Advisory Committee meetings are an incredibly intense and high stakes endeavor within the drug development process. Millions in R&D costs, potential revenue, and patients served can come down to an eight hour meeting. When the FDA ultimately sides with the Advisory Committee’s recommendation approximately 85% of the time, these meetings have to go well.
Over the course of my 25+ year regulatory career, I’ve participated in numerous Advisory Committee meetings across a variety of therapeutic areas. Some went smoothly, and others didn’t. In my experience, when things don’t go well, it’s usually because of three main problems.
1. Lack of Preparation
There is no such thing as over preparing. I cannot emphasize this point enough. Teams should begin serious preparation four to six months in advance. What does this look like?
Teams must know every benefit and potential risk in their application and prepare for every question or issue that could possibly arise from the panel and committee members. You might have your presentation and narrative laid out, but the committee can take the discussion wherever they want. Prepare for these detours by outlining likely Q&A, conducting mock panels, and polishing slides and backups.
To answer all these questions, it's also important to gather the appropriate expert team. I would commonly have a core team comprising the moderator, clinical experts, and clinical safety experts. I would also have about a dozen other experts in the bull pen. Come prepared to demonstrate that the team has thought of everything: plans to address weaknesses, lifecycle studies, future development plans, and safety of the drug in the marketplace, etc.
2. Lack of Credibility
You need to show the Advisory Committee that you are the world’s top authority on the disease and therapy. How do you do that? First, know your data better than anyone else. Know its strengths and its flaws inside and out.
Second, you must be transparent about the flaws – and it’s okay to have some flaws. It’s a fatal mistake, however, to take a defensive posture and not proactively address these problems head-on. Also, never be dismissive of a safety question – another fatal mistake. Take them seriously and demonstrate that you have thoroughly considered them. Hiding vulnerabilities that eventually are discovered erodes your credibility. Once an FDA reviewer loses trust in you, the review process becomes more difficult.
Third, pick your moderator very carefully. His or her presence at the microphone is an opportunity to set the tone of scientific credibility. The moderator must understand the quality of the data and be able to triage questions to the appropriate team member, who can articulate benefits, risks, and the science behind it.
3. Lack of Communication
Avoid surprises at all cost. How? Through good communication. Throughout the entire review process, a good regulatory professional and FDA project manager will stay in constant contact to make sure no surprises come up. There are opportunities throughout the review process to communicate and align with the FDA. Take advantage of all of them.
Through proper communication, you can establish a good working relationship and alignment with the FDA before the meeting.
Parting Advice for the Big Day.
Whether this is your first AdComm Meeting or your 21st, remember that there is nothing more important than scientific credibility.
Be thorough. Be transparent. Be proactive.
Joe Lamendola, Ph.D. is the Senior Vice President of YourEncore's Regulatory Practice and the former Vice President of U.S. Regulatory Affairs at Bristol-Myers Squibb, where he was responsible for 20+ approvals across 10+ therapeutic areas.