SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1 Clinical Trial Required)

Purpose The NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs have provided the small business community with critical seed funding to support the development of a wide variety of technologies that benefit society. The main objective in SBIR/STTR Phase I is to establish the technical merit and feasibility of the proposed research and development (R&D) efforts, whereas in SBIR/STTR Phase II and Phase IIB it is to continue the R&D efforts to advance the technology toward ultimate commercialization. At the conclusion of an SBIR/STTR Phase II or Phase IIB award, it is expected that the SBC will fully commercialize their product or technology using non-SBIR/STTR funds in Phase III. Some projects initiated with SBIR or STTR funding require support beyond the SBIR/STTR Phase II award to achieve commercialization. The development of medical biotechnology products is often impeded by a significant funding gap, known as the “Valley of Death,” between the end of the SBIR/STTR Phase II award and the commercialization stage. A number of NIH Institutes and Centers (ICs) participate in the Phase IIB program, which provides additional support to mitigate the funding gap with a second Phase II award. However, Phase IIB programs can be limited in the amount of outsourcing allowed and some projects require technical assistance and R&D studies that are typically outsourced to contract research organizations (CROs) (e.g. regulatory assistance, IND/IDE enabling studies, toxicology, manufacturing, clinical trials). Some SBCs also require additional funding beyond the Phase IIB to commercialize a technology or attract third party funding. In addition, SBIR/STTR awards may not support activities important for commercialization, such as product development and market planning, market research, and costs related to license agreements and partnerships. The SBIR and STTR programs were reauthorized and extended through 2022 under Public Law 114-328, Section 1834 and Public Law 115-232, including the reauthorization of the Commercialization Readiness Pilot (CRP) Program to the NIH. This funding opportunity announcement (FOA) aims to implement the CRP Program at NIH. The goal of this FOA is to facilitate the transition of previously funded SBIR/STTR Phase II/IIB projects to the commercialization stage by providing additional support for later stage research and development (R&D) and product development not typically supported through Phase II or Phase IIB grants or contracts, often because they are normally outsourced to CROs. This FOA supports CRP awards to: Phase II or IIB SBIR/STTR awards that have ended or will close out by the requested start date ("Type 2" Renewal applications). Phase II or IIB SBIR/STTR awards that will be active at the requested Project Start date ("Type 1" New applications). Please note: Only those applicants who have received Phase II or Phase IIB funding from NIH are eligible for this program, as described in Section III.1. Phase II and Phase IIB awardees with funding from a non-participating NIH Institute/Center should note that some NIH Institutes/Centers participate in the following: The Phase IIB Competing Renewal supports those Phase II projects that require extraordinary time and effort in the research and development phase. (See https://sbir.nih.gov/sites/default/files/2019-2_SBIR-STTR-topics.pdf for more information) Applicants cannot submit a Phase IIB and CRP concurrently; see Section III. The Commercialization Readiness Pilot (CRP) Program: Technical Assistance (SB1) (Clinical Trial Not Allowed) (PAR-20-128) supports technical assistance activities for Phase II and Phase IIB awardees. The SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1) (Clinical Trial Not Allowed) (PAR-20-129). Scientific/Technical Scope NIH ICs participating in this FOA may accept applications based on any topic within their mission or based on specific topics. While general topic areas are listed below, applicants should read the specific interests of the ICs carefully prior to submission. Topic areas appropriate for this FOA include, but are not limited to the following: Technical Assistance: Development of regulatory strategy, including assembling the documentation needed for the Investigational New Drug (IND) or Investigational Device Exemption (IDE) submission to the Food and Drug Administration (FDA) Design and planning for a clinical trial including: Preparation of documents required to support a clinical trial (e.g., case report forms, pharmacy manual, study coordinator manual, monitoring plan), preparation of clinical trial protocol, and preparation of investigator's brochure Development of an intellectual property strategy, including analysis of the patent landscape in the US and abroad Technical assistance associated with manufacturing, including industrial production methods necessary to ensure consistent and controlled scale-up manufacturing according to recognized quality standards and in compliance with expected good manufacturing practices (GMPs). Other technical assistance through a third-party technical assistance provider, including market research. Late Stage Research and Development Activities: Independent replication/confirmation of key studies Systematic research on development and optimization of industrial production methods necessary to ensure consistent and controlled scale-up manufacturing according to recognized quality standards and in compliance with expected good manufacturing practices (GMPs) and applicable FDA requirements, including measures and activities to control manufacturing of upstream and downstream processes, batch compounding, dosage form production, in-process sampling, testing, process validation and related production requirements. Activities to bring the development process under Design and Quality Systems Control Animal studies to develop surgical techniques relevant to a device In vitro and animal testing to meet FDA recognized ISO/ASTM Standards Optimization of the device design with respect to the human functional anatomy Device, software, and firmware design verification and validation activities GLP compliant large animal studies Identification of the most simple, reliable, and cost-effective device configuration for more advanced clinical trials and eventual market approval Process optimization and synthesis, including development of analytical methods to determine drug purity and development of a clinical trial formulation IND/IDE enabling studies, including toxicology Chemistry, Manufacturing, and Control (CMC) activities for IND-enabling pharmacology/toxicology tests Pharmacokinetic/ADME (absorption, distribution, metabolism, excretion) studies Tumorigenicity, immunogenicity, mutagenicity and teratogenicity evaluations GMP manufacturing of clinical trial supplies Optimization of delivery systems Development and validation of biochemical assays required for clinical trials (e.g., pharmacokinetic, pharmacodynamic, and/or immunogenicity assays) Clinical studies and clinical trials (Note: not every Institute or Center at NIH supports clinical trials through