TTC Invention Development Program

Mission and Goals

Mission

The mission of the Invention Development Program is to accelerate the development timeline of NCI intramural inventions by advancing the technologies through critical, early stages of the validation.

Goals

• Close the “technology gap" toward commercializing an invention from one of the National Cancer Institute's research Divisions
• De-risk the opportunity with pre-clinical proof-of-concept data to better attract commercial licensees and co-developers
• To inform the NCI’s patenting process

General Information

• Why IDP? Recognizing the challenges to researchers seeking an industry partner for commercial development, NCI TTC created the IDP, an internal funding program to de-risk early-stage technologies and make them more attractive to industry partners, entrepreneurs and investors;
• Who can apply? Open to NCI Principal Investigators, permanent research staff, and post-docs with a letter of support from their supervisory PI or Lab/Branch Chief;
• Why apply? The IDP invites NCI inventors to apply for funding if they are facing technical or budgetary challenges to develop a commercially relevant invention in the areas of therapeutics, diagnostics, or devices;
• Easy application process. Proposals are 2-3 pages and should focus on a minimum number of pre-clinical proof-of-concept studies. If the application is approved, the applicant will present the proposal to an evaluation team. The IDP will assist with the proposal and presentation;
• Funding level
  • Stage I: Funding of up to approximately $50K, for example for production of a therapeutic agent
  • Stage II: Follow-on IDP funding, based on positive Stage I results, up to approximately $30K, for example for in vivo validation studies
• There is no application deadline. Stage I and Stage II applications will be evaluated on a rolling basis in monthly meetings where the inventor will discuss their proposal with a panel of subject matter experts. Funding is subject to evaluation and recommendation by the IDP Evaluation Panel and availability of funds;
• Does not provide funds for basic science publications, although that may be a side benefit;
• IDP will fund three to five new projects each year on a first come-first funded basis until funds are obligated. Remaining applications will be rolled into the following fiscal year if the applicant desires;
• The IDP has funded the following types of studies for various therapeutics and devices:
  • Efficacy, e.g., rodent xenografts, biodistribution/imaging
  • Toxicity, Maximum Tolerated Dose (MTD), PK
  • Stability, solubility
  • Scale-up and production of lead agents or intermediates to accommodate preliminary animal studies and to provide samples to potential collaborators
  • Prototype device development
• IDP conducts market analysis and can help with a development plan; 
• IDP provides project management support: locating, coordinating, and managing resources and contracts;
• IDP facilitates discussions with companies and other stakeholders to determine market and technical needs.

Strategic Fit

The TTC IDP does not stand alone. It is part of a comprehensive strategy to bring NCI biomedical solutions to the public.

• The IDP only considers NCI discoveries in patent prosecution, i.e., those with at least a provisional patent filing, or issued patents;
• The IDP fills the technology gaps that can be a barrier to entry to other internal and external resources such as licensing, co-development research agreements (CAs, CRADAs), the NCI CCR Drug Development Collaborative, the NExT Program, FLEX, and NCI Center for Advanced Preclinical Research CAPR);
• Responds to technical challenges posed by potential company collaborators;
• Leverages expertise from the TTC and the TTC's Technology Advancement and Marketing Unit (TAMU) to facilitate the development of NIH discoveries by identifying key markets and potential development partners (CRADAs, licenses), market validation studies.

Note: IDP strongly recommends that validation studies are conducted by a third party. IDP utilizes the facilities at Frederick National Laboratory for Cancer Research (FNLCR) as well as outside contractors such as through CREx.

Apply for Funding

If you are an NCI inventor, you can apply:

• directly to the IDP (download application form below and email to Dr. Geoffrey Ravilious)
• through referral by the TTC's Technology Review Group
• through your TTC Technology Transfer Manager

IDP Review and Evaluation

IDP Review

• Following receipt of an application for funding, the TTC will conduct a market analysis to examine the commercialization potential of an invention.
• The best time for IDP funding is between Provisional and National Stage filings of patent prosecution, but IDP will consider inventions at all stages of patenting.

How IDP Evaluates Applications

Criteria

• Discoveries or inventions under patent prosecution
• NCI researchers named as inventors on an Employee Invention Report or patent application
• Researchers who are not Principal Investigators need approval of their Lab or Branch Chief prior to applying for funding
• Potential to partner with an organization that can develop or commercialize the technology through a CRADA or license
• In most cases, all inventions pass through scientific review at least once via the TTC's Technology Review Group (TRG). Inventions that have gone through "Bypass" will be evaluated separately;
  • TRG meets monthly to recommend to the Division Director whether an invention should proceed through patent prosecution
  • TRG Reviewers are NCI Principal Investigators who have deep experience leading scientific teams, patenting, and licensing
• Therapeutics, devices, and diagnostics
• Pre-clinical proof-of-concept studies for inventions in patent prosecution. The IDP cannot fund research for scientific publications;
• Utility (i.e., new/unique device) or composition of matter (i.e., new molecule) patents for which NCI retains patent rights
  • Methods patents are generally not considered strong enough to support business enterprises. Discoveries that involve products discovered or made by outside entities (e.g., combination therapies) may be considered on a case-by-case basis.

Commercialization

• What is the (commercial) product? (therapeutic, diagnostic, device, vaccine)
• Orphan drug status?
• Feedback obtained from companies?
• How does this technology serve an unmet medical need?
• What differentiates it from currently available technologies and what data support this?
• How many other technologies address this problem and what is their stage of development?
• Type: Composition of matter, method, or utility
  • When was the patent application made (filing date)
  • What is the current stage of patent prosecution?

Programmatic

• Specific technical challenge(s) to address
• Facilities/Services needed
• Availability of services
• Estimated cost

Evaluation Panel

IDP Evaluation Panel consists of NCI and FNLCR staff with commercial and/or product development experience. A funding recommendation is made by consensus vote (the IDP Lead is recused), in a closed meeting following the proposal presentation.

Contact Us

If you have questions about the IDP, please email Senior Invention Development and Marketing Specialist, Dr. Geoffrey Ravilious, or your Technology Transfer Manager.

Downloads

• IDP Project Proposal Form
• IDP Presentation Template