NCATS is seeking pharmaceutical company partners for its Discovering New Therapeutic Uses for Existing Molecules (New Therapeutic Uses) program. Participating companies provide access to and information about assets that funded academic researchers test for new therapeutic uses.
Supported projects have generated new knowledge and methods that improve health through smarter science. The program’s template agreements shorten the time needed to form new public-private partnerships between academic medical centers and pharmaceutical partners.
Interested companies should contact NewTherapeuticUses@mail.nih.gov to discuss becoming a New Therapeutic Uses partner for the next funding opportunity.
NCATS coordinates funding opportunity announcements to seek promising candidates for repurposing ideas from the academic community. For these announcements, participating companies establish a template agreement and provide non-confidential information about available assets for which applicants can propose new therapeutic uses.
NCATS conducts NIH peer review of all applications and supports Phase I (if needed) and/or Phase II clinical trials for meritorious projects. If a pharmaceutical partner’s assets are selected for a funded project, the company uses the template agreement to establish a collaboration with the academic investigator and provides the drug or biologic and placebo. The company also provides documentation that enables funded investigators to file or cross-reference an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA).
Requirements for pharmaceutical partner participation and asset selection criteria include the following:
Number of Assets
New pharmaceutical company partners must contribute at least three assets to participate in a funding opportunity announcement.
- Mechanism of action is known.
- Pharmacokinetics are suitable for the mechanism to be explored in a new indication.
- Phase I clinical trial has been completed, and safety profile is understood.
- Assets currently in clinical development can be included.
- New molecular entities and biologics are accepted.
- Provide asset information to be posted on the NCATS website. View examples.
- Provide clinical supply for Phase I and Phase II clinical studies (drug or biologic and placebo).
- Provide regulatory documents (i.e., cross-reference letter or study reports) to enable a funded investigator to file an IND application in time to meet project timeline and milestones.
- Use template agreements that are negotiated with NCATS. View samples.
- Agree not to remove assets 90 days before a pre-application receipt date for a funding opportunity, unless something unanticipated (e.g., new safety information from FDA) becomes available.
Become a Partner
Contact NewTherapeuticUses@mail.nih.gov to discuss partnering with NCATS through the New Therapeutic Uses program. Asset lists are refreshed twice each year.