James V. McArdle, Ph.D.

Jim is President of McArdle & Associates, LLC, an established provider of CMC consulting services.

He received a BS degree in chemistry from Brown University, and a Ph.D. in chemistry from the California Institute of Technology. He was a National Institutes of Health postdoctoral fellow at the University of California, Berkeley, for two years.

Jim began his career in the pharmaceutical industry at SmithKline Beecham. He spent 16 years at SmithKline, including four years at SmithKline's Tonbridge, England, chemical development site. He eventually had worldwide responsibility for analytical development within the chemical development area at SmithKline.

Jim joined Isis Pharmaceuticals in August of 1999, as Vice President, Analytical Development and Quality, and contributed to the development of oligonucleotide antisense therapeutics.

In November of 2006, he joined Archemix Corp. as Vice President, Chemistry, Manufacturing, and Controls, and worked with oligonucleotide aptamers. He is a former chairman of the Analytical R&D Steering Committee of the Pharmaceutical Research and Manufacturers of America (PhRMA).

Jim has served on a number of ICH Expert Working Groups in the Quality area, including acting as topic leader for Q3C (residual solvents), deputy topic leader for M4Q (the Quality section of the Common Technical Document), and deputy topic leader for Q8 (Pharmaceutical Development). He also functioned for two years as Chairman of the Manufacturing and Marketing section of an initiative sponsored by the Asia Pacific Economic Cooperation forum (APEC) to encourage innovation in life sciences in that part of the world.

Jim can be reached by phone at 760-652-5216, or by email at: jim@mcardlecmcconsulting.com.