Translating regenerative medicine therapies: Why (bio)manufacturing matters

Please contact Lisa Spicer at lms8@psu.edu for Zoom information.

Abstract

Over the past 10+ years we have seen a growth in product innovations moving towards market in the Regenerative Medicine space with the FDA expecting to approve 10 to 20 Cell & Gene Therapy products per year by 2025. As product innovations increase a coinciding shift towards engineering solutions focused on process innovations is necessary to drive wide scale implementation and commercially viable endpoints. An example of this standardization of off-the-shelf, widely available microchip technology supporting a massive technology wave throughout the last decades. Similarly, human mesenchymal stem/stromal cells are "a microchip" or critical raw material across a wide range of developing therapeutic technologies. In this talk I will outline how a biomanufacturing and bioengineering focus on solving critical challenges in this space such as standardization, quality & regulatory considerations, engineering focus on scalability, and solutions aimed at key manufacturing points can streamline clinical implementation and success of these next-gen therapies. I also hope to highlight some alternative career pathways in the bioengineering and biotechnology space.

Bio

Dr. Joseph Candiello is a bioengineer with years of experience working at the nexus of biomaterials, biophysics, and organoid engineering. During 10+ years in academic research, he focused primarily on engineering a stem cell based vascularized islet organoid system for diabetes research as well as biophysics of interstitial tissue development. Prior to his PhD, Joe received his BS (Hons) from the Pennsylvania State University in Engineering Science and Mechanics, where he currently serves on the department IPAC. Dr. Candiello joined RoosterBio as Field Application Scientist in 2017 before moving to his current role as Senior Product Manager overseeing bringing new and innovative products to support global MSC-based therapeutics.