A CAREER IN THE PHARMACEUTICAL INDUSTRY: PRACTICE YOUR PROFESSION

Michael Dunne, MD NIH/NIAID Career Symposia June 5, 2015

Change is afoot….. Now what do I do?

• Government funded research is under pressure • >90% of clinical practices will be owned by a hospital

corporation • Everyone will work for someone in the future…

• In the Pharmaceutical Industry: • High-throughput screening is not as productive as hoped • More consolidation is coming • …and more Spin outs • More research being done in smaller organizations

• Big data will change everything

The Clinician in Industry • Overarching mission of clinicians in industry • The structure of research in a business environment • Where does the clinician fit in? • Practical things you need to know • Questions you need to wrestle with • The Good and the Bad

The Role of the Clinician in Industry

• Bring clinical relevance to research • Champion ideas that are good for patients • Prioritize good and relevant ideas to gain funding • Guide the science • Ensure patient safety • Deliver data that meets regulatory requirements • Enable the integration of new drugs into clinical practice

Deliverables

Research Funding Industry: The Moving Parts

Collaborations and Publications

New Drug Approvals

Public Health Interactions

Large Pharma

Director Senior

Director Executive Director

Vice President

Senior Vice

President

Chief Medical Officer

Chief Science Officer

Chief Executive

Officer

Clinical Development Program(s)

Interdisciplinary Interactions

Mid-cap Pharma

Small-cap Pharma

Research Based Biotechnology

Generic Industry

Privately Held Public Markets

Contract Research Organizations

Prioritizing then funding ideas varies with the size of the organization

Large Pharma Mid-cap Pharma Small-cap Pharma

Concept

Venture Funds

Private Equity

Stock Market IPO/secondary

Reinvestment of Profits

Debt Financing

FY 2012 President’s Budget Request NIH Total Program Level $31,987 Million

Research Project Grants 53%

Research Centers 9%

Other Research 6%

Research Training 2%

R&D Contracts 11%

Intramural Research 11%

Res. Mgmt. & Support

5% All Other 3%

Clinicians in Industry

• Phase 1

• Phase 2

• Phase 3

• Phase 3b

• Phase 4

• Investigator Initiated Studies

• Medical Information

FDA Approval Clinical Development Medical Affairs

Typical Experience at Entry

• Fellowship • 1-2 year private practice

• >5 years private Practice

Director

Senior Director

Executive Director

Vice President

Senior Vice President

Chief Medical/Science/Executive Officer

Things I’ve Wanted to Know About Industry

• What do I actually do all day? • What kind of projects will I work on? • Can I see patients while working in Industry? • With all the mergers how long will I keep my job? • Will I give up my scientific independence? • What is the role of the commercial organization? • Can I achieve a work-life balance?

Hours at Work

Kane L, Peckham C. Medscape Physician Compensation Report 2014

Satisfied with Medicine as a Career

Kane L, Peckham C. Medscape Physician Compensation Report 2014

Relative Compensation

Kane L, Peckham C. Medscape Physician Compensation Report 2014

Relative Compensation

Kane L, Peckham C. Medscape Physician Compensation Report 2014; Salary.com; Glassdor.com

Medical Director, Pharmaceutical Industry

The Good and the Bad

The Good

• Opportunity for clinical research

• Broad view of Medicine • Collaboration with good

scientists • Good work-life balance • Opportunity for advancement

The Bad

• Narrow focus on one product • Bureaucracy • Challenging environment for

influence • Rewards are long(er) term • Subject to change in

corporate priorities

Questions you need to answer for yourself • Would I enjoy research, clinical or bench, all day, every day? • Are you willing to work in a team environment? • Will you feel good about your contribution to medicine in an industry

setting? • Are you comfortable defending clinical perspectives in an environment of

individuals who are not clinically trained?...and will challenge you? • Can you accept criticism of your data by a skeptical audience?

• Relman AS. The new medical-industrial complex. N Engl J Med 1980; 303: 963-70. • Heinemann L, Hompesch M. Journal of Diabetes Science and Technology Volume 2,

Issue 4, July 2008. • Shuchman M. Commercializing clinical trials--risk and benefits of • the CRO. N Engl J Med. 2007;357(14):1365-8. • Stossel TP. Regulating academic-industrial research relationships--solving the

problems or stifling progress? N Engl J Med. 2005;353(10):1060-5. • Kesselheim AS, Robertson CT, Myers JA, et al. A randomized study of how

physicians interpret research funding disclosures. N Engl J Med 2012; 367: 1119-27. • Rothman KJ. Conflict of interest: the new McCarthyism in science. JAMA 1993; 269:

2782-4.

Advice for long run • Follow the Drug

• Miracles in a bottle do not grow on trees • Be where the decisions are made

• They need you to be part of the decisions • Socialize your opinions

• It’s a huge team effort and face-time matters

Patients (always first)

Products

People (who staff the projects)

Process

A CAREER IN THE PHARMACEUTICAL INDUSTRY: PRACTICE YOUR PROFESSION

Michael Dunne NIH/NIAID Career Symposia June 5, 2015