- Your Insider Advantage for FDA Advisory Committee Meetings
Guidance from the inside track.
- Trusted Expertise from Those Who Led the Committees
Who We Are
AdCom Insider is a specialized consultancy dedicated to helping biopharmaceutical companies prepare 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.
- led by the former FDA division head who collectively directed and managed hundreds of Advisory Committee Meetings.
Leadership
Prabhakara Atreya
Co-founder
As former Director at CBER 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 committee meetings with biotechnology and pharmaceutical companies, while reviewing and recommending approvals for a diverse portfolio of vaccines, cell and gene therapies, and blood products regulated by the FDA. In this role, she also oversaw the preparation and announcement of funding opportunities and authored statements for grant funding decisions, supporting advisory committee actions on 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 molecular biology, virology, and pediatric infectious diseases at the NIH, FDA, and other U.S.-based academic institutions.
Timothy Cote
Co-founder
Dr. Timothy R. Cote, MD, MPH 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.
- Your goal is FDA approval. Our goal is to get you there.
Our Services
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. 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
Clear, compelling communication is critical. We help you:
- Develop persuasive key messages
- Structure briefing 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.
- Got questions for our regulatory experts? We’re here to help.
Contact Us
Tina Wang
BD Lead
tina@adcom-insider.com
ERIC SMITH-SOKOL
BD Lead
eric@adcom-insider.com
