DoD Amyotrophic Lateral Sclerosis Therapeutic Development Award
The ALSRP Therapeutic Development Award (TDA) mechanism was first offered in FY07. Since then, 128 Therapeutic Development Award applications have been received, and 12 have been recommended for funding. The TDA supports the preclinical assessment of therapeutics for ALS. The proposed studies are expected to be empirical in nature and product-driven but may have a hypothesis-driven approach, provided the focus is on therapeutics. It is anticipated that the agents and/or data generated from these awards will lead to the advancement of new therapies for ALS. The TDA mechanism is designed to support preclinical testing and development of therapeutics for ALS. Applications must include preliminary data relevant to the phase(s) of the preclinical development process covered by the proposed research. The application should include a clear statistical plan of analysis, if appropriate. Applicants must clearly and explicitly articulate what impact the project may have on therapeutic development for ALS. Clinical trials will not be supported with this Program Announcement/Funding Opportunity. Therapeutic Development Award applications are limited to the areas of programmatic interest listed below. Applications must focus on one or more of these areas to be considered for funding. Applications that do not focus on at least one of the following areas will be administratively withdrawn. • Development and/or validation of high-throughput screens to define targets with therapeutic potential or to identify lead agent candidates for ALS treatment and be an asset for the ALS research community; • Development, modification, and/or validation of preclinical model systems in order to assess lead compounds and potential therapeutics by pharmacological and/or pharmacokinetic testing. Such models would also serve as improved tools for the ALS research community; • Development and optimization of pharmacologic agents through Adsorption, Distribution, Metabolism, Excretion (ADME) studies, and toxicology testing, including Investigational New Drug (IND)-enabling pharmacology/toxicology testing; • Formulation and stability studies, design and implementation of full-scale, pilot current Good Manufacturing Practice (cGMP) production of therapeutics and/or delivery systems for use in advanced preclinical and initial clinical trials; • Development of pharmacologic agents up to IND submission to initiate Phase I clinical trials after the award’s completion. In contrast, investigators interested in more basic research focused on ALS therapeutics should consider the FY13 ALSRP Therapeutic Idea Award, which does not require preliminary data (http://cdmrp.army.mil/funding/alsrp.shtml). If a therapeutic agent(s) that is the subject of a Therapeutic Development Award application was initially developed under an ALSRP Therapeutic Idea Award (TIA), the applicant should describe the role of the TIA in that development. The preclinical drug development process may require resources beyond those available at a single organization. Therefore, Therapeutic Development Awards are open to investigators participating in collaborations focused on identifying and/or testing lead agents for the treatment of ALS. Collaborations should be dedicated to a single, preclinical development project rather than an additive set of subprojects. If a collaboration is proposed, letters confirming/supporting the collaboration are required. If the collaboration is multi-organizational, participating organizations should ensure the success of the collaboration by resolving potential intellectual and material property issues and by removing organizational barriers that might interfere with achieving high levels of cooperation. A proposed means to resolve these issues must be delineated in an Intellectual and Material Property Plan to be included with the application. Due to the nature of the work involved in the development process, biotechnology and pharmaceutical companies are invited to apply. Whether a biotechnology or pharmaceutical company applies for this mechanism as an individual applicant or as part of a collaboration, the company is expected to leverage its own resources to complement the funding provided by this award.
Office: U.S. Army Medical Research Acquisition Activity
301-682-5507
