Welcome to the Advanced Therapy Medicinal Products and Biologics Focus Group
Our Focus Group explores the development, manufacture, regulation and clinical use of advanced therapy medicinal products (ATMPs). This includes medicinal products that are based on gene therapy, somatic cell therapy or tissue engineering.
We bring together individuals from a range of disciplines from academia to industry to reflect the unique challenges that are presented by this exciting area of pharmaceutical sciences and welcomes those who are interested in this area.
What are Advanced Therapy Medicinal Products and Biologics (ATMPs)?
Advanced Therapy Medicinal Products and Biologics (ATMPs) include new therapeutic products that are typically based on gene therapy somatic cell therapy or tissue engineering. It presents new opportunities for the therapeutic resolution of medical problems that have either been beyond the scope of traditional small molecule drugs or they may offer a more effective treatment regimen. It also presents new challenges in our understanding of design, analysis, manufacture, dosing, delivery and biological monitoring of this complex group of medicines.
Take a look at our promotional video on YouTube
Advanced Therapy Medicinal Products and Biologics (ATMPs) Webinars
Take a look at the first in our Cell and Gene Therapies Video Interviews.
Dr Julian Braybrook became the Government Chemist in June 2018. He is currently Director of Measurement Science for the National Measurement Laboratory at LGC, a life sciences research and testing company, where he is responsible for the science strategy and partnership development of metrology (measurement science) and regulatory analysis programmes, in support of the UK National Measurement System.
Julian joined LGC in 1988 and has carried out a variety of roles, delivering and managing national and European analytical research innovation and contract service solutions for a wide range of chemical and biotechnology applications. He has a degree in Chemistry from the University of London and a PhD from the University of Cambridge for research into novel contrast agents for magnetic resonance spectroscopy and imaging. Julian has an honorary DSc from Kingston University London for his contributions to chemistry, is a Chartered Chemist and Fellow of the Royal Society of Chemistry (CChem FRSC).
Take a look at the second in our Cell and Gene Therapies Video Interviews.
Professor Fiona Thistlethwaite is an honorary professor at The University of Manchester. She graduated from The University of Cambridge MB PhD programme in 1999. Her PhD, under the supervision of Professor Sir Martin Evans, explored the molecular mechanisms that lead to cancer in inherited breast cancer syndromes.
Following training posts at Liverpool Royal, The Royal Marsden and The Christie, she became a consultant at The Christie in 2007. Her clinical practice is in Experimental Cancer Medicine and immune-oncology and her academic focus is clinical trial development in immunotherapy and adoptive T-cell therapy.
Fiona leads the Manchester health consortium, iMATCH, which was awarded almost £9 million by Innovate UK to ensure that more patients benefit from a new generation of advanced cell therapies. She is the Medical Director of the Christie Clinical Research Facility which delivers over 400 clinical trials to cancer patients.
We hosted a festive webinar on Advanced Therapies and Biologicals which took place on 6th December 2024. Speakers were as follows:
Arpan Desai, CEO, CamGene
Presentation Title: New frontiers in mRNA therapeutics: technologies and applications
Arpan Desai PhD is the CEO of CamGene, he has over a decade of experience leading project and platform initiatives in the RNA therapeutics space. He has a track record of creating innovative delivery approaches and progressing LNP-based projects from discovery into the clinic across multiple therapeutic areas. He was previously founding managing director of NanoVation UK for 2 years. Key achievements: >£2M of innovate UK grants, £100k of fee for service contracts, established a portfolio of 15 collaborations and 9 people. Prior to that he served as a director at AstraZeneca, where he was been involved in leading mRNA-based projects and platform activities encompassing gene editing, vaccines, and protein replacement approaches. This has included playing key roles in collaborations with Moderna, Ionis, VaxEquity and Regulus. He established and led a global matrix team of RNA delivery scientists with the mission of creating new delivery technologies for mRNA. He established key infrastructure for the design and optimization of LNPs. Moreover, several key advances in LNP platform science were obtained, such as the development of a proteomic based screening method for in vivo LNP assessment, evaluation of higher throughput methods for LNP optimisation and evaluation of almost 100 external technologies. His work on understanding how LNPs interact with different tumour cells facilitated the selection of preclinical models to assess LNP performance. This ultimately resulted in AZs first LNP based mRNA project progressing to the clinic (MEDI1191 partnered with Moderna Therapeutics).
Conor Barry, Associate VP, Global Biologics Technical Head, Piramal Pharma Limited
Presentation Title: Bioconjugates – the Past, the Present and the Future?
Conor has over 19 years experience in the research, development and manufacture of complex Biologics, with a particular focus on Bioconjugates. He has worked in roles of increasing responsibility across the academia, biotech, big-pharma and CDMO sectors.
He currently leads R&D activities across a global network of development and manufacturing facilities for Piramal Pharma Solutions. Prior to joining Piramal held senior positions within AstraZeneca, leading ADC Analytical Sciences, and serving on the ADC pipeline leadership team. Previously he worked as a Research Fellow in bioconjugation at Oxford University, and has over 20 peer-reviewed scientific publications.
Conor holds qualifications in:
Strategy & Innovation (Post-graduate Diploma, Oxford University)
Organic Chemistry (Ph.D., University of Bristol, UK)
Chemistry (B.Sc. (Hons), University College Cork, Ireland)
Janet Glassford, Expert Quality Assessor, MHRA
Presentation Title: Common Issues with ATMPs – a Quality Assessor’s Perspective
Janet Glassford is an Expert Quality Assessor at the MHRA with a special interest in ATMPs. Her role includes the assessment of ATMP marketing authorisations, early access assessments, innovation licensing pathway applications and the provision of scientific advice, and support to the innovation office. Since joining the Agency in 2010, she has assessed a wide range of biological products, including numerous ATMPs (encompassing gene therapies, somatic cell therapy medicinal products and tissue engineered products). She has also contributed to various regulatory/scientific guidelines.
Prior to becoming a regulator, she gained more than 18 years laboratory-based research experience. Her research interests and publications centred on the cell biology of haematological malignancies. During this time she acquired substantial hands-on experience of a wide variety of molecular and cell biological techniques relevant to ATMPs.
Meet the Group
Focus Group Leads
Focus Group Members
Why You Should Get Involved
Do you work or have any specialist knowledge or interest in this area? If so, then we would love you to
join us and contribute to our plans.
We would like to undertake a review of current education provision of Advanced Therapy Medicinal Products and Biologics in the delivery of the Pharmacy and Pharmaceutical Science degree and secure sponsorship for Essay competition entitled Towards Patient-centred Biotherapeutics
