advisory committee meeting preparation & management series · •an fda advisory committee...
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Advisory Committee Meeting
Preparation & Management Series
January 13th, 2015
AdCom Preparation:
Best Practices
Why is this Series Important?
• MILLIONS of dollars may ride on its outcome, as well as the company’s
reputation
• An FDA Advisory Committee (AdCom)
Meeting is one of the most significant events in the life cycle of any product
• Yet, internal experience with
these meetings is often lacking 3
Series Overview AdCom Preparation:
Best Practices January 13, 2015
Content Development January 15, 2015
Anticipating & Responding to Questions
January 20, 2015
How to Find the Best External Support
January 22, 2015 4
• Provide you with the tools and
resources YOU NEED to successfully
plan and execute an FDA AdCom meeting
Today’s Objectives
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What is an Advisory Committee? • An advisory committee is a panel of appointed individuals who provide
FDA with independent (non-binding) expert advice on scientific, technical
and policy issues
• 18 drug advisory committees (e.g. Oncologic Drugs Advisory Committee
(ODAC)
• 18 panels of the medical device advisory committee (e.g. Obstetrics and
Gynecology Devices)
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Committee ‘Make-Up’
• Standing committees are composed largely of
academic scientists, with limited product/category
expertise due to conflict requirements – as well as a
consumer, industry (non-voting) and sometimes a
patient representative
• MEETING-SPECIFIC rosters are designed to include
individuals with certain therapeutic expertise, and are
modified as needed based on conflicts and availability
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Sponsor ESSENTIALS for AdCom
Success
• Unambiguous benefit/risk profile presented in a compelling manner
• Alignment with the goals of FDA and public policy
• Passion, commitment and dedication
• Stakeholder involvement/engagement
• Connection with the committee
• Q&A responsiveness and engaging presenters
• Smooth slide retrieval
• Effective project management
•PRACTICE, PRACTICE, PRACTICE! 8
HOW Do You Begin?
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Develop a Compelling Storyline
• Create KEY MESSAGES that can
RESONATE through all program
deliverables
- Weave through submission, briefing
book / panel pack and
presentation(s)
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Ensure Internal and External Alignment
Team Input,
Refine Key
Messages
Stakeholder
/ KOL Input
FDA Interaction and Feedback
TIP: Align Message with Key Data
Focus on the benefit(s) to PATIENTS 11
• Consider likely FDA position, WHO FDA will choose for
committee and HOW FDA will brief them
• Evaluate composition of the standing committee (and likely
alternates)
– How will this specific committee respond to gaps in data?
– What are their hot buttons?
• Analyze previous decisions/voting records and understand
member personalities
KNOW Your Audience
Connecting with the Committee…
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Presenters should be….
• Passionate, knowledgeable (a mix of internal team members and external KOLs) and engaging
• Recognized / Respected
• Patient-focused • Effective Q&A responders
Picking the Right Messengers
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for Presenters
• Be clear, concise and compelling
• Be persuasive, while maintaining critical scientific
credibility
• Address panelists personally to acknowledge their
concerns
• Assert control during Q&A
• Utilize external consultants to support position
• Maintain poise when challenged
• Reiterate and reinforce key messages throughout
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• Addresses concerns and provides
perspective… – Demonstrates that the team KNOWS what is important
and has considered possible implications
Q&A Responsiveness:
Why is it Important?
HOW Do You Prepare for Q&A?
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Draft a list of potential questions
Develop
“Issues List”
Craft responses;
identify figures / charts from BB
Develop Slides Determine who
will be the appropriate
person to deliver the response
Practice
Identify Issues and Prepare Responses
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Smooth Slide Retrieval
• Slide retrieval can be a headache – but shouldn’t be
• A high quality slide management system can make back-up slide retrieval a snap
• Even with the best system – PRACTICE makes PERFECT!
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Practice, practice, practice!
• Build rehearsal plan (basic to stretch)
• Involve stakeholders early (include senior
management)
• Conduct 2-3 MOCK REHEARSALS
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More About Mocks….
Mock rehearsals should be:
• Moderated
• Independent (no friends and family)
• Guided by “current” briefing book
• Preceded by ‘internal’ mock sessions
• Followed by an effective feedback session
Mock rehearsals allow the team to get comfortable with the feel of the committee as well as the meeting structure
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Getting to the Finish Line: Effective Project Management
Realistic timelines, resources and team
engagement are necessary for SUCCESS
• Sequence key milestones appropriately
• Track tasks, deliverables and budgets against
established timeline
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• Aim to have a kickoff meeting at least 6 months before the AdCom;
plan for a day-long event
• Engage everyone relevant to the project, including MANAGEMENT
At the meeting…
1) Review product, category, dynamics, and issues 2) Define success criteria
3) Outline objectives, milestones, timelines and responsibilities
Crafting a Timeline
Begin with a session:
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Research/Crafting the Message
Identifying the Messengers
Presentation Development
Q & A Preparation
Briefing Book/Slide Development
Mock Rehearsals
Logistics
AdCom Meeting Management
Month 1-2 Month 3 Month 4 Month 5
What Does an Ideal Timeline
Look Like?
Useful Tools and Resources FDA AdCom Meeting Calendar
http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm
FDA Live: A Cost-Effective Way to View Live and Archived FDA Meetings
http://www.fdalive.com/webcast.cfm
FDA 101: Advisory Committees
http://www.fda.gov/downloads/ForConsumers/ConsumerUpdates/ucm048045.pdf
FDA Advisory Committees; Laws, Regulations & Guidance
http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/LawsRegulationsGuid
ance/default.htm
ISS AdCom Toolbox
http://www.innovativescience.net/FDA-AdComm/Toolbox/
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• Innovative Science Solutions (ISS) is a team of highly qualified regulatory,
clinical, and communications professionals skilled at managing all aspects of
the FDA Advisory Committee / Panel meeting process
• ISS has over a decade of experience across most therapeutic categories, a
long-standing relationship with the FDA, a state-of-the-art slide management
system and the scientific and business acumen to navigate complex advisory committee meeting issues
• ISS is a leader in complex regulatory reviews (drugs and devices) and is a
recognized expert in priority review, accelerated review, animal rule, Rx-to-
OTC switch, cardiovascular medical devices, antiviral drugs, biosimilars, aesthetics, and personalized medicine
• We provide a one-stop solution for all the mission critical elements and deliver
unparalleled service
Who is ISS?
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Thank you!
Questions?
Steven M. Weisman, Ph.D.
Head of Clinical & Regulatory Support
Innovative Science Solutions, LLC [email protected]
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