Profiles of Communities of Practice (CoP) leaders. These leaders are central to the success of ISPE’s CoPs, which spearhead the generation of ISPE’s gold standard content, including Good Practice Guides, Pharmaceutical Engineering articles, conference presentations, and training programs.
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Frank Henrichmann is an expert in quality management, computerized system validation, and compliance, especially in clinical trials and pharmacovigilance. With over 25 years of experience in quality functions within the pharmaceutical industry, he has gained deep expertise in implementing and validating computerized systems within GxP-regulated environments, having worked with organizations...
Thanabalan “Thana” Subramanian is Head of the Digital Quality team in the quality, regulatory, digital consultancy firm Product Life Group. He is responsible for a team of 20 consultants and supports the Digital Quality Center of Excellence, covering IT compliance, computer software validation (CSV), data integrity, CSV auditing, and CSV training. Before joining Integrity, he worked for...
Michelle Vuolo is currently Head of Quality at Tulip Interfaces, Inc., a platform developer that enables manufacturers of many industries to build digital content to manage their operations. Before joining Tulip, Michelle spent more than 24 years in the biopharmaceutical and medical devices industries in quality control (QC) laboratories, engineering technical support, quality assurance...
Stephanie Stärkle is a project engineer at VTU Engineering in Switzerland, where she leads engineering projects from concept to execution in GMP-regulated environments including cost estimation, equipment design and specification, deadline management, and coordination with cross-functional stakeholders such as vendors, quality assurance, operations, and qualification. She holds a bachelor’s...
Nina S. Cauchon is Director Regulatory Affairs (RA) Chemistry, Manufacturing, and Controls (CMC) at Amgen Inc. where she leads RA-CMC advocacy and external engagement. She has experience leading both early phase and commercial programs, including small molecules and biologics. Her areas of interest are regulatory challenges for innovative modalities and emerging technologies, CMC aspects of...
Celeste Frankenfeld Lamm encourages young professionals to identify and pursue the aspects of their jobs they feel passionate about, “The things that get you out of the bed in the morning tend to be the areas where you are going to perform strongly. Once you’ve identified them, it’s important to make your own opportunities. Let leadership know your work passions, express interest in teams or...
As the Senior Director of Personalized Supply Chain at Cencora World Courier (formerly AmerisourceBergen), Andrea Zobel leads the cell and gene therapy (CGT) and direct-to-patient service lines for this specialty logistics provider. With a background that includes experience gained across academia, pharmaceutical services, and clinical trials logistics, Andrea focuses on defining strategy,...
Ben Stevens serves as Director of Chemistry, Manufacturing, and Controls (CMC) Policy and Advocacy at GSK. He has over 15 years of experience in the industry having worked for Alnylam Pharmaceuticals where he led the global CMC regulatory development of vutrisiran (a treatment for polyneuropathy and cardiomyopathy), and oversaw its US New Drug Application and the EU Marketing Authorization....
Krisha Patel is Co-Founder of Assurea LLC, a digital compliance consulting firm that provides IT and validation services, software assurance, and custom artificial intelligence solutions for biotech companies. With a degree in bioprocessing science and more than 12 years of experience in computer system validation and quality assurance, Patel has worked with cell and gene therapy companies,...
Massimiliano Cesarini, MEng, was named CEO of Biogenera SpA, Bologna, Italy in 2024. He began his career at Duferco Engineering in energy generation, then moved to Comecer Group, holding roles as project and product manager, and global sales manager for the pharma and advanced therapy medicinal product (ATMP) division. He eventually joined Omnia Technologies Group establishing the Omnia Life...
