BioInsights - 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

Dr. Nina Bauer is the Commercial Head of Cell Therapy at MilliporeSigma, the life science business of Merck KGaA, Darmstadt, Germany. Nina joined MilliporeSigma through the acquisition of FloDesign Sonics in October, 2019, where she was the Chief Commercial Officer.

The core of her activities within MilliporeSigma is the launch of FDS’ first commercial product, the ekko™ acoustic cell processing system, and related products and services. She has developed a passion for solving cell and gene therapy manufacturing bottlenecks during her time as Lonza’s Head of Autologous Cell Therapy business. As part of that role, she was also in charge of establishing novel manufacturing technologies, most notably the Octane Cocoon™ platform.

Previously, 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. Nina holds a Master in Neurobiology from Stony Brook University (NY), a PhD in Neuroscience from the University of Oldenburg (Germany), and an MBA from the University of Edinburgh (Scotland).

Natika Calhoun

Regulatory Consultant, Merck KGaA

Natika Calhoun is a regulatory Subject Matter Expert for biological APIs, virus and gene therapy products, antibodies, linkers, and antibody-drug conjugates, based in California, USA. In her current role, she consults on regulatory topics and works directly with customers as a Regulatory liaison to support technical writings, filings, and submission success for biological products.

She previously served as the site Head of Quality for MilliporeSigma’s viral vector manufacturing site in Carlsbad, California, USA, where she was responsible for leadership of the Quality unit, and for preparing the facility for commercial and inspection readiness to support its first FDA and EU licensed products, which resulted in successful FDA and EMA inspections. With over 25 years of Quality and Regulatory experience, Natika brings a strong background in aseptic processing, GMP manufacturing, and leading regulatory inspections. Natika holds a B.S. in Biology from UC, San Diego, M.S. in Biology – Molecular Cell Science from U. of Memphis, and Certificate in Biotech Management from Vanderbilt Univ., Owen Graduate School of Business.

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.

Matt Muldoon

Senior Director Supplier Management, Allogene Therapeutics

Matthew Muldoon is the Sr. Director of Sourcing and Supplier Management at Allogene Therapeutics. He is responsible for organizing supplier engagement activities to ensure supply of the equipment and materials utilized at Allogene’s internal allogeneic cell therapy manufacturing plant in Newark, CA. In his previous role as Director of Biotech Sourcing for Bayer in Berkeley, CA, he was primarily responsible for external vendor interactions supporting the recombinant rFVIII franchise, Kogenate®, Kovaltry® and Jivi® and various radiology medical devices. Earlier in his career, Matt worked in Operational and Manufacturing Sciences capacities at Merck’s Westpoint, PA site producing bulk Zostavax® and Varivax® vaccine.