MD&M West

Amarjit “Al” Luniwal holds a PhD in Medicinal Chemistry, a Master of Science (Pharmaceutical Chemistry emphasis), and a BS in Pharmaceutical Sciences.  Dr. Luniwal has several years’ of laboratory experience with primary expertise in the areas of synthetic organic chemistry, analytical chemistry, mass spectrometry data interpretation, and toxicology/biocompatibility testing.  He did postdoctoral research in molecular biology, and drug design and development at the Center for Drug Design and Development, University of Toledo prior to joining NAMSA’s analytical services department as a senior chemist.  He has published his research in several peer reviewed scientific journals and has co-authored a book chapter in ‘Analogue Base Drug Design III’ on SERMs and is a co-inventor for a granted patent from the US PTO.  Dr. Luniwal has been with NAMSA for over eight years, where he currently serves as a board certified toxicologist (DABT) and focuses on materials characterization and toxicological evaluation of extractables and leachables from biomaterials used to make medical devices, and risk assessment for biocompatibility and biological safety of the medical devices.  Dr. Luniwal serves as a review editor for Frontiers in Pharmacology and Frontiers in Oncology and is an associate member of ACT and a full member of SOT.

Andy Wyen is a Board Certified Senior Toxicologist at NAMSA. With over 16 years’ medical device industry experience, his previous positions include R&D Technician, Chemist and Biocompatibility Study Director. Andy’s expertise includes In Vitro methods, analytical chemistry, chemical characterization, study direction, biocompatibility and toxicology. He obtained his Bachelor and Master Degrees in Pharmacology/Toxicology from the University of Toledo (Ohio, U.S.).

Mark has been involved in preclinical safety and performance evaluations of class II and III medical devices for the past 15 years. He has been associated with medical device design and testing, operating over a wide range of therapeutic areas, including cardiovascular, structural heart, electrophysiology, neurostimulation, pulmonary therapies, GI systems and oncology. He has been primarily involved in successful study design and negotiations with the U.S. Food and Drug Administration (FDA) and other regulatory groups when questions or issues arise surrounding medical device submissions.

Mark’s time in the Pharmaceutical and MedTech industries also includes 20+ years in Pharmaceutical Discovery, which has provided him a thorough understanding of complex devices and combination products in the preclinical arena, including managing large animal interventional and surgical research. Dr. Smith is also responsible for oversight of assay development and strategies in hemocompatibility assessment of medical devices, specifically in thrombogenicity, with the continuing development of an In Vitro ovine blood loop assay.

Dr. Smith was one of the co-founders and served as Chief Scientific Officer at American Preclinical Services (APS), established in 2005.  With the acquisition of APS by NAMSA in 2021, Mark transitioned to a role with the Commercial Team and now works directly with the Technical Advisors and Business Development Executives engaging in initial Client interactions and early program strategies, study design and planning.