DoD Amyotrophic Lateral Sclerosis Therapeutic Development Award

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The Therapeutic Development Award supports the preclinical development of therapeutic leads for ALS. The proposed studies are expected to be empirical in nature and product-driven.New for FY15: The maximum period of performance is 2 years. The Therapeutic Development Award no longer supports development of model or screening systems or the conduct of screening. Those activities are now supported under the ALSRP FY15 Therapeutic Idea Award mechanism.Applications must clearly identify a lead molecule, or limited group of lead molecules, possessing demonstrated biological activity on a pathway relevant to ALS disease onset and/or progression.The FY15 Therapeutic Development Award supports a wide range of post-discovery development activities ranging from post-discovery validation right up to IND submission. Supported activities must begin with lead compounds in hand and can include (1) secondary validation of leads obtained from screening or by other means to demonstrate target selectivity and mechanism of action, (2) optimization of potency and pharmacological properties and development of structure-activity maps via synthesis and testing of derivatives and sister compounds, (3) studies of formulation and stability, and/or (4) development of GMP production methods, (5) collection of data needed for Food and Drug Administration (FDA) Investigational New Drug (IND) applications to include compound characterization, absorption, distribution, metabolism, excretion (ADME) studies, and dose/response and toxicology studies.Validation of existing biomarkers and development of them as markers for mechanism-specific drug activity and/or clinical progression, in parallel with therapeutic lead validation and development, is also of interest.

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