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
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
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