Why Is Technology

Commercialization So Important

For Scientists?

Steven M. Ferguson

Deputy Director,

Licensing & Entrepreneurship

NIH Office of Technology Transfer

DHHS Email: sf8h@nih.gov

Technology Commercialization

Programs Provide Many Benefits

• Provides means getting innovative products to the market for public benefit

• Commercial & public recognition of important technologies

• Attracts new R&D resources & partnerships for lab

• Obtains return on investment

• Stimulates economic development

Technology Commercialization: An

Interdisciplinary Field

Scientific Discovery Commercialization

Intellectual

Property or

Patents

Critical Elements of Technology

Commercialization – Transition from

Science to Business

• Scientific Invention

– “Not an occupation for the ELITE” (Kary B. Mullis)

– Inventions are important, but not everything important is an

invention!

• Business Development

– Set realistic goals as early as possible and make progress

toward the goal continuously

– It is a marathon but not a sprint

Discovery

Exploratory Development

Full DevelopmentRegistration

Project Team

and Plans

Project Team

and Plans

Synthesis

of Compounds

Synthesis

of Compounds ScreeningScreening

Studies in Healthy

Volunteers (Phase I)

Studies in Healthy

Volunteers (Phase I)

Early Safety

Studies

Early Safety

Studies

CandidateCandidateFormulations

Developed

Formulations

Developed

Extensive Safety

Studies

Extensive Safety

Studies

NDA/MMANDA/MMA

Studies in 100-300

Patients (Phase II)

Studies in 100-300

Patients (Phase II)

Clinical Data

Analysis

Clinical Data

Analysis

Candidate Medicine Tested in

3-10,000 Patients (Phase III)

Candidate Medicine Tested in

3-10,000 Patients (Phase III)

Large Amounts of

Candidate Medicine

Synthesized

Large Amounts of

Candidate Medicine

Synthesized

Example: The Long Road For New

Biomedicines

Example: The Long Road For New

Biomedicines

Source: Pfizer

The Scientist’s Dilemma

• The invention is only a good start.

• Continuation of development can be problematic.

• Interacting with “companies” is both enlightening and distracting. How can it be done properly?

• Interacting with patent attorneys is enlightening, distracting and can be very frustrating at times

• Continuation into uncharted R&D waters - we can predict everything but the future!

The Scientist’s Basic Obligations For

Successful Commercialization

• Keep accurate lab notebooks - bound lab

notebooks are essential - dated and signed.

• Disclosure - abstracts, meeting talks,

publications online all constitute disclosure, you

risk loss of non-U.S. rights! Beware the

"website trap".

The Scientist’s Basic Obligations For

Successful Commercialization (cont.)

• Work with tech transfer office staff, law firm and commercial partners.

• CDAs/MTAs (Confidential Disclosure Agreements / Material Transfer Agreements) - are essential for the transfer of information and reagents - don’t aim to please interested third parties without first contacting your tech transfer office.

Patenting and Commercializing My

Invention: Is It Worth It?

• Yes, and it’s your job and the job of others.

• The public benefits when new products are

developed.

• Development usually requires patent protection to

enable companies to take necessary financial risks.

• Patent prosecution can always be (and often is)

abandoned - but cannot be (re)started when it’s too

late and disclosures have been made.

Patenting and Commercializing My

Invention: Is It Worth It? (Cont.)

• Won't it interfere with sharing of my reagents? (It

need not!)

• What about the culture of publish or perish? (Can

have both patents & publications!)

TECHNOLOGY TRANSFER

BUSINESS DEVELOPMENT

ATTORNEYS

Scientific

Discovery

Intellectual

Property

Technology

Transfer

Financial

Capital

Corporate

Partnership

R&D

Clinical trials

Regulatory

Manufacturing

Sales &

Marketing

Product Commercialization:

From Lab Bench to Customer

Technology Commercialization at

Universities and Federal Labs

• Lab evaluate inventions for patenting

• Lab works closely with inventors

• Work with law firms and management of patents

• Identify and negotiate with a commercial partner

for license or collaboration agreements

• Managing relationship with commercial partners

Technology Commercialization at

Small Companies

• Management of intellectual properties

• In-license technologies from universities and

research institutes or develop in-house

• Out-license or partner with large companies

• Entrepreneurial focus & opportunity

• High risk firm / high risk technology match

Technology Commercialization at

Large Companies

• Part of a large technology portfolio

• Specialized in larger markets areas

• More in-licensing than out-licensing deals

• More stable commercialization (historically) but

at slower pace

• Tend to work with later stage technologies

Can Commercialization Make Me

Rich As An Inventor?

• Answer - yes and no!

• Academic & Federal labs share license and royalty

payments with individual inventors.

• There are payment caps or restrictions on the level

of commercial involvement at most institutions.

• Largest rewards (and risks!) and level of

involvement come from entrepreneurial activity

separate from the lab.

Scientists As Entrepreneurs

• Scientific knowledge & research alone will not

generate economic prosperity.

• New ideas from research are complex & not

always understood and commercialized by

existing firms.

• Often entrepreneur is needed to facilitate

development of new ideas from research labs.

Scientists As Entrepreneurs (Cont.)

• Entrepreneurship enables investment to seed new

knowledge & a means of harvesting research results.

• Commercialization leads to news firms & industries,

job creation and economic growth.

• “Ivory Tower-only" image of scientists changing.

• Now “local heroes of the global village”.

• Difference between U.S. and many other countries.

Source: Kauffmann Foundation

Why Have Scientists Succeeded In

the U.S. As Entrepreneurs?

• Not due to geographic origin (many not native U.S.).

• More about institution, legal and organizational support for entrepreneurship.

• Bayh-Dole Act seen as stimulus for commercializing federally-funded research in U.S.

• Grants a proven engine for entrepreneurship.

• 25% of NCI grant recipients from 1998-2003 started their own company.

Why Have Scientists Succeeded In The

U.S. As Entrepreneurs? (Cont.)

• SBIR grants foster the kind of research that

translates new science findings into product

opportunities.

• Incubators, technology parks, start-up programs,

entrepreneurial training programs, social networks

all have assisted the process.

Source: Kauffmann Foundation; Washington Post

Growing Entrepreneurial Scientists

· New and emerging companies founded by

scientist/entrepreneurs have driven the development of

innovative products.

· Funding & training scientists (especially at academic

research centers) can provide the next wave of

innovative small companies in the U.S. or elsewhere.

· Business & entrepreneurial training programs can

provide the spark for such developments.

Summary:

Technology Commercialization -- An

Exciting & Important Field For Scientists

• Increasing integrated into program goals of the research enterprise.

• Can increase public impact of your science.

• Institutional staff available to support commercialization of your inventions.

• Highest opportunity for control / reward come from entrepreneurial activity away from the lab.

Acknowledgements

• A very special thanks to Kai Chen, Ph.D., M.B.A.

and David FitzGerald, Ph.D.