The SEED Award for Product Development Research supports company formation and preclinical research and development efforts that advance an interesting oncology technology toward a commercially viable business opportunity, ie, make it more attractive to private funding agents.
Donor Name: Cancer Prevention & Research Institute of Texas
State: Texas
County: All Counties
Type of Grant: Grant
Deadline: 06/30/2023
Size of the Grant: $3 million
Grant Duration: 36 months
Details:
CPRIT provides project funding via a 3-year contract, with the opportunity to extend the contract duration based upon project progress. Funding is milestone driven, meaning that the company must fulfill the contractual G&Os associated with one funding tranche before receiving the next disbursement of funds.
CPRIT’s Product Development Research Program Priorities
In addition to overarching principles that include scientific excellence, impact on cancer, and increasing the state’s life science infrastructure, CPRIT’s Oversight Committee establishes annual priorities for each of its 3 programs. The priorities guide CPRIT on the development of RFAs and the evaluation of applications considered for awards.
The Product Development Research Program’s priorities for 2024 are as follows:
- Funding novel projects that offer therapeutic or diagnostic benefits; ie, disruptive technologies
- Funding projects addressing large or challenging unmet medical needs
- Investing in early-stage projects when private capital is least available
- Stimulating commercialization of technologies developed at Texas entities
- Supporting new company formation in Texas or attracting promising companies to Texas that will recruit staff with life science expertise, especially experienced C-level staff
- Providing appropriate return on Texas taxpayer investment.
Funding Stage for SEED Awards
The SEED Award for Product Development Research supports company formation and preclinical research and development efforts that advance an interesting oncology technology toward a commercially viable business opportunity, ie, make it more attractive to private funding agents.
The ideal SEED Award applicant will be a company with compelling preclinical/discovery stage data around a novel target, compound, device, etc, that warrants further development efforts to establish preclinical proof of concept (POC) on the road to commercialization.
- Typically, a SEED Award applicant has completed the following activities:
- Identified a novel therapeutic, diagnostic technology, or clinical tool and shown a biological effect
- Conducted preliminary safety and toxicology testing (in the case of therapeutic agents)
- Shown the product can be manufactured at small scale or as a prototype
- Assessed the business opportunity and organized a business plan that begins to address key issues (clinical utility, target market, financial plan, IP strategy, technical challenges, etc.) and lays out a preliminary development plan (formulation, toxicology, scale up, IND-enabling studies, phase 1 clinical trials, regulatory pathway, etc.)
- Established a company
- SEED Awards provide the funding for the company to begin IND/IDE-enabling studies to support filing the IND/IDE (or equivalent). As an example, in the case of drug candidates, specific technical activities the SEED Award mechanism can fund may include the following:
- Performing target validation
- Conducting lead optimization
- Performing target and cellular potency studies
- Developing and validating biomarker/pharmacodynamic (PD) marker assays
- Determining pharmacokinetic (PK) and exposure parameters; determining whether concentrations that result in significant cell death or tumor growth inhibition in vitro can be safely achieved in vivo; establishing in vivo PD POC
- Evaluating biopharmaceutical properties (absorption/bioavailability, distribution, metabolism, and clearance in rodents and nonrodents)
- Optimizing synthetic/bioengineering route
- Developing a prototype clinical formulation
- Expanding preclinical safety characterization in non-GLP studies
- Expanding in vivo preclinical efficacy characterization in tumor models, including where feasible patient-derived xenograft models, that most closely approximate the initial target indication
- SEED Awards may be used to carry out comparable activities for other classes of applications such as medical devices or diagnostics.
- Specific business activities the SEED Award mechanism can fund may include the following:
- Competitive analysis
- Extent of unmet need
- Target product profile (TPP)
- Description of development plans including integrated project milestones
- Preparation of clinical development plan
- IP development plans
Funding Information
- Award Maximum: $3 million
- Duration: Maximum of 36 months
Allowable Expenses
Companies may use CPRIT funds for expenses associated only with activities directly related to the specific project that CPRIT is funding. Allowable expenses include the following:
- Salary and fringe benefits
- Research supplies
- Equipment
- Clinical trial expenses
- IP acquisition and protection
- External consultants and service providers
- Travel in support of the project
- Other appropriate research and development costs, subject to certain limitations set forth by Texas law.
Eligibility Criteria
CPRIT considers a company to be Texas-based if it fulfills at least 4 of the following criteria:
- The US headquarters are physically located in Texas
- The chief executive officer resides in Texas
- A majority of the company’s personnel, including at least 2 other C-level employees (or equivalent), reside in Texas
- Manufacturing activities take place in Texas
- At least 90% of grant award funds are paid to individuals and entities in Texas, including salaries and personnel costs for employees and contractors
- At least 1 clinical trial site is in Texas
- The company collaborates with a medical research organization in Texas, including a public or private institution of higher education.
For more information, visit CPRIT.
