On this page, you will meet the speakers of the MEB Science Day 2025.
Professor of Clinical Epidemiology of Cardiovascular diseases, Erasmus MC, Vice-chair MEB, Chair MEB Science Committee
Prof. dr. Eric Boersma studied Mathematics and Epidemiology. He is full professor of Clinical Epidemiology of Cardiovascular Diseases at Erasmus MC, Rotterdam, where he leads the Clinical Epidemiology and Innovation Unit of the department of Cardiology. He has over 30 years experience in the fields of cardiovascular diseases and biostatistics. His teaching and research interests focus on statistical and epidemiological methods for clinical data analysis, risk modelling in cardiovascular diseases, with emphasis on the role of imaging and blood biomarkers, and sex differences in medicine. He has published over 900 journal articles in these areas. He is chair of the Erasmus MC Cardiovascular Institute, vice-chair of the Dutch Medicines Evaluation Board (MEB), chair of the MEB Science Committee and member of the Health Council of the Netherlands.
Head of Science Department, MEB & Associate Professor Drug Regulatory Science, Utrecht University
Dr. Marjon Pasmooij, is head of the Science Department at the Dutch Medicines Evaluation Board (MEB), Associate Professor Drug Regulatory Science at Utrecht University, and co-chair of the Regulatory Science Network Netherlands (RSNN) and EMA-HMA European Platform for Regulatory Science Research. Marjon studied Cell Biology in Wageningen, and did her PhD at the Dermatology Department of the University Medical Center Groningen on a rare genetic skin disease. Marjon has been employed by the MEB in various roles since 2007. She worked as a clinical assessor for 10 years in the field of gynaecology and dermatology.
Since 2018 Marjon heads the Science Department, and coordinates the Regulatory Science activities where the MEB is involved in (about 23 PhD projects, and 20-25 Master students yearly). She is also part of the EMA-HMA EU-Innovation Network, which facilitates the development of innovative medicines and associated technologies and aims to strengthen engagement with innovators, and a member of the Therapeutic Scientific Committee of the International Rare Diseases Research Consortium (IRDiRC).
Head of Innovation and Development Accelerator & Regulatory Science and Innovation Task Force, EMA
Dr. Falk Ehmann, MD, is Head of the Innovation and Development Accelerator (TRS-INO) at the European Medicines Agency (EMA). His main responsibilities include co-chairing the EU Innovation Network, managing the EMA’s Innovation Task Force and Business Analysis and Forecasting (BAF) activities promoting Innovation and novel methodologies in drug development across the EU and beyond. He held various positions and responsibilities at the EMA since 2004, including manager of Scientific Advice teams during product development and working as Product Team Leader in the Oncology and Anti-Invectives therapeutic areas.
Prior to joining the EMA he held the positions as Project Team Leader at the Robert Koch Institute (RKI) and Charite, Berlin. Falk Ehmann studied Medicine and European and International law at the Universities of Hamburg, Munich, Berlin and King’s College London. He published more than 30 articles in peer reviewed Journals.
Senior Assessor Biopharmaceuticals, MEB
Dr. Marcel Hoefnagel is trained as a Biologist, with a PhD in (Plant) Biochemistry at Leiden University. Since 2002 he works as a senior assessor of Biopharmaceuticals, specialised in vaccines, allergens, biosimilars, immunogenicity, and Cell and Gene therapy products at the Dutch Medicines Evaluation Board (MEB). Marcel is chair of the Quality Innovation Group (QIG) at EMA. The QIG supports the translation of innovative approaches to the design, manufacture and quality control of medicines.
Marcel is also chair of the Substance Validation Group (SVG). The SVG is involved in development and maintenance of EU-SRS (EU- Substance Registration System; a database with all ingredients in medicinal products in their molecular structure). Besides, he’s involved in various research projects to support the assessment of (bio)pharmaceuticals and other regulatory activities.
Head of Regulatory Affairs at Fondazione Telethon
Sean Russell is an experienced biotechnology executive, with particular expertise in commercial cell and gene therapy regulatory affairs and product development. He has held multiple concurrent leadership positions within the advanced therapies and pharmaceutical ecosystem as Head of Regulatory Affairs for Fondazione Telethon, Senior Vice President (SVP) Regulatory Affairs for Achilles Therapeutics, and Managing Partner for the specialist consulting group PrimeRA Pharma Partners.
Sean’s experience in medicinal product development spans all development stages, from research concept to commercialisation, across many different product types (including somatic cell therapy, ex vivo genetically modified cells and in vivo gene therapy) and international geographies. In addition to delivering specific developmental projects, Sean contributes to many industry wide initiatives including the EU Regulatory Advisory Group of the Alliance for Regenerative Medicine and currently sits on the Board of Directors of The Organisation for Professionals in Regulatory Affairs (TOPRA).
Non-clinical assessor, MEB
Britt Duijndam, Msc., is a non-clinical assessor at the Dutch Medicines Evaluation Board (MEB) since 2021, and she is involved in several research projects within the MEB aiming to evaluate the (non-) clinical development strategies and regulatory approval of oligonucleotide-based therapeutics. She is a member of the internal drafting group supporting the EU regulatory experts in drafting the new ICH S13 Guideline on “Non-clinical safety studies for oligonucleotide-based therapeutics”, and a member of the ICH S7/E14 Implementation Working Group for the “Clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential”.
