Ron Jankowski, PhD (Cook MyoSite, Inc.)
Topic: Challenges and Biostatistics Considerations in Cell Therapy Clinical and Manufacturing Sciences
The cell and gene therapy field continues to emerge as a legitimate therapeutic modality with the continued, and accelerating, approval of such products in the US market and worldwide. These products aim to provide corrective and restorative solutions to conditions and diseases with high unmet medical need. However, they also present a multitude of manufacturing and clinical challenges not previously faced within the realm of traditional pharmaceutical development. We will discuss some of the challenges, opportunities, and continued evolution of this field from a personal perspective in the development of an autologous muscle cell-based therapy.
Ron is Vice President, Regulatory and Scientific Affairs at Cook MyoSite, Inc. and has over 20 years of experience in translational medicine and product development. He earned his PhD in Bioengineering from the University of Pittsburgh and is active in various local organizations and universities in supporting the evolving medtech and biotech ecosystem in Pittsburgh.