Rapid translation of a cellular therapeutic: Choosing product & process development solutions for clinical manufacturing readiness

Cell therapies face regulatory and manufacturing challenges long before they are accessible to patients. Even as therapies prove effective and safe, raw material and manufacturing decisions made during early development can either stall progression or rapidly accelerate it. In this webinar, we will explore traditional challenges associated with incorporation of human mesenchymal stem cells (hMSC’s) into cell therapies and the advances being made to improve clinical manufacturing readiness.

How an industrialized supply chain enables rapid translation
The importance of building manufacturing scalability into early process development
How "off-the-shelf" solutions can support regulatory compliance
The value commercial partnerships bring to the translational journey
The MONACO trial illustrates rapid translation for timely treatment of COVID-19 patients

Ashish Patel, PhD

Clinical Senior Lecturer and Consultant Vascular and Endovascular Surgeon, The National Institute for Health Research (NIHR) Guy’s and St Thomas’ Biomedical Research Centre (BRC)

Ashish Patel is a Clinical Senior Lecturer in the School of Cardiovascular Medicine & Sciences at King’s College London and Consultant Vascular and Endovascular Surgeon at Guy’s and St Thomas’ NHS Foundation Trust, London, UK. His British Heart Foundation-funded Ph.D., focusing on monocyte/macrophage biology in tissue remodelling, was awarded in 2013. He completed his Higher Surgical Training in General & Vascular Surgery as a Clinical Academic Lecturer at King’s College London & Guy’s & St Thomas’ NHS Foundation Trust. During this time, he received an Academy of Medical Sciences Grant and the Circulation Foundation’s George Davies Visionary Award. Dr Patel’s research interests are focused on the bench-to-bedside development and translation of novel cardiovascular advanced therapies, particularly for the treatment of peripheral arterial disease. He is an investigator within the BHF Centres of Regenerative Medicine and a Phase I accredited Principal Investigator at Guy’s & St Thomas’ NHS Foundation Trust. His research is funded by the Royal College of Surgeons, Rosetrees Trust, Advanced Therapies Network and the Frances and Augustus Newman Foundation.

Joseph Candiello, PhD

Senior Product Manager, RoosterBio Inc

Dr. Joseph Candiello is a bioengineering expert 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 previous studies understanding the biophysical properties of developing interstitial tissues during his PhD in Bioengineering at the University of Pittsburgh. Prior to his PhD, Joe received his BSc from the Pennsylvania State University in Engineering Science and Mechanics, where he currently serves on the department's Industry & Professional Advisory Council. Dr. Candiello joined RoosterBio as a Field Application Scientist in 2017 before his current role as Senior Product Manager helping to bring new and innovative products to the market to support MSC based therapeutics.