this FOA. Please see below the section of Interests of Specific Institutes/Centers) Unlike typical SBIR and STTR research and development grants or contracts, companies have the option of out-sourcing a significant portion of the work requested through the CRP, provided the expert services are appropriate for the work proposed and well justified in the application. The SBC should perform a substantive role in the oversight and management of the R&D proposed, including appropriate oversight of all scientific, programmatic, financial, and administrative matters related to the grant. Therefore, NIH expects the SBC to request enough funds to enable management of the activities. The remainder of the funds can be distributed among the subcontractors, consultants and SBC depending on the type of work proposed. CRP awards cannot be used to pay filing fees associated with filing patents or FDA submissions. CRP applicants cannot request the separate Technical and Business Assistance (TABA) funding allowed in Phase I and II projects. Interests of Specific Institutes/Centers For specific information about the mission of each NIH IC, visit the List of NIH Institutes, Centers, and Offices website. National Eye Institute (NEI) The National Eye Institute (NEI) is interested in CRP applications from NEI Phase II SBIR-funded applicants in the General Topic Areas listed above, provided they are within the NEI mission. The NEI will only accept CRP applications from SBIR Phase II or SBIR Phase IIB awardees. Applications for research involving human subjects can be submitted in response to this FOA, but NEI may decline funding of any application that includes human subjects for programmatic or administrative reasons. SBIR applicants considering projects involving human subjects are strongly encouraged to contact Scientific/Research staff. National Heart, Lung, and Blood Institute The NHLBI will accept CRP applications from NHLBI Phase II and Phase IIB funded institutions, provided they are within the NHLBI mission. NHLBI also participates in the Commercialization Readiness Pilot (CRP) Program: Technical Assistance (SB1) (PAR-20-128) so applicants interested in only requesting technical assistance should apply through that funding opportunity. National Institute on Aging NIA’s Office of Small Business Research invites NIA Phase II and Phase IIB awardees to apply to the Late-Stage Commercialization Readiness Pilot Program (CRP), provided that the proposed R&D falls within NIA’s mission. Applications addressing Alzheimer’s disease (AD) and AD-related dementias (ADRD) are of particular interest. NIA also participates in the Technical Assistance CRP Program (SB1) (PAR-20-128), which is exclusively dedicated to providing funding for technical assistance. NIA will accept budgets up to $1,750,000 total costs per year and up to the 3 years, providing that total proposed award funding support for the entire budget period does not exceed $3,360,358 total costs. National Institute on Alcohol Abuse and Alcoholism (NIAAA) The National Institute on Alcohol Abuse and Alcoholism (NIAAA) is interested in CRP applications from NIAAA Phase II or Phase IIB funded applicants in the General Topic Areas -listed above, except that NIAAA will not provide support for clinical trial-related activities under this CRP FOA. NIAAA will support only proposed CRP projects on the development of novel therapies that are within the NIAAA mission. Applicants are encouraged to contact Scientific/Research staff about anticipated activities prior to submission. Applicants considering projects involving any type of human subjects research are strongly encouraged to contact program staff for consultation before submission. NIAAA also participates in the Commercialization Readiness Pilot (CRP) Program: Technical Assistance (SB1) (PAR-20-128) and applicants interested in requesting only technical assistance should apply through that funding opportunity. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) The NICHD is interested in Late Stage Commercialization Readiness Pilot Program (CRP) applications consistent with the topic areas listed in the NICHD section of the PHS 2019-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA, provided their topics are also within the priority areas of the NICHD extramural research branches and the National Center for Medical Rehabilitation Research. The NICHD will only accept CRP applications from NICHD-funded SBIR Phase II/Phase IIB awardees and may decline funding of any application that includes human subjects for programmatic or administrative reasons. Potential applicants considering projects involving human subjects research are strongly encouraged to contact program staff early in the process of preparing a submission. For information about NICHD's Small Business Program, https://www.nichd.nih.gov/grants-contracts/SBIR_STTR. National Institute on Deafness and Other Communication Disorders (NIDCD) The National Institute on Deafness and Other Communication Disorders (NIDCD) is interested in CRP applications in the General Topic Areas listed above, provided their projects are within the NIDCD mission areas. NIDCD will only accept CRP applications from NIDCD SBIR and STTR Phase II or Phase IIB awardees and may decline funding of any application for programmatic or administrative reasons. Potential applicants are strongly encouraged to contact program staff noted in the Phase II award early in the process of preparing a submission. National Institute of Mental Health (NIMH) The National Institute of Mental Health (NIMH) is interested in CRP applications from NIMH Phase II and Phase IIB funded applicants in the General Topic Areas listed above. NIMH will only support proposed CRP projects that are within the NIMH mission. For information about NIMH's Small Business Program, please visit http://www.nimh.nih.gov/funding/small-business-research-programs.shtml National Institute for Neurological Disorders and Stroke (NINDS) The National Institute for Neurological Disorders and Stroke (NINDS) is interested in CRP applications from NINDS Phase II/IIB funded applicants, provided they are within the NINDS mission. For those studies that use an FDA-regulated intervention, NINDS will give priority to those applications with (a) A protocol submitted under an open IND and the IND is not under full or partial hold. (b) A protocol submitted as an original IDE or as a new study under an open IDE, and FDA has fully approved the IDE or IDE supplement. (c) A protocol submitted under an IND and is on full or partial hold. (d) A protocol submitted as an original IDE or as a new study under an open IDE, and FDA has conditionally approved the IDE or IDE supplement. (e) A protocol is exempt from an IND. (f) A protocol is either exempt from the IDE regulations or does not require IDE approval because it is determined to be nonsignificant risk. NINDS may decline funding of any application that includes human subjects for programmatic or administrative reasons. SBIR applicants considering projects involving human subjects research are strongly encouraged to contact program staff early in the process of preparing a submission.