Katharine Miller, Bayer. “CMC Challenges and Opportunities for Cell and Gene Therapies”

Consistency and purity in manufacturing is critical to the success of cell and gene therapies. Entrepreneurs developing such therapies need to know what factors are involved as they look ahead to clinical trials. Join us on Tuesday, August 20 to learn from Katharine Miller, Vice President, Global Head of Biologics Development Analytical and Quality at Bayer.

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About the Speaker

Katie Miller is Vice President, Global Head of Biologics Development Analytical and Quality at Bayer. She is a biopharmaceutical executive with 30+ years of industry experience leading multiple CMC functions (Analytical Development, Product Development, Quality Control, Quality Assurance) in the development and commercialization of advanced therapeutics including cell and gene therapies, antibodies and antibody-drug conjugates, inhalation and parenteral formulations, multi-API solid oral dosage forms, and device/combination products.

Her successful track record includes supporting multiple programs from pre-IND/IMPD through marketing authorizations (BLA, MAA, NDA, NDS), commercial launches, and product lifecycle management in diverse geographies (US/CAN/EU/AUS/Asia/ME/SA).

Katie’s effective leadership is based on a broad foundation of deep technical expertise, a demonstrated ability to manage multiple projects to tight timelines and evolving regulatory requirements, active cross-functional collaboration and long-view strategic planning, and a commitment to talent and team development by establishing an environment of authenticity, empathy and shared ownership.

She has a particular focus on building forward-looking and holistic product characterization plans, demonstration of potency/mechanism of action, and comparability for advanced therapeutics.