The Therapeutic Development Award 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 Therapeutic Development Award 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

a. Areas of interest:

i. 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;

ii. 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;

iii. 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;

d. 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

iv. Development of pharmacologic agents up to IND submission to initiate Phase I clinical trials after the award’s completion

b. Elegibility Information:

i. Independent investigators at all academic levels (or equivalent) are eligible to submit applications.

ii. Cost sharing / matching is not an elegibility requierement.

c. Funding:

i. The maximum period of performance is 3 years.

ii. The maximun allowable direct cost for the entired period of performance are $1,500,000 plus indirect cost.

iii. All direct and indirect costs of any subaward (subgrant or subcontract) must be included in the total direct costs of the primary award.

iv. The applicant may request the entire maximum funding amount for a project that may have a period of performance less than the maximum 3 years.

v. Regardless of the period of performance proposed, the applicant may not exceed the maximum allowable direct costs.  Indirect cost shall be proposed in accordance with the organization's negotiated rate agreement.

d. Dates:

i. Pre-application deadline:

       - VHIR's deadline: May 10th, 2014

       - Official deadline: May 13th, 2014

ii. Invitation to submit an Application: June 2014.

e. More information: HERE