Britt obtained a Master degree in Biopharmaceutical Sciences at Leiden University, and is a PhD student at the Leiden Academic Centre for Drug Research under the supervision of prof. dr. Bob van de Water and dr. Jan Willem van der Laan. In her PhD project, she developed a human cell-based reporter imaging platform for the evaluation of estrogenic compounds in relation to cell proliferation and potential tumor formation. This new-approach-method can be incorporated in a weight-of-evidence approach to determine the carcinogenic potential of pharmaceuticals and chemicals.
Head Division Translational Genomics of Neurodegenerative Diseases, & Hertie-Institute for Clinical Brain Research, University of Tübingen
Prof. dr. Matthis Synofzik, MD, is head of the research division 'Translational Genomics of neurodegenerative diseases' and senior consultant neurologist at the Hertie Institute for Clinical Brain Research & Center of Neurology, University of Tübingen, Germany. Using latest next-generation genomic sequencing techniques, he has been leading or involved in the identification of over 20 novel ataxia and spastic paraplegia (HSP) genes in the last 10 years. Matthis leads several worldwide EU-funded consortia on rare neurological diseases like PREPARE, PROSPAX and EVIDENCE-RND, and is Chair of the global trial-readiness platform 'ATAXIA GLOBAL INITIATIVE'.
Theses large-scale endeavours allow his research group to directly draw on large global patient, biomaterial, NGS datasets and outcome measure modelling to inform comprehensive and thorough development and evaluation of individualized ASO treatments for severe brain diseases. As part of the steering committee of the 1 MUTATION 1 MEDICINE (1M1M) consortium, he has already charted the path to establish this exciting novel therapy approach of ultra-individualized ASO treatments in Europe (Synofzik et al, 2021, Nucleic Acid Therapy). This work is paralleled by his work in the transatlantic IRDiRC N-of-1 Taskforce as well as transatlantic N-of-1 Collaborative (N1C). His lab is developing a scalable platform for individualized ASOs for severe brain diseases, from bedside to bench to bedside, with Ataxia teleangiectasia (A-T) as a forerunner showcase disease.
Clinical assessor, MEB, researcher, UMCG & Member Scientific Advice Working Party, EMA
Dr. Viktoriia Starokozhko, PharmD, ERT, is a clinical assessor at the Dutch Medicines Evaluation Board (MEB). She earned her PhD in Pharmacy at the University of Groningen. At the MEB and the European Medicines Agency (EMA), she is responsible for evaluation of medicine dossiers and provides scientific advice to drug developers. She is also a member of Scientific Advice Working Party and the EMA-HMA EU- Innovation Network, as well as a vice-chair of the Haematology Working Party, EMA.
Viktoriia is further a researcher at the University Medical Center Groningen. Her research in regulatory science focuses on the optimization of the drug-development process, facilitation of regulatory decision-making and biomarker qualification.
Senior Clinical assessor, MEB & Member Committee for Advanced Therapies, EMA
Dr. Emmely de Vries has a broad scientific background. She studied Biomedical Sciences at Utrecht University, followed by a master in Neuroscience and Cognition. She wrote her PhD thesis on the effect of inflammation and fasting on thyroid hormone metabolism at the University of Amsterdam in the group of prof. dr. Eric Fliers. After a 3 year postdoc on the effects of food intake on the metabolism of medicines, she left academia to pursue a career which was more on the interface of science and society.
Emmely has worked with the Dutch Medicines Evaluation Board (MEB) as a clinical assessor since 2018, specialized in the assessment of rare metabolic disorders. Since the end of 2023 she is the Dutch member of the Committee for Advanced Therapies at EMA.
Chair MEB & em. Professor of Pharmacotherapy, Utrecht University
Em. prof. dr. Anthonius de Boer, MD, was trained for three years in internal medicine followed by a PhD research period in clinical pharmacology. After his PhD graduation in 1990 he was appointed as assistant professor in Clinical Epidemiology followed by an associate professorship of pharmacotherapy. In 1994 he was registered as epidemiologist and in 1996 as clinical pharmacologist.
He was appointed in 2001 as professor of pharmacotherapy and director of the Pharmacy School. From 2007-2015 he was the head of the Department of Pharmaceutical Sciences, Utrecht University, from 2002-2014 he was a member of the Central Ethics Committee of the Netherlands (CCMO) and from 2014-2017 he was the chairman of the Drug Committee of the National Health Care Institute (ZiN). He was the chairman of the Board of the National Institute of Post-Academic Education of Pharmacy, chairman of the Certification Committee of the Dutch Society of Clinical Pharmacology and Biopharmacy (NVKFB) and member of the Programme Goed Gebruik Geneesmiddelen of ZonMw. In addition to his appointment at Utrecht University he started as the chairman of the Medicines Evaluation Board of the Netherlands in 2017. In 2022 he retired from university.