“ICH guidelines have become highly recognized as delivering high quality products.”
At the heart of a great pharmaceutical development team is understanding the global landscape and what it takes to navigate historic differences in health, safety, and quality regulations to deliver quality products to patients.
“There was a time every country had different requirements for the most fundamental pharmaceutical studies,” says Larry Wigman, UCSC Extension instructor of the new ICH Quality Guidelines: Intent and Overview class in the Biotechnology division.
“Pharmaceutical development and regulatory professionals face the same challenges across the globe, but back in the day, every different registration required different protocols for simple studies. For example, there were multiple stability conditions to support store at room temperature.”
The International Council for Harmonisation (formerly the International Conference on Harmonisation) was founded in 1990 to “harmonize” disparate guidelines within the global pharmaceutical industry.
“In last few years, the ICH guidelines have become highly recognized as delivering high quality products.”
Leaders managing teams of scientists and clinical researchers in the flourishing biopharma industry of Silicon Valley are in high demand, especially those who understand the current industry trends.
ICH Quality Guidelines: Intent and Overview, a two-unit class starting May 19, is one of the elective courses in the Development Track of the Biotechnology certificate program. It is aimed at professionals in the quality or regulatory areas of pharmaceutical development and people who are looking to grow into leadership roles in the industry.
“This is exciting stuff—understanding the effect of globalization and how it affects health safety and quality,” Wigman says. “Especially in the Bay Area, the marketplace is growing rapidly with new companies building skyscrapers every day.”
Wigman, a principal scientific manager at Genentech’s Small Molecule Analytical Chemistry and Quality Control Department, was part of the Genentech team to commercialize the first small molecule drug for basal cell carcinoma in 2012. He joined the joined the relatively new SMACQC Group to lead the analytical develop of small molecule therapeutics about seven years ago.
“The best part of the job is taking innovative new medicines to patients,” he says.
Wigman is an analytical chemist by training with a master’s degree from San Diego State University and a doctorate from Duke University. Previous work experience includes leadership positions at Regulitics, Sanofi Research, Kylan Technologies and Pfizer Research. He has taught at several colleges and published dozens of articles and patents.