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Programme

This event series is split over 3 separate dates in May; 12th, 19th and 26th May.

May series of virtual webinars have been organised by Academy of Pharmaceutical Sciences Advanced Therapy Medicinal Products (ATMPs) Focus Group. These will run in May for 3 consecutive weeks.

The APS are pleased to announce a unique opportunity of a virtual webinars which will introduce the scientific principles underlying Advanced Therapy Medicinal Products (ATMPs), focussed on cell and gene medicines. Presentations will encompass concepts of cell/organ targeted gene delivery, product processing, manufacture and working with regulatory agencies. The current understanding in each field will be discussed alongside known barriers and potential solutions to their development for clinical use.

This is a unique opportunity to join with experts from Academia, NHS and the Pharmaceutical Industry to explore drug delivery strategies, product development, manufacture, regulatory frameworks and the clinical trial process for cell and gene-based medicines.

Three webinars will run, 12, 19 and 26th May 2021

They will start at 1.00pm and we aim to finish at 3.00pm. There will be an opportunity for Q&A after the talks.

You can register for one seminar or for all three.

You will be sent a ZOOM INVITE a day before the event and then one hour before the start. Please click to join.

The meeting is suitable for those from across academic, industrial and health-care sectors who work or have an interest in cell and gene therapy and ATMP regulations. The broad scope will suit postgraduate students, early career scientists and those transitioning into the pharmaceutical sciences with a focus to ATMPs, or established regulatory experts wishing to gain further insight into the underpinning science and technology, and vice versa. Experts in the respective areas will present and there will be opportunity for discussion and debate within the forum.

Wednesday 12th May 2021-DRUG DESIGN AND DEVELOPMENT

Wednesday 12th May 2021

Presentations

ARPAN DESAI-Associate Principal Scientist, Advanced Drug Delivery, Pharmaceutical Science, Research and Development, Astra Zeneca, UK

Design and Delivery methods for gene therapies

CHRISTINE DUFES-Reader (Associate Professor) in Nanomedicine Strathclyde Institute of Pharmacy and Biomedical Sciences (SIPBS) Glasgow, UK

Development of gene-based nanomedicines for cancer therapy

CHRIS VAN DER WALLE-Director, Formulation, Cell & Gene Therapies, GlaxoSmithKline, UK

Formulation considerations for T-cell therapies

Arpan Desai-Astra Zeneca

Arpan completed his first degree in Biotechnology at the University of Edinburgh, following which he obtained a PhD from the AZ/University of Nottingham Doctoral Training Centre in Targeted Therapeutics, where he studied the uptake and intracellular trafficking pathways of polymeric nanoparticles using pH-based nanosensors. He joined AZ in 2013 where he has worked primarily in the field of nucleic acid delivery. He has played a leading role in AZs formulation and delivery development activities for therapeutic nucleic acids with a focus on understanding cellular delivery mechanisms of mRNA using non-viral delivery vehicles. He has played a leading role in a number AZs collaborations to develop nucleic acid-based therapeutics including Moderna Therapeutics (mRNA), Ionis (ASOs) and Regulus (anti-miRs). More recently, he has established AZs Nucleic Acid Drug Delivery (NDD) team. This is a global discovery research focused group with the ultimate mission of apply delivery science to help advance nucleic acid based therapies into the clinic.

Christopher F. van der Walle- Formulation, Cell & Gene Therapy,GlaxoSmithKline.

Chris van der Walle obtained his PhD in peptide chemistry from King’s College London, where he was subsequently awarded a Maplethorpe Fellowship. He moved to the University of Oxford to study cell-matrix interactions before taking up lectureships at the Universities of Bath and later Strathclyde, becoming a Reader. In 2012, he joined the Biopharmaceutical Development group of MedImmune to formulate monoclonal antibodies, then merging with AstraZeneca as Director-Fellow to develop early stage messenger RNA lipid nanoparticle therapeutics. He currently leads the Formulation team in Cell & Gene Therapy at GlaxoSmithKline, focussed to T-cell therapeutics. He has published over 90 research articles, reviews and book chapters and retains an interest in high concentration protein solutions, nanoparticulate formulation and gene therapyDr Christine Dufès is a Reader in Nanomedicine and Director of the Postgraduate School at the Strathclyde Institute of Pharmacy and Biomedical Sciences (SIPBS).

