J. Mark Wiggins, B.S., M.S. is the Owner and Compendial Consultant with Global Pharmacopoeia Solutions LLC, which he formed after more than 30 years of experience in the pharmaceutical industry. He was previously Director of Compendial Affairs at Merck, with more than 15 years of experience submitting new and revised monographs to pharmacopeias, as well as reviewing and responding to proposed compendial changes from around the world. He also has experience in the testing and release of excipients for use in formulation design, scale-up, and clinical supplies in support of new product R&D and in the synthesis and characterization of active pharmaceutical ingredients for use in the treatment of HIV/AIDS, cancer, diabetes, hypercholesterolemia, and depression.
Mark has been an active participant in pharmaceutical industry associations in the US and abroad and has represented PhRMA on the ICH Q4B activities to harmonize general chapters in the pharmacopoeias. He has been an invited speaker at international meetings in the US, UK, Europe, India, Japan, Korea, and China, including the Ph. Eur. workshop “Quality of Medicines in a Globalized World. Mark holds B.S. and M.S. degrees in Chemistry from Trinity University and the University of Wisconsin.
