1. Strategic Analyses and Interpretation: Regulatory Intelligence for Decision Making Amy N. Grant Director, Regulatory Strategy & Science ViroPharma Incorporated

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3. 3 Strategic Analysis and Interpretation Strategic –Ask, “Why are we going to do this in the Future” –Focus upon the key issues and decisions upfront including impact to the company –Foster a “real-time” strategy based upon specific needs of the company, e.g., 1, 3, 5, 10 year strategic plan –Stay future focused and situational in order to cope with change

4. 4 Strategic Analysis and Interpretation Strategic (continued) –Adapt and adjust over time –Monitor and anticipate changes in regulatory environment –Consider global and regional markets “Climate is what we expect, weather is what we get.” Mark Twain

5. 5 Strategic Analysis and Interpretation Analysis –Break down a complex issue into smaller parts to gain a better understanding Interpretation –Put together and communicate significance and meaning of findings as a whole

6. 6 Strategic Analysis and Interpretation Decision makers and Analysts need: Less information and intelligence, not more Concise verbal and written communication An understanding of decisions being considered

7. 7 Strategic Analysis and Interpretation Decision makers and Analysts need (continued): Discussion, not long email threads Sound Judgment based upon experience Access to people with different views

8. 8 Regulatory Analysis Formal, conventional approaches, e.g., –Regulatory Opportunities Scientific Advice, Orphan designation, etc. –Strengths, Weaknesses, Opportunities, Threats (SWOT) –Scenarios, war games –Competitor analysis –Tabulations and other calculations presented in appendices

9. 9 Regulatory Analysis Strategic approaches, e.g., –“Thin-sliced” –Focused upon decisions –Iterative conversations –Updated continuously

10. 10 Regulatory Analysis Strategic approaches, e.g., (continued) –Focused upon risk analysis and risk mitigation planning –Key findings from formal, conventional analysis available in appendices –Alignment with cross functional departments

11. 11 Regulatory Analysis “In the real world – when it comes to fast-moving, high-stakes situations like battlefields (or emergency rooms, or auditions, or late- night shoot-outs in the Bronx) – that kind of formal, conventional analysis doesn’t help that much. It comes down to decision-making ability. It is the kind of wisdom that someone acquires after a life- time of learning and waiting and doing. It is judgment. The ability to move quickly and instinctively on the field of battle – is so critical that it is what makes it possible for problem solving and for achievements against seemingly great odds. Judgment matters: it is what separates winners from losers. “ (p. 260, Gladwell, Blink) “You can have lots of analytical intelligence and very little practical intelligence.” (p. 101, Gladwell, Outlier)

12. 12 Interpretation Communicate relevance of findings as a whole by providing: –context of analysis –reality check –what is important –discussion and debate –next steps

13. 13 Decision Making See the situation clearly Know what you want Expand the Possibilities Evaluate and Decide Act (Thresholds, Dr. Milton Burglass)

14. 14 Regulatory Strategic Plan Authors Audience Focused Content –Executive summary –Text –Appendices Decision support Alignment with cross-functional departments

15. 15 Regulatory Intelligence Applied to Strategy Understand context of product, disease area, and external environment Identify regulatory opportunities View regulatory competitive landscape Find emerging signals and patterns

16. 16 Regulatory Intelligence Applied to Strategy (continued) Talk with others Apply experience and findings Filter out less important elements Communicate what is important Continue this iterative process

17. 17 References Burglass, M. E. & M. G. Duffy (1974) Thresholds: Teacher’s Manual. Cambridge, MA: Correctional Foundations. Gladwell, M. (2005) Blink: The Power of Thinking without Thinking. NY: Little, Brown and Company. Gladwell, M. (2008) Outliers: The Story of Success. NY: Little, Brown and Company.