Patients who have a serious or life threatening condition for which no satisfactory alternative therapy exists and who cannot enter a clinical trial may, under certain circumstances, gain access to new investigational medicines through what is known as "pre-approval access" or "compassionate use." The prospective benefits of non-regulatory approved medicines may outweigh the potential risks for many critically ill patients. However, a number of ethical and safety concerns have been raised related to ensuring that unapproved treatments are equitably distributed via systematic approaches, that society as a whole is best served through scientific studies on the risks and benefits of new medicines, and that individual patients are protected from undue harm.
To address these important issues, the NYU School of Medicine and the New York Academy of Sciences will present a two-day colloquium, Pre-Approval Access: Can Compassion, Business, and Medicine Coexist? International stakeholders — including representatives of patient-advocacy organizations, regulatory agencies, pharmaceutical companies, foundations, NGOs, and government — will come together to explore the ethical, legal, and social challenges surrounding compassionate use. This meeting aims to galvanize discussion through a series of debates and will open with a lecture by Arthur Caplan, PhD, Founding Director, Division of Medical Ethics at NYU School of Medicine.
*Reception to follow.
The colloquium will be livestreamed during the two days of the colloquium. Registration for each day is separate, and if you would like register for Day 1 of the livestream, please click "Register for the 10/28/15 Livestream," if you would like to register for Day 2 of the livestream, please click "Register for the 10/29/15 Livestream," and if you would like to register for both days of the livestream, please register for each of the two days separately.
This event is free, but registration is required. To attend, please click on the "Register Now" button in the grey box at the top of this page. Your registration will be complete upon receipt of a confirmation email. If you do not receive a confirmation, please contact firstname.lastname@example.org for assistance. Although on-site registration may be possible on the day of the event, pre-registration is highly encouraged due to space limitations.
This symposium is made possible with support from