1. Chapter 5 Preparing for Key FDA Meetings and Advisory Committee Meetings 1

2. General Preparation for FDA Meetings  Goal: Maximize FDA interaction opportunities  Establish open and upfront relationship  Demonstrate credibility for product/issue  Tell a clear story (set information in context) 2

3. General Preparation for FDA Meetings (continued)  Companies should take the following 10 steps for any meetings with the FDA: 1)Know your audience 2)Know the issues 3)Set a goal for each FDA conversation or meeting 4)Know your position 5)Provide pertinent materials for each meeting in a timely way to allow FDA to adequately analyze the information Preliminary proposed agenda 3

4. 10 Steps (Continued) 6)Anticipate concerns and interests, and be prepared to sufficiently answer likely FDA questions Proactively prepare acceptable contingency scenarios 7)Be Organized 8)Listen carefully to what FDA is actually saying Watch body language 9)Record Feedback Including documenting when FDA mutes the phone 10)Foster a flexible, collaborative and non-adversarial relationship 4

5. Advisory Committee Meeting  Strategic planning for a potential meeting must be a part of any product development process (PMA, NDA, or BLA)  Voting members may not have an in-depth product-specific knowledge Preparing for an Advisory Committee Meeting Three (3) step approach: Analysis Content development Testing of strategy and materials 5

6. Understanding the Audience Knowing how people may vote is critical Study past votes Review previous meeting transcripts www.fda.gov Viewing meeting videos www.fdalive.com Analyze interests Identify relationships among committee members Possible ‘field trip’ to see the committee in action 6

7. Evaluating the Data/Science It is important to first develop a strategic message Conduct a brainstorming session Figure out the high level messages Discuss and prioritize the data Incorporate the data into a message matrix to serve as a guide to outline and develop the presentations Assign individual ‘owners’ 7

8. Analyzing the external environment It is important to pay attention to the public and political environment Identify the most influential patient and consumer groups and healthcare associations Assess opinions of medical experts and societies Listen to what the financial analysts are saying about the product and its impact Third party advocates (key opinion leaders and medical experts) can help support a sponsor’s goal. It is critical that all financial relationships be appropriately disclosed; transparency is extremely important 8

9. Selecting the team  Start with a senior R&D or regulatory person  Ideal team: regulatory, medical, clinical, toxicology, statistics, pharmacovigilance, and marketing  Key team areas to cover: ◦ Presentation ◦ Briefing book ◦ Scientific advisors ◦ Regulatory ◦ Communications ◦ Slide development ◦ Logistics 9

10. Writing Your Material  Briefing Book ◦ Short & concise ◦ 100-150 pages ◦ Never include new data  Core Presentation Script ◦ 45-90 minutes ◦ Control the story around the data ◦ Context and clear explanation are essential ◦ Script every word of the presentation  Q&A Book ◦ Map for the day of the hearing  Slides ◦ Less is more ◦ Having a data triage team for Q&A slides 10

11. Final Considerations  Practice makes perfect Conduct mock Advisory Committee hearings Internal team rehearsals Consult with External experts  48 hours before the meeting, FDA will release final names of the Advisory Committee members and the specific questions they will pose This is a great time to refine your strategy  Also remember the meeting organization or security to ensure the meeting runs smoothly 11