Seed Full Awards for Product Development Research
- 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
Award Maximum: $3 million, Duration: Maximum of 36 months
Seed Preliminary Applications for Product Development Research
- 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
Award Maximum: $3 million, Duration: Maximum of 36 months
Texas Diagnostic and Devices Company Full Awards for Product Development Research
- 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.
Award Maximum: None, Duration: Maximum of 36 months
Texas Diagnostic and Devices Company Preliminary Applications for Product Development Research
- 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.
Award Maximum: None, Duration: Maximum of 36 months
Texas New Technologies Company Full Awards for Product Development Research
- 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.
Award Maximum: None, Duration: Maximum of 36 months
Texas New Technologies Company Preliminary Applications for Product Development Research
- 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.
Award Maximum: None, Duration: Maximum of 36 months
Texas Therapeutics Company Full Awards for Product Development Research
- 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
Award Maximum: None, Duration: Maximum of 36 months
Texas Therapeutics Company Preliminary Applications for Product Development Research
- 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
Award Maximum: None, Duration: Maximum of 36 months
NOTE: Award mechanism-specific forms shown above, supercede the generic documents below. If the form is not listed with the award mechanism, please use the generic version of the form below.
Application Templates
Templates
Word/Excel
PDF
Product Development Research Programs: Biographical Sketch
Product Development Research Programs: Capitalization Table
Product Development Research Programs: Budget Justification
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