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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.
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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.
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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.
