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.
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.
Growing up on a farm, Allen Koester thought he would design farm equipment after earning his degree in mechanical engineering.
Although he didn’t know it at the time, Nathan Temple’s service as a naval officer on the USS Asheville in Hawaii prepared him perfectly for a career in pharmaceutical engineering. “You learn so much, so quickly, on a submarine.”
The impact people have on others’ lives is not always obvious. For many, the Advil mini pill might not seem like a big deal, but for people who have trouble swallowing pills, like cancer patients, the tiny pill has made a huge difference in their ability to manage pain. It’s projects like that, as well as treatments for bladder cancer and transthyretin amyloidosis, that Tammy Spain is most...
