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.
Speakers:
- 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.