National Cancer Institute (NCI) Small Business Innovation Research (SBIR) Innovative Concept Award Program – Fiscal Year 2025
ID: 75N91024R00013Type: Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNIH NCIBethesda, MD, 20892, USA

NAICS

Research and Development in the Physical, Engineering, and Life SciencesT (54171)

PSC

HEALTH R&D SERVICES; HEALTH CARE SERVICES; APPLIED RESEARCH (AN12)

Set Aside

Total Small Business Set-Aside (FAR 19.5) (SBA)
Timeline
    Description

    Presolicitation HEALTH AND HUMAN SERVICES, DEPARTMENT OF NATIONAL INSTITUTES OF HEALTH is seeking proposals from small businesses to develop innovative technologies for the treatment and prevention of Pediatric Cancers and/or Rare Cancers. The proposals should focus on the development of therapeutic or preventative technologies, devices, diagnostic technologies, or digital health tools. The aim is to demonstrate technical feasibility and proof-of-concept for highly innovative and potentially transformative technologies. The solicitation encourages proposals for rare cancers with a 5-year survival rate of less than 50%. The proposals should include experiments to obtain initial de-risking and proof-of-concept data. The awards will also include requirements to enhance entrepreneurship skills and develop a business model and commercialization plan. This is a total small business set-aside solicitation, and only eligible small businesses with no more than 500 employees will be considered. The solicitation is anticipated to be available on or around April 12, 2024, with a closing date in late September for receipt of proposals. Other SBIR and STTR contract and grant opportunities are also available. For more information, please refer to the NCI SBIR Program website.

