Plenary Speakers

Interdisciplinary Biomedicine: An International Conference on Shared Methods and Discoveries will feature plenary sessions by some of the world’s leading thinkers and innovators in the field, as well as numerous parallel presentations, by researchers and practitioners.

Steven S. Kuwahara
Stuart Madden
Marcus McNeely

Garden Conversations

Plenary Speakers will make formal 30-minute presentations. They will also participate in 60-minute Garden Conversations - unstructured sessions that allow delegates a chance to meet the speakers and talk with them informally about the issues arising from their presentation.

Please return to this page for regular updates.

The Speakers

Steven S. Kuwahara
Originally from Hawaii, Dr. Kuwahara holds degrees in Biochemistry from Cornell and the University of Wisconsin. Starting as an Assistant Professor of Chemistry at the California State University, Long Beach, he began his industrial career in the Division of Biologic Products at the Michigan Department of Public Health (now BioPort Corp.), where he became the head of Quality Control. Here he developed expertise in the testing of blood derivatives, coagulation factors, viral and bacterial vaccines. He moved to the Hyland division of Baxter Healthcare where he was in charge of assay development and quality control. He later became responsible for quality systems for a biological device. After a short period with a contract testing laboratory and another blood fractionator, he became the director of quality control with a gene and cell therapy company. He is currently the head of his company, GXP BioTehnology LLC.

Dr. Kuwahara is an experienced analytical biochemist that has applied his academic knowledge to quality control in the pharmaceutical industry. His work has also dealt with all aspects of GMP and GLP in relation to biopharmaceuticals. He has worked with small molecules, proteins, cells, gene therapy vectors and nutritional supplements.

Dr. Kuwahara has written several papers and book chapters and serves on the editorial advisory boards of BioPharm, BioQuality, and the Journal of GXP Compliance for whom he also writes a column called “GLP Forum.” He and a colleague have recently published translations of the Chinese GMPs and the Inspection Checklist for the Chinese GMP Certificates. He has held certifications as a CQA, CQT, and CQE from the American Society of Quality and was certified (RAC) by the Regulatory Affairs Professionals Society.

Stuart Madden
Dr. Madden is Vice President, Scientific Affairs, at Icon Clinical Research. His current role entails strategic drug development planning and consulting. The role covers drugs, biologics and combination products. He also has responsibilities for the scientific and regulatory oversight and management of all CMC activities pertinent to the product’s development. He has over 20 years in the pharmaceutical industry working on drug development, from proof of concept through to commercialization. His experience in research, development and manufacturing settings has provided him with an excellent background in addressing the challenges in bringing a product to market.

Dr. Madden received his BS degree in chemistry and his PhD in physical chemistry from the University of Wales, Swansea, UK. Dr Madden then spent two years as a Post Doctoral Fellow at San Diego State University, California. His PhD and post doctoral research focused on modelling adsorption mechanisms in High Performance Liquid Chromatography systems.

Dr. Madden has held a number of positions with several international pharmaceutical companies, primarily within research and development and also has experience in commercial manufacturing. Prior to joining Icon Dr. Madden was Senior Director of Analytical Sciences for the Elan Corporation, specializing in the development of modified release solid oral dosage forms from conception through NDA submission and commercialisation.

Dr. Madden has published in areas of adsorption mechanisms in HPLC, novel degradation chemistry in formulated products and contributed to texts on In Vitro-In Vivo correlations and is an inventor on several patents.

Dr. Madden is a Chartered Chemist and Fellow of the Royal Society of Chemistry.

Marcus McNeely
Marcus McNeely has been in the field of Biotech and Pharmaceutical metrology and validation for over sixteen years. He has managed GMP/GLP/GSP biotech calibration programs in both manufacturing and laboratory environments, in addition to involvement in various biopharmaceutical quality programs. He has also been responsible for GMP, calibration and systems training for large groups and individuals worldwide. As Project Manager at Blue Mountain Quality Resources Marcus consults with biotech, pharmaceutical, and medical device companies on best practices in every step in establishing, managing, and maintaining a calibration program. He regularly contributes and presents papers, editorials and technical documents at numerous conferences, web venues and symposia. Marcus holds a degree in electronics engineering technology and has been an active member of the Healthcare Metrology Committee for many years. He is additionally a member of International Society for Pharmaceutical Engineering (ISPE).