DOD Amyotrophic Lateral Sclerosis, Clinical Biomarker Development Award | HT9425 23 ALSRP CBDA

Opportunity Information: Apply for HT9425 23 ALSRP CBDA

The DOD Amyotrophic Lateral Sclerosis (ALS) Clinical Biomarker Development Award is a FY23 funding opportunity from the Department of Defense (managed through the U.S. Army Medical Research Acquisition Activity, USAMRAA) focused on accelerating practical biomarkers that can make ALS clinical trials more informative and efficient. The central aim is to support projects that develop and validate biomarkers specifically intended to "enrich" ALS therapeutic trials, meaning they help improve trial design and interpretation by identifying the right patients, tracking disease change more precisely, or clarifying whether a treatment is having a biological or clinical effect. A key feature of this opportunity is that proposed biomarkers do not need to be universal for all ALS patients; they can be tailored to a particular therapy, a class of therapies, or a defined ALS subgroup, such as individuals with a specific genetic mutation or other identifiable disease subtype.

A strong emphasis is placed on clearly defining what kind of biomarker is being developed and how it will be used in real-world therapeutic development. Applicants are expected to specify the biomarker category and, importantly, its intended context of use (COU). In practice, this means explaining exactly where the biomarker fits in the treatment development pipeline, for example as a tool for patient selection/stratification, a pharmacodynamic marker showing target engagement, a prognostic marker, a marker of disease progression, or another clinically meaningful role. The opportunity also highlights regulatory considerations, signaling that proposals should think beyond exploratory research and address how the biomarker could be positioned for acceptance or use in ALS trials and potentially clinical practice, including considerations relevant to evidentiary standards and trial integration.

The types of projects encouraged under this award are those grounded in patient-relevant data and clinically connected sample collection. Examples include leveraging patient-based resources to link biospecimens (such as blood, cerebrospinal fluid, tissue, or other samples) with rigorous molecular datasets, helping convert samples into robust, interpretable molecular readouts. Another example is collecting and analyzing biospecimens alongside an anticipated or ongoing clinical trial, which can be a powerful way to ensure the biomarker is evaluated in a trial-like setting and tied to therapeutic exposure and clinical endpoints. The opportunity also calls out studies that correlate trial-related datasets, including biosample analyses, imaging results, or epidemiological information, with clinical outcomes or treatment responses, aiming to build evidence that a biomarker meaningfully reflects disease state or therapeutic impact. Finally, it explicitly includes improved measurement of disease progression, including the development or application of digital biomarkers, which can involve sensor-based, app-based, wearable, or remote monitoring approaches designed to quantify function and progression more continuously or sensitively than traditional clinic-based assessments.

From an administrative standpoint, this is a discretionary opportunity with funding provided through either grants or cooperative agreements, indicating that some awards may involve more direct government involvement or collaboration than a standard grant, depending on the project and mechanism. The opportunity is listed under CFDA 12.420 and is open to an unrestricted applicant pool, meaning organizations of many types may apply (subject to any additional eligibility language that might appear in the full announcement). The opportunity number is HT9425 23 ALSRP CBDA. It was created on February 8, 2023, with an original closing date of July 13, 2023. The listing indicates an expected number of awards around 10. The award ceiling is shown as 0 in the source data, which typically means the ceiling was not specified in that particular summary field and would need to be confirmed in the full funding announcement or program guidelines.

Overall, this award is geared toward biomarker projects that are designed with clinical trials in mind from the start, are explicit about how the biomarker will be used and interpreted, and produce outputs that can concretely improve ALS therapeutic development, whether by sharpening patient selection, strengthening outcome measurement, or better linking biological changes to clinical benefit.

• The Department of Defense, Dept. of the Army -- USAMRAA in the science and technology and other research and development sector is offering a public funding opportunity titled "DOD Amyotrophic Lateral Sclerosis, Clinical Biomarker Development Award" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 12.420.
• This funding opportunity was created on Feb 08, 2023.
• Applicants must submit their applications by Jul 13, 2023. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• The number of recipients for this funding is limited to 10 candidate(s).
• Eligible applicants include: Unrestricted (i.e., open to any type of entity above), subject to any clarification in text field entitled Additional Information on Eligibility.

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