The Therapeutic Development Award supports research ranging from validation of therapeutic leads to 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 collaborate with those having substantial expertise in ALS research and/or ALS model systems.
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 (GMP) production methods
- IND-enabling studies, to include compound characterisation, absorption, distribution, metabolism, and excretion (ADME) studies, and dose/response and toxicology studies in relevant model systems
Funding & Duration
The maximum period of performance is 2 years.
- Application submissions to the standard Therapeutic Development Award (TDA) will be awarded at up to USD $1M (approx AUD $1.29M).
- Application submissions to the TDA with the Therapeutically Relevant Marker Option will be awarded at up to USD $1.25M (approx AUD $1.62M).
Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Independent investigators at all academic levels (or equivalent) are eligible to submit applications. An eligible PI, regardless of ethnicity, nationality, or citizenship status, must be employed by, or affiliated with, an eligible organisation.
Submission Requirements & Due Dates
- 22 June 2018 – pre-proposal submitted via eBRAP.org
- August 2018 (TBC) – full applications (by invitation only) submitted to Research Services internal review.
- Please email firstname.lastname@example.org if you are considering applying for this scheme.
- See also: Submitting an Application to Research Services for Review