With 5,000,000 pregnancies each year in Europe alone, there is a pressing need to fill the knowledge gap in medicine safety during pregnancy and breastfeeding. ConcePTION has spent 5 years working to set up an ecosystem for pharmacovigilance in pregnancy and breastfeeding. LifeSaver (Living Impact on Fetal Evolution) is just getting started on their journey towards advancing risk assessment for drugs and chemicals in pregnancy. Together, we work to fill the knowledge gaps. On 14 May 2024, we shared what we do and how we complement each other in a joint webinar.
Watch it in its entirety, or pick and choose below.
Building an ecosystem for medicine safety in pregnancy & breastfeeding – Miriam Sturkenboom & Marjolein Willemen, ConcePTION
Miriam Sturkenboom and Marjolein Willemen, ConcePTION coordinators, shared ConcePTION’s vision of ensuring that women are empowered and enabled to make decisions about their health in the delicate periods of pregnancy and breastfeeding.
Securing better lives: Project showcase – challenges, goals & next steps – Michael Gasik, LifeSaver
Michael Gasik shared the LIFESAVER project’s mission and vision – and the fact that LifeSaver goes beyond medicine safety alone and looks at chemical use also. And particularly to answer unmet needs regarding drugs and chemicals transport through placental tissues.
Non-clinical & clinical approaches to determine secretion of medicines in breast milk – Pieter Annaert, ConcePTION
Pieter Annaert presents ConcePTION’s clinical lactation studies and the complexities of carrying them out, how ConcePTION has managed, and how non-clinical methods can help fill the knowledge and data generation gap regarding medicine safety during breastfeeding.
Risk assessment, mitigation measures & regulation improvement for a safer pregnancy and healthier newborns – Thomas Zadrozny, LifeSaver
Thomas Zadrozny talks about how LifeSaver has integrated different technologies to resolve the problems identified, especially the lack of reliable methods to identify and address exposure risk in the first trimester and the value of their artificial placenta.
Panel: Realising impact – moderated by Jasper Levink, ConcePTION
Panelists Miriam Sturkenboom, Marjolein Willemen, Michael Gasik, Pieter Annaert, and Thomas Zadrozny discuss how the projects combined efforts can support the sustainability of our efforts and have policy impact that favours the improvement of maternal health & pregnancy pharmacovigilance.
About the speakers
Michael Gasik
Michael Gasik is the Chairman and co-founder of Seqvera Ltd. Oy (Helsinki, Finland) and the Ambassador (Finland) of the European Orthopaedic Research Society (EORS). He is a Full Professor at Aalto University Foundation (Espoo, Finland) and has held visiting professorships in the UK, Japan, Italy, Portugal, and Estonia. With over 300 publications and patents spanning 30 years, he has led numerous EU, IEA, and national projects. Michael was appointed EORS Ambassador for Finland in 2020 and has served in various international committees and organizations, including COST Actions and the European Connected Health Alliance (ECHA). He specializes in developing innovative in vitro testing methods and owns the LinkedIn group ‘Advanced Testing of Biomaterials’. Michael founded Seqvera Ltd. (www.seqvera.com) in 2016, focusing on biomaterials, medical devices, and advanced therapy medicinal products (ATMP) development in compliance with regulations like MDR 2017/745 and IVMDR 2017/746.
Miriam Sturkenboom
Miriam Sturkenboom, PhD (cum laude), is the head of the Department of Data Science and Biostatistics at the Julius Center, University Medical Center Utrecht, Netherlands. She holds a pharmacy degree and a Master’s in Epidemiology from Harvard School of Public Health. Previously, she was a professor at Erasmus MC and is currently a professor of Real World Evidence at UMC Utrecht. Her research focuses on real-world data transformation into evidence on drug use, effectiveness, and safety in vulnerable populations. She leads international projects funded by the European Commission, IMI, and other organizations. Notably, she coordinated the IMI-funded ADVANCE project and now leads the ConcepTION project on drug safety during pregnancy and lactation. She also serves as president of vac4eu.org and coordinates COVID-19 vaccine safety studies for the EMA.
Marjolein Willemen
Marjolein Willemen, PharmD, PhD, is Medical Policy Lead at Novartis. In this role, she is responsible for driving the strategy and development of Global Guidelines to ensure patients’ rights and ethical standards across Novartis, on topics including, but not limited to, Diversity, Equity and Inclusion in Clinical Trials, Post Trial Access, and Additional Research. Another part of her work focuses on external collaborations, which includes her role as Industry Lead for IMI ConcePTION, a public-private partnership funded by the Innovative Medicines Initiative. Before joining Novartis, Marjolein worked for Tillotts Pharma, and she started her career at the Medicines Evaluation Board (MEB) in the Netherlands, where she worked in drug safety and pharmacovigilance for more than 10 years before joining the pharmaceutical industry. Marjolein is a pharmacist and a clinical epidemiologist by training and holds a PhD in clinical epidemiology and a PharmD from Utrecht University in the Netherlands.
Pieter Annaert
Pieter Annaert trained as a pharmacist at KU Leuven and obtained his PhD in pharmaceutical sciences from the same university. After his postdoctoral fellowship at the University of North Carolina at Chapel Hill and gaining 5 years of industry experience in preclinical pharmacokinetics at Janssen Pharmaceutica, he initiated his academic career at the Drug Delivery and Disposition research unit of the Faculty of Pharmaceutical Sciences, where he is currently appointed as full professor. He has been the promotor of about 15 PhD researchers and is currently supervising a team of 10 PhD researchers in the fields of drug clearance prediction, drug-induced liver injury and perinatal pharmacology, with and emphasis on leveraging in vitro and in silico methods to explore mechanisms underlying pharmacokinetics. Since 2020, he is chairing the KU Leuven Department of Pharmaceutical and Pharmacological Sciences. In 2017, he co-founded the contract research start-up company BioNotus, where he serves as scientific director.
Thomas Zadrozny
Thomas Zadrozny, a visionary leader in technology management, has been involved in all stages of the Technology Readiness Level cycle. His expertise encompasses foundational research to market and financial access, including key areas like prototyping and industrial production. He has significantly contributed to over 25 EU-funded Key Enabling Technology projects, providing strategic insights in exploitation, dissemination, communication, and advising startups and industrial firms on technology integration, access to market and finance.
Jasper Levink
Jasper Levink is a serial entrepreneur and consultant, operating at the interface of science and business. He was involved in the ConcePTION project from the very beginning and is currently involved in the sustainability of the project.