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This two-day course covers various issues and challenges in regulatory science for gene and cell-therapy medicinal products.
The course plans to have CPD approval by the Royal College of Pathologists.
It's aimed at those in a wide range of roles that regularly face challenges in production, testing and registration of advanced therapy medicinal products (ATMPs).
The course will
- reveal up-to-date gene/cell therapy development, production technology and regulation
- clarify ethics, clinical trial designs and commercial licensing issues.
As a wide range of novel gene and/or cell therapies are developed in clinical and preclinical studies, the important question of how to deliver potentially beneficial therapies to patients is often neglected.
In this course we'll discuss the regulations required to help make future medicinal products safe and effective, which evolve alongside advances in science and technology.
You'll be taught by experts at UCL, MHRA (Medicines and Healthcare products Regulatory Agency) including specialists who work to develop and deliver NIBSC (National Institute for Biological Standards and Control) standards, and the Cell and Gene Therapy Catapult (CGT).
Course structure and teaching
The course will be taught on Monday 7 and Tuesday 8 November.
The course will take place in person. However, due to disruption that will be caused by the planned rail strike on 7 November, the course will now also be available to attend virtually. Details about joining virtually will be released shortly.
Join ten expert lectures, two panel discussions and access online learning materials, including additional reading and web-based quizzes to help your understanding.
You'll benefit from lectures and e-learning materials created by experts active in:
- global frontier research
- clinical development (e.g. UCL academics running gene therapy clinical trials)
- medicinal product standards (NIBSC)
Lecturers representing MHRA will also demystify their roles, tasks and abilities in therapy development.
Discussion sessions and reception/coffee breaks will give you opportunities for networking.
You can download a schedule for the training.
Who this course is for
This course is for anyone interested in the translational side of gene and cell therapy.
It will be particularly useful for those involved in producing, testing and registering ATMPs.
We welcome interest from:
- staff at pharmaceutical companies or SMEs
- staff at regulatory authorities (e.g. MHRA, Public Health England, Department of Health and equivalents from other countries)
- national ethics services (NRES in UK)
- academic clinicians and allied health professionals from research hospitals
- scientists and students from other universities and other academic institutions
By the end of this course you'll:
- have improved your knowledge of regulatory science for gene and cell therapy medicinal products, including the underpinning science, GMP (good manufacturing practice) production, ethics, and first-in-man trial design and licensing
- be able to apply this knowledge in your future contribution to translational development of advanced therapy
You'll need an undergraduate-level of knowledge in biology.
A good knowledge of the principles of gene and/or cell therapies is also desirable.
Cost and concessions
The fees are:
- £1,100 - standard price
- £800 - public sector, university academics
- £550 - students
For BSGCT members, reduction of the above fees by £100 will be available.
You can receive a full refund on cancellations up to five working days before the start of the course.
Dr Yasu Takeuchi
Yasuhiro is Associate Professor of Molecular Virology at the Division of Infection and Immunity, UCL. He’s been based in London for 33 years, initially at the Institute of Cancer Research and then UCL. He studied Biochemistry at the University of Tokyo and obtained an MSc on the physicochemical study of nucleic acids, and then a PhD on molecular biology of small nuclear RNA. He started his research on retroviruses on being appointed as a junior lecturer at Gunma University, Japan in 1986. Since then he's been working on human viruses, HIV and HTLV and mammalian gammaretroviruses including porcine endogenous retroviruses. His research on retrovirus biology has involved several aspects of infection and evolution with an emphasis on envelope-receptor interaction. The applied side of his research has focused on the use of retroviruses as vectors for gene therapy and zoonotic infection in xenotransplantation. In September 2016 he started a secondment for 30% of time in the Advanced Therapy Division in NIBSC (presently, Biotherapeutics and Advanced Therapies, Scientific Research and Innovation, Medicines and Healthcare products regulatory agency).
Dr Katherine Cornish
Kate completed her PhD in retinal photoreceptor transplantation at UCL. Following that she moved to the Maurice Wohl Neuroscience Institute at King’s College London to examine human neurodevelopment through directed differentiation of induced pluripotent stem cells. In 2019 she joined the UK Stem Cell Bank at the MHRA as a senior stem cell biologist. Since then she has focused on clinical grade stem banking and the development of a programme of work around standardisation of stem cells and cell therapies.
Dr Leo Perfect
Leo is a senior scientist in the Cell Therapy group in the Science, Research and Innovation division of the MHRA. His research is focused on addressing the novel manufacturing and regulatory challenges presented by cell based advanced therapies. He is particularly interested in the use of NGS approaches to this end. Leo completed his PhD in neuroscience at King's College London and moved to the MHRA in 2018.
"This course is an absolute must for anyone who is interested in bringing gene and cell therapy from bench to bedside. I attended all sessions of the five-day programme and enjoyed every minute of it. The organisers put together a comprehensive and well balanced set of lectures covering both regulatory affairs and practical information offered by scientists who pioneered some of these advanced therapies. Representatives of the different regulatory bodies presented a clear overview of the regulatory aspects of gene and cell therapy removing the uncertainties/insecurities very often associated with this aspect of translational research. It was gratifying to hear that MHRA and EMA are well aligned, and that they offer exploratory meetings with researchers at early stage so that preclinical and clinical studies can be tailored to meet the regulatory standards. Lively discussions after the sessions added to the overall learning experience, and there were plenty of opportunities to interact with the speakers and attendees."[Dr Els Henckaerts, Department of Infectious Diseases, King's College London, 2016]
"The Regulatory Science for Advanced Gene and Cell Therapy course is an invaluable tool for anyone interested in translational medicine. I attended the five-day programme and was positively amazed at the ease and expertise of an absolutely astounding group of speakers, who effortlessly lead us through all stages of bench-to-bedside research. From how to appropriately design pre-clinical studies, to how to set-up a clinical trial and ultimately apply for a new therapy to be licensed, all topics were addressed in an uncomplicated and yet extremely detailed and accurate way. All speakers were experts in their field and very approachable, with a series of interactive sessions and group discussions being held, which contributed to solidify all attendees' learning even further."[Rita Rego, Division of Infection and Immunity, UCL, 2016]
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Course information last modified: 30 Nov 2022, 16:01