What the buyer needs
AI summaryThe Sean M. Healey & AMG Center for Integrated ALS Care and Discovery at Mass General Brigham seeks experimental therapies for inclusion in the HEALEY ALS Platform Trial Next Generation, a phase 2 or phase 2/3 adaptive platform trial. Selected partners will collaborate with the trial team to optimize regimen design and operational implementation, while industry partners must supply investigational product, matching placebo, open IND cross-reference, and partial funding. Biotechnology and pharmaceutical companies, academic investigators, and other organizations with a strong scientific rationale and sufficient preclinical and clinical evidence for ALS may apply. Applicants must execute a Confidential Disclosure Agreement with MGB before emailing their Therapy Application Form to [email protected] by November 20, 2026, at 5:00 PM EST. The HEALEY ALS Platform Trial Therapy Evaluation Committee will evaluate applications on biological rationale, preclinical data, clinical trial readiness, and available biomarkers, with decisions announced in Q1 2027. Up to two awards of up to $5,000,000 USD each will be applied toward eligible direct clinical trial operational and vendor costs rather than awarded directly as a grant.
Scope of work
- Investigational products for inclusion in the HEALEY ALS Platform Trial Next Generation
- Matching placebo and investigational product supply
- Cross reference to an open IND
- Partial funding support for the treatment regimen
- Collaborative optimization of regimen design within the Master Protocol
How proposals are evaluated
| Criterion | Weight / scoring |
|---|---|
| Strength of the biological rationale and relevance of the therapeutic target or mechanism to human ALS | Not specified |
| Preclinical data supporting the target, mechanism, and investigational therapy | Not specified |
| Clinical development and trial readiness, including safety and pharmacology data, open IND, manufacturing and supply, and previous human trial experience | Not specified |
| Availability of relevant biomarkers, including pharmacodynamic and/or target-engagement biomarkers | Not specified |
Minimum qualifications
- Strong scientific rationale for ALS
- Sufficient preclinical and clinical evidence to support advancement into a Phase 2 or Phase 2/3 clinical trial
- Open IND for industry partners
- Ability to provide investigational product, matching placebo, and partial funding support
Documents to include with your response
- Confidential Disclosure Agreements (CDAs)
- ALS Platform Trial Therapy Application Form
How to submit
- Method
- Instructions
- Submit Confidential Disclosure Agreements (CDAs) and the Therapy Application Form via email. CDAs are executed between MGB and the institution or company before the Therapy Application Form is submitted.