GLOBAL REGULATORY STRATEGY CONSIDERATIONS

1. GLOBAL REGULATORY STRATEGY CONSIDERATIONS SCIENTIFIC SARAH POWELL EXECUTIVE DIRECTOR, REGULATORY STRATEGIES SEPTEMBER 14-17, 2008 BOSTON, MA.

2. Discussion Points • What is a regulatory strategy? • Who’s involved in setting strategy? • What tools are available to assist in setting strategy? • How should the strategy be maintained?

3. Strategic Management Source: David, F Strategic Management, Columbus:Merrill Publishing Company, 1989 Strategic management is the art and science of formulating, implementing and evaluating cross-functional decisions that will enable an organization to achieve its objectives

4. Drug/Device Comparison *Depending on device class may require clinical studies

5. Regulatory Strategy Defines the plan for developing the product with the goal of obtaining regulatory approval in desired markets and lifecycle management/maintenance post approval

6. Influences on Regulatory Strategy External Influences Competitive Products Technology Patients Patient Advocacy Groups Etc. Regulatory Strategy Regulatory Influences Regulatory Authorities Guidelines Standards Organizations Etc. Internal Influences Regulatory Affairs Product Development Manufacturing Etc.

7. Developing Regulatory Strategy • Know your target label • What claims do you want to support? • How is this different from competitive products?

8. Developing Regulatory Strategy • Know your target market(s) • Where do we want to obtain approval to market commercially? • What filing options are available for my product type? • Orphan product, accelerated approval, conditional approval, etc?

9. Developing Regulatory Strategy • Know your target market(s) • What are the regulatory authority expectations for obtaining approval? • Clinical trial support • Previous marketing experience • Manufacturing supportive information • Etc. • How do the expectations vary by region? • What if any meetings will need to occur with authorities?

10. Developing Regulatory Strategy • Know your target market(s) • What competitive products are already marketed? • What was done to support registration? • What claims can they make in their labeling? • What is the safety profile? • What competitive products are in development and where are they in the development process?

11. Developing Regulatory Strategy • Know your target markets • Intellectual property considerations • What patent protections are available? • Can security/integrity/quality be ensured? • Define criteria for success • May include approval(s) or “early kill”

12. Developing Regulatory Strategy • Internal resource needs • Global regulatory expert/manager • Leads internal team • Leads planning of strategic meetings with health authorities • Manages creation of global regulatory strategy documentation • Provides advice on global regulatory requirements and submission standards

13. Developing Regulatory Strategy • Internal resource needs • Global regulatory expert/manager cont. • Identifies corporate resource needs for strategy execution • Helps define budget and timelines • Internal Project Team • Includes representatives from all disciplines related to product development • Strong working knowledge of product development process

14. Developing Regulatory Strategy • Internal resource needs • Internal Project Team cont. • Experience in preparing information needed for regulatory submission • Understanding of global requirements for registration and maintenance • Understanding of competitive landscape • Strong communication and presentation skills

15. Developing Regulatory Strategy • External resource needs • Consultants • Can provide advice on local requirements or scientific issues • Compilation of regulatory submissions and lifecycle management • Staff supplementation • Marketing advisors

16. Developing Regulatory Strategy • External resource needs cont. • Contract Research Organizations • Manages trial preparation activities and execution • Investigator agreements, distribution of relevant materials, informed consent, translations, etc. • Health authorities • Scientific advice • Regulatory guidance

17. Developing Regulatory Strategy • External resource needs cont. • Attorneys • Advisory boards

18. Information Sources • Free information sources • Regulatory authority websites • Discussion groups/blogs • Harmonization or standards setting organization websites (ICH, HL7, ISO, etc.) • Regulatory alerts or newsletters

19. Information Sources • Fee or subscription based • Professional journals or newsletters • Regulatory intelligence databases • Regulatory alerts or newsletters • Freedom of Information requests

20. Strategy Execution and Maintenance • Successful execution depends on • Detailed project plan • Clear designation of organizational roles and responsibilities • Effective support systems and procedures • Effective communication and decision making

21. Project Planning • Develop detailed project plan based on global regulatory strategy document goals and objectives • Include resource assignments and timelines • Should be created early in project • Revise as necessary • Communicate, communicate, communicate

22. Accountability Clearly defined roles and responsibilities Realistic expectations Defined metrics/criteria for success Allow for the “early kill”

23. Support Systems and Procedures • Planning tools • Project planning • Regulatory intelligence • Registration/submission planning • Registration/submission tracking • Reporting capabilities are key • Remember the communicate, communicate, communicate

24. Support Systems and Procedures • Other Systems • Document and records management • Adverse event reporting • Procedures • Clinical study initiation and approval • Submission standards (global and regional) • Program management • Etc.

25. Communication and Decision Making • Regulatory strategy is a living document – you must EXPECT change • Some examples: • Regulations evolve and change • Agencies can change their minds • New intelligence on similar product • Change in target label or markets • Pressure from patients, advocacy groups or media

26. Communication and Decision Making • Modification to strategy is a business decision • In the modern world of business, it is useless to be a creative original thinker unless you can also sell what you create. Management cannot be expected to recognize a good idea unless it is presented to them by a good salesman* *Source: David M. Ogilvy

27. Communication and Decision Making • Expect conflict • Balance resource cost with expected revenue • Time, money, people vs. income • Be sensitive to cultural and language issues • Write it down!

28. Communication and Decision Making • Evaluate and criticize yourself • What are we doing well? • What could we do better next time? • Celebrate the successes • Remember success can be an “early kill”

29. Conclusion Think globally Be prepared Good project management is critical Expect change Use tools, systems, and people for their intended purpose Communicate

30. Contact Information Sarah Powell Executive Director, Regulatory Strategies E-mail: sarah.powell@thomsonreuters.com Phone: (916) 580-3852 Website: http://www.liquent.com