First in a Series
I was thrilled to see the prototype Tissue Foundry publicly unveiled In June during our Meeting in the Millyard Spring Summit. It was very satisfying to see ARMI members come together to generate this outward and visible manifestation of the ARMI | BioFabUSA technical roadmap - a feat that few roadmaps achieve, especially those written by new communities. It will take continued involvement by the entire ARMI community to develop the Tissue Foundry when the BioFab USA-funded technical projects are incorporated into the scalable, modular, automated, closed manufacturing line.
As much as I will savor seeing the Tissue Foundry mature right above my eyes in the same building that housed a 19thCentury machine shop that was America’s advanced manufacturing for its time, I realize that simply having a novel technology (no matter how innovatively it is manufactured) is insufficient to allow a great scientific notional product to translate to a commercial product. When I arrived at the FDA/CBER’s Office of Therapeutics Research and Review in 2000 there was great excitement about the prospect of new medicines for the new millennium from monoclonal antibodies, recombinant proteins, and tissue engineered medical products (TEMPs). Now, a generation later, the monoclonals and recombinants are biotech mainstays in both clinical practice and industry bottom lines, yet TEMPs have not matured as an industry. This divergence in industry maturity is certainly due, in part, to the increased manufacturing complexity of TEMPs relative to the biotech products. BioFabUSA’s technical projects and Tissue Foundry are addressing this complexity with bold initiatives.
Five key factors, in addition to manufacturing, are essential to a good idea making it from an academic achievement to part of a clinician’s armamenterium. These factors are not in the engineering, scientific, or medical curricula in sufficient depth for one to master them without additional training or experience. They are, nevertheless, at least as important as the scientific and engineering foundations of a TEMP (or other advanced therapy) with respect to full commercialization. These five factors shape the Fall Summit:
· Realistic Clinical Targets
· Accessible Capital
· Conducive Regulatory Strategy
· Expanding the Available Workforce
· Rational Reimbursement Environment
Recognizing this reality, ARMI | BioFabUSA has designed our Fall Summit to provide informative talks addressing these topics, interspersed with thought provoking interactive panel sessions to provide a fertile environment for the field to further grow. Regardless of what perspective you come from within our heterogeneous community and membership you will find areas within the workshop to learn and to teach. In the days and months after every summit, we hear of relationships and collaborations that were sparked by the chance encounters at these events. Through these meetings our community is strengthened and grows into an innovative industry. I’m looking forward to seeing you all in Manchester on October 16 and 17, 2019.
Over the next few weeks I’ll delve deeper into the RACER blueprint with blog posts dedicated to each component.