Expanded Access Protocol (EAP) Programs
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 our 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). EAPs also generate data that may be useful alongside traditional trial data, in the development of new therapies for everyone.
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.
Healey & AMG Center Director Merit Cudkowicz, MD, MSc and Co-Director of the NCRI Sabrina Paganoni, MD, PhD explains how the Expanded Access Program increases access to experimental treatments for patients with ALS, while participant Shawn Sarbacker of TechVsALS shares what the EAP program means to him.- Ellen CorindiaBeing part of the EAP has been wonderful, mainly because I know I am helping advance the field toward an effective treatment for ALS.
ALS EAP Participant
- Bruce RosenblumThe 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.
ALS Advocate and EAP Advisor/Participant Healey & AMG Center Director Merit Cudkowicz, MD, MSc explains how the Expanded Access Program increases access to experimental treatments for patients with ALS, while participant Bruce Rosenblum shares what the EAP means to him.
Expanded Access Supporters
TechVsALS
TechVsALS is a community fundraising campaign founded by 30-year tech industry veteran and person with ALS (pALS) Shawn Sarbacker. Shawn was diagnosed with ALS in 2020, and actively receives care from Dr. Merit Cudkowicz at the Healey & AMG center. The TechVsALS team works to engage companies, foundations, organizations, and individuals to sponsor Expanded Access Protocol programs nationwide to extend, and perhaps save, the lives of those suffering from ALS while accelerating novel treatments and cures.
Learn more
In the Community
In February 2023, Miron Golfman set out on the 1,000-mile Iditarod Trial in Noam Alaska as part of the Iditarod Trial Invitational. Miron participated this year to raise awareness and funds in support of the Expanded Access Protocol Program at the Healey & AMG Center in honor of his uncle, Bruce Rosenblum. He biked the entire trail and completed the ride in 17 days. An incredible accomplishment!
To learn more, or support Miron’s fundraising efforts, visit ridetoendure.com.
Expanded Access Information for Patients
Frequently asked questions and helpful online resources for people interested in participating in an EAP.
I AM ALS Helps Fund Expanded Access
I AM ALS is collaborating with the HEALEY ALS Platform Trial to support expanded access.
Clinical Trial Options at Mass General
At the Sean M. Healey and AMG Center for ALS, we are committed to radical change and acceleration of converting ALS research into enduring treatments.
Transforming Medicine Through Innovation
Expanded Access Programs at the Sean M. Healey and AMG Center for ALS are funded by multiple sources, including contributions from donors like you. Thank you for partnering with us in the quest to discover life-saving therapies for individuals affected by ALS.