Biotechnology Commercialization in the USA

1. Biotechnology Commercialization in the USA University Research to the Marketplace

2. Overview • Current climate for university-industry interactions in the USA • University lab to the marketplace • Anatomy of a university-company “deal” • Careers at the university/industrial interface

3. Reference Points ME WA VT NH MA MT ND MN NY OR RI ID WI MI SD CT MD NJ WY PA DE IA OH NE IN IL WV Washington D.C. NV VA UT CA CO KY KS MO NC TN SC OK AR AZ NM GA AL MS AK TX LA FL HI

4. Recent Statistics • 2017: 1080 startups come out of US universities • 755 new products created • 1996-2015: >11,000 new companies started • 4.3 million jobs supported • >200 new drugs and vaccines created since 1980

5. Current Environment • University discoveries are at an embryonic stage - high risk, high investment needed • Investors and large corporations stay away from high risk projects • Startup companies can accept risk • Universities are now more focused on startups

6. Universities and Startups • Students and post-doctoral fellows are highly interested • University researchers are encouraged to start new companies – startups or “spin-offs” • Universities experiment with ways to advance startup formation • Led by university tech transfer office

7. Universities Encourage Startups • Faculty/student seminars • New curricula focused on entrepreneurship • Business plan competitions • Internal funds to advance technologies • Innovation districts • Maker’s spaces • Shared work space for young companies • Hackathons

8. Faculty Relationships with Corporations Have Broadened • Consulting – scientific advisor • Sponsored researcher • Entrepreneur – startup founder

9. Faculty Entrepreneurs • Desire to make an impact • Peers have done it • Personal financial rewards • Desire for corporate-sponsored research dollars • Provide jobs for trainees

10. University – Industry Relationships Are Multiple • Vendor/client – product sales • Legal - licensing of intellectual property • Scientific collaboration - corporate-sponsored research • Advisory - corporations on university boards • Educational - specialized courses for corporations • Philanthropic - corporate donations

11. Discovery to Marketplace • Research discovery with practical application • Disclosed to technology transfer office • Commercial potential? • Protectable as intellectual property? • Research for concept validation • Licensed to company • Product development: prototype, safety/efficacy, mfg, QC/QA, regulatory approval • Product sales

12. Timelines • University discoveries are not products • Product development can easily take 2-10 years and lots of money • Shorter for IT, software, digital media • Mid-range for medical and other devices • Longer for drugs and vaccines • Success rate can be low – very high risk

13. Inventions of Medical Import • Drugs/vaccines • Therapeutic processes - cellular • Gene therapy • Medical devices • Diagnostics • Research instrumentation • Research reagents

14. Inventions of Non-medical Import • Plant varieties - breeding, genetic engineering • Computer-driven agriculture • Food processing • Animal vaccines • IT

15. How Does a University License Work? • Property licenses: intellectual vs. tangible • License grants the company the right to make, use and sell the invention • Exclusive vs. non-exclusive • Territory • Length of license term • Financial return – equity, % of sales (royalty), other fees

16. What Happens to the Money? • License revenue generally split 3 ways: • University • Inventors’ school/department • Inventors

17. University Inventions +/- • (+) No restrictions in research topics • (+) 10-20 years ahead of the market • (-) Very early, high risk, investors are reluctant • (-) Universities are technology-driven, companies are market-driven • (-) Universities think that the hard work is done at the concept stage