Contact: Elio Peraza
Location: This event has ended.
These webinars aim to inform potential grant applicants and answer questions about the NINDS Amyotrophic Lateral Sclerosis (ALS) Intermediate Patient Population Expanded Access (U01 Clinical Trial Required) RFA-NS-25-024. The goal of this announcement is to support the conduct of scientific research utilizing data from expanded access (EA) for investigational drugs or biological products for patients living with ALS who are not eligible for ongoing ALS clinical trials. These webinars will provide an overview of the funding opportunity, including requirements and eligibility, and will include a Q&A session.
All investigators interested in learning about the NINDS ALS Expanded Access program are encouraged to register and participate. You are also encouraged to submit questions before the meeting to Elio Peraza.
The receipt date for this ALS Expanded Access Funding Opportunity is January 24, 2025.
Post Event Summary
Post-webinar Materials
Expanded Access RFA TA Webinar Slides Oct 2024(pdf, 2796 KB)
2025 EAP FAQs(pdf, 286 KB)
The Accelerating Access to Critical Therapies (ACT) for ALS Act was passed into law on December 23, 2021 (P.L. 117-79). Section 2 authorized a grant program for scientific research utilizing data from expanded access to investigational drugs for individuals who are not otherwise eligible for clinical trials for the prevention, diagnosis, mitigation, treatment, or cure of amyotrophic lateral sclerosis (ALS). The statute limits the grant program to phase 3 clinical sites sponsored by a small business concern.
NIH released RFA-NS-25-024 to implement Section 2 of ACT for ALS. In the frequently asked questions (FAQs), we have pointed out the relevant sections of ACT for ALS that establish the requirements of this NIH grant program.
Eligibility Requirements See ACT for ALS Sec. 2(e) for definition of participating entity and participating clinical trial, and Sec. 2(a) for expanded access New Drug Application (IND) authorization requirements.
Contact Information
Please direct all inquiries to:
Amy Tsou, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)/Division of Clinical Research
Email: amy.tsou@nih.gov
Emily Caporello, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)/Division of Translational Research
Email: emily.caporello@nih.gov
Dina Lyon, M.S., R.N.
National Institute of Neurological Disorders and Stroke (NINDS)/Division of Clinical Research
Email: dina.lyon@nih.gov
Amelie Gubitz, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)/Division of Neuroscience
Email: gubitza@nih.gov