A CAREER IN THE PHARMACEUTICAL INDUSTRY: PRACTICE YOUR PROFESSION. Michael Dunne, MD NIH/NIAID Career Symposia June 5, 2015

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1 A CAREER IN THE PHARMACEUTICAL INDUSTRY: PRACTICE YOUR PROFESSION Michael Dunne, MD NIH/NIAID Career Symposia June 5, 2015

2 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

3 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

4 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

5 Industry: The Moving Parts Research Funding Generic Industry Deliverables Small-cap Pharma Research Based Biotechnology Clinical Development Program(s) Mid-cap Pharma Contract Research Organizations Privately Held New Drug Approvals Large Pharma Public Markets Director Senior Director Executive Director Vice President Senior Vice President Chief Medical Officer Chief Science Officer Interdisciplinary Interactions Public Health Interactions Collaborations and Publications Chief Executive Officer

6 Prioritizing then funding ideas varies with the size of the organization Concept Small-cap Pharma Mid-cap Pharma Large Pharma Private Equity Venture Funds Stock Market IPO/secondary Reinvestment of Profits Debt Financing

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9 FY 2012 President s Budget Request NIH Total Program Level $31,987 Million Research Centers 9% Other Research 6% Research Training 2% Research Project Grants 53% R&D Contracts 11% Intramural Research 11% All Other 3% Res. Mgmt. & Support 5%

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11 Clinicians in Industry Clinical Development Phase 1 Phase 2 Phase 3 FDA Approval Director Senior Director Executive Director Vice President Medical Affairs Phase 3b Phase 4 Investigator Initiated Studies Medical Information Senior Vice President Chief Medical/Science/Executive Officer Typical Experience at Entry Fellowship 1-2 year private practice >5 years private Practice

12 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?

13 Hours at Work Kane L, Peckham C. Medscape Physician Compensation Report 2014

14 Satisfied with Medicine as a Career Kane L, Peckham C. Medscape Physician Compensation Report 2014

15 Relative Compensation Kane L, Peckham C. Medscape Physician Compensation Report 2014

16 Relative Compensation Medical Director, Pharmaceutical Industry Kane L, Peckham C. Medscape Physician Compensation Report 2014; Salary.com; Glassdor.com

17 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

18 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: Heinemann L, Hompesch M. Journal of Diabetes Science and Technology Volume 2, Issue 4, July Shuchman M. Commercializing clinical trials--risk and benefits of the CRO. N Engl J Med. 2007;357(14): Stossel TP. Regulating academic-industrial research relationships--solving the problems or stifling progress? N Engl J Med. 2005;353(10): Kesselheim AS, Robertson CT, Myers JA, et al. A randomized study of how physicians interpret research funding disclosures. N Engl J Med 2012; 367: Rothman KJ. Conflict of interest: the new McCarthyism in science. JAMA 1993; 269:

19 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

20 A CAREER IN THE PHARMACEUTICAL INDUSTRY: PRACTICE YOUR PROFESSION Michael Dunne NIH/NIAID Career Symposia June 5, 2015