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ATMPs from academia to industry getting it right first time (GIRFT)
Published on February 28, 2022 41 min
A selection of talks on Pharmaceutical Sciences
RNA therapeutics: clinical applications and methods of delivery
- Prof. John P. Cooke
- Houston Methodist Research Institute, USA
Overview of nonclinical safety assessment
- Dr. Claudette L. Fuller
- Merck Research Laboratories, USA
Drug-induced liver injury: risk factors and drug development in DILI
- Prof. James H. Lewis
- Georgetown University Medical Center, USA
Drugging conformational states of GPCRs
- Prof. Dr. Peter Kolb
- Philipps-Universität Marburg, Germany
Hello. I'm Mark Lowdell, I'm the Professor of Cell and Tissue Therapy at University College London, and I direct the Centre of Cell Gene and Tissue Therapeutics at the Royal Free Hospital in London. I'm the CSO of one of the companies I've spun out, INmuneBio Inc. I'm going to talk to you about the development of Advanced Therapy Medicinal Products, or ATMPs, from academia to industry, how important it is and how you might go about Getting It Right First Time, GIRFT, as it's known.
I have a number of disclaimers and declarations. I'm a founder of a number of companies and I'm a consultant to many others, some of which are listed here. The opinions that I'm going to present today are my own, And they're not necessarily those of any of my employers or any of the companies listed above.
What I'm going to talk about today is the development of Advanced Therapy Medicinal Products, which includes gene therapies, somatic cell therapies and tissue-engineered products. Where we are today in 2021 is not that different from where we were five or six years ago. The vast majority of ATMPs are developed by investigators. Most of those are clinical, and the majority of the clinical trials are led by investigators. Those which are not investigator-led, are largely spin-outs from academia into small biotech companies or, increasingly, spin-offs where pharma has bought into academic spin-out companies. But to go from a successful investigational Advanced Therapy Medicinal Product into a successful marketed ATMP is challenging. It requires these products to be cost-effective and deliverable at the scale that the patient population needs, and we'll discuss that a length later on. Equally, they have to be easily technically transferred from small pharma to big pharma, or from academia into small pharma.