To support the commercialization of a drug, we are including three example projects.

Solution: Building FDA Modernization Act Section 114 structure, process and execution. (FDAMA 114)

• FDA Modernization Section 114 (FDAMA 114) education
• Creation of FDAMA 114 policies and procedures
• Creation of first FDAMA 114 promo piece
• Training field sales force on FDAMA 114 promotional piece

Solution: Support commercial development of a phase II oncology product.

• Reviewed the environmental context in therapeutic space
• Creation of Payer Value Proposition
• Creation of Communication Plan & Evidence Plan

Solution: US payer insights on the relevance of Patient Reported Outcomes.

• Interview of 12 US payers across diverse health plans
• Qualitative analysis of responses to identify payer needs