Anti arrhythmic / Cardio Renal
Organized and managed global team preparing for US FDA Advisory Committee; subsequently assisted in preparation for EU breakout session. An unusually challenging product profile with risk minimization action plan requirements.
- Developed and maintained key message inventory
- Provided strategic and tactical input on core presentation
- Wrote and edited briefing packages for US and EU hearings
- Coached all presenters and backups on content and delivery
- Provided extensive Q&A training for presenters and bullpen
- Composed in-depth profiles of AC Committee members
- Drove project management function, with attention to timeline, deliverables, budget
- Organized and facilitated three mock panels, including identification of expert panelists
- Managed activities, output, budget of slide production house
- Facilitated dialogue on risk/benefit strategy and coordinated with consultants
Contraceptive Device / Obstetrics and Gynecology Devices
Planned preparation activities and prepared team for appearance at Device Panel meeting. Team was composed of a small number of internal members, with large parts of the presentation being made by outside experts.
- Developed and maintained key message inventory
- Provided strategic and tactical input on core presentation
- Produced 5 minute video presentation demonstrating device usage
- Provided extensive Q&A training for presenters and responders
- Organized and facilitated mock panels
Emergency contraceptive / Reproductive Health Nonprescription
Held key position on consultant team in preparing small company with no prior FDA hearing experience and controversial class issues achieve majority committee support* for OTC switch
- Provided counsel on comprehensive strategy and content
- Delivered team orientation on best practices for FDA meetings
- Refined presentation strategy
- Provided 'real time' agency intelligence
- Coached individual presenters
- Organized and supervised mock panel sessions
- Developed and executed Q&A training for presenters and bullpen
- Provided War Room and onsite coaching and support
*Joint Advisory Committee Approval, 23-4
Endocrine and Metabolic
Played lead role on global team charged with managing simultaneous US and European submissions; unusually challenging novel product profile with risk management issues.
- Served as lead consultant on both US, European core teams
- Facilitated team summit on Advisory Committee preparations
- Coached all presenters and backups on content and delivery
- Provided extensive Q&A training for presenters and bullpen
- Composed in-depth profiles of AC Committees (Endocrine and Anesthesia)
- Provided intelligence on new acting director, deputy director
- Composed drug storyline for US, Europe
- Organized and facilitated two mock panels, including identification of expert panelists
- Managed activities, output, budget of slide production house
- Facilitated dialogue on risk/benefit strategy
First in class antibiotic / Anti-infective
Revitalized team following “Not Approvable” letter; structured and supported process to prepare for second, successful Advisory Committee hearing* and ultimate approval
- Created FDA Panelist Profile video
- Presented training session on FDA communications
- Condensed follow-up training for development team
- Coached company presenters
- Executed intensive Q&A preparation for lead presenter
- Developed oral and visual presentation material
- Conducted Two-day team motivational conference
*Unanimous approval [after initial rejection]
Novel vaccine / Biologics, Vaccines and Related Biological Products
Class: Sole advisor providing targeted support to global team preparing for FDA Advisory Committee discussion meeting on product class. Team had little knowledge of anticipated meeting focus, 30 minutes for their presentation and seven weeks to prepare.
- Provided orientation session on the AC process
- Established calendar of events and coordinated team progress
- Identified and recruited experts for mock panel
- Organized and conducted formal rehearsal and mock panel session
- Strategized on and rehearsed for Q&A with presenters and bullpen
- Developed background research package on AC members
- Consulted on presentations and slides with individual presenters
- Edited briefing package, with focus on executive summary
- Oversight and management of graphics production and slide vendor
Opioid analgesic / Anesthetic and Life Support
Led small specialty pharmaceutical company's multi-functional team to unanimous approval* by implementing aggressive benefit/risk positioning and a groundbreaking Risk Management Program
- Comprehensive preparation for FDA Advisory Committee
- Developed and implemented strategy to overcome subsequent “not approvable” letter and hostile FDA review division
- Coordinated efforts of regulatory, clinical and advocacy resources both inside and outside company
- Developed and negotiated groundbreaking Risk Management Program several years prior to issuance of FDA guidances on this topic
*Unanimous Advisory Committee approval
Sedative / Anesthetic and Life Support
Advised and assisted team preparing for US FDA Advisory Committee; product presented special challenges as it is a novel prodrug of a well known currently approved product with significant political and regulatory considerations.
- Developed key message inventory
- Provided strategic and tactical input on core presentation and briefing package
- Coached all presenters on content and delivery
- Provided extensive Q&A training for presenters and bullpen
- Composed in-depth profiles of AC Committee members
- Organized and facilitated three mock panels, including identification of expert panelists
- Facilitated discussions between company, external experts and professional associations
Vasopressin V2 Receptor Antagonist / Cardio Renal
Advised and assisted team preparing for US FDA Advisory Committee; brought in at late date to organize and drive the final month’s activities in collaboration with other consultants. Product presented interesting challenges related to surrogate endpoint considerations.
- Developed and maintained key message inventory
- Provided strategic and tactical input on core presentation through multiple late stage iterations
- Guided team in development of Q&A processes
- Provided extensive Q&A training for presenters and responders
- Organized and facilitated mock panels, including identification of expert panelists
