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

FAQs: DOD ALS Clinical Biomarker Development Award (FY23)

What is the DOD ALS Clinical Biomarker Development Award?

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). It focuses on accelerating practical biomarkers that can make ALS clinical trials more informative and efficient.

What is the main goal of this funding opportunity?

The central goal is to support projects that develop and validate biomarkers specifically intended to enrich ALS therapeutic trials. In this context, "enrich" means improving trial design and interpretation by helping identify the right patients, track disease change more precisely, or clarify whether a treatment is having a biological or clinical effect.

What does it mean for a biomarker to "enrich" an ALS trial?

Enrichment refers to using a biomarker to strengthen a therapeutic trial by improving patient selection or stratification, increasing sensitivity to disease progression, or providing clearer evidence that a therapy is engaging its target or producing an effect that matters clinically.

Do proposed biomarkers need to apply to all ALS patients?

No. A key feature is that biomarkers do not need to be universal for all ALS patients. They may be tailored to a particular therapy, a class of therapies, or a defined ALS subgroup (for example, individuals with a specific genetic mutation or other identifiable disease subtype).

What types of biomarker uses are emphasized?

Applicants are expected to clearly define the biomarker category and its intended use in therapeutic development. Examples of intended uses mentioned include patient selection/stratification, pharmacodynamic biomarkers showing target engagement, prognostic biomarkers, and markers of disease progression, among other clinically meaningful roles.

What is a "context of use (COU)" and why is it important here?

The context of use (COU) is an explicit description of how and where the biomarker will be used in the treatment development pipeline. This opportunity places strong emphasis on defining COU so the biomarker is positioned for real-world trial integration and interpretation rather than remaining purely exploratory.

Does the opportunity address regulatory considerations?

Yes. The opportunity highlights regulatory considerations and signals that proposals should think beyond exploratory research. Applicants are encouraged to 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.

What kinds of projects are encouraged under this award?

Projects encouraged include those grounded in patient-relevant data and clinically connected sample collection. Examples include linking biospecimens to rigorous molecular datasets, collecting biospecimens alongside an anticipated or ongoing clinical trial, correlating trial-related datasets (biosamples, imaging, epidemiology) with clinical outcomes or treatment responses, and improving measurement of disease progression, including digital biomarkers.

What biospecimen types are mentioned as relevant?

The opportunity references biospecimens such as blood, cerebrospinal fluid (CSF), tissue, or other samples, particularly when they are linked to rigorous molecular datasets to produce robust, interpretable molecular readouts.

How can clinical trials be incorporated into a biomarker project?

One encouraged approach is collecting and analyzing biospecimens alongside an anticipated or ongoing clinical trial. This can help evaluate the biomarker in a trial-like setting and tie biomarker behavior to therapeutic exposure and clinical endpoints.

What kinds of datasets may be correlated with clinical outcomes?

The opportunity calls out correlating trial-related datasets, including biosample analyses, imaging results, or epidemiological information, with clinical outcomes or treatment responses to build evidence that a biomarker meaningfully reflects disease state or therapeutic impact.

Are digital biomarkers within scope?

Yes. The award explicitly includes improved measurement of disease progression, including development or application of digital biomarkers. Examples of digital approaches mentioned include sensor-based, app-based, wearable, or remote monitoring methods that quantify function and progression more continuously or sensitively than traditional clinic-based assessments.

What administering organization manages this opportunity?

The opportunity is from the Department of Defense and is managed through the U.S. Army Medical Research Acquisition Activity (USAMRAA).

What funding mechanisms may be used?

Funding may be provided through grants or cooperative agreements. Cooperative agreements can indicate more direct government involvement or collaboration than a standard grant, depending on the project and mechanism used.

Is this a discretionary funding opportunity?

Yes. The opportunity is described as discretionary.

What is the CFDA number for this opportunity?

The listing identifies CFDA 12.420.

Who is eligible to apply?

The listing indicates an unrestricted applicant pool, meaning organizations of many types may apply, subject to any additional eligibility language that may appear in the full announcement.

What is the opportunity number?

The opportunity number is HT9425 23 ALSRP CBDA.

When was the opportunity created and when did it close?

The listing indicates it was created on February 8, 2023, with an original closing date of July 13, 2023.

How many awards were expected?

The listing indicates an expected number of awards around 10.

What is the maximum award amount (ceiling)?

The award ceiling is shown as 0 in the source summary data, which typically means the ceiling was not specified in that field. The ceiling would need to be confirmed in the full funding announcement or program guidelines.

What characteristics would make a proposal align well with the intent of this award?

Proposals align well when they are designed with ALS clinical trials in mind from the start, clearly define the biomarker category and context of use, rely on patient-relevant data and clinically connected samples, and produce outputs that can concretely improve therapeutic development (for example, better patient selection, stronger outcome measurement, or clearer linkage between biological change and clinical benefit).