Demonstrate Technical Feasibility

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: Safety Efficacy Value Cost of goods Convenience The TTP should be comprehensive but not overly complicated – an overly complex TPP can: Extend the development time Increase the technical risk and manufacturing cost Make it more difficult to get FDA approval Increase the cost and time to get a product to market 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) Ensure that these properties make the compound still viable for further development and that they are supportive of your TPP Consider hiring a consultant with domain expertise in your product area to develop RFPs and seek proposals from CMOs	Contract Manufacturing Organizations (CMOs) Product Development Consultants
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

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:

Safety
Efficacy
Value
Cost of goods
Convenience

The TTP should be comprehensive but not overly complicated – an overly complex TPP can:

Extend the development time
Increase the technical risk and manufacturing cost
Make it more difficult to get FDA approval
Increase the cost and time to get a product to market

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)

Ensure that these properties make the compound still viable for further development and that they are supportive of your TPP

Consider hiring a consultant with domain expertise in your product area to develop RFPs and seek proposals from CMOs

Contract Manufacturing Organizations (CMOs)

Product Development Consultants

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

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