Expanding Access to Investigational Products

Overview

At the Sean M. Healey & AMG Center for ALS, we are dedicated to developing effective treatments for ALS and to providing people with ALS access to experimental therapies through Expanded Access Protocol (EAP) programs.  

EAPs are a pathway for people with a life-threatening condition or serious disease to gain access to an investigational medical product when they are not eligible for a clinical trial. These investigational products – drugs, biologics, or medical devices – are currently being studied, but not yet approved by the US Food and Drug Administration (FDA). Alongside traditional data, EAPs can also provide data that may be useful in developing new therapies.

We have built a dedicated team at the Healey & AMG Center to rapidly implement EAPs for people with ALS at Mass General and are working with several other research centers across the US.

Being part of the EAP has been wonderful, mainly because I know I am helping advance the field toward an effective treatment for ALS.

- Ellen Corindia
ALS EAP Participant

The main thing that keeps me going now is that if all the time I spend here at the Healey & AMG Center can help answer even a single question that will lead researchers to a better answer for ALS even one day sooner so that one patient, and that patient's family, doesn't have to go through what myself and my family are going through, it's worth every minute of the time I spend here.

- Bruce Rosenblum
ALS Advocate and EAP Advisor/Participant