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Printable Handouts
Navigable Slide Index
- Introduction
- Disclaimer and declaration
- Advanced Therapy Medicinal Products (ATMP)
- ATMP development
- This is the fastest moving field in drug discovery
- What are the problems? (1)
- What are the problems? (1)
- EU MA Since Regulation (EC) 2007 / 1394 n=12
- Real World challenges in commercial drug development
- If you can find money for PD?
- GIRFT: Mesenchymal Stromal Cells (MSC)
- Defining the product: Challenges of FCM
- Defining the product: BLA failures
- Novel data from flow cytometric analysis
- What is unique about ATMPs?
- Scale-out of manufacturing is the primary challenge
- Final element of TPP: Is it affordable? (1)
- Final element of TPP: Is it affordable? (2)
- Current and near-future challenges
- Summary
- Thank you!
Topics Covered
- Advanced Therapy Medicinal Products (ATMPs)
- ATMP development
- Requirements for a successful ATMP
- Challenges in commercial drug development
- Getting It Right First Time (GIRFT)
- The uniqueness of ATMP
Talk Citation
Lowdell, M. (2022, February 28). ATMPs from academia to industry getting it right first time (GIRFT) [Video file]. In The Biomedical & Life Sciences Collection, Henry Stewart Talks. Retrieved October 12, 2024, from https://doi.org/10.69645/OXZR1513.Export Citation (RIS)
Publication History
Financial Disclosures
- Professor Lowdell is a founder and shareholder of Achilles Therapeutics Ltd., Autolomous Ltd. (Director), INmuneBio Inc. (Chief Scientific Officer and Director), INmune Ventures Inc. (Director), and Novamune Ltd. (Director). Professor Lowdell is also a consultant to Advent Bio Services Ltd., Autolus Ltd., Avectas Ltd., NWBio Therapeutics Inc., Quell Therapeutics Ltd., and ViroCell Biologics Ltd..
A selection of talks on Pharmaceutical Sciences
Transcript
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0:00
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.
0:33
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.
0:52
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.