Rapid translation of a cellular therapeutic from research to clinic

Cell & Gene Therapy Insights 2022; 8(3), 445


Published: 1 May 2022
Ashish Patel, Joseph Candiello

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. Utilizing scalable manufacturing processes and translation friendly raw materials during product development​ of MSCs and extracellular vesicle (EV) therapies will enable cell therapy developers to accelerate leading candidates into clinical trials, ultimately enabling more curative treatments to reach patients.

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 PhD, 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 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.

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Authorship & Conflict of Interest

Contributions: All named authors take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Acknowledgements: None.

Disclosure and potential conflicts of interest: Candiello JE is an employee of Rooster Bio. The authors declare that they have no other conflicts of interest.

Funding declaration: The author received no financial support for the research, authorship, and/or publication of this article.

Article & copyright information

Copyright: Published by Cell and Gene Therapy Insights under Creative Commons License Deed CC BY NC ND 4.0 which allows anyone to copy, distribute, and transmit the article provided it is properly attributed in the manner specified below. No commercial use without permission.

Attribution: Copyright © 2022 Rooster Bio. Published by Cell and Gene Therapy Insights under Creative Commons License Deed CC BY NC ND 4.0.

Article source: Article based on a webinar which can be found here.

Webinar recorded: Mar 10 2022; Revised manuscript received: Apr 8 2022; Publication date: May 5 2022.