J. Mark Wiggins

Director in Regulatory Policy and Compendial Affairs
Merck & Co., Inc.

J. Mark Wiggins , is a Director in Regulatory Policy and Compendial Affairs at Merck & Co., Inc., West Point, PA, U.S.A. (known as MSD outside the United States and Canada), with over 30 years’ experience in the pharmaceutical industry. His current responsibilities include preparing and submitting new and revised monographs to the pharmacopoeias for drug products, drug substances, and excipients, as well as reviewing and responding to proposed compendial changes published by pharmacopoeias around the world. Prior to his current position, Mr. Wiggins was responsible for testing and releasing excipients for use in formulation design, scale-up, and clinical supplies. He also has experience in the synthesis and characterization of active pharmaceutical ingredients for use in the treatment of HIV/AIDS, cancer, diabetes, hypercholesterolemia and depression.
Mr. Wiggins has been an active participant in compendial harmonization efforts, serving as PhRMA representative on the ICH Q4B Expert Working Group, and leading several face-to-face meetings with pharmacopoeias on the topic of harmonization. He is also an active contributor to several industry-based compendial discussion groups, and has chaired the US-based PhRMA compendial team, which has important connections with EFPIA, based in the EU. He has been an invited speaker in several international meetings, including presentations on compendial harmonization at the Ph. Eur. workshop on "Quality of Medicines in a Globalized World", and more recently at meetings with the pharmacopoeias and regulators in the US, Europe, India, Japan, Korea, and China.
Mr. Wiggins has authored several papers covering each area of his career. Recent articles include introductions to the concepts of the "Ideal Pharmacopoeia" and "Compendial Globalization", as well as the industry perspective on the pilot project to achieve “Prospective Harmonization” for API monographs. Mr. Wiggins holds degrees in Chemistry from Trinity University and the University of Wisconsin, both in the US.