National Institute of Allergy and Infectious Diseases (NIAID) put out a call on 22 Oct 2020 for applications for its Applicant Assistance Program (AAP). The AAP provides no cost support for US-based companies planning to apply for a Phase II, Fast Track, or Direct-to-Phase II Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) Awards. The SBIR/STTR programs are also known as America’s Seed Fund and provide early-stage capital for technology commercialization in the US. Go here for the home page for these programs. Note that Phase I and Phase II do not refer to clinical development but rather refer to feasibility work (Phase I) and actual R&D (Phase II).
Also note (19 June 2022 update), that SBIR/STTR have been rebranded as NIH SEED with everything moved to this new website: https://seed.nih.gov/. I have tried to update the links in this archived newsletter to match the new structure but be aware that you may need to hunt around a bit to finding the information you need.
Only 25 applications will be accepted, so you are encouraged to apply promptly! More details are found below my signature.
All best wishes, –jr
John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Operating Partner, Advent Life Sciences. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: https://amr.solutions/blog/. All opinions are my own.
=== FURTHER DETAILS ===
Participants in the AAP will work one-on-one with a Senior Consultant from Foresight Science & Technology, who will help you prepare your proposal with services such as: Outlines or Checklist, Market Data for Commercialization Plan, Review and Feedback on Commercialization Plan, Research Strategy, Budget, or Attachments.
To be eligible for the program, you must meet the following criteria:
- The research area of interest aligns with the mission of NIAID.
- The company intends to submit a Phase II, Fast Track, or Direct-to-Phase II application SBIR/STTR application.
- The company intends to submit an application for the January 5, 2021 deadline.
- The company must be eligible to apply for NIH SBIR/STTR grants based on the NIH Small Business Eligibility Criteria.
If you meet these eligibility requirements, Apply Now! Participation is limited to the first 25 qualified applicants.
Each company may submit only one application to the AAP.
For assistance regarding the Application Form, please contact: Mrs. Kelli Cardoso, Project Coordinator Foresight Science & Technology, Email: firstname.lastname@example.org
For specific questions about the AAP, please contact: Konstantin Izvolsky, Ph.D., Director of Consulting and Training Foresight Science & Technology, Telephone: (401) 273-4844, ext. 4003, Email: email@example.com
NIAID encourages participation from small businesses that are owned or operated by individuals who are traditionally underrepresented in biomedical sciences, such as women-owned small businesses, socially/economically disadvantaged small businesses, and companies located within Historically Under-utilized Business (HUB) Zones.
=== DEFINITIONS and useful links ===
In general, SBIR/STTR grants are for US-based small businesses, and they have Phasing, with increasing time and dollars as a company proceeds through the Phases. Phase 1 is feasibility. Phase 2 is full-on R&D. Normally, these are two separate grant applications and reviews, but the fast-track allows a single award to include Phase 1 and Phase 2. Also normally, you have to have a Phase 1 before you can apply for a Phase 2, but the Direct-to-Phase 2 allows you to skip the Phase 1 application phase for SBIRs (not for STTRs).
These grants have been extremely successful (https://seed.nih.gov/portfolio/stories) and product developers within the US are encouraged to consider them. The NIAID AAP is intended to provide guidance on navigating the different mechanisms below.
- https://seed.nih.gov/ – Home page for SBIR/STTR grant information for NIH programs.
- https://www.niaid.nih.gov/grants-contracts/sbir-budget-guidance-update – Waiver topics allowing more SBIR/STTR funding and longer SBIR/STTR grant periods are sometimes available.
- https://seed.nih.gov/ – Description of Application types, expanded below.
SBIR/STTR Grant Mechanism: The United States Congress created the SBIR program in 1982 and the STTR program in 1992. These programs congressionally require eligible governmental agencies to set aside a percentage of their extramural budget so that domestic small businesses can engage in R&D that has a strong potential for technology commercialization.
