The intent of the FY23 ALSRP Clinical Biomarker Development Award is to support the development of biomarkers to enrich clinical trials in Amyotrophic Lateral Sclerosis (ALS). Biomarker development projects can be relevant to a specific therapy, a class of therapeutics, or to a specific ALS subtype (such as a particular genetic mutation) and do not have to broadly apply to all patients. A description of the biomarker category and intended context of use (COU) in ALS therapeutic development, including regulatory considerations for use in ALS clinical trials or clinical practice, is an important component.
Examples of studies appropriate for submission to the FY23 ALSRP Clinical Biomarker Development Award include, but are not limited to:
• Using patient-based resources to link biosamples to rigorous molecular data.
• Collecting and analyzing biospecimens as a companion to an anticipated/ongoing clinical trial.
• Correlation of clinical trial-related data (e.g., biosample analysis, imaging, or epidemiological data) with clinical outcomes or responses to therapies.
• Strategies to better measure disease progression, including the development or use of digital biomarkers.
Deadlines:
• Required Pre-Application Deadline: April 13, 2023
• Invitation to Submit an Application: May 2023
• Application Submission Deadline: July 13, 2023
Independent investigators at all academic levels (or equivalent) are eligible to be named as Principal Investigator (PI) on an application.
Early-career investigators and/or early-career physician-scientists (defined as independent, nonmentored investigators within 10 years of their last training position e.g., postdoctoral fellowship, medical residency, clinical fellowship as of the application submission deadline) are encouraged to apply.
The anticipated direct costs budgeted for the entire period of performance for an FY23 ALSRP Clinical Biomarker Development Award should not exceed $750,000. Refer to Section II.D.5, Funding Restrictions, for detailed funding information.
