Navigating regulations - novel cell therapy platforms and their path to clinical manufacturing

Thursday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

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Navigating regulations - novel cell therapy platforms and their path to clinical manufacturing

The rapidly commercializing field of cell therapy is a space where novel modalities are colliding with accelerated regulatory processes and newly developed manufacturing equipment. Because of this, a good understanding of the regulatory space is critical on both the therapy developer and supplier sides of the industry. Join our expert panel for a discussion on the current regulatory environment and best practices for working with suppliers to ensure consistent manufacturing standards.

Attendees will learn:

How evolving regulatory and manufacturing strategy trends impact cell therapy development programs
Considerations for introducing novel equipment in cell therapy manufacturing
Examination of supplier qualification and validation documentation that help expedite cell therapy market approval

Nina Bauer

Head of Commercial, Gene Editing and Novel Modalities, Merck KGaA

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.

Natika Calhoun

Regulatory Consultant, Merck KGaA

Anthony Davies

Founder and CEO, Dark Horse Consulting

Anthony founded Dark Horse Consulting in 2014, bringing 20+ years of leadership experience in product, process and manufacturing development to cell and gene therapy companies in need. Anthony has a proven track record in managing pharmaceutical pipelines, is a skilled liaison with international regulatory agencies, and has an intense familiarity with a wide range of biologics, and cell and gene therapies. He is a highly sought-after keynote speaker and chair of national and international conferences and seminars, noted for his provocative, thoughtful and sometimes contrarian presentations.