You are here

Share:

TTC Invention Development Program

CONTENTS


Addressing a challenge

Challenged by a lack of relevant pre-clinical data, many inventions in NCI’s patent portfolio encounter a rocky path to eventual commercialization: companies perceive early-stage technologies as too risky to develop if they have only in vitro proof of concept data. Important discoveries may also lack sufficient data to support a successful patent application.

Solution

The TTC Invention Development Program seeks to de-risk pre-clinical NCI discoveries that have on-going patent activity by funding critical, commercially-relevant proof-of-concept studies.

Goal

  • The TTC wants to validate inventions with proof of concept data prior to a patent reaching National Stage with the USPTO. 

  • Funding the minimum of commercially-relevant preclinical proof-of-concept studies that are critical to attracting attention from companies. The goal of the IDP is to close the “technology gap toward commercializing an NCI discovery; to de-risk the opportunity for partners with pre-clinical proof-of-concept data; and also to inform the TTC’s patenting process. The IDP does not provide funds for scientifc research, although that may be a side benefit;

  • The IDP aims to fund three to five new projects each year. New applications will be evaluated on a rolling basis in monthly meetings where the inventor will discuss their proposal. The IDP will fund projects on a first come-first funded basis until funds are obligated. Remaining applications will be rolled into the following year if the applicant desires;
  • The IDP invites NCI inventors to apply for funding if they are facing technical or budgetary challenges to develop therapeutics, diagnostics, or devices with commercial potential.

    The IDP has funded the following types of studies for therapeutics and devices:

    • Efficacy, e.g., rodent xenografts
    • Biodistribution/imaging
    • Toxicity, Maximum Tolerated Dose (MTD), PK
    • Stability
    • Solubility, formulation, delivery agents
    • Scale-up and production of lead agents or intermediates to permit animal studies and provide samples to potential customers
    • Prototype device development

    Strategic fit

    The TTC invention Development Program does not stand alone, but 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, and have not yet been issued. This covers a time period of three to four years.
    • 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 (RCAs, CRADAs), the NCI CCR Drug Development Consortium, the NExT Program, FLEX, and CAPR
       
    • If you are an NCI inventor, you can apply:
      • directly to the IDP 
      • through referral by the TTC's Technology Review Group
      • through your TTC Technology Transfer Manager

     

    How the IDP adds value

    • Responding to technical challenges posed by potential company collaborators
    • Leveraging expertise from the TTC and the TTC's Invention Development and Marketing Unit to facilitate the development of NIH discoveries by identifying key markets and potential development partners (CRADAs, licenses), market validation studies
    • Quantifying opportunities in specific markets via market analysis
    • Project management: locating, coordinating, and managing resources and contracts
    • Facilitating discussions with companies and other stakeholders to determine market and technical needs
    • Funding of projects has included:
      • Building a device prototype for customer evaluation
      • Analytical services not otherwise available to the researcher
      • Solubility, formulation
      • Scale-up/production of lab-quality materials for small animal studies and collaborator samples
        • Biologics
        • Small molecule
      • In vivo studies: Toxicity, PK, efficacy, pathology/histology, imaging/biodistribution in murine models

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

      Applying for funding

      IDP review

      • Prior to funding, an opportunity analysis will examine the likelihood of commercializing an entity, including:
        • Stage of research
        • Stage of patent prosecution
        • Priority of research in inventor’s portfolio
        • Public health impact and need
        • Potential for orphan drug status
        • Competitive market position with respect to target, mechanism of action
      • The best time for IDP funding is between PCT and National Stage filings of patent prosecution, but IDP will consider inventions with provisional applications
      • Funding is milestone-based, with Stage I funding of up to $30,000 and Stage II funding of up to $50,000, subject to evaluation and recommendation by the IDP Evaluation Panel
      • Stage II funding is based on successfully completing Stage I project milestones

      Assessing Proposals

      Criteria
      • Discoveries or inventions under patent prosecution
      • NCI researchers named as inventors on a 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, passing through scientific review at least once via the TTC's Technology Review Group (TRG)
        • 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 
      • 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, nor are discoveries that involve products discovered or made by outside entities (e.g., combination therapies)

        Questions about these criteria can be directed to John Hewes and your Technology Transfer Manager.

        Commercialization
        1. What is the (commercial) product? (therapeutic, diagnostic, device, vaccine)
        2. Orphan drug status?
        3. What feedback has been obtained from companies?
        4. 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?
        5. Strength of the patent
        • Type: Composition of matter, method, or utility
        • When was the patent application made (filing date)
        • What is the current stage of patent prosecution?
         Technical
        1. Known target or a new target
        2. Uniqueness of the mechanism of action
        3. Current stage of the research
         Programmatic
        1. Specific technical challenge(s) to address
        2. Facilities/Services needed
        3. Availability of services
        4. 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, in which the IDP Lead is recused, in a closed meeting following the proposal presentation.

        Questions?

        Contact John Hewes tel. 240-276-5515, or email 

        ^Back to Top^

         

         

        Updated
        Friday, January 11, 2019