1. Going “Pro” The Rise of Professionalism in Clinical Research and Pharmaceutical Medicine Greg Koski, PhD, MD, CPI Associate Professor of Anesthesia Harvard Medical School President Elect, Academy of Pharmaceutical Physicians & Investigators and Trustee of the Association of Clinical Research Professionals Former Director, Office for Human Research Protections U.S. Department and Health and Human Services

2. Clinical Research in Evolution 1974-1999 –Pre-Gelsinger Era 2000-2002 –Post-Gelsinger Crisis –The Tipping Point: Johns Hopkins 2003-2006 –Transition for Translation –The Cultural Imperative 2006-present –The Professional Paradigm Emergence

3. “Someday, I’m gonna be a professional ”

4. Justice Louis Brandeis Described Basic Elements of Professionalism: “First, a profession is an occupation for which the necessary preliminary training is intellectual in character, involving knowledge and to some extent learning as distinguished from mere skill; Second, it is an occupation which is pursued largely for others and not merely for one’s self; Third, it is an occupation in which the amount of financial return is not the accepted measure of success.”

5. Additional Elements of a “ Profession” Membership is limited to qualified individuals Standards for qualification are established by the members Standards based on competence, strive for excellence Behavior is self-regulated

6. Characteristics of Professionals Knowledge and Skills Altruism Responsibility Accountability Leadership Caring Compassion Communication Scholarship Excellence Respect Honesty Integrity Adapted from the National Board of Medical Examiners

7. Professionalism in Medical Education Before Flexner (1910) –Proprietary Medical Schools –No or Few Standards After Flexner –Rise of Academic Medical School –Standards for Curriculum –Competency by Examination –Validation by Accreditation and Certification

8. Clinical Research Training Options ‘On the job’ ‘On the job’ Supervisor, mentor, SOPs Supervisor, mentor, SOPs Self study (books, Internet) Self study (books, Internet) Local medical meetings (ACRP, AAPP, medical schools) Local medical meetings (ACRP, AAPP, medical schools) Sponsor monitoring, audits, inspections Sponsor monitoring, audits, inspections Investigator Meetings Investigator Meetings Technical Courses Technical Courses Academe vs. Business Academe vs. Business Conference vs. distance learning Accredited vs. non accredited Diplomas and degrees Diplomas and degrees MSc, PhD, Fellowships MSc, PhD, Fellowships Adapted from Hans de Han, AAPP

9. Proprietary Training Courses AAPPAMAACRP Barnett International Cambridge Healthtech Institute Center for Business Intelligence DIA Institute for International Research Parexel Pharmaceutical Education & Research Institute (PERI) Pharmaceutical Training Institute PharmaTechSOCRAUniteck

10. Certification of Clinical Research Professionals The Clinical Research Team –Non-physicians Clinical Research Associates Clinical Research Coordinators –IRB Professionals –Regulatory Professionals and Administrators

11. Evolution of Investigator Certification Multiple Proprietary Providers Unitary Proprietary Provider Recognition –by the profession –by authorities –by sponsors –By the public Independent Professional Board Public Expectation

12. Proprietary Certification Eligibility Criteria, circa 2005

13. APPI Certified Physician Investigator (CPI) Compliance with Regulations, Laws, Statutes, Codes and Guidelines Protection of Study Participants Conduct of the Study Managing the Study Site and Organization Ethics and Professional Conduct Adapted from Hans de Han, AAPP

14. What is Pharmaceutical Medicine? The medical discipline devoted to… discovery, research & development… supporting ethical promotion and safe use of… medical products (drugs, vaccines, devices, diagnostics, etc) to… improve health and quality of life of society

15. Pharmaceutical Medicine Curriculum Drug discovery Preclinical testing (pharmacology, toxicology, pharmacokinetics, etc) Pharmaceutical development Clinical Pharmacology Clinical trial design Medical statistics Regulatory affairs, medicolegal and ethic issues Market support, drug labeling Drug safety monitoring, pharmacovigilence Pharmacoeconomics Risk:benefit assessment Management and Administration Adapted from Hans de Han, AAPP

16. Pharmaceutical Medicine “Going Pro” American Board of Medical Specialties American Board of Internal Medicine Sub-Specialty Board Sub-Specialty Board Sub-Specialty Board CAQCAQ

17. Current Events Where are we headed? The TeGenero Disaster Renegotiating the Grand Bargain The Opportunities –For Industry –For Government(s) –For Global Capacity Building

18. Thank You! Please join me in acknowledging the many unselfish individuals who volunteer to participate in clinical research for the benefit of science and society, for without them, there would be no clinical research—they are the strongest justification for professionalism in clinical research.