| J. Mark Green, Ph.D., Analytical Chemistry Consultant|
Dr. J. Mark Green is an Analytical Chemistry Consultant, providing expertise and practical guidance in analytical development from pre-IND phase through commercialization.
Dr. Green was previously Director of Pharmacy and Analytical Development with Lautheus Medical Imaging, where he was responsible for the development, validation, and transfer of analytical methods for drug substances and drug products. Additionally, he was responsible for stability testing, analytical support of safety assessment studies, and the preparation of CMC sections of regulatory submissions.
Dr. Green has over 30 years of experience in drug development, and previously worked for Bristol-Myers Squibb, DuPont Merck and DuPont. He has published and lectured on analytical method validation, and on applications of HPLC, TLC, and Chiral Chromatography. Dr. Green received his PhD in Analytical Chemistry from the University of Illinois.
| David E. Wiggins, Analytical/Stability Consultant|
David E. Wiggins is an Analytical/Stability Consultant within the pharmaceutical industry with a focus on pre-market stability, analytical method validation and method transfer.
Mr. Wiggins was previously Sr. Associate Director of Analytical Development for Bayer Consumer Care. Prior to joining Bayer, Mr. Wiggins worked for Schering-Plough and Merck with responsibility for Method Optimization, Method Validation, Method Transfer and Stability (both pre- and post-market). These responsibilities have additionally included involvement with multiple NDA submissions, ANDA submissions and FDA general and PAI inspections.
Mr. Wiggins has over 35 years experience in the pharmaceutical industry in both a QC and an R&D setting. During this time, he has been instrumental in establishing and updating stability and method validation policy to be consistent with the changing regulatory requirements. Mr. Wiggins has frequently lectured on stability and analytical method validation in the US, Puerto Rico, and throughout Europe. He has been active in submitting comments and validated stability-indicating analytical methods to the U.S. Pharmacopeia and has been an invited speaker to FDA, university, and industry conferences.