CTI Frequently Asked Questions

What is the collaboration between NIH and Pfizer?

NCATS has entered into a research collaboration under a cooperative research and development agreement (CRADA) with Pfizer’s Centers for Therapeutic Innovation (CTI) to involve intramural research programs at the National Institutes of Health (NIH). Pfizer is bringing its drug development expertise to complement NIH’s research. The program is managed by Pfizer and NCATS via a joint steering committee.

CTI is part of Pfizer’s Worldwide Research & Development division. CTI partners at academic medical centers, disease foundations and NIH aim to translate promising science into clinical candidates more quickly. CTI was founded on a collaborative model, with shared decision making and aligned incentives.

The CTI model features the first NIH-wide biologics initiative that NCATS will coordinate on behalf of all NIH intramural researchers. The goal is to identify biologic compounds with a pathway or target of interest to NIH and to Pfizer, then attempt to move these compounds into the clinic rapidly to establish proof-of-mechanism.

This agreement does not preclude NIH researchers from working with other biopharmaceutical partners.

How will the CTI model work at NIH?

Through this collaboration, NIH’s intramural scientists will have the opportunity to respond to CTI calls for proposals two times each year. A joint steering committee composed of members from NIH and Pfizer will review submissions. If selected, the NIH intramural investigator will receive access to Pfizer’s drug development expertise and publishing rights — as well as a dedicated project team to help investigate the target or pathway.

The call for proposals is part of CTI’s established process to identify research projects. NIH investigators are invited to participate in CTI calls for proposals alongside academic medical centers within CTI’s network of partners.

NIH investigators can submit their first pre-proposals under this partnership for targets that are tractable with biologics (i.e., surface proteins, secreted proteins). The steering committee will make decisions based on ability to demonstrate a strong link from targeted pathway to disease, ability to address unmet medical needs, and ability to show a path to proof-of-mechanism in humans. If selected, a team of scientists from CTI and NIH will work together to submit a full proposal and project plan to advance the research.

The number of projects will depend on the merit of the individual research proposals submitted, as evaluated by the steering committee, and the resources available.

When will NIH intramural investigators have the opportunity to submit CTI pre-proposals?

Pfizer’s CTI program has two calls for proposals each year. Learn more about the CTI call for proposals.

What types of CTI projects are of interest for further development?

Each call for proposals may contain different areas of therapeutic focus. Review the call for proposals to explore the types of projects appropriate for CTI.

Are Pfizer scientists going to work at NIH?

The agreement allows the flexibility for scientists from both organizations to work at each other’s facilities.

Under what mechanism will NIH intramural investigators work with CTI?

In coordination with the NIH Office of Technology Transfer and the Office of the General Counsel, NCATS has negotiated a NIH-wide “umbrella” cooperative research and development agreement (CRADA) for approved NIH CTI projects. Coordinate with your Institute or Center’s technology transfer office and technology development coordinators to learn more about the terms and conditions of the NIH-Pfizer CTI CRADA.

Who will own the intellectual property (IP) discovered through this project? If Pfizer commercializes a compound produced through this collaboration, how will NIH receive compensation?

Pfizer has the first right of refusal to exclusively license clinical probes and other IP developed under the NIH-Pfizer CTI CRADA. However, if Pfizer decides not to license a jointly developed clinical probe, NIH has the option of licensing that probe to another company.

Research rights are not compromised by this collaboration. Should Pfizer decide not to move forward with a project, NIH still owns all the background IP that it brought to the partnership, and the investigator may continue his or her research independently from CTI.

Who do I contact if I want to submit a pre-proposal?

NIH investigators should contact their NIH Institute or Center’s technology transfer office (TTO) to submit a pre-proposal. If TTO staff have any questions about the process, they can contact NCATS or Manjula Donepudi, Ph.D., at Pfizer CTI for more information.