Product Development Research
CPRIT’s Product Development Research Program funds projects at Texas-based companies developing novel products or services intended to benefit cancer patients. Groundbreaking science is most valuable when it is translated into cancer drugs, diagnostics, and therapies that are available to all Texans. Product development activities convert novel laboratory findings into a safe and reliable product available to treat cancer patients. CPRIT supports projects that accelerate the development of promising research discoveries through the crucial early stages of regulatory development.
Summaries of the four Requests for Application are listed below:
Texas Therapeutics Company RFA
Funding available through this RFA supports the ongoing research and development of innovative products, services, and infrastructure with significant potential impact on patient care. Generally, at this stage, the company has identified and characterized a lead compound; demonstrated efficacy in multiple translationally relevant animal models; completed pilot/dose ranging toxicology studies; determined the feasibility of a scalable, GMP compliant manufacturing process, including release assays; and identified a prototype formulation suitable for further development. The applicant is typically within one year from filing an IND/IDE or already in Phase 1.
With appropriate justification, companies may use CPRIT funds to support the following:
• Studies that establish preclinical proof of concept (safety and efficacy)
• CMC/manufacturing development
• GLP safety studies to support INDs
• Phase 1 in humans to establish safety and a recommended dose for phase 2
• Phase 2 studies to determine safety and efficacy in initial targeted patient population
Texas Device and Diagnostics Company RFA
Funding available through this RFA supports the ongoing research and development of diagnostic tests and devices to treat, detect, diagnose, monitor, and assist in the treatment of cancer. Relevant areas include:
• Devices and assays for cancer detection, diagnosis, prognosis, monitoring, treatment and prediction of response or resistance to treatment
• Markers for cancer prevention and control, companion diagnostic to a therapy
• Development of diagnostic tests to distinguish high-risk early lesions
Generally, at the time that an applicant applies to CPRIT pursuant to this RFA, the company has developed a commercial prototype of the device or a pictorial representation of the functional components/elements of the device. With respect to diagnostics, the company has developed assays that work on human samples and whose importance is well justified for development into clinical assays. The applicant should be working toward submitting an Investigational Device Exemption (IDE) or a 510(k) or Premarketing Approval (PMA) and is typically within one year from filing an IDE (or later stage work.) Potential applicants that are not at or near this stage of product development should consider applying for a Texas Seed Company Award.
With appropriate justification, companies may use CPRIT funds to support studies that establish preclinical proof of concept, product validation, design, production, manufacturing and development, and clinical studies demonstrating safety and efficacy.
Texas New Technologies Company RFA
Funding available through this RFA supports the ongoing research and development of new and emerging technologies for the detection, diagnosis, prognosis, monitoring, or treatment of cancer. CPRIT created this RFA to fund new and emerging technology projects that do not easily fit into any of the three other CPRIT Product Development Research RFAs. Proposals may include, but are not limited to, bioinformatics, artificial intelligence, production of radionuclides or their precursors, manufacture of cell-based therapies, processes to improve the quality of the samples used for cancer research or clinical care, and biomanufacturing of therapeutics.
With appropriate justification, companies may use CPRIT funds to support studies that establish preclinical proof of concept, product validation, design, production, manufacturing and development, and clinical studies demonstrating safety and efficacy.
Texas Seed Company RFA
Funding available through this RFA supports company formation, as well as early research and development of novel oncology therapeutics, devices, treatment-oriented information technology products, diagnostics, or tools. The objective of the SEED Award program is to start with an interesting technology and to progress it toward a commercially viable business opportunity, i.e., make it more attractive to private funding agents. Typically, applicants have 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
PDR Review Process FAQ
Q: What is CPRIT’s Product Development Review Process?
A: This is the current Product Development review process:
- Applicants will submit a preliminary application comprised of a 2-page executive summary, a slide deck of up to 16 slides providing an overview of the scientific basis for the proposed project, and a 1-page explanation of the project’s aims and requested budget.
- The company may submit the preliminary application at any time while the portal is open.
- The Product Development Review Council (PDRC) will judge the application for scientific merit and consider whether the company presents a compelling idea for CPRIT investment.
- If the PDRC sees sufficient scientific merit and a persuasive premise for the project, it will invite the applicant to submit a full application.
- CPRIT will notify the applicant of the PDRC’s decision within 3 – 5 weeks of submission. The review process will end for those applicants not invited to submit a full application. Applicants not successful in the preliminary or the full application review process will have limited opportunities to resubmit an application.
- For applicants invited to submit a full application, CPRIT will offer a specific date and time for the applicant to present their proposal to the review panel via zoom.
Q: Is the CPRIT award a grant or some other type of investment?
A: CPRIT awards grants to fund product development projects through a competitive, peer reviewed process. Although these are grants, CPRIT provides all funds via a contract specifying agreed-upon goals and objectives and requires, among other terms, matching funds contributed by the company and an agreement to share revenues via royalty payments, equity, or some other arrangement in the mutual interest of the state and the company.
Q: How long are the awards?
A: All CPRIT RFAs support three-year projects in Texas, with an opportunity to extend the duration of contract to fully expend awarded funds.
Q: How much will CPRIT award for a project?
A: Except for Seed Company Awards, which CPRIT caps at $3 million per project, applicants may request any amount of funding appropriate to the work proposed and the development stage.
All requested funds must be well justified. CPRIT will evaluate requests for a significant amount of funding more stringently to ensure that the project is of demonstrable importance in terms of innovation and impact as not to displace other worthy investments.
CPRIT has approximately $70 million per fiscal year available for investment in product development awards. CPRIT reserves the right to close the application portal until the next fiscal year if CPRIT exhausts its annual allocation for product development awards.
Q: Can a company located outside of Texas apply for a CPRIT product development award?
A: CPRIT encourages companies located outside of Texas to apply to one of the four RFAs. As a condition of receiving the CPRIT grant, the company must meaningfully commit to locating in Texas and maintaining its business presence within the state. CPRIT developed Texas location criteria that all CPRIT-funded companies use to signal commitment to Texas and to developing the state’s life science ecosystem.
CPRIT takes the company’s obligation to Texas seriously. Be aware that Texas taxpayer-supported general obligation bonds fund all Product Development awards. Do not apply if it is not your intention to locate and maintain your business in Texas. Fraud, deception, or other bad faith actions to evade the obligation to establish and maintain status as a Texas company will result in termination, repayment, and any other remedy available by law or contract.
Because companies from outside the state are eligible to apply for any product development award, CPRIT has retired the Relocation Company RFA.
