Mission: Ensure team members anticipate all drug approval issues of interest to the FDA and the advisory committee concerning client's proposed drug or medical device. Help key presenters develop and deliver data-driven sponsor's presentations. Ready team members to effectively answer all questions and retrieve convincing backup slides to support responses.

Significant Work: We have assisted clients in pursuing approval of 90 new indications (drug/devices/biologics); of the 90, 61 have won FDA marketing approval and 11 more are pending final decision. Of the 40 different FDA advisory committees, CCA has prepared sponsors for 19 separate divisions. Our preparation process is adaptable to any advisory committee.

Research: Through research interviews and document analysis, we acquire an understanding of drug pharmacology and mechanism of action, preclinical research, clinical trials, adverse events, possible protocol violations, and potential FDA and advisory committee concerns.

Level of Effort: Three intense "hands on" sessions working with responses to drug approval issues and development of sponsor presentations. Private coaching is also available for outside experts and team members, as needed.

• Stage I – Sponsor’s Presentation, Extensive Q&A, Mock AC (4.0 days)
• Stage II – Refine Sponsor's Presentation, Issue Cards, Q&A with Backup Slide Retrieval, Mock AC (4.0 days)
• Stage III – Final Fixes and Rehearsals just preceding advisory committee (3.0 days)

Content Highlights:

• Research interviews to identify critical issues
• Early strategy meeting, (preferably 4-6 months before health authority meeting)
• Guide development of sponsor's presentation
• Presenters/responders develop Issue Cards for all priority issues
• CCA's Question and Answer System
• Strategy for backup slide indexing and retrieval
• Coaching on delivery style once the message is set
• Participants lock in skills through extensive on-camera coaching
• Last day of each session devoted to mock advisory committee meetings

Location: Conducted privately at a location of your choice.

Bottom Line: Our winning record provides you with the best edge for drug approval.

E-mail or call for more details, 972.713.7474