    Point(s) of Contact
    Similar Opportunities
    A Solicitation of the National Institutes of Health (NIH) and The Centers for Disease Control and Prevention (CDC) for Small Business Innovation Research (SBIR) Contract Proposals
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) seek proposals from small businesses for innovative research projects under the Small Business Innovation Research (SBIR) program. The upcoming solicitation, PHS-2025-1, will open on August 2, 2024, with a closing date of October 18, 2024, and aims to foster healthcare technological innovation and commercialization. Research topics span cancer research, aging, and various health concerns. Offerors must demonstrate the technical and commercial viability of their proposals. This solicitation invites applications for Phase I, Fast Track, and Direct to Phase II projects, with evaluations based on scientific merit, commercial potential, and performance quality. Successful small businesses could receive funding for their research initiatives, contributing to NIH and CDC mission objectives.
    A--BPCA Pediatric Trials Network
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is soliciting proposals for an Indefinite Quantity Contract to establish and manage the Best Pharmaceuticals for Children Act (BPCA) Pediatric Trials Network. This initiative aims to create a robust infrastructure for conducting pediatric clinical trials, emphasizing compliance with federal regulations and ethical standards in research practices. The contract, which has a performance period from May 19, 2025, to May 18, 2033, offers a minimum compensation of $2,500 and a maximum potential value of $149 million, contingent on successful performance. Proposals are due by November 4, 2024, and interested parties can contact Elizabeth J. Osinski at eo43m@nih.gov or 240-550-5028 for further information.
    A--Request for Proposals - Phase I Clinical Trials
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is seeking proposals for Phase I clinical trials aimed at developing small molecule and biologics therapeutics, as outlined in RFP No. 75N95024R00086. The selected contractor will be responsible for comprehensive services including protocol development, trial management, and reporting to regulatory agencies, with a focus on safety, tolerability, and pharmacokinetics of the investigational therapeutics. This initiative is crucial for advancing therapeutic development in the field of neurology, ensuring compliance with FDA and ICH GCP standards throughout the trial process. Proposals are due by October 3, 2024, with a contract performance period from April 1, 2025, to March 31, 2035, and a maximum contract value of $233,227,446. Interested parties can contact Evan C. Feely at evan.feely@nih.gov or +1 301 827 5301 for further information.
    DRAFT Decentralized Engineering of Cells Informed by Dynamic Evidence (DECIDE) Exploration Topic
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health's Advanced Research Projects Agency for Health (ARPA-H), is soliciting proposals for the Decentralized Engineering of Cells Informed by Dynamic Evidence (DECIDE) exploration topic. This initiative aims to enhance access to curative cell therapies for pediatric patients with rare genetic diseases by developing novel quality assurance mechanisms at Academic Medical Centers (AMCs) over a structured 24-month program. The program will focus on identifying manufacturing variability, improving batch quality through signature identification methodologies, and creating statistical tools to guide production decisions, ultimately streamlining the development of small batch autologous cell therapies. Proposals are due by October 22, 2024, and interested parties should direct inquiries to the designated email address provided in the solicitation.
    Chemistry, Manufacturing and Controls and Related Services for Development of Drug Substances
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health (NIH), is seeking proposals for Chemistry, Manufacturing, and Controls (CMC) services related to the development of drug substances. The primary objective is to ensure the Division of Preclinical Innovation (DPI) receives drug substances of adequate quality and quantity to support preclinical and Investigational New Drug (IND)-enabling studies, adhering to current Good Manufacturing Practice (cGMP) standards. This procurement is crucial for advancing therapeutics from preclinical stages to market readiness, emphasizing a multidisciplinary approach and compliance with regulatory requirements throughout the drug development pipeline. The Request for Proposals (RFP) is expected to be released on or about October 4, 2024, with contract awards anticipated in the second quarter of FY2025. Interested parties may contact Samson Shifaraw at samson.shifaraw@nih.gov for further information.
    POSEIDON (Platform Optimizing SynBio for Early Intervention and Detection in ONcology)
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the National Institutes of Health's Advanced Research Projects Agency for Health (ARPA-H), is soliciting proposals for the POSEIDON program, which focuses on developing advanced at-home Multi-Cancer Early Detection (MCED) tests using synthetic biology. The program aims to create low-cost, accessible tests for the early-stage identification of over 30 solid tumors, utilizing breath and urine samples, with an emphasis on integrating these tests with telehealth systems and ensuring accessibility for underserved populations. This initiative is critical for transforming cancer diagnostics, potentially saving millions of lives and reducing the economic burden of late-stage cancer care, with a target commercialization price of $100 or less. Interested parties must submit their Solution Summaries by November 6, 2024, with a priority submission date of October 16, 2024, and can contact the POSEIDON Team at POSEIDON@arpa-h.gov for further information.
    NIH Small Business Program Office | 2024 Outreach Activities
    Active
    Health And Human Services, Department Of
    Special Notice HEALTH AND HUMAN SERVICES, DEPARTMENT OF NIH Small Business Program Office | 2024 Outreach Activities The National Institutes of Health Small Business Program Office is organizing the May 2024 Vendor Outreach Engagement on Thursday, May 23, 2024, from 10:00 am to 12:00 pm in Bethesda, Maryland, United States. This event aims to expand and accelerate the National Institute of Environmental Health Sciences' contributions to scientific knowledge of human health and the environment. It also focuses on the health and well-being of people everywhere. The Office of Acquisitions, a full-service contracting organization, will provide comprehensive contracting services during the event. These services include Research and Development (R&D) contracting, Non-Research and Development (Non-R&D) contracting, Simplified acquisitions, Small business program assistance, and Purchase card oversight. To participate, interested companies must register by clicking the orange "Register" button on the event page. Each company is limited to four attendees, and there is a registration limit of 400 people. This event is free of charge and serves as a substitute for the NIH Small Business Program Office's May 2024 1-on-1 consultations. Additionally, the NIH Small Business Program Office presents the January 2024 Vendor Outreach Engagement - Newbie Open Forum. This forum, held on Wednesday, January 24th, 2024, from 11:00 am to 12:30 pm at Rockledge II, is specifically for prospective vendors who do not have NIH's past performance as a prime contractor. The forum provides an opportunity for vendors to interact with the NIH SBPO, learn about the NIH's contracting needs, and network with attendees. Space is limited for this event, with each company limited to one attendee. The registration limit is 40 people. Similar to the May 2024 event, this forum substitutes the NIH Small Business Program Office's January 2024 1-on-1 consultations and is free of charge. To join the NIH Small Business Office listserv, interested individuals can copy and paste the provided link into their web browser. The room number and additional details for the event will be provided the day before the event. Please ensure the success of this procurement notice to prevent my family from becoming homeless.
    PREPARATION AND DISTRIBUTION OF RESEARCH DRUG PRODUCTS
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH), specifically the National Institute on Drug Abuse (NIDA), is seeking proposals for the preparation and distribution of research drug products under a presolicitation notice. The contract will involve acquiring, importing, and exporting drugs and chemical compounds, as well as developing and analyzing various drug dosage forms, including marijuana and nicotine research cigarettes, to support drug abuse and addiction research. This contract is critical for maintaining a reliable supply of authentic controlled and uncontrolled drug compounds for the research community, with an anticipated award of one indefinite delivery, indefinite quantity (IDIQ) contract over a five-year period. Interested parties must possess a current DEA registration and comply with FDA’s current Good Manufacturing Practices, with proposals due approximately 45 days after the release of the RFP, expected on or about September 20, 2024. For further inquiries, contact Scott Duernberger at scott.duernberger@nih.gov or 301-594-0670.
    A--To Expand the Workscope of the PACT III Program
    Active
    None
    Presolicitation A federal procurement notice has been issued by the Department of Research and Development. The notice is for the expansion of the Production Assistance for Cellular Therapy (PACT) III program. The purpose of this acquisition is to reintroduce the manufacture and distribution of cellular products for use in human subjects participating in clinical trials under investigational new drug (IND) applications for the cell product. This procurement is set aside for SBA Certified Women-Owned Small Businesses (WOSB).
    Office-Wide Innovative Solutions Opening for Health Science Futures (HSF)
    Active
    Health And Human Services, Department Of
    Presolicitation notice from the HEALTH AND HUMAN SERVICES, DEPARTMENT OF, NATIONAL INSTITUTES OF HEALTH, NIH ADVANCED RESEARCH PROJECTS AGENCY FOR HEALTH (ARPA-H) is seeking innovative solutions through individual Office-wide solicitations. The Office-wide ISOs will target specific areas of interest and may request abstracts and/or proposals. The goal is to select revolutionary ideas to improve health outcomes for all Americans. The solicitation will award Other Transactions and Cooperative Agreements, making the Federal Acquisition Regulations (FAR) not applicable. This notice includes DRAFT Office-wide ISOs for each ARPA-H Mission Office (HSF, PHO, RSO, and SSO). Questions regarding the DRAFT solicitations should be submitted through the provided link.