Expanded Access News & Webinars
The Healey & AMG Center is committed to communicating news and updates about Expanded Access Protocols (EAPs).
For the most recent EAP updates, read our latest EAP newsletter.
Upcoming EAP Webinars
The Healey & AMG Center hosts public Q&A webinars for the ALS community. Join us at 5:00-5:30pm Eastern Time on the second Thursday of each month to discuss news and updates about Expanded Access, ask questions, and hear from doctors and industry professionals at MGH and beyond.- Thursday, November 14th, 5:00 pm EST: Monthly EAP Discussion featuring Dr. David Walk and Never Surrender - Click here to register
Click here to register for upcoming webinars
Webinar Recordings
Featured EAP Webinars
Watch Recording
January 25, 2024: CNM-Au8 Update and Q&A with Clene Nanomedicine
Sabrina Paganoni, MD, PhD of Massachusetts General Hospital was joined by Jinsy Andrews, MD, MSc of Columbia University and Karen Ho, PhD from Clene Nanomedicine to discuss news and updates about CNM-Au8, the investigational product studied in Regimen C of the HEALEY ALS Platform Trial, and answer questions from the audience.
Watch Recording
May 14, 2021: NEALS 2021 ALS Drug Development Webinar Series: Site Considerations
Drs. Suma Babu and Katherine Nicholson discuss some of the issues faced by sites in a clinical trial including the specific steps and resources a site needs to open and run a clinical trial and an expanded access program.
Watch Recording
Monthly EAP Updates
September 12, 2024: EAP Update with Dr. Suma Babu
August 8, 2024: EAP Discussion with Dr. Namita Goyal and Amanda Stevens
Watch Recording | Download Slides
July 11, 2024: EAP Discussion with Patient Advisory Committee Members
Sabrina Paganoni, MD, PhD of Massachusetts General Hospital was joined by guest speakers Lauren Webb, LCSW and Steve Kowalski to discuss their perspective on Expanded Access Protocols (EAPs) and hear about their advocacy efforts as members of the EAP Patient Advisory Committee. The discussion highlighted online resources to learn more about EAPs and research opportunities in the ALS space.
Watch Recording | Download Slides
June 13, 2024: RAPA-501 EAP Discussion with Dr. James Berry
May 9, 2024: EAP Discussion with Shawn Sarbacker and Dr. Hristelina Ilieva
Watch Recording | Download Slides
April 18, 2024: Expanded Access and Patient Navigation
Watch Recording | Download Slides
March 14, 2024: EAP Discussion with Dr. Jinsy Andrews
Sabrina Paganoni, MD, PhD, of Massachusetts General Hospital was joined by Jinsy Andrews, MD, Msc, FAAN, FANA, of Columbia University to discuss news and updates about Expanded Access in the field of ALS research. Dr. Andrews provided an overview about Expanded Access, outlined plans for Clene Nanomedicine's upcoming NIH-funded EAP for CNM-Au8, and answered questions from the audience.
Watch Recording
February 8, 2024: EAP Discussion with Dr. Rick Bedlack and Gwen Petersen
Sabrina Paganoni, MD, PhD, of Massachusetts General Hospital was joined by Richard Bedlack, MD, PhD, MS of Duke University and Patient Advocate Gwen Petersen to discuss progress and ongoing initiatives for Expanded Access in the field of ALS research. The guest speakers shared their experiences advocating for EAPs and answered questions from the audience.
Watch Recording
January 18, 2024: Pridopidine Update and Q&A with Prilenia Therapeutics
Sabrina Paganoni, MD, PhD of Massachusetts General Hospital was joined by Michael Hayden, MBChB, PhD, Chief Executive Officer of Prilenia Therapeutics, to discuss news and updates about Pridopidine, the investigational product studied in Regimen D of the HEALEY ALS Platform Trial, and answer questions from the audience.
Watch Recording
January 11, 2024: Expanded Access Discussion with Amy Tsou, MD, MSc of the NIH
Sabrina Paganoni, MD, PhD, and Suma Babu, MBBS, MPH, of Massachusetts General Hospital were joined by Amy Tsou, MD, MSc and other guest speakers from the National Institute of Neurological Disorders and Stroke (NINDS) to discuss news and updates about Expanded Access in the field of ALS research. Dr. Tsou provided an overview of ongoing Expanded Access initiatives and answered questions from the audience.
Watch Recording
December 14, 2023: EAP Update with James Berry, MD, MPH
James Berry, MD, MPH and Merit Cudkowicz, MD, MSc of Massachusetts General Hospital presented news and updates about Expanded Access in the field of ALS research. Dr. Berry provided an overview of ongoing and upcoming Expanded Access Protocols (EAPs) happening in parallel with the HEALEY ALS Platform Trial, and answered questions from the audience.
Watch Recording
November 9, 2023: EAP Update with Suma Babu, MBBS, MPH
Suma Babu, MBBS,MPH of Massachusetts General Hospital presented news and updates about Expanded Access in the field of ALS research. Dr. Babu provided an overview of ongoing and upcoming Expanded Access Protocols happening in parallel to the HEALEY ALS Platform Trial, and answered questions from the audience.
Watch Recording
September 28, 2023: EAP Update with Sabrina Paganoni, MD, PhD
Sabrina Paganoni, MD, PhD of Massachusetts General Hospital presented updates on the HEALEY ALS Platform Trial and answered questions from the audience. This week, the conversation focused on updates about Expanded Access progress and initiatives.
Watch Recording
Press Releases
2024
- May 2024: The Sean M. Healey & AMG Center for ALS and Rapa Therapeutics announce first participant enrolled in Expanded Access to RAPA-501 Protocol (EAP)
- April 2024: The Sean M. Healey & AMG Center for ALS and Prilenia Therapeutics Announce First Participant Enrolled in NIH-Sponsored ACT for ALS Expanded Access Protocol for Pridopidine
2023
- October 2023: Sean M. Healey & AMG Center for ALS awarded NIH U01 Grant to support Expanded Access to Pridopidine in Collaboration with Prilenia Therapeutics
- October 2023: Sean M. Healey & AMG Center for ALS awarded NIH U01 Grant to support Rapa Therapeutics’ Expanded Access Protocol of Epigenetically Reprogrammed RAPA-501
- September 2023: Sean M. Healey & AMG Center for ALS and the University of California, Irvine Announce First Participant Enrolled in Expanded Access Protocol Program for Trehalose
- April 2023: Sean M. Healey & AMG Center for ALS announces first patient dosed in Expanded Access for Trehalose Funded by a Grant from the National Institute of Neurological Disorders and Stroke (NINDS)
- March 2023: The axeALS Foundation in partnership with the Sean M. Healey & AMG Center for ALS establishes Expanded Access Protocol (EAP) Program at the University of California, Irvine
2022
Publications
- Multicenter expanded access program for access to investigational producst for amyotrophic lateral sclerosis [June 2024]
- Expanded access protocol (EAP) program for access to investigational products for amyotrophic lateral sclerosis (ALS) [April 2023]
- Safety and activity of anti-CD14 antibody IC14 (atibuclimab) in ALS: Experience with expanded access protol [December 2022]
- An expanded access protocol of RT001 in amyotrophic lateral sclerosis- Initial experience with a lipid peroxidation inhibitor [October 2022]
EAP Opportunities
Current and upcoming expanded access protocols
Information for Patients
Common questions and helpful resources about expanded access