Assets & Agreements for NIH-Industry Partnerships

Through the New Therapeutic Uses NIH-Industry Partnerships initiative, NCATS has collaborated with several pharmaceutical industry partners to make a number of partially developed assets available to academic researchers to crowdsource ideas for new uses. Projects using these assets are designed to go directly into Phase II clinical trials, studies that provide data on the preliminary effectiveness for the intended use. Some projects may need a Phase I clinical trial within the target populations to determine dosing, safety and tolerability. Learn more about these industry-provided assets.

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.

Participating companies provide clinical supplies of drugs and matched placebos to funded investigators at no charge. These companies also provide documentation so that funded investigators can file an Investigational New Drug application with the Food and Drug Administration.

To streamline the legal and administrative process for partnering across multiple organizations, NIH created template agreements. These agreements help facilitate complex negotiations among all parties involved in the program, enabling the research to begin faster. Learn more about the template agreements.

Learn more about becoming a pharmaceutical company partner for the New Therapeutic Uses program.