SBIR/STTR Phase 1: Feasibility and Proof of Concept: Phase I awards are intended to establish the technical merit, feasibility, and commercial potential of the proposed research and research and development (R/R&D) efforts. These applications help determine the quality of performance of the small business prior to providing further Federal support in Phase II.
SBIR/STTR Phase 2: Research/Research and Development Phase II awards are intended to continue the R/R&D efforts initiated in Phase I. Funding is based on the results achieved in Phase I and the scientific and technical merit and commercial potential of the project proposed in Phase II. Only Phase I awardees are eligible for a Phase II award (see exception in Direct to Phase 2 below).
SBIR/STTR Fast-track: incorporates a submission and review process in which both Phase I and Phase II grant applications are submitted and reviewed together as one application. Because both phases undergo review at the same time, the NIH Fast-Track mechanism can reduce or eliminate the funding gap between phases. Fast-track applications are considered new (Type 1) in the NIH grant numbering system.
SBIR/STTR Direct Phase 2: allows a Phase 2 award without a requirement for a Phase 1 award. Section 5106 of the SBIR/STTR Reauthorization Act of 2011 authorized that NIH may ‘issue a Phase II award to a small business concern that did not receive a Phase I award for that research/research & development’. This ‘phase flexibility’ is called a ‘Direct-to-Phase II’ SBIR award. The SBIR Direct-to-Phase II authority is not available to the STTR program and not available for the CDC, FDA, and ACL SBIR programs. See https://www.sbir.gov/tutorials/program-basics/tutorial-4.
Current funding opportunities (most current list is here):
- The National Institute of Allergy and Infectious Diseases (NIAID) Applicant Assistance Program (AAP) opened on October 22, 2020. This program provides no cost support for companies planning to apply for a Phase II, Fast Track, or Direct-to-Phase II SBIR or STTR Award. Go here for details.
- Novo REPAIR Impact Fund closed its most recent round on 31 Jul 2020. Go here for current details.
- 2020 funding rounds for CARB-X have not been announced.
- The Global AMR R&D Hub’s dynamic dashboard (link) summarizes funders and projects by geography, stage, and more.
- It’s not a funder, but AiCuris’ AiCubator offers incubator support to very early stage projects. Read more about it here.
- ARLG (Antibiotic Resistance Leadership Group, link) is currently open for applications for its 2-year ARLG Fellowship program. The application deadline is 1 Dec 2020; full details are here.
- Finally, you might also be interested in the most current lists of R&D incentives (link) and priority pathogens (link)
Upcoming meetings of interest to the AMR community (most current list is here):
- In case you missed it, the 24 Sep 2020 Bootcamp #1 (“Moving from preclinical to clinical-stage: Challenges & opportunities”) is now available for replay: Get it here. The video for the 8 Oct 2020 Bootcamp #2 (“Exploring safety issues in antimicrobial drug development”) will follow shortly — check back at the current meetings webpage (link) to find it.
- 21-25 Oct 2020 (online meeting): IDWeek 2020. Go here for details.
- 26-29 Oct 2020 (online meeting): Annual ESPID meeting (European Society for Pediatric ID, #38)
- 27 Oct 2020 (online, 9a-5p EST): FDA Workshop entitled “Development Considerations of Antimicrobial Drugs for the Treatment of Gonorrhea.” Go here to register.
- 27 Oct 2020 (online meeting): BARDA Industry Day, a discussion of U.S. Government medical countermeasure priorities. Mark your calendar now and watch this website for details.
- 28 Oct 2020 (online, 17:00-18:30 CET): GARDP-sponsored webinar entitled “Developing antibiotics for children – medical need and regulatory challenges” moderated by Sally Ellis. Go here to register.
- 29 Oct 2020 (online, 4-6pm Paris): 5th anniversary ICARe (Interdisciplinary Course on Antibiotics and Resistance) webinar. This fabulous week-long residential course can’t be held this year but Patrice Courvalin is organizing a 2-h anniversary webinar both for former attendees and anybody else who is interested. Speakers will include Patrice as well as Helen Boucher, Gerry Wright, Erin Duffy, and me. Go here to register.
