On the Road to Excellence

1. On the Road to Excellence Stuart R. Warren, J.D., Pharm.D. Deputy Director August 2010

2. Roadmap • Our Context • Our Motivations • Progress Along Our Journey • Approaches to Quality • Political-Competitive Strategy • Speed Bumps & Roadblocks • Leadership Strategy • Tactics • As a Small Organization • The Future

3. Our Context Pharmacy Center 5 Coordinating Centers

4. Our Mission To provide creative and innovative pharmaceutical, scientific, technical, operational and educational support to clinical studies to improve the health and care of the Veteran and the Nation.

5. Our Vision We are pioneers in developing and managing the pharmaceutical aspects of clinical trials, while setting industry standards and exceeding customer expectations.

6. What is a Clinical Trial? • An experiment in humans comparing the effect and value of an intervention (a therapy) against a control • Intervention can be a drug, device, or strategy intended to treat or prevent disease • Control can be active or placebo • A highly regulated activity!

7. VA Cooperative Studies Program • National infrastructure for developing & executing: • Multi-site clinical trials • Epidemiological research • Genomic medicine research • 38 year history of executing landmark studies

8. VA Cooperative Studies Program • First VA Cooperative Study: 1940s evaluated streptomycin for tuberculosis in WW II veterans • Program formally established in 1972 • Over 175 clinical trials and studies to date • Landmark studies in cardiovascular disease, infectious diseases, surgery, gastroenterology, mental health, oncology, and endocrinology

9. What is a Cooperative Study? • A clinical trial involving investigators and patients at multiple sites • Investigators cooperate to try to answer a medical question • Conducted under a common protocol

10. CSP Study Findings A few examples • Warfarin helps prevent stroke • Blood pressure management reduces heart attacks & strokes • Aspirin helps reduce heart attacks & death • Antiarrhythmic drugs should not be routinely used post MI

11. CSP Study Findings • Increasing HDL cholesterol reduces the risk of heart attacks • Diabetics can have  quality of life using an insulin pump • Shingles vaccine is effective in preventing shingles and reducing symptoms in patient with shingles

12. CSP 403 CSP in the News

13. CSP News Makers

14. A Recent CSP Study

15. Current CSP Studies • > 30 active • 5 mental health/substance abuse + NIDA • 4 cancer • 4 general and cardiac surgery • 4 neurology • 3 cardiovascular • 2 renal • Others: • infectious disease • diabetes • COPD • genetics • spinal cord injury • rheumatoid arthritis • nutrition in elderly

16. Our Business Pharmaceutical expertise: • Study design/protocol • Investigational drugs • Packaging anddistributing to study sites • Patient safety • Regulatory compliance—FDA

17. Our Business

18. Our Motivations • Why embark on this journey? • Obstacles, opposition • “Good enough for government work” • Scientist/academics • Risks • Major motivators • Our mission and vision • Survival

19. Progress: Where did We Start?

20. Progress: Our Starting Line 1978–1995 (18-year period) • Emphasis on Regulatory Compliance • Veterans Affairs • Food and Drug Administration • Drug Enforcement Administration • Nascent entrepreneurial mindset

21. Progress: New Approaches 1996–2009 (14-year period) • Emphasis on Quality and Performance Excellence Management • ISO 9001 • ISO 15378 • Baldrige Criteria

22. Approaches to Quality: Why Baldrige and ISO? • The obvious: synergy between • ISO requirements • Baldrige: Measurement and Process Management • The unexpected: ISO links regulations and Baldrige through process documentation • Structure and discipline

23. Two Major Quality Management Approaches • Quality Management System • Focus on Process Management • ISO 9001 • Performance Excellence Model • Focus on Results-Oriented Improvement • Baldrige Award, Deming Prize, European Quality Award Tsiakals, J.J., ASQ ISO 9000:2000 Handbook, edited by Cianfrani, Tsiakals & West 2002.

24. Quality Management and Performance Excellence • Relationships between Quality Management (ISO 9001) andPerformance Excellence(Baldrige) • Analogy to Abraham Maslow’s Hierarchy of Human Needs • Used in leadership training for the USAF during WWII Tsiakals, J.J., ASQ ISO 9000:2000 Handbook, edited by Cianfrani, Tsiakals & West 2002.

25. Maslow’s Hierarchy of Human Needs Tsiakals, J.J., ASQ ISO 9000:2000 Handbook, edited by Cianfrani, Tsiakals & West 2002

26. Quality Hierarchy – Goals* *Adapted from Tsiakals

27. Quality Hierarchy – Objectives* *Adapted from Tsiakals

28. Albuquerque Journal, July 18, 2010; New York Times, July 16, 2010

29. Quality Hierarchy Performance Management System Baldrige Criteria for Performance Excellence Competitive Advantage Efficiency Quality Management ISO 9001 & ISO 15378 Regulatory Management VA, FDA, DEA & EPA Quality Goals

30. Competitive & Political Strategy

31. Competitive & Political Strategy

32. Competitive & Political Strategy

33. Speed Bumps & Roadblocks External • Traditional bureaucratic mindset • Reactive vs. proactive • Lack of external support (resources) • “Laudable goals. Go for it. No money.”

34. Speed Bumps & Roadblocks Internal Struggles & Debates: “What do you want me to do: my job or Baldrige?” “Need time to work on OFIs.” “Won’t new visibility lead to criticism?” “What if we fail?”

35. Leadership Strategy: Our MapA Culture of Excellence

36. Leadership Strategy (Our GPS) A culture of excellence: • Appeal to noble instincts • Getting the right people in the right positions • Employee engagement • Deployed the strategy and motivations • Focus on external threats and survival • “Invasion from Mars”

37. Leadership Strategy • Flexibility: exploit opportunities • Investments: strategic planning and training • Unwavering optimism “ • It is amazing what you can accomplish if you do not care who gets the credit.” • –Harry S. Truman

38. Operational Strategy Get better (and be recognized): • Train in quality principles • Exploit synergy between Baldrige and ISO • Staff involvement • Apply, apply, apply… • 18 applications, 12 site visits in 14 years • “Accepts constructive criticism”

39. As a Small Organization • Advantages: • Easier to change direction? • Disadvantages: • Limited financial and human resources • Can’t just start new departments • People have to wear multiple hats—no “specialists”

40. Tactics Along the Way “ It is not the strongest of the species that survives, nor the most intelligent that survives. It is the one that is the most adaptable to change.” –Charles Darwin “No one has to change. Survival is optional.” – W. Edwards Deming

41. Tactics Along the Way Adaptability and flexibility: • Rotated category champions • Developed measures integration team • Distributed the work • Cross-functional ISO audit teams • Measures ownership • Rewards

42. Key Decisions & Milestones National Award Baldrige Journey State Award  ► VA Carey Trophy ISO Journey ISO 15378   ► ISO 9001 Regulatory Focus  ► 1978 ‘93 ‘96 ‘03 ‘04 2009  

43. Quality Future: The Road Ahead • Feedback report: 29 OFIs • Quality participation • CSP-wide ISO certification • Measures and benchmarks Process and Attitude  Quest for Excellence…. “ • Arriving at one goal is the starting point to another.” • –John Dewey

44. Who Should Get the Credit?

45. Special Thanks