THIRD 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 armamentarium. 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 A of RACER – Accessible Capital.
Prudent product development requires, in the addition to a focus on realistic clinical targets (discussed in my last post), different and more significant capital sources than typical basic research sources (NIH, NSF, DoD, or Non-Profit Grants). Unfortunately for those trying to develop their good idea into a product, training into what the sources of this capital are, how to obtain it, and how and when to use it are not in the scientific and medical training curricula. Similarly, legal and business curricula do not delve into the scientific realities of regenerative medicine products that make commercialization more challenging than creating a new app. In addition, these curricula typically don’t spend much time on the regulatory environment that also slows time to market. To move the sector forward, these two groups with disparate goals must develop relationships across their professional knowledge gaps and work together to get individual products all the way from bench to business. The financial, legal (commercial and intellectual property), and operational realities of each specific product development plan must be considered to make capital both accessible and contributory to overall business success.