A Career in the Pharmaceutical Industry: Practice your ... · A CAREER IN THE PHARMACEUTICAL...
Transcript of A Career in the Pharmaceutical Industry: Practice your ... · A CAREER IN THE PHARMACEUTICAL...
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?
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