Basel Epidemiology Seminar on
Pregnancy Research – Postponed
Date and time:
March 20th, 2020
Novartis Pharma AG
Auditorium U2, Fabrikstr. 6 (Visitor Center)
Novartis Campus, Basel
- Free of charge
- (We kindly request also Novartis associates to register for the event.)
- Visitor badges shall be picked up at the main gate, latest 15 min prior to start of the seminar.
13:00 – 13:15 Conny Berlin (Novartis, Basel)
Welcome & Introduction
13:15 – 13:45 Julia Spöndlin (University Basel)
Building a mother-baby cohort using Swiss claims data
13:45 – 14:15 Tania Schink (BIPS, Bremen)
Establishment of a framework to study the utilization and safety of drugs during pregnancy in the German Pharmacoepidemiology Research Database (GePaRD)
14:15 – 14:30 Break
14:30 – 15:00 Kiliana Suzart-Woischnik (Bayer, Berlin)
Experience from the Betaferon pregnancy registry
15:00 – 15:30 Lisa Prach (Novartis, Basel)
Evolving strategies to address health authority requests in reproductive toxicity: an industry perspective
15:30 – 16:00 Panel discussion
Abstracts and speaker’s bio:
Julia Spoendlin is a trained pharmacist and pharmacoepidemiologist working at the Basel Pharmacoepidemiology Unit (BPU) at the Universtiy of Basel and the University Hospital Basel. She completed her doctoral thesis in pharmacoepidemiology and a training in clinical pharmacy in Basel at the BPU in 2013, where she also worked as a postdoctoral researcher for 2 years after. Between 2016 and 2018 she joined the Division of Pharmacoepidemiology at the Brigham and Womens Hospital in Boston for a 2-year postdoctoral fellowship. During this time she also completed a Master in Publich Health.
In her talk at the BES, Julia will talk about the current progress and future goals in the establishment of a mother-baby cohort using Swiss claims data (the Swiss MOBA) to evaluate drug use and safety during pregnancy in Switzerland. This project has been initiated in 2019 in collboration with the Department of Health Sciences at the Swiss health insurance Helsana as well as with the unité médicaments en vie réelle at the centre hospitalier universitaire vaudois (CHUV). It aims to fill the information vacuum around drug utilization during pregnancy in Switzerland. The presentation will focus on the technical aspects of builiding the Swiss MOBA using Swiss claims data as well as on an evaluation of the use of antiseizure drugs during pregnancy in Switzerland.
Tania Schink is a statistician and pharmacoepidemiologist and the head of the drug safety unit at the Leibniz Institute for Prevention Research and Epidemiology – BIPS in Bremen, Germany. She has more than 10 years of experience in pharmacoepidemiology, working on EU funded multi-database studies, Post Authorization Safety Studies, and research projects regarding the use and safety of drugs in vulnerable populations such as the elderly and pregnant women.
In her talk at the BES, she will detail the preparatory work that is needed to be able to study utilization and safety of drugs during pregnancy based on claims data: 1. Identification of pregnancies and the classification of their outcomes (e.g. livebirth, stillbirth, induced abortion). 2. Development of an algorithm to estimate the beginning of pregnancy / gestational age. 3. Establishment of a procedure to link newborns with their mothers.
Kiliana Suzart-Woischnig (to be added).
Lisa Prach has been an Epidemiologist in the Quantitative Safety and Epidemiology department at Novartis since June 2019. She completed her PhD in Molecular and Cell Biology and Master in Public Health from the University of California Berkeley (UCB). She lead several studies at UCB and the University of California San Francisco, working on primary data collection and secondary data use in observational research related to infectious diseases and maternal and child health. She also worked at the California Department of Public Health on newborn screening surveillance for cystic fibrosis. She currently leads the scientific aspects of the Gilenya Pregnancy Registry for Novartis.
In her talk at the BES, Lisa will describe the evolving strategies Novartis has developed and proposed to robustly address health authority requests regarding issues of reproductive toxicity. She’ll generally describe past experiences and challenges as well as highlight new strategies under development. Her talk will touch briefly on pregnancy registries, enhanced pharmacovigilance in pregnancy, and secondary (claims) database use as complementary strategies to assess drug safety in pregnancy.