DoD Amyotrophic Lateral Sclerosis, Therapeutic Development Award
The FY21 ALSRP Therapeutic Development Award supports research ranging from validation of therapeutic leads through U.S. Food and Drug Administration (FDA) Investigational New Drug (IND)-enabling studies. The proposed studies are expected to be empirical in nature and product-driven. Applicants with limited ALS experience are strongly encouraged to include collaborators with substantial experience in the relevant ALS model systems, endpoints, and pathophysiology. Examples of activities that will be supported by this award include: · Confirmation of candidate therapeutics obtained from screening or by other means, including optimization of potency and pharmacological properties and testing of derivatives and sister compounds. · Validation of early pilot studies, including the use of multiple ALS model systems and/or replicating preliminary data with more time points or additional doses. · Studies on formulation and stability leading to Good Manufacturing Practice production methods. ...