Started in Pharma Regulatory Affairs over 14 years ago, initially in a manufacturing facility in Ireland. Joined Ivowen regulatory affairs consultancy over nine years ago and became Regulatory Affairs and Business Manager after four years. Became Managing Director and owner of the consultancy in 2021.
Dr. Tony Cundell worked for Merck Research Laboratories in Summit, New Jersey, as the Senior Principal Scientist in early phase drug development. Earlier in his career, he worked at a director level in Quality Control and Product Development organizations at the New York Blood Center, Lederle Laboratories, Wyeth Pharmaceuticals and Schering-Plough.
Dr. Denby is a Biochemical Engineer. Over the years he has worked at AstraZeneca, Oxford BioMedica and Becton, Dickinson and Company. In 2017, he founded BioFrey and has revolutionised availability of extractable data and change notification practices around single use systems facilitating uptake of these systems.
James L. Drinkwater is the current Head of GMP Compliance at Franz Ziel Germany. James is based in the UK for the global role and separately supports the Not-for-profit society: Pharmaceutical and Healthcare Sciences Society: PHSS an educational platform in GxP. James is the ex-Chairman (10 years) of the PHSS and currently Co-leads the Annex 1 and CCS Guidance focus groups
Dr. Huemer received his MD in medicine at the Medical University of Vienna and his PhD in Biology at the University of Vienna and subsequently specialized in Medical Physiology, followed by a long medical career in research, teaching, medical practice. Between 2007 - 2023 he worked at the Austrian Medicines & Medical Devices Agency.
Dr. Felix Tobias Kern is the Associate Director - Head of Compliance Launch and Technology Center at the Merck KGaA in Darmstadt (Germany). He studied pharmacy in Mainz (Germany) and graduated at the Ludwig-Maximilians-University in Munich (Germany). He is an expert pharmacist for pharmaceutical analytics and pharmaceutical technology.
Michael worked for Innovate UK for four years as a Health Innovation Lead and was responsible for the management of a UK government grant funding programme called the Biomedical Catalyst that provided £30M per annum to supports UK SMEs developing innovative health & life science products. Before joining Innovate UK, Michael was a Group Manager at Medicines & Healthcare Products Regulatory Agency (MHRA) where he led a team that was responsible for safety & surveillance of all medical devices in UK.
Through more than 17 years of experience with high-ranking, international pharmaceutical and biotechnological companies as well as Contract Research Organizations Karin has acquired proven expertise in the field of clinical research and compliance with high quality standards. As a trained biologist with a PhD in cancer research Karin started her career in clinical research as a Freelance CRA.
Len has over 30 years of experience in both industry and academia. He is a member of a regulatory advisory group for ATMPs. Len has undertaken development and manufacturing of 18 new biological entities, including first-in-man/first-in-class cell and gene therapies, viral vectors, biologics, and monoclonal antibodies. His regulatory and licensing experience covers the MHRA, EMA and FDA.
Dr Mark Powell a Fellow of the Royal Society of Chemistry (RSC) with over thirty years’ experience as a senior analytical chemist. Mark has served as both Honorary Secretary and Honorary Treasurer of the RSC’s Analytical Division and led a working group on continuing professional development until July 2016.
Dr. Rensing studied biology and medicine at Tübingen, Heidelberg and Amherst, USA. During his clinical career he contributed to more than 40 clinical trials in all phases. He has worked in hospital management, the pharmaceutical industry as well as at The Paul-Ehrlich-Institute (PEI) as a clinical assessor.
Tara Scherder has over 20 years’ experience in the pharmaceutical and biopharmaceutical industries as a statistician, engineer, and master black belt. Her passion is the powerful combination of science and statistics to increase knowledge, optimize both manufacturing and business processes, and reduce risk.
Prof. Schönermark studied Medicine at the universities of Göttingen, Munich, Heidelberg, London and Cape Town After PhD, and spent post doc time and various stays abroad, including at Columbia University in New York and Dartmouth Medical School, Hanover NH, Specialist examination for ENT medicine and activity as Managing Senior Physician at the Ear, Nose, Throat Clinic Hannover Medical School followed by further training in systemic therapy Postgraduate Certificate in Neuro Leadership.
David Schwicker has biopharmaceutical consulting expertise spanning more than 25 years. Founder of ORPHA Strategy Consulting, and former Vice President with PAREXEL International in the United States. David is a sought-after expert for accelerating marketing authorization, time to launch, early patient and market access of ATMPs.
Martin offers expertise in both strategy as well as operational implementation. He has worked in diverse roles, climbing in responsibility, in marketing, sales business development and market access access in Akzo Nobel, Novartis, Coloplast and Tillotts Pharma. He was responsible for profit and loss of triple digit million-euro budgets and realised double digit compounded annual growth. He also managed acquisition and integration of two double digit million annual sales Product acquisitions of Astra Zeneca and Astellas.
Swa joined Janssen Pharmaceutical (part of Johnson & Johnson) in 1981 and until 1995 had increasing responsibilities within the organisation, mainly in the Quality Control Unit. From 1995 he joined the Quality Assurance department. In 2005 was Senior Manager GMP Compliance Chemical Operations in Belgium, on sites Geel – Olen – Beerse. In 2009 was appointed as Director Global Compliance of EMEA and Asia Pacific for Johnson & Johnson.
Dr. Waring is a licensed physician, epidemiologist and senior pharmacovigilance expert with 25 years of full-time industry and consulting experience in clinical drug safety and post-marketing pharmacovigilance. His key areas of expertise include pharmacovigilance system and process consulting, safety data assessments and safety risk management planning.
Dr. Wise-Blackman is a consultant and project lead at BioData Solutions, with over 24 years of experience. Her attention is devoted to providing guidance to small and large biotechnology and pharmaceutical companies in support of drug development. Her work includes supporting regulatory approval of large molecule therapeutics.