-profile cases have brought the potential of providing early access to unproven, investigational drugs into the public forum. In the spring of 2014, a massive social media campaign aimed at the small biotech company, Chimerix, attempted to persuade the company to provide an experimental medication to a child with a viral infection following a bone marrow transplant. More recently, the Ebola outbreak has raised questions about who should receive the small number of experimental treatments available, and when it is ethically justifiable to use a drug that has never even been tested in humans, on a desperately ill patient.
In this webinar, we will review the regulatory framework that governs the use of investigational drugs outside clinical trials (formerly called “compassionate use”), and we will discuss the ethical challenges of these complicated situations.
- Art Caplan, PhD; Drs. William F and Virginia Connolly Mitty Chair & Director, Division of Medical Ethics at NYU Langone Medical Center
- M. Michelle Berrey, MD, MPH; CEO of Chimerix, Inc.
About the Author
Dr. Lindsay McNair has extensive experience in the pharmaceutical industry. Prior to joining WCG, she was a consultant to pharmaceutical and biotechnology companies, providing medical guidance on clinical development strategies and study designs for new drug studies, and medical oversight of all phases of clinical trials. Dr. McNair teaches graduate-level courses on the scientific design of clinical research studies. She has been actively involved in IRB work for 18 years, and has a Master’s of Science in Bioethics with a concentration in research ethics.Follow on Twitter More Content by Dr. Lindsay McNair, MD, MPH, MSB | Chief Medical Officer, WCG