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.
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...
Ferdinando E. Aspesi, PhD, is a Senior Partner at Bridge Associates International, LLC, New Jersey, USA, where he advises pharmaceutical companies on quality strategy, organizational design, and quality and compliance issues. In his more than 44 years of experience in the industry, Aspesi has worked in active pharmaceutical ingredient (API) and drug products quality assurance and quality...
Brandi Stockton is Founder of The Triality Group, LLC, where she provides quality, regulatory, and compliance consulting services for life sciences companies. She has more than 20 years of GxP experience, with a specialization in computer systems quality and data integrity. Brandi joined ISPE in 2014. In addition to being chair of the GAMP Americas Community of Practice, she is a member of the...
Mark Cherry is the IT Compliance Director and GXP subject matter expert at AstraZeneca. A chartered engineer, he has been with AstraZeneca for 22 years and was previously with GlaxoSmithKline in a variety of computer compliance and engineering roles. He has been a member of ISPE since 1999.
In addition to serving on the GAMP Europe Community of Practice (CoP) as Chair, he led the team...
For more than 22 years, James P. Wabby has dedicated his career to quality operations, regulatory compliance, and regulatory affairs pertaining to medical device technology, medicinal delivery platforms, complex generics, companion diagnostics, digital medicine, and combination product areas. In 2017, during one of the biggest regulatory changes within the European Union in over 20 years,...
Ester Lovsin Barle’s journey from veterinary lecturer in Slovenia to the Global Head of Product Sustainability and Stewardship at Takeda Pharmaceuticals in Switzerland was fueled by her curiosity and passion for continual learning and a desire to help others do the same. “We are never at the end of our learning curve, and it’s so important to continue to learn and be open-minded about new...
Anil Mathai first heard about ISPE 30 years ago. “I attended Drexel University, where you are required to complete three cooperative education jobs. One of mine was for Rhône-Poulenc Rorer, Inc. in Collegeville, Pennsylvania. While I was there, I learned about validation and decided that I wanted to be in pharmaceuticals as a chemical engineer.”
After completing her doctoral degree at Oklahoma State University, Sarah Pope Miksinski received a fellowship at the National Institutes of Health. While working there, she realized that research was not the best career path for her.
Rod Freeman started his career in the pharma-ceutical industry as an analytical chemist.
