Aetion joins experts from around the world at ICPE 2024 to discuss advances in pharmacoepidemiology.

The International Society for Pharmacoepidemiology (ISPE) will host its Annual Meeting in Berlin this week. From August 24-28, 2024, the International Conference for Pharmacoepidemiology (ICPE 2024) will bring together leading experts from industry, government, academia, and non-profit organizations to discuss advances in pharmacoepidemiology and challenges facing the field. Aetion is a proud sponsor of this year’s meeting and our scientists will be sharing their recent work and perspectives throughout the conference.

Pre-Conference Skills Courses

Aetion will contribute to several pre-conference skills courses aimed at introducing fellow researchers to methodological approaches and best practices for conducting high-quality pharmacoepidemiology studies. Aetion Co-Founder and President, Jeremy Rassen, along with John