SECOND IN A SERIES
BY DR. RICHARD MCFARLAND
CHIEF REGULATORY OFFICER, ARMI | BIOFABUSA
The RACER Blueprint is comprised of Five key factors, in addition to manufacturing, that are essential to a good idea making it from an academic achievement to part of a clinician’s armamenterium. They are as important as the scientific and engineering foundations of a TEMP (or other advanced therapy) with respect to full commercialization.
- Realistic Clinical Targets
- Accessible Capital
- Conducive Regulatory Strategy
- Expanding the Available Workforce
- Rational Reimbursement Environment
This blog post takes a deeper dive into the R of RACER – Realistic Clinical Targets.
The principal challenge that must be surmounted for any product idea to transition to an actual commercially viable product is to identify a need for the product. For some products such as the fidget spinner a commercial need might be generated simply through marketing. However, for regenerative medicine products the commercial need is best determined by actual clinical need. Prudent clinical product development requires a detailed understanding of the current clinical need, and a clear-eyed evaluation of alternative treatments.
Research findings without realistic clinical target indications are good ideas, at best, that may generate first in human clinical trials, but will seldom result in usable, commercial products. Eventually regulators and/or payors will determine which of these two alternatives a developer has- when this happens after many years of effort it can be brutal. It is much more prudent to use techniques that allow you to focus on a realistic clinical target early in development. Use of a robust Clinical Target Product Profile to guide product development from the beginning greatly increases the ROI of time and money in the endeavor. We will provide ways to do this at the upcoming ARMI|BioFabUSA Fall summit on Oct 16-17. Join us!