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Cell & Gene Therapy Insights

Cell & Gene Therapy Insights

Issue Vol 4 Issue 5

Commercial Insights
Interview

Advances in Enabling Smart Technologies across the Cell Therapy Supply Chain

Spotlight Article

Interview

Maria Papathanasiou

Supply Chain Management Part 2: Creating a Logistics Strategy for Commercialization

Papathanasiou headshot

Maria Papathanasiou holds a PhD degree in Chemical Engineering and is currently a full-time Research Associate at the Department of Chemical Engineering at Imperial College London, working with Professor Nilay Shah. Her primary research focus is the modeling and optimization of CAR T cell supply chain models, with four key objectives: (i) scalability, (ii) cost efficiency, (iii) timely delivery of therapies and (iv) minimization of risk of product loss. Other research areas include the development of mathematical tools for optimization, monitoring and control in pharmaceutical and biopharmaceutical manufacturing.

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Logistical Considerations of the Cell Therapy Supply Chain at the Point of Care

Spotlight Article

Interview

Karen Coopman

Supply Chain Management Part 2: Creating a Logistics Strategy for Commercialization

Karen Coopman has a background in pharmacology and has always had an interest in healthcare. The overarching theme of Karen’s research is the manufacture of cellular therapies. The ultimate aim is to generate a viable stem cell bioprocess such that clinically relevant cell numbers can be generated whilst ensuring product potency, purity and safety. Developing scalable systems for stem cell growth and improving methods of cell preservation are the current focus of her group. A Reader in Biological Engineering at Loughborough University, she is the Director of the EPSRC/MRC Centre for Doctoral Training in Regenerative Medicine and is also on the Steering Group of BioProNET and Chair of ESACT UK, the UK Society for Cell Culture Biotechnology.

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Government Initiatives in Promoting Cell & Gene Therapy Manufacturing & its Associated Supply Chain in the UK

Spotlight Article

Interview

Magdalini Papadaki

Supply Chain Management Part 2: Creating a Logistics Strategy for Commercialization

Dr Magdalini Papadaki is Head of Product and Process Innovation for ABPI. She is responsible for the UK’s industry strategy in innovative products (i.e. ATMPs, Synthetic Biology, new R&D tools) and novel development pathways for accelerated production and regulatory/clinical assessment. Before joining ABPI, Magda was a Lead Technologist for the Innovate UK Regenerative Medicine program. She is also a subject matter expert on adaptive pathways and new iterative development approaches and was member of the NEWDIGS consortium on the Adaptive Licensing paradigm in MIT, Boston, MA. A stem cell and gene therapy scientist by training, combining over a decade in research with regulatory and business experience in the EU and USA. Magda has worked extensively in the global space of public–private partnerships, including the EU Innovative Medicines Initiative (IMI) and the US/FDA Critical Path initiative. Her industry experience was with Novartis, as OTC DRA and Access Director for Greece and Cyprus. She holds a PhD in Gene Therapy and Stem Cells, an MPhil in Bioscience Enterprise from the University of Cambridge, UK and an MSc in Pharmacology from the University of Oxford, UK.

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Opportunities & Challenges for Decentralizing Cell & Gene Therapy Manufacturing

Spotlight Article

Interview

Steve Goodman

Supply Chain Management Part 2: Creating a Logistics Strategy for Commercialization

Steve Goodman is the head of drug product manufacturing at bluebird bio, where he oversees production of cellular therapies across their portfolio of products and is accountable for the long-term technology strategy to expand access of these treatments to serve global patient requirements. Before joining bluebird in January 2018, Steve was at GSK where he held a number of roles across research, development, manufacturing and supply chain. These included roles leading cross-functional teams in the design, development and transfer of clinical and commercial chemical manufacturing processes; designing and implementing supply chain strategies for ex vivo and in vivo gene-modified cell therapies as well as for small molecule medicines; and managing manufacturing operations to ensure the safe and efficient supply of important commercial respiratory products to global patients. Most recently he served as Director of Manufacturing and Strategy for the Cell and Gene Therapy unit where he was responsible for the external manufacturing of the entire value chain to support GSK’s ex vivo cellular therapies, and for defining and executing the vector manufacturing strategy. Steve joined GSK in 2002 following a PhD and post-doctoral fellowship in organic synthetic chemistry at Harvard University.

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Perspective

ISCT 2018 Commercialization Signature Series

Perspective

Supply Chain Management Part 2: Creating a Logistics Strategy for Commercialization

The second ISCT Commercialization Committee Signature Series was held this past January at the Phacilitate meeting. After a successful inaugural event in 2016 at the ISCT North American Regional Meeting, focused on a broad overview of challenges and roadblocks to commercialization, this event turned it’s focus towards product characterization and comparability, essential topics to adequately harness and control any product development, but of particular complexity in the context of live replicating cell products.

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Expert Insight

Translating Regenerative Medicine Science into Clinical Practice: the Local to Global pivot

Spotlight Article

Expert Insight

Richard P Harrison, Aileen Gracias & William Mitchell

Supply Chain Management Part 2: Creating a Logistics Strategy for Commercialization

Research into cell and gene therapies is globally dispersed, which creates scientific opportunities, but in turn, significant commercial challenges. In order to successfully bring promising scientific endeavors through to commercial opportunity, greater cross-border coordination of supply side activity considerations such as academic institutions, funding gaps, intellectual property, and commercial entities as well as demand-side issues of reimbursement, regulatory policy, stakeholder engagement and patient engagement should be advocated for.

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