Why is this Important? You want to make certain you have a viable and valuable product but do not want to over complicate the commercial offering
|Key Actions||Things to Consider||Tool Kit|
|Define the Target Product Profile (TTP)||The TPP defines what the product should be able to do (“in a perfect world”). It should solve the unmet medical need and provide clear evidence of:
The TTP should be comprehensive but not overly complicated – an overly complex TPP can:
The TPP deserves a considerable amount of thought because, once established, changes should only be made when informed by emerging data and other information (manufacturing feasibility, regulatory input and the competitive landscape).
Resist modifying it solely to accommodate unproven assumptions around product development
What will it take to satisfy FDA requirements for approval and make the product competitive?
|Characterize your lead compound for production||Get an estimate of what the product will cost to manufacture in volume (COGS)
Define all key pharmacologic properties for your lead (potency, selectivity, affinity, etc)
Consider hiring a consultant with domain expertise in your product area to develop RFPs and seek proposals from CMOs
|Contract Manufacturing Organizations (CMOs)|
|Run multiple convincing experiments that demonstrates technical feasibility of the product||How well does it perform against the current standard of care (If it exists?)
Fast and simple experiments that demonstrate that the product is likely to work
Be able to generate a single slide demonstrating the solution in a simple and easy to understand manner for non-technical investors