- 3-27 Nov 2020 (online, 4-week course, 10 sessions, 2-3h/session): First WHO Training Course in Infodemic Management. Infodemic = “information” + “epidemic” = rapid and far-reaching spread of both accurate and inaccurate information making it difficult to learn essential information about an issue. This is a training program for country-level preparedness. Application deadline is 18 Oct 2020. Go here for more.
- 5 Nov 2020 (online, 9-10.30am EST) webinar entitled “Aiming in the dark: what happens when disease spreads without diagnosis”, the third webinar in a 4-part series sponsored by Wellcome Trust entitled “AMR in the Light of COVID-19 Webinar Series; From hypothetical to reality: How COVID-19 foretells a world without antibiotics.” Go here to register.
- 16 Nov 2020 (online, 9.30a-4.00p EST): FDA workshop entitled “Potential Approach for Ranking of Antimicrobial Drugs According to Their Importance in Human Medicine: A Risk Management Tool for Antimicrobial New Animal Drugs.” Go here for the FR notice and here for extended details, including registration.
- 17 Nov 2020 (online, 17:00-18:30 CET): GARDP-sponsored webinar entitled “Discovery of new antibacterials using artificial intelligence (computational chemoinformatics)” moderated by Laura Piddock. Go here to register.
- 18-24 Nov 2020 (everywhere): World Antimicrobial Awareness Week. For resources, go here for WHO’s home page for the week. The focus will be on two messages: “Antimicrobials: handle with care” and “United to preserve antimicrobials.”
- 19 Nov 2020 (online, 9-10.30am EST) webinar chaired by Jeremy Knox entitled “Responding to difficult-to-treat infections: Role and responsibilities of governments, researchers, clinicians, industry and patients”, the final webinar in a 4-part series sponsored by Wellcome Trust entitled “AMR in the Light of COVID-19 Webinar Series; From hypothetical to reality: How COVID-19 foretells a world without antibiotics.” Go here to register.
- 26-28 Jan 2021 (online, runs ~7.30a-5.00p Central each day): 4th Annual Texas Medical Center Antimicrobial Resistance and Stewardship Conference. Sponsored by McGovern Medical School, ARLG, and the Gulf Coast Consortia, the agenda includes both poster sessions and keynotes. The call for abstracts closes 18 Dec 2020. Go here for more details.
- 9-12 Jul 2021 (Vienna): Annual ECCMID meeting (#31)
- 18-21 May 2021 (Albuquerque, New Mexico): Biannual meeting of the MSGERC (Mycoses Study Group Education and Research Consortium). Save-the-date announcement is here, details to follow.
- 20-24 June 2021 (Toronto): International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD-12). Go here for details.
- 3-7 Jun 2021 (Anaheim), ASM Microbe 2021. Go here for details.
- 27 Jun-2 Jul 2021 (Ventura, CA): Gordon Research Conference entitled “Antimicrobial Peptides”. Go here for details, go here for the linked 26-27 Jun Gordon Research Seminar that precedes it.
- 5-21 Aug 2021 (Marine Biology Laboratory, Woods Hole, MA): Residential course entitled “Molecular Mycology: Current Approaches to Fungal Pathogenesis.” This 2-week intensive training program has run annually for many years and gets outstanding reviews. Go here for details.
- 8-11 Oct 2021 (Aberdeen, Scotland): 10th Trends in Medical Mycology. Go here for details.
- 16-24 Oct 2021 (Annecy, France): Interdisciplinary Course on Antibiotics and Resistance (ICARe). This is a soup-to-nuts residential course on antibiotics, antibiotic resistance, and antibiotic R&D. The course is very intense, very detailed, and gets rave reviews. Registration is here and is limited to 40 students.
- 6-11 Mar 2022 (Il Ciocco, Tuscany): Gordon Research Conference entitled “New Antibacterial Discovery and Development”. Go here for details, go here for the linked 5-6 Mar Gordon Research Seminar that precedes it.