The SIGMA Consortium was proud to attend the 41st Annual ISPE Conference, held in Washington, DC from August 22–26, 2025. This year’s event brought together leading experts in pharmacoepidemiology and real-world evidence (RWE) for a week of science, collaboration, and innovation.
SIGMA members were highly visible throughout the conference, with banners at the RTI Health Solutions and PHARMO Institute booths, daily live updates, and a strong presence from the SIGMA Office team—including Carla Franzoni, Josine Kuiper, and colleagues.
Featured SIGMA Poster Presentations at ISPE 2025
Studying Paternal Drug Exposures and Offspring Outcomes: Feasibility Assessment of Large European Databases. Authors: Colas S, Bonnet H, Fraticelli L, Bignon E, Jove J, Ehrenstein V, Giner-Soriano M, Reinold J, Schafer W, Tolppanen AM, Cesta CE, Cohen JM, Pajouheshnia R, Kuiper J, Houben E, Kurzinger ML, Longin J, Carcaillon-Bentata L.
- This study evaluated the feasibility of using large European databases to investigate the impact of paternal drug exposures on neurodevelopmental outcomes in offspring. The research team evaluated data availability across multiple countries and institutions, demonstrating the potential for robust, multinational pharmacoepidemiologic studies in this area. Their work highlights the importance of collaborative approaches to address complex questions in medication safety and reproductive health.
Safety of Paxlovid Among Patients with Moderate or Severe Hepatic or Renal Impairment. Authors: Rebordosa C, de Luise C, Aguado J, Bertran S, Boric K, Campbell C, de Jong H, Dureau-Pournin C, Far M, Fernandez-Garcia S, Foraster M, Giner-Soriano M, Gini R, Jove J, Leaney JL, Mao Y, Margulis AV, Messina D, Younus M, Nab L, Ouchi D, Roberto G, Saigi-Morgui N, Sakr D, Sturkenboom MCJ, Thurin NH, Andaur Navarro CL.
- This poster presented preliminary results from a post-authorization study assessing the safety of Paxlovid in patients with moderate or severe hepatic or renal impairment in three European countries. Leveraging real-world data from several European cohorts, the study provided early insights into Paxlovid use in these vulnerable populations, contributing to the optimization of COVID-19 treatment strategies.
Safety of Paxlovid in Pregnancy. Authors: Margulis AV, de Luise C, Aguado J, Andaur Navarro CL, Boric K, Campbell C, Carsin AE, Dureau-Pournin C, Far M, Fernandez-Garcia S, Foraster M, Gandhi S, Giner-Soriano M, Gini R, Jove J, Leaney JL, Mao Y, Messina D, Nab L, Ouchi D, Rebordosa C, Roberto G, Saigi-Morgui N, Sakr D, Sturkenboom MCJ, Thurin NH, de Jong H.
- This collaborative study assessed the safety of Paxlovid in pregnant individuals using data from three European countries. The poster summarized initial results, focusing on maternal, pregnancy and fetal outcomes following exposure to Paxlovid during pregnancy. The research underscores the value of multi-country data networks in generating timely evidence to inform clinical decision-making and regulatory guidance for medication use in pregnancy.
Conference Highlights
- SIGMA’s presence at the PHARMO and RTI-HS booths made these spaces hubs for scientific exchange and networking.
- The SIGMA Office team was on-site to share insights and connect with the global RWE community.
- Live updates and real-time snippets shared during the conference highlighted the enthusiasm and engagement of SIGMA members and visitors.
- The conference wrapped up with a celebration of new connections, impactful science, and momentum for future collaborations.
SIGMA thanks all collaborators, presenters, and attendees for making ISPE 2025 a success. We look forward to continuing our mission to advance pharmacoepidemiology and real-world evidence in Europe and beyond.