Dr Christine Dufès is a Reader in Nanomedicine and Director of the Postgraduate School at the Strathclyde Institute of Pharmacy and Biomedical Sciences (SIPBS). Christine obtained a Doctorate in Pharmacy (with Distinction and congratulations of the Jury, 1997) and a PhD (with a European Label, Distinction and congratulations of the Jury, 2002) from the University of Poitiers (France). After four years as a post-doctoral researcher at the Cancer Research UK Beatson Laboratories in Glasgow, she was appointed as a Lecturer at SIPBS in 2006, obtained fellowship of the Higher Education Academy in 2007 and became a Senior Lecturer in 2012 and a Reader in 2019. Her research focuses on the development of targeted drug- and gene-based nanomedicines for cancer therapy and brain delivery. It resulted in 2 patents, 48 peer-reviewed publications in high-impact journals, 4 book chapters and attracted 3300+ citations (h-index: 26).
Christine has been awarded the Bourse d’Excellence Lavoisier (2002), the Award of the 9th Annual Symposium of the United Kingdom and Ireland Controlled Release Society (2003), the Biochemical Journal Young Investigator Award (2009) and the Tom Gibson Memorial Award (2012) for her research. She also received the “Best Overall” Strathclyde Teaching Excellence Award (2013) for her teaching and was shortlisted in the category “Best in Faculty of Science” in 2015 and in 2018. She is a Trustee of the British Society of Nanomedicine and Member of the Editorial Boards of 7 journals (Journal of Interdisciplinary Nanomedicine, Journal of Liposome Research, Journal of Nanotechnology: Nanomedicine & Nanobiotechnology, Journal of Pharmaceutical Sciences, Pharmaceutical Nanotechnology, Pharmaceutics and Scientia Pharmaceutica).

Wednesday 19th May 2021-MANUFACTURE

Wednesday 19th May 2021

Speaker

JULIE KERBY-Managing Director Industrialisation, Cell and Gene Therapy Catapult

Short presentation on Manufacturing for advanced medicinal and therapeutic products followed by discussion

Facilitators

ZAHRA RATTRAY-Chancellor’s Research Fellow and Lecturer in Translational Pharmaceutics, Strathclyde Institute of Pharmacy and Biomedical Sciences (SIPBS). Glasgow UK & FRANK THIELAM-Takedo

SPEAKER

Julie Kerby Cell and Gene Therapy Catapult- Managing Director Industrialisation

Julie is the director of industrialization, manufacturing at the Cell and Gene Therapy Catapult. She has more than 20 years’ experience across large pharma, biotech and academic laboratories, including 7 years at Pfizer Ltd as Biology Lead for a cell replacement therapy for Age Related Macular Degeneration which achieved First-in-Human in 2015. At the Catapult, Julie is responsible for the development and technical transfer of cell and gene therapy manufacturing processes ensuring they meet quality and regulatory requirement

FACILITATORS

Dr Zahra Rattray -Chancellor’s fellow and lecturer in Translational Pharmaceutics, Strathclyde Institute of Pharmacy and Biomedical Sciences

Dr Rattray holds a MPharm and a PhD in Drug Delivery from the University of Manchester, where she also completed a postdoctoral role developing new tools for characterizing antibody aggregation.
In 2014 Zahra took up a role at AstraZeneca Pharmaceuticals where she contributed to a diverse molecule portfolio ranging from small molecules to microsphere-based polymeric delivery systems. She subsequently undertook a postdoctoral role at the Yale School of Medicine in 2018 where she worked in collaboration with Patrys Ltd to develop the PAT-DX1 platform as monotherapy and drug delivery.
In September 2018, Zahra joined the University of Strathclyde as a Chancellor’s Research Fellow and Lecturer, where her research team develops bioanalytical measurements for profiling the biological fate of drug delivery systems. Dr Rattray is currently serving as the co-lead for the Advanced Therapy Medicinal Products Focus Group for the Academy of Pharmaceutical Sciences and has an active interest in developing novel bioanalytical measurements for predicting biological fate of these complex medicines.

Frank Thielmann- Operational Excellence director, Takeda, Switzerland.


