Charles A. Heffernan

Charles Heffernan serves as the Director of Advanced Therapies and Biologics at PM Group, bringing over 23 years of biotechnology industry experience across the full product lifecycle, including research and development, facility and process design, capital projects, technology transfer, commissioning and qualification, new product introduction, technology management, and regulatory licensure and compliance. He currently leads PM Group's U.S. design initiatives for advanced therapies and biologics, oversees the firm’s Biophorum engagement, and co-chairs the ISPE Good Practice Guide on Cell Therapy Equipment.Throughout his career, Charles has advised clients on the design of processes and facilities for a wide range of products, including vaccines, monoclonal antibodies (mAbs), blood fractionation products, plasmids, viral vectors, cell therapies, gene therapies, and nucleic acid-based therapies. In this talk, he and his co-presenter Erich Bozenhardt from United Therapeutics will showcase the application of Pharma 4.0, automation and robotics to solve real-world cell therapy manufacturing challenges, ultimately expanding patient access to these life-saving therapies.