Marc Wiles has joined NDA’s UK team as the new General Manager for the UK office, one of NDA’s three offices across Europe (UK, Germany and Sweden). Marc was formerly a Director, Regulatory Affairs (Non Clinical and Clinical) and General Manager for ERA Consulting in the UK. He brings with him extensive pharmaceutical experience, particularly in the biologics / biosimilars/ ATMPs arena, as well as a strong interest in technology.
As General Manager for the UK, Marc’s main priority will be to lead and manage the UK team of consultants which includes a mix of regulatory and pharmacovigilance experts. The team is critical to supporting pharmaceutical clients based locally in the UK, across Europe, and the rest of the world. The team members, like their counterparts in Sweden and Germany, support strong interactions with the major regulatory bodies in the EU and collectively have a wealth of expertise, built up from working within the regulatory bodies themselves and the life science industry. Clients range from small biotech companies through to Top 10 global pharmaceutical organisations and Marc will be integral in working together with the team to ensure the delivery of first class services and support during a part or the complete life cycle of a medicine.
Further background on Marc
During his time at ERA Consulting, Marc was responsible for heading-up its entire UK-based regulatory group. As well as managing and directing the team, Marc supported business development, as well as driving all of its IT infrastructure upgrades.
Prior to ERA, Marc spent a year as Senior Vice-President, Operations for ProImmune Inc based in Oxford (but with UK and US based operations). In this role, Marc oversaw QA, research and development, Cellular Analysis Services, facilities, IT and HR. Marc also spent a year working for Novexel SA in France as Head of Toxicology/Drug Safety Evaluation, and a further four years at Shire, based in Boston in the US, as Senior Director, Nonclinical Development, and Senior Director, Preclinical Research. There, Marc was responsible for all nonclinical development activities (biologics; proteins) – based on enhancing HGT’s preclinical research capabilities; and managing change and growth of the nonclinical development organisation. Previously, Marc has overseen nonclinical development activities for 14+ current marketed products including antiviral, antibacterial, oncology, oligonucleotide and protein replacement therapies by way of example.
Earlier in his career, Marc spent a number of years as a Research Scientist / Research Associate Professor, a Medical Physiology Course Coordinator, Research Scientist, to name but a few, all at The George Washington University Medical School [GWUMS]; Department of Physiology and Experimental Medicine – Washington, DC.
Marc is a present and past member of a number of societies, including: Society for Leukocyte Biology (SLB), American Physiological Society (APS), American Association for Cancer Research (AACR, and American Association for the Advancement of Science (AAAS). He has contributed and written a number of papers, as well as providing peer reviews for the American Journal of Physiology [Lung Cell & Molecular Biology, Cardiovascular Physiology & Cell Physiology Sections] , Blood, Cancer Research, Circulation Research, Journal of Leukocyte Biology, Free Radicals in Biology and Medicine, and Microvascular Research. In addition, Marc has been a key contributing author to a recent authoritative publication on the development of ATMPs (Advanced Therapy Medicinal Products).
We are delighted to have Marc joining our team!