Approvals Team Experience
The experience of our team
The BOLDAPPROVALS core team is highly experienced in leading more than 250 preparations for FDA Advisory Committee meetings and in tackling complicated challenges with cross-functional client teams.
Our core team combines scientific expertise and communication consulting with innovative IT and AV technology capabilities, giving you everything you need to succeed at an Advisory Committee meeting.
In addition to the core team, we have access to the full support of 100 additional scientists, presentation slide specialists, graphic designers, and project managers. This broader team enables us to supply each client with the personnel needed to address the unique requirements of their team, product, and circumstance.
Consultancy
Our consultants have a proven track record in helping teams prepare for FDA AdComm meetings, submission messaging, and FDA meetings. With their expertise in communication strategy and delivery, our consultants bring out the best in teams. Our lead consultant has more than 30 years of experience, has led over 110 AdComm preparations.
Scientific
Our scientific team comprises PhD-level scientists who offer an integrated approach to scientific messaging and content development. We have in-house specialists across multiple therapeutic areas, including rare diseases, rheumatology, neurology, ophthalmology, oncology, cardiology, and infectious diseases.
Technical
Our technical team are FDA AdComm specialists, covering slide support, meeting technology, slide switching, and a complete AV and IT support package. They have delivered more than 200 AdComms, both in-person and virtually.
Steven Clifford Cohen
Steven Cohen is the Managing Director of BOLDAPPROVALS.
Steven is an industry leader with over 30 years of experience. He has led more than 110 global teams in preparation for FDA Advisory Committee meetings (AdComms) across a wide range of therapeutic areas, virtually and in person.
He’s conducted numerous submission messaging workshops, helping teams develop the communication strategy of their FDA New Drug Applications (NDAs) and Biologics License Applications (BLAs). He has supported FDA meetings at key milestones, including End of Phase 2 (EoP2), Pre-NDA/BLA, Application Orientation (AOM), and Mid- and Late-Cycle Meetings. He has coached over 1000 scientists, clinicians, regulatory affairs professionals, and leaders across functional groups and disciplines.
Steven has a particular set of skills to help clients overcome the most challenging communication hurdles. He is adept at crafting clear and compelling arguments from complex data and helping individuals and teams deliver them credibly. He’s a deft facilitator who can help a team develop and align on a communication strategy, messaging, responses to questions, and approaches to managing critical issues.
A division of BOLDSCIENCE
BOLDAPPROVALS is a division of BOLDSCIENCE® Inc. a scientifically creative global medical communications agency. BOLDSCIENCE creates impactful programs for pharmaceutical clients who need a compelling voice to communicate with their audiences. We support investigational and commercial products throughout their lifecycles with a complete package of strategic, medical writing, project management, creative, and digital services.
For clients preparing and delivering high-stakes presentations, our sister division, BOLDPRESENTATIONS, helps to elevate your presentations with start-to-finish services that take you from concept to execution. These include training seminars in presentation strategy and delivery skills, communication strategy and content development, visualization services, production support, and team and individual rehearsal and coaching.