FDA Insider guidance for biotech innovators
- Your Insider Advantage for FDA Advisory Committee Meetings
Who We Are
- Trusted Expertise from Those Who Led the Committees
AdComInsider is a specialized consulting company dedicated to helping biopharmaceutical companies prepare well for FDA Advisory Committee Meetings.
Founded by two former FDA directors, Dr. Prabha Atreya and Dr. Tim Cote, we bring unmatched insider knowledge to maximize your chances of success at these high-stakes public meetings.
Leadership
- led by the former FDA division head who collectively directed and managed hundreds of Advisory Committee Meetings.
Prabhakara Atreya, Ph.D.
Co-founder
As former Director at CBER, FDA from 2010 to 2025, Dr. Prabhakara Atreya demonstrated exceptional leadership and subject matter expertise in directing the FDA/CBER Advisory Committee program. She managed numerous high-profile, multi-faceted FDA Advisory committee meetings involving many biotechnology and pharmaceutical companies, where the Committees reviewed and recommended approval actions for a diverse portfolio of vaccines, cell and gene therapies, allergenic, and blood products regulated by the FDA. In this role, she also collaborated, trained, and supported many biotech and pharmaceutical company staff in their preparation and participation, in more than 200 FDA advisory committee meetings addressing issues of high public health significance.
Dr. Atreya holds a Ph.D. in Biochemistry from Memorial University of Newfoundland, St. John’s, Canada. Her postdoctoral work and peer-reviewed publications span research in biochemistry, cell and molecular biology, virology, and pediatric infectious diseases at the NIH, FDA, and other U.S.-based academic institutions.
Timothy Cote,
MD, MPH
Co-founder
Dr. Timothy Cote is the co-founder of AdCom Insider. He also serves as founder and CEO of Only Orphans Cote, based in Cambridge, MA, where he leads a team of experts specializing in rare diseases and orphan drug regulatory strategy.
As the former Director of the FDA’s Office of Orphan Products Development (OOPD) from 2007 to 2011, Dr. Cote guided the agency’s implementation of the Orphan Drug Act and personally signed decisions on more than 1,400 orphan drug designation applications. His extensive regulatory experience includes significant work with biologics, further deepening his expertise across the full spectrum of therapeutic development.
Dr. Cote received a bachelor’s degree from Syracuse University, his medical doctorate from the Howard University College of Medicine and a Master of Public Health (MPH) from the Harvard School of Public Health.
AdCom Insider's Services
- Every Advisory Committee is different, and every advisory committee meeting is different.
Navigating FDA Advisory Committee Meetings with Insider Expertise
- FDA Advisory Committee Meetings are among the highest-stakes milestones in the drug and biologics approval process. With decades of experience inside the FDA managing and directing these very meetings, AdCom Insider provides clients with the preparation, insight, and confidence they need to succeed.
Strategic Planning & Risk Assessment
- Every Advisory Committee is different, and every advisory committee meeting is different. We analyze the composition of your panel, anticipate likely concerns, and identify risk areas in your data package. This insider-informed perspective ensures that your team enters the meeting fully prepared for the issues most likely to shape the outcome.
Message Development &
Slide Strategy
- Develop persuasive key messages
- Structure briefing document content with clarity and precision
- Build slide decks that are simple, credible, and regulator-friendly
Mock Advisory Committees
- Nothing replaces practice. We design and lead realistic mock panel rehearsals to test your content and delivery. By simulating FDA committee dynamics, we strengthen your team’s ability to respond under pressure and refine your messaging in real time.
Executive &
Team Coaching
We prepare your executives, scientists, and medical experts to communicate with confidence:
- Coaching for presentation delivery and Q&A handling
- Training on how FDA panelists think and what they prioritize
- Insider feedback from former FDA leaders who have run these meetings themselves
Briefing Document & Submission Guidance
- We provide strategic input on briefing books and regulatory submissions to ensure clarity, compliance, and impact. Our insider perspective highlights what FDA reviewers and committee members will focus on—and how to address it directly.
Why choose AdCom Insider?
- Your goal is FDA approval. Our goal is to get you there.
When you only have one chance to get it right, turn to a partner who never leaves success to luck.
When the stakes are highest — when you’re facing an FDA Advisory Committee — you have to prepare well to win. You need more than solid data. You need an experienced steady mentor and a skilled partner to guide you through the process, and help you develop a clear, strategic story that moves experts to desired recommendations to influence Agency action.
Over 15+ years of experience, we’ve steered sponsors through landmark FDA Advisory Committees, consistently turning “Go or No-Go” moments into victories.
We deliver end-to-end support, from in-depth gap analysis and narrative workshops to immersive mock sessions, final-hour rehearsals, and flawless on-site execution.
Contact Us
- Got questions for our regulatory experts? We’re here to help.
Tina Wang
BD Lead
tina@adcom-insider.com
ERIC SMITH-SOKOL
BD Lead
eric@adcom-insider.com
