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The University of Pittsburgh. Office of Enterprise Development, Health Sciences. Creating the Best Investments. Carolyn Green, Director Office of Enterprise Development, Health Sciences University of Pittsburgh Schools of Health Sciences.

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the university of pittsburgh

The University of Pittsburgh

Office of Enterprise Development, Health Sciences

Creating the Best Investments

Carolyn Green, Director

Office of Enterprise Development, Health Sciences

University of Pittsburgh Schools of Health Sciences

slide2

“One way to have a good idea is to have a lot of ideas, and throw the bad ones away.”

~Dr. Linus Pauling

American theoretical chemist and biologist 1901-1994

the evolution of biomedical research
The Evolution of Biomedical Research

1940

1943 – DNA is shown to be the basic genetic material

1950

1953 – Watson and Crick identify DNAs double helix

1960

1966 – DNA’s complete genetic code deciphered

1970

  • 1972 - Paul Berg makes first rDNA
  • 1977 - First human protein (somatostatin) manufactured in bacteria
  • 1978 - Herb Boyer uses e-coli to make recombinant human insulin

1980

  • 1980 – Kary Mullis invents PCR; The patent is sold in 1991 for $300M
  • 1981 – Ohio University scientists produce first transgenic animals
  • 1982 – Genentech markets recombinant human insulin
  • 1986 – Chiron granted a license for recombinant hepatitis B vaccine; Genentech markets rt-PA

1990

  • 1990 – First gene therapy on 4 year old with ADA
  • 1996 – Genetic maps of humans and mice complete; Avonex approved for treatment of MS
  • 1997 – FDA approves Rituxan for non-Hodgkin’s lymphoma; Dolly is cloned in the UK
  • 1998 – Embryonic stem cells grown for the first time; an inexpensive E. coli biosensor sold

2000

2000 – Pharmacogenomics produce Herceptin with accompanying diagnostic test

slide5

UNIVERSITY

INDUSTRY

Knowledge for Knowledge’s Sake

Management ofKnowledge for Profit

Teaching

Profits

Research

Commercializationof New and UsefulTechnologies

Service

Product R&D

EconomicDevelopment

Academic FreedomOpen Discourse

ConfidentialityLimited Public Disclosure

Conflicting Values - Common Interest

overcoming barriers to success
Overcoming barriers to success…
  • Cultural barriers
  • Legal barriers
  • Financial barriers
  • High risks associated with all embryonic technologies
slide10

Cultural Barriers

Entrepreneurship is….

  • Not part of the cultural norm in academic medicine
  • May restrict ability to publish
  • Hampered by restrictive policies and procedures
  • Rarely a factor in performance evaluation
  • Considered to be a distraction from primary research and teaching focus, impedes career advancement

Legal and Financial Barriers

  • Compliance with Bayh Dole Act, NIH guidelines, other laws
  • Private Inurement / Private Benefit (FMV)
  • Unrelated Business Income Tax (UBIT)
  • Tax Exempt Bond Financing restrictions
  • Resources to support growing patenting and business development activities
slide11

Embryonic technologies require a plan to reduce risk, build value

  • Academic discovery ≠ Commercial validation
  • A risk assessment should encompass three key areas
    • Scientific
    • IP
    • Market
  • Prioritization and execution of risk reduction activities -eg
    • Animal experimentation
    • Freedom to operate analysis
    • Application selection and competitive review
  • Inventor may not have skills needed to validate or enough knowledge to select most appropriate use

Faculty nearly always under estimate time and effort required to overcome the commercialization hurdles that lie ahead.

slide13

Intellectual Property Timeline (OTM):

Preliminary

Research

Invention

Disclosure

Provisional

Patent

Patent

Application

PCT/Intl

Filing

Concept Development Timeline (OED):

Preliminary

Research

Viability

Assessment

Opportunity

Incubation

Preparing for

Partnership

Patent

Analysis

Application

Development

Licensing or

Start-Up Options

Market

Analysis

Funding

Assistance

Product

Development

Competitive

Analysis

Business Model

Development

Pitching to

Investors

slide14

One page opportunity summary; identification of OED lead

Concept Development Timeline (OED):

Viability Assessment

Patent

Analysis

Market

Analysis

Competitive

Analysis

  • market size & growth
  • problem/product
  • definition
  • customer demand
  • feasibility/regulatory
  • issues
  • prior disclosures
  • novelty, usefulness
  • competing patents
  • “freedom to operate”
  • platform technology?
  • barriers to competitors
  • differentiation
  • sustainable advantage
slide15

Concept Development Timeline (OED):

Opportunity Incubation

Funding

Assistance

Application

Development

Business Plan

Development

  • defined customer need
  • proof of concept data
  • clinical development
  • plan with milestones
  • that reduce risk &
  • increase value
  • execute plan
  • federal
  • state/local gov
  • corporate
  • HNW Individuals
  • foundations
  • internal sources
  • monetization strategy
  • product/service pricing
  • reimbursement
  • market entry strategy
  • rough timeline
  • rough financials

Two page executive summary; two minute “elevator pitch”, two PowerPoint slides

slide16

Concept Development Timeline (OED):

Preparing for Partnership

Licensing Options

Start up Options

Closing the Deal

  • valuation
  • extraction of FMV
  • projected financial needs
  • projected exit strategy
  • COI, COC, EOC
  • identifying potential partners
  • making contacts
  • getting a face to face meeting
  • contract facilitation
  • role of the inventor
  • finding management
  • incubator resources
  • scaling up the science
  • funding
  • role of the inventor

Helping the inventor to understand what lies ahead; facilitating communication and progress toward clinical development

two organizations working together
Six nationally ranked schools of health sciences + top ranked bioengineering

Over $600M research funding

Ranked 8th in NIH funding

Exceptional history of fostering multi-disciplinary bioengineering-clinician research teams

Developing sophisticated intramural and extramural entrepreneurial support

Two Organizations – Working Together

University of Pittsburgh

  • $5.4B revenues
  • 19 hospitals + a network of care facilities
  • 40,000+ employees
    • (Largest employer in Commonwealth of PA)
  • One of the country’s fastest growing health insurance plans
  • Financially healthy
  • Recruitment growth of 10%/year
  • Biotechnology venture fund
  • Diversified, entrepreneurial and willing to invest in the future.

…to create a nationally and internationally renowned

center of medical excellence.

Source: 2004 NIH Awards to Domestic Institutions of Higher Education

overcoming translational research challenges
While we have had successes, they have been largely serendipitous

Road to commercialization is long and difficult

Most faculty lack the experience and skills to drive commercialization

Internal funding for “the last mile” is often difficult to find

Resource partners exist, but are difficult for a novice to navigate

  • Make the process nimble
  • Make access to experts part of the process
  • Provide funding to reduce commercial risk factors
  • Provide an experienced navigator from start to finish
Overcoming Translational Research Challenges
  • Create a Program that drives commercialization
contact information
Contact Information

Carolyn Green, Director

Office of Enterprise Development, Health Sciences

University of Pittsburgh

412-623-3204

greence@upmc.edu

www.oed.pitt.edu