Dr Thielmann has a PhD in Physical Chemistry/ Material Science from the University of Duesseldorf, Germany. Frank joined Novartis Pharmaceutical Development (Basel, Switzerland) in July 2007 as Formulation Lab Head. From August 2009 until February 2011 he managed the pharmaceutical development group at the Horsham site, UK. Upon his return to Basel he took on the responsibility for the local formulation technology platform until February 2012.

Subsequently he joined Novartis Technical Operations where he was managing the setup of a new solid dosage form manufacturing facility and the transfer of the corresponding portfolio before moving to the Biotechnology department as global Leader for PMO & Operational Excellence in November 2016, In this role Frank had an additional responsibility as Operational Excellence Head of the new Novartis manufacturing facility for Cell & Gene Therapeutics in Switzerland.

In November 2019, Dr Thielmann moved to a new responsibility at Takeda Manufacturing & Supply as Operational Excellence Director, where he is responsible for the implementation of process improvement in the manufacturing of a wide portfolio ranging from small molecules to ATMPs.

Dr Thielmann is member of the Steering Committee of the Material Science and Biotherapeutics Focus Group in the British Academy of Pharmaceutical Sciences.

Wednesday 26th May 2021-CMC REGULATION AND CLINICAL USE

Wednesday 26th May 2021

JOANNE BROADHEAD-Vice President CMC Project Delivery
Freeline Therapeutics Limited, Stevenage Bioscience Catalyst, Gunnels Wood Road, Stevenage, Herts, SG1 2FX, UK

 In vivo gene therapy: CMC challenges in clinical trials’

ALICE MASON-Lead Pharmacist, Advanced Therapy Medicinal Products
The Royal Marsden NHS Foundation Trust, London, UK

Clinical Applications and Trial Process

ALICE MASON-Lead Pharmacist, Advanced Therapy Medicinal Products
The Royal Marsden NHS Foundation Trust, London, UK

On completion of her Masters of Pharmacy (MPharm) degree from the University of Bath, Alice begun work in the NHS. Alice spent 7 years at King’s College Hospital where she completed a Post Graduate Diploma in General Pharmacy Practice at University College London before qualifying as an Independent Prescriber and specialising in haematology-oncology. Alice spent 5 years as a specialist pharmacist in haematology-oncology at King’s College Hospital where she began her work with cell and gene therapies, including to help deliver the first commercial CAR-T programme in the UK.
Since April 2020, Alice has been the Lead Pharmacist for ATMPs at the Royal Marsden Hospital where she works with a range of cell and gene therapies in the NHS and clinical trial setting.
Alice is an active member of the Pan UK Pharmacy Working Group for ATMPs.

JOANNE BROADHEAD-Vice President CMC Project DeliveryFreeline Therapeutics Limited,

Joanne has a Pharmacy degree from Bath University and a PhD in Pharmaceutical Sciences from the University of Rhode Island, USA.  Joanne began her career as a formulation scientist at a biotechnology company in the US before returning to the UK in 1996 to take up a role at Astra’s Leicestershire site (subsequently AstraZeneca).  Joanne held various roles in parenterals development and manufacturing at AZ until the site closure in 2011.  Joanne subsequently worked as a consultant for several years and in this capacity provided long term technical and regulatory support to the late stage development of a viral vaccine.   Joanne joined Freeline in 2016 and now leads the CMC project delivery group with responsibility for CMC project leadership and CMC regulatory submissions for Freeline gene therapies.

Event information

APS MEMBERS FREE FOR ALL THREE WEBINARS

Non-Members

Students and Early career researchers – £10 per webinar & £25 to attend all 3 webinars
Others- £20 per webinar and £50 to attend all 3 webinars
All prices ex VAT

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Non-Members – Early Careers and Students (three webinars)

£25.00

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Members – Free Tickets For Members At The Members Hub  (12th May)

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Non-Members – Early Careers and Students – (12th May)

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Non-Members – Others (12th May)

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Members – Free Tickets For Members At The Members Hub  (19th May)

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Non-Members – Early Careers and Students – (19th May)

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Non-Members – Others (19th May)

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Members – Free Tickets For Members At The Members Hub  (26th May)

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Non-Members – Early Careers and Students – (26th May)

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Non-Members – Others (26th May)

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