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Advanced therapy medicinal products (ATMPs).

Advanced therapeutics and medicinal products (ATMPs) include new ptherapeutic 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.

The 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.

The Focus Group brings 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.
The Focus Group is currently represented by academic staff and a range of individuals from Pharmaceutical companies including Novartis, GlaxoSmithKline, Pfizer. Bespak, Arecor and Envigo. Many of our members have interests that span other focus groups and we welcome opportunities to work together to provide bespoke day courses and facilitate the contribution of breaking news in our area of expertise at our annual conference.

Zahra Rattray is a Chancellor’s research fellow and lecturer at the University of Strathclyde Institute of Pharmacy and Biomedical Sciences. Her lab is interested in biologics aggregation, the nuclear import pathway for drug delivery, and developing biologically-relevant in vitro tests for evaluating nanomedicine performance. Prior to joining Strathclyde, Zahra was a postdoctoral researcher at Yale School of Medicine where she investigated the re-engineering of cell-penetrating lupus autoantibodies as monotherapy, and for drug delivery applications. Roles prior to 2016 include: senior formulation scientist at AstraZeneca Pharmaceuticals for various parenteral and pre-clinical projects, and a postdoctoral associate at the University of Manchester focusing on protein aggregation

My interest is to understand the mechanisms of the vascular complications of diabetes and from this to develop novel treatment and screening models for new therapeutics. This predominately involves the use of biological compounds (DNA and proteins) and reflects my wider interest in the area of delivery, formulation, characterisation and legislation of Biotherapeutics. In addition to my research interests I have been instrumental in developing the course curriculum for teaching to prospective Pharmacists at RGU in order that they are able to respond effectively to the use of Biological compounds within their work environment. This is an exciting area and the majority of new therapeutics coming onto the market are of this nature and present their own unique challenges.

With over 20 years of experience in the formulation, development and delivery of biotherapeutics I have a keen interest in the evolution of biological therapies, especially the challenges these bring to delivery, specifically combination products including a biotherapeutic and a drug delivery device.

Dr Kevin King’s work with Pfizer’s global research units to ensure that our biotherapeutic molecules and vaccines are designed to have quality attributes that will meet the target product profile and the necessary physiochemical profile to enable their success in the marketplace. My industrial scientific leadership roles have focused on R&D in areas such as analytical characterization, formulation and process development. This has led to successful development of analytical, formulation and delivery technologies for a broad range of biotherapeutic modalities such as recombinant proteins, vaccines and cell and gene therapies from the discovery stage to commercial launch.

Dr Frank Thielmann is a Material Scientist by training. He joined the Novartis Biologics Manufacturing department as the Lead for PMO & Operational Excellence in 2016. In July 2018 he took on additional responsibility for new the Novartis European manufacturing site for Cell & Gene Therapeutics in Switzerland before moving to Takeda end of 2019. At Takeda Frank is responsible as Operational Excellence Director for the implementation of process improvement in the manufacturing of a wide portfolio ranging from small molecules to ATMPs.

After 14 years in academia I hopped over to the biopharmaceutical industry, first learning about the formulation of monoclonal antibodies in MedImmune before moving onto mRNA-lipid nanoparticle therapeutics in AstraZeneca. I now lead the Cell & Gene Therapy Formulation team at GlaxoSmithKline in Stevenage. Along the way I have been lucky to meet both inspiring academics and industrial leaders, and studied some great science!

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