The recent EMA recommendation for approval of Kymriah and Yescarta serves as yet another sign of the commercial arrival of cell therapies and their growing global appeal. As these novel therapeutics expand beyond US boundaries, Akron has taken the following steps to help our clients better understand the regional regulatory differences, innovations and tools available to support and accelerate this path to worldwide access:
- Co-Founding of Standards Coordinating Body (SCB) – As presented during the Industry session at ISSCR in Melbourne by Kim Bure, Sr Director of Global Sales, the SCB is a non-profit dedicated to unifying communications and directing projects which coordinate the standards efforts of all stakeholders – researchers, healthcare organizations, corporate entities and standards development organizations. Two important SCB achievements thus far include:
- Progress towards approval of ISO 20399 Ancillary Materials for Cell Therapy
- Presentation of the Rapid Microbial Testing Method project at the ISO meeting in Beijing
- Participation in Phacilitate’s Trade Mission to Korea and Japan – This event provided a forum to reach out to local companies and emerging startups regarding their evolving pipelines, many of which are now growing to include CAR-T therapies as well as the MSC and iPSC programs for which the region has been strong historically. In addition it enabled proactive discussions regarding regulatory differences such as the goal of tertiary animal-free material usage from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.
- Innovative Tools for Commercial Production – Large scale production of pharmaceutical grade cGMP cytokines has made implementing higher quality ancillary materials attainable at reduced COGS, even in early clinical stages, and strengthens comparability throughout the approval process. Other available tools like rapid mycoplasma testing with a proprietary control that reduces false positives and DMSO-free CryoNovo cryopreservation agents to enhance patient safety further aid in expediting commercialization.
It is Akron’s mission to serve our clients from development to bedside and we look forward to being your partner in this exciting journey. Akron will be in Philadelphia next week for the 11th annual Business of Regenerative Medicine: Innovation, Clinical Translation, and Entrepreneurship Symposium. Click here for details!