Jose L. Reynal, MD VP, Trial Coordination and Site Management – Americas Region Global Clinical Operations – J&J PRD

1. Diversity in Clinical Trials Jose L. Reynal, MDVP, Trial Coordination and Site Management – Americas RegionGlobal Clinical Operations – J&J PRD

2. Agenda • Global Clinical Operations & Therapeutic Areas • Rationale, Significance, Importance of Diversity • U.S. Population Projections • U.S. Population participating in Clinical Trials versus J&J Trials • Clinical Trials lack minority participation • Investigator/patient benefits • Responsibilities of serving as an Investigator • Q&A

3. Global Clinical OperationCenter of Excellence • Improve speed, quality, and cost of clinical operations • Give all Johnson & Johnson Pharma companies access to global clinical development • Provide an operational service that can be expanded to include new Pharma R&D companies • Can be leveraged to other J&J segments GCO

4. J&J PRD Therapeutic Area Focus Cardiovascular& Metabolism Neuroscience ID/Vaccines Schizophrenia, bipolar, Alzheimer’s pain & stroke HIV, HCV and influenza Heart disease, diabetesand obesity Immunology Oncology Breast, lung, prostate, B-cell malignancies, colorectal cancer Rheumatoid arthritis, psoriasis and pulmonary diseases

5. Rationale for Diversity • The United States demographic landscape has been changing at an ever increasing pace over the last several decades • The pharmaceutical industry has not adequately increased the number of minority subjects to reflect the representation within the population as a whole, nor to reflect adequate representation for specific disease states • The main reason for low minority representation in clinical trials is that minority patients are more likely to be cared for by minority physicians • The insufficient number of minority clinical physicians/investigators has led to low minority study subject participation into clinical trials

6. Significance of Diversity • If our clinical trials do not reflect proportional minority representation in general, or disease specific proportional representation, then the conclusions drawn regarding efficacy and safety may be flawed. • If the subjects in Phase 2 or 3 clinical trials are not representative of the population that is most likely to receive the treatment, then we may see data in Phase 4 trials which may raise unexpected safety and/or efficacy concerns. • It is highly probable that Regulatory Agencies will mandate that clinical trials be representative of the population most likely to be served. • Data from Clinical Trials related to diverse populations can be leveraged to support the commercialization of products to customers.

7. Importance of Diversity Some of the most significant chronic health conditions: diabetes & cardiovascular disease disproportionately impact specific minority groups (Office of Minority Health)

8. County-level Estimates of Diagnosed Diabetes for Adults aged ≥ 20 years: United States 2007 Centers for Disease Control and Prevention: National Diabetes Surveillance System. Available online at: http://www.cdc.gov/diabetes/statistics/index.htm. Retrieved 2/5/2010.

9. Minorities in Clinical Research

10. Minorities Become Majority • is Today • - % Ethnic Population • 3 States • California 57% • New Mexico 56% • Texas 54% • 4 of Top 5 Cities • New York 64% • Los Angeles 67% • Chicago 67% • Philadelphia 57% • Boston 46% *% Ethnic Population (All AA, HH and Asian) US Census 2000, Quick Facts

11. Participants in U.S. Clinical Trials

12. Clinical Trials: GCO 2010 RAVE Database

13. Clinical Trials: GCO 2010 INFORM Database

14. Lack of Minority investigators in Clinical Trials Minority physicians are interested in participating in clinical trials; however they lack: • awareness of clinical trials • trained clinical trial staffing • staff experience in clinical research • infrastructure • finances to conduct clinical trials The top two criteria when considering a physician for a clinical trial are, staff and experience; therefore, these physicians are less likely to be approached or selected to conduct clinical research trials. Powell, J.H., Fleming, Y. Walker-McGill, C.L., Lenior, M. (2008). The Project IMPACT Experience to Date: Increasing Minority Participation and Awareness of Clinical Trials. JNMA v 100 (2).

15. Lack of Minority Participation Subject • Poor access to primary medical care • Health care happens in ER • Lack of preventative care Investigator • Perceived increased cost to recruit, retain minority subjects • Limited access to minority patients at academic centers

16. Lack of Minority Participation Cultural • Language barrier • Patient-physician relationships • Failure to acknowledge disease, need for treatment • Perceived loss of control • Role of faith

17. Investigator Benefits “As a clinical trial investigator, you will play an integral role in the development of medicines and medical devices used to help combat disease, treat chronic and degenerative diseases, and improve the health of people worldwide. You may be able to offer your patients alternatives that could only be available through their participation in clinical trials.” Pharmaceutical Product Development (2011). Why be an Investigator: Retrieved February 17, 2011 from http://www.clinicaltrials.com/investigators/advantages.htm

18. Investigator Benefits • Professional development: Be on the cutting edge of your therapeutic area of expertise, meet other investigators, exchange ideas, plan future collaborations, and work with investigational medications and processes that are not yet approved by the FDA. • Professional recognition: Use your role as an investigator to co-author articles for publication and be recognized as a thought leader within the medical community. Pharmaceutical Product Development (2011). Why be an Investigator: Retrieved February 17, 2011 from http://www.clinicaltrials.com/investigators/advantages.htm

19. Investigator Benefits • Personal satisfaction: Offer your patients new medical alternatives that may only be available through participation in clinical trials. • Compensation: Clinical trials may provide compensation for your time and resources. • Role in the advancement of medicine: Be a leader in your field by potentially bringing breakthrough drugs and medical devices – products that could impact the health of people around the world – to market. Pharmaceutical Product Development (2011). Why be an Investigator: Retrieved February 17, 2011 from http://www.clinicaltrials.com/investigators/advantages.htm

20. Patient Benefits • Offers opportunity for patients to receive an experimental medicine only available through a clinical trial • Receive specialized/focused medical care associated with the clinical trial • Awareness: enhance understanding of their disease/condition

21. Investigator Responsibilities Supervision of the conduct of a clinical investigation: • Protecting the rights, safety and welfare of the subjects under the investigator’s care • Ensuring that the trial is being conducted according to the signed investigator statement, International Conference Harmonization (ICH) guidance for industry, E6 Good Clinical Practice (GCP): Consolidated Guidance are followed U.S. Department of Health & Human Services. Food & Drug Administration. (2009). Guidance for Industry. Investigator Responsibilities-Protecting the Rights, Safety, and Welfare of Study Subjects.

22. Investigator Responsibilities (cont’d) • Understand the drug property: potential risk & side effects • Controlling drugs, biological products, and devices under investigation • Ensure that staff to whom a task is delegated is qualified by education, training, and experience U.S. Department of Health & Human Services. Food & Drug Administration. (2009). Guidance for Industry. Investigator Responsibilities-Protecting the Rights, Safety, and Welfare of Study Subjects.

23. Investigator Training • Good Clinical Practice • Overview on Clinical Trials and Clinical Trial Process • Principles of Clinical Pharmacology • Introduction to the Principles and Practice of Clinical Research • Ethical and Regulatory Aspects of Clinical Research • Dangerous Goods Training • Safety Reporting (i.e SAE/AE, definitions) *On-line courses are available through NIH, CITI, and commercially available Investigator training groups

24. Are you interested? If interested in being considered as an investigator for upcoming J&J GCO clinical trials, complete the short questionnaire

25. Q&A