Implementation & Execution (Clinical Development Plan)
March 23, 2019Discovery and Requirements
March 25, 201911-18 step process:
For a recent cellular therapy client, performing a gap analysis was critical in their initial fundraising. By identifying exactly what additional information was needed to obtain an IND, they presented successfully to investors.
Reimbursement is its own strategic morass. By creating an overall portfolio clinical development plan, we can anticipate any resistance that may be brought by medical societies or payers. For a client in a very competitive space with huge existing competition, this enabled us to plan a sequential new coding strategy to minimize resistance.