SummaryProviding patient access to investigational treatments outside of clinical trials is once again in the spotlight of media scrutiny. Earlier this year, social and popular media attention pressured one company to provide an investigational treatment to a young cancer patient. Then, states began debating and passing “Right to Try” bills to set up a new pathway to allow access to investigational drugs.
In addition, the media questioned how a handful of patients gained access to an investigational treatment after being infected with Ebola virus in the West African outbreak. In this webinar, we cover the current state of expanded access to investigational drugs, discuss the implications of passing state Right-to-Try bills, and explore how we might balance individual needs with public health interests.
- Learn about FDA’s pathway for providing expanded access to investigational drugs
- Understand the potential implications of state “Right-to-Try” legislation for various stakeholders, including patients, providers, FDA and industry
- Explore various stakeholders’ expectations of expanded access and “Right-to-Try” bills and potential ways to balance competing interests
Other speakers include:
Dr. Alison Bateman-House, Deputy Director, NYU Working Group on Compassionate Use and Rudin Postdoctoral Fellow in the Division of Medical Ethics, NYU Langone Medical Center
Dr. J. Russell Teagarden, SVP, Medical & Scientific Affairs, National Organization for Rare Disorders
Mr. Kenneth I. Moch, former CEO of Chimerix Inc.
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