A presentation at the Global Genes rare drug development symposium on government funding
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This presentation from June 12 2020 gives a brief overview of my experience of 15 years of applying for government grants to fund small companies. Prior to this I had no experience of applying for such grants. The bottom line for rare disease groups / families is find a scientist that can do this or assist you. please also see www.collaborationspharma.com
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A presentation at the Global Genes rare drug development symposium on government funding
- 1. Leveraging Government Funding to Build Companies Sean Ekins, CEO, Collaborations Pharmaceuticals, Inc.
- 2. A brief history of my grant funding • GeneGo – 2005 Phase II SBIR $750,000 • Snowden – 2007 3 STTRs $890,000 • CDD – 2010- 2018 4 STTR and SBIRs ~$2.8M • Phoenix Nest 2014-2018 5 STTRS ~$7.5M • CPI 2016-PRESENT 16 grants ~$7.5M
- 3. CPI background • Founded 2015 • No Angel or VC funding • >$7.5M in grant funding and a robust molecule and services pipeline make us a stable partner • Leverage NIH and DOD funding to de-risk assets. • 8 FDA orphan drug designations • Several patents / provisionals submitted • Trademarks for our machine learning software and name/tag line Assay Central, MegaTox, MegaPredict, MegaTrans, Collaborations Pharmaceuticals, Inc. and No Disease is Too Small
- 4. Pipelines Preclinical In vitro Preclinical In vivo Clinical NIH/DOD Funding M achine Learning PatentFiling Indication Ebola Marburg Chagas Disease M. tuberculosis A M. tuberculosis B M. tuberculosis C M. tuberculosis D HIV Batten CLN1 Batten CLN1 HNPP* C. Neoformans Hepatitis B Staphylococcus A Rhino/Enterovirus Acute Flaccid Myelitis M. Abscessus Norovirus Pitt Hopkins Syndrome Sialidase Alzheimer’s Disease COVID-19 Italics = biologic *optioned from Vanderbilt Univ. ODD
- 5. NIH NIAID R41AI108003-01 R41AI134561-01A1 NIH NIGMS R43GM122196 R44GM122196-02A1 1R41GM131433-01A1 3R44GM122196-03S1 NIH NCATS R21TR001718 1UH2TR002084-01 NIH NINDS 1R01NS102164-01 1R43NS107079-01 NINDS 3R43NS107079-01S1 3R43NS107079-01S2 1R43AT010585-01 1R43ES031038-01 W81XWH1810802 HDTRA1-19-1-0020 One North Carolina SBIR/STTR Matching Funds © 2019 Collaborations Pharmaceuticals Inc. Non-Proprietary Slides. NIEHS
- 6. What We Do Our Mission: ▶ We use real drug discovery intelligence alongside artificial intelligence to develop clinical candidates for rare, neglected and unmet therapeutic needs. ▶ We are also a contract services organization, using AI and Machine Learning to deliver results based on our clients needs ▶ We focus on: ▶ Early Drug Discovery, hit to lead to candidate ▶ Challenging ADME/Tox problems ▶ Challenging new data sets ▶ In addition to custom services work, we offer packaged collections of models -Our goal is to be your partner of choice for machine learning- © 2020 Collaborations Pharmaceuticals Inc. Non-Proprietary slides.
- 7. How to do it – what you need to begin • Initially STTR/SBIR • Need for an academic collaborator (if STTR) • You need a Principal Investigator (STTR or SBIR) • You need a company • You need to do ~ 5 registrations on govt websites, grants.gov, Commons etc… • You need an idea of what you want to write • You may need some preliminary data (does not have to be data you generated)
- 8. Overview • $100Ms set aside for NIH STTR / SBIR • $1bn set aside for Defense STTR / SBIR • Payline is higher than for academic grants • Payline for SBIR better than STTR – varies by NIH group • Academics need a company to go after these grants • This is non-dilutive funding https://sbir.nih.gov
- 9. Small print • STTR – you need to collaborate with an academic/ institute – Must do 40% of the work and the institute must do at least 30% minimum. • SBIR – you can collaborate with an academic etc..upto 33% of grant goes to them in Phase I and 50% in Phase II. • SBIR ..or you can keep all the money for your company • SBIR normally 6 months – 1 yr. $256,580.. • STTR normally 1yr $256,580.. • Phase 2 – 2-3 years for a total of $1,710,531 • Straight to Phase II, Fast track etc…
- 10. The Proposal • Cover letter • Aims – 1 page • Summary – 1 page • Narrative – 4-5 sentences • Strategy 6 pages • References • Data and Software Sharing Plan • Budget justification – CPI • Facilities • NIH Multiple-PI Leadership Plan • Animal Justification • Biosketches – 5 page max • Authentication of Key Biological and/or Chemical Resources Letters of support
- 11. Phase II • Write a report on the work so far..included in.. • 12 page strategy doc laying out what we want to do in phase II • 12 page commercialization • Examples of applications / collaborations
- 12. Strategy – 12 pages • I. Significance • Overview • Improvements to scientific capabilities • Impact on practice if aims are achieved • Commercialization pathway • II. Innovation • III. Approach • Specific aims and overall research strategy • Phase 1 progress report • Preliminary studies prior to phase I • Methodology • Milestones and benchmarks for success • Expected outcomes • Problems, alternative strategies and risk assessment • IV. Scientific rigor
- 13. Commercialization – 12 pages • Value of project, expected outcomes and impact • Company • Market, customer, and competition • Intellectual property (IP) protection • Finance plan • Production and marketing plan • Revenue stream
- 14. • Good luck