Let’s talk integration

Tuesday 08:00 PDT / 11:00 EDT / 15:00 GMT / 16:00 CET

Sponsor

The complexities of integrating processes and scaling-up the manufacturing of cell and gene therapies is a topic that is prevalent in our maturing industry. Vendors and producers are focusing heavilyon developing purpose-built solutions, integrating as many steps as possible, sometimes leveraging entirely new technologies rather than legacy approaches from the blood processing and biologics sector. This can present new challenges as the implementation often impacts process development, automation and regulatory teams within an organization.

This webinar provide a short example of the ekko™ system processing cell aggregates while integrated with a bioreactor. A cross-functional panel discuss integration challenges and learnings related to an integration strategy.

A comprehensive view of key considerations when implementing integrated solutions from the perspective of process development, automation and regulatory
First-hand examples of implementing automation strategies and technologies
When, where and how to consider implementing such technologies and the balance of risk / benefit

Nina Bauer

VP Business Development, FloDesign Sonics Inc

Nina Bauer, a key figure in the cell and gene therapy community joined FloDesign Sonics in September as VP of Business Development. She leads the commercial aspects of establishing, launching, and further adoption of this disruptive technology. Previously Nina led Lonza’s Autologous Cell Therapy business, with manufacturing sites in the US and Europe. As part of this role, she was also in charge of establishing novel manufacturing technologies, most notably the Octane Cocoon™ platform. Prior to joining Lonza, Nina held business development roles at the Cell Therapy Catapult (London), and the University of Edinburgh, and worked as Life Science Consultant for regenerative medicine businesses.

Mark Dudley

Senior Vice President, Product Development at Adaptimmune Ltd

Dr. Mark Dudley is a Senior Vice President at Adaptimmune Therapeutics, a leader in genetically modified T cell therapies for solid cancers, where he is responsible for manufacturing and development. Dr. Dudley has been a pioneer in the field of immunotherapy manufacturing, and has developed and implemented innovative early process design with accompanying analytics for multiple therapies. Previously, as Director of New Cell Products in the Cell and Gene Therapies division of Novartis Pharmaceutical Corp, Dr Dudley was responsible for establishing scalable, GMP-compliant production strategies and facilitating globalization of CAR-T products and platforms.

As Director of the Cell Manufacturing Facility at the Surgery Branch of the National Cancer Institute, NIH, in Bethesda, MD, Dr Dudley investigated tumor rejection antigens, T cell specificity and function, and methods for the generation and administration to patients of T cell therapies. His work has resulted in more than 100 peer-reviewed publications, and he is co-author on numerous seminal papers including early tumor-infiltrating lymphocytes studies demonstrating that adoptive T-cell transfer has tumor eradicating potential. Dr. Dudley earned a PhD in Biological Sciences at Stanford University, and had post-doctoral fellowships at The University of Pennsylvania in Philadelphia, PA and at the Jackson Laboratory in Bar Harbor, ME.

Jon Ellis

Cell Therapy Manager at Invetech

Jon Ellis is the San Diego Cell Therapy Manager at Invetech, an engineering and consultancy firm focused on the development of platforms and systems for commercial-scale GMP manufacturing. Prior to joining Invetech in 2018, Jon had 15 years’ experience in the cell therapy industry, initially in GMP manufacturing management and process implementation and, more recently, in development of novel cell isolation and selection technologies.

Christiane Niederlaender

Vice President Technical at

Christiane Niederlaender. has spent 9 years at the UK medicines regulator MHRA, most recently as the Unit Manager of the Biologicals Unit. In that capacity she chaired and oversaw all formal scientific advice meetings and had in-depth involvement of Brexit preparedness. At the same time Christiane was a Senior Assessor and the UK delegate at the EMA committee for advanced therapies (CAT). She was UK CAT Rapporteur responsible for managing the portfolio of all UK ATMP products (cell and gene therapies). She was also the Rapporteur for the EMA CAT Gene Therapy Guideline and quality lead for gene therapy section of new draft guideline for investigational ATMPs. She was a drafting group member in all other quality related ATMP drafting groups, including GMP for ATMPs. Prior to joining MHRA, Christiane worked with the UK regulator for the European Tissues and Cells Directive as a quality manager and inspector. Christiane has experience in CMC and regulatory strategy for all types of biological products, with a particular focus on gene and cell therapies, novel biotherapeutics, biosimilars and vectored vaccines. While at MHRA, she was the principal quality/CMC assessor for 10 centralized MAAs, including two full dossier applications for ATMPs as sole UK quality assessor (including CAR-T, see publications). She has in depth knowledge of all European procedure types, both centralized and MR/DCP, and can give advice on ATMP classification, ODD and the PRIME program. As an ex-member of the EMA CAT committee, Christiane is familiar with the thinking of all European regulators in the ATMP space and is used to dialogue and negotiation with many regulatory agencies, as well as presenting her thinking during committee discussions. Christiane undertook her undergraduate studies in biochemistry, neurobiology and molecular biology at Heidelberg University in Germany before obtaining her PhD in molecular developmental neurobiology at Kings College London in the UK. Christiane has published her academic research in many high impact journals, including Nature.