The private sector holds many of the assets and data needed for efficient drug repurposing. However, because innovative ideas for new uses of these resources can come from a variety of organizations, including NIH and the broader biomedical research community, public-private partnerships and collaborations are critical to this research. Through the New Therapeutic Uses program’s NIH–Industry Partnerships initiative, pharmaceutical companies provide researchers with access to the partially developed therapeutic candidates (referred to as assets) and related data.
These assets have undergone significant pre-clinical and safety testing in humans and are ready for additional testing in patient populations. Making information about these promising assets available to the research community gives scientists an opportunity to explore potential new therapeutic uses in previously unexplored disease areas. NCATS invites collaborating pharmaceutical companies to identify assets suitable for adult indications as well as for pediatric indications.
Requirements for pharmaceutical partner participation and asset selection criteria follow:
- Number of assets: New pharmaceutical partners should contribute at least three compounds for the solicitation. (View the assets.)
- Asset characteristics:
- The mechanism of action is known.
- The pharmacokinetics are suitable for exploring the mechanism for a new indication.
- The Phase I clinical trial has been completed. The safety profile is understood.
- Assets currently in clinical development can be included.
- Major company responsibilities include:
- Providing asset information to be posted on the NCATS website
- Providing pre-clinical and clinical supplies for studies (both drug and placebo)
- Providing regulatory documents (e.g., cross-reference letter or study reports) to enable a funded investigator to file an Investigational New Drug (IND) application in the U.S. in time to meet the project timeline and milestones
- Using template agreements that are negotiated with NCATS (View sample template agreements.)
- It is understood that assets should not be removed during an application cycle unless something unanticipated (e.g., new safety information from the Food and Drug Administration) becomes available.
Please email NewTherapeuticUses@mail.nih.gov if you work for a company that wishes to partner with NCATS and would like to publicly post assets in fall 2018.