By: Ethel Rubin, PhD, Entrepreneur-in-Residence, NIH Office of the Director Office of Extramural Research
Thank you for welcoming me, my National Institutes of Health colleagues, and our four sponsored companies to your Annual Summit in Boston last month! It was a pleasure to speak with many of you in person, to learn more about angel investing and your respective sweet spots. We hope you learned more about NIH’s seed investment fund. National Institutes of Health invests over $1B funding available to life science companies annually in the form of grants and contracts.
But, the Institutes and Centers that comprise NIH have services that go beyond funding. Companies have used these types of additional resources and services for further development of their technologies towards commercialization. The product development enabling programs highlighted below allow small businesses to apply for free services – why shouldn’t your company utilize them?
From the National Heart, Lung, and Blood Institute (NHLBI):
Production Assistance for Cellular Therapies (PACT)
- IND-enabling preclinical studies and other services (Regulatory, manufacturing, process dev and study protocol dev) for cell therapy products.
BioLINCC: Clinical Specimen and Data Repository
- Companies may request samples or data from collections of more than 145 NHLBI-funded population-based studies.
From the National Center for Advancing Translational Sciences (NCATS):
Bridging Interventional Development Gaps (BrIDGs)
- Partnering with companies to advance drugs for late-stage pre-clinical development and into clinical testing.
- Offers collaboration with NCATS scientists to produce pre-clinical data as well as research and clinical material needed for regulatory filings.
Therapeutics for Rare and Neglected Diseases (TRND)
- Supports pre-clinical drug development (lead optimization to FDA IND filing) of treatments for rare conditions and tropical diseases.
- In limited cases, NCATS may also support clinical studies such as natural history and patient-finding studies.
From the National Cancer Institute (NCI):
NCI’s Experimental Therapeutics Program (NExT)
- NCI built project teams for the discovery and development of oncology therapeutics and imaging agents.
- For more information on the NCI Experimental Therapeutics (NExT) Program, including legal arrangements surrounding IP, visit the NExT website.
Trans-NIH Initiatives:
NIH’s Blueprint Neurotherapeutics Network
- Company support for small molecule drug discovery and development, from hit-to-lead chemistry through phase I clinical testing.
- Choose to receive funding to do the work on your own, access to NIH-funded contract research organizations (CROs) for activities to outsource, or get access to consultants with drug dev expertise. The company decides what combination of funding, CROs, and consultants will best fit their needs.
- IP for compounds developed belongs to Company.
From the National Institute of Mental Health (NIMH):
Toxicological Evaluation of Novel Ligands Program
- Toxicology and safety assessment of promising, target-selective compounds for PET, SPECT, and MRI imaging.
- Limited assessment of novel psychoactive agents for clinical research and as potential therapeutics.
- Toxicology and safety data generated by the program will be used to support an FDA IND or for Radioactive Drug Research Committee (RDRC) evaluation of a compound for human studies.
From the National Institute of Biomedical Imaging and Bioengineering (NIBIB):
Biomedical Technology Resources (BTR)
- Company access to advanced instrumentation, software, data and support.
- Potential interactions include long-term collaboration, routine analysis or consultation.
- Biomedical Technology Resources also provide hands-on laboratory training, short courses, workshops and online resources.
From the National Institute on Drug Abuse (NIDA):
- Many programs to extend the value of our investments in companies and development of lifesaving technologies across lifecycle of product development. Review opportunities from target identification through phase 3 trials and beyond.
The above is a noncomprehensive list of the services available to companies. The best way to stay current on what is available is to subscribe to National Institutes of Health’s SBIR/STTR Listserv – this is the easiest way to stay updated on NIH SBIR/STTR’s upcoming events, funding announcements, reauthorization updates, important deadlines and more.
Add your email address and select the SBIR-STTR NIH SBIR-STTR Funding Opportunities list.
Monday, May 21, 2018 