1. Grant funding for biotech-academia collaborations
April 23, 2019

2. My career path PhD Rockefeller University (1988) Post-doc Mount Sinai
Post-doc UCSF
Research Assistant Professor UCDavis
Galileo Pharmaceuticals (1999)
L2 Diagnostics (since 2002)

3. L2 Diagnostics A rarer type of biotech business model
Started in 1998 by the Section of Rheumatology at Yale, as a diagnostics testing company focused on Lyme disease and lupus
R&D branch now much larger than the diagnostic reference lab. 15- employees, 3,500 sq. ft. facility
Focused on (very early) pre-clinical research on a wide variety of topics
Mostly grant-funded

4. L2 Diagnostics – Research areas
Infectious diseases
Diagnostics: Tickborne diseases, Pseudomonas, Zika virus, Kawasaki disease,…
Vaccines: Tickborne diseases, mosquito-borne diseases, Leishmania, malaria, …
Anti-infectives: Tuberculosis, S. aureus, Pseudomonas, dengue virus
Cancer
Hepatocellular carcinoma
Breast
Glioma
Inflammation
Anti-MIF compounds
Diagnostics
Chemical-triggered asthma, response to radiotherapy, biomarkers of autoimmune attacks

5. L2 Diagnostics – Grant funding
Most grant funding mechanisms are open to for-profit businesses
(Surprisingly) sustainable
STTR/SBIR ONLY

6. A primer on small-business grants (1)
SBIR
2.5% of extramural research budget for agencies with a budget >$100M
PI must be with small business concern. No need for academic partner
Small business concern must accomplish % of the work
STTR
0.3% of extramural research budget for agencies with a budget >$1B
PI can be with small business concern or with academic partner
Academic partner(s) must accomplish 40-60% of the work

7. A primer on small-business grants (2)
Phase I: 1 (or 2) year - $225K-300K per year total costs
Phase II: 2 (or 3) years - $1-3M total costs
Funds are split according to work proposed, within mandated guidelines
(Usually) reviewed by specialized study sections. Review criteria are (meant to be) the same as for academic grants
Success rate: 20% for Phase I, 40% for Phase II. Only about 10% of Phase I progress to Phase II
Must have a product as a final product. Market can be a small one
No dilution of equity. No reach-through provision for intellectual property

8. L2 Diagnostics – Grant funding
STTR/SBIR ONLY

9. Grant-funding in biotech
Impact on culture (publications, conferences)
Impact on scientific activity
Agility
NIH is much less controlling than VC
Grants can fund efforts peripheral or preliminary to main focus (e.g. Sanaria)
Need to be on cutting edge
Need not address a large market
Impact on lifestyle
Time spent writing
Salaries

10. No, we are not unique
Ambergen, Inc. Watertown MA

11. Biotech-Academia collaboration
Collaboration, as opposed to licensing and running with it
This process has consequences on multiple fronts
Type and scope of projects
Funding considerations – Role of small-business grants
A meeting of cultures

12. Collaborating in the “valley of death”
Reproducibility
Breadth of applicability (animal models, bacterial strains, human populations)
Scaling up
Production / stability issues
Cost
Toxicity
False positive / False negative rates

13. Biotech-academia collaborations: a meeting of cultures
All collaborations involve a loss of control
Communication
Expectations
TRUST

14. https://www. polleverywhere

15. https://www. polleverywhere

16. https://www. polleverywhere