Member, Management Board, Biopharmcor BV; Director, Pharmaceutical Development
Dr. Madden serves as Vice President Scientific Affairs of the BioPharmcor Group as well as at ICON PLC where his role is providing strategic consulting expertise to clients in optimizing their product development programs. This support includes significant regulatory interactions, notably with US and EU regulators, to discuss and agree key aspects of pharmaceutical programs at all stages of development. This has covered a wide range of dosage forms including specialized delivery systems and combination product development and a wide range of therapeutic areas for both small molecules and biologics, including a number of monoclonal antibodies for biosimilar development programs.
Dr. Madden has over 30 years’ experience in the pharmaceutical industry working on drug development, from proof of concept through to commercialization holding a number of positions with several international pharmaceutical companies and also has experience in commercial manufacturing. His experience in both development and manufacturing settings has provided him with an excellent understanding and ability in addressing the challenges that drug development presents in bringing a product to approval.
Dr. Madden has significant experience and expertise in both NCE and 505(b)(2) development. This experience includes significant regulatory interactions with FDA to discuss and negotiate development strategies with respect to the biopharmaceutics and clinical pharmacology programs.
Prior to joining ICON PLC, Dr. Madden was Senior Director of Analytical Sciences for the Elan Corporation, specializing in the development of modified release solid oral dosage forms from product concept through to regulatory submission to commercialisation.
Dr. Madden received his BS degree in chemistry and his PhD in physical chemistry from the University of Wales, Swansea, United Kingdom. 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. He is a Chartered Chemist and Fellow of the Royal Society of Chemistry.
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 has several patents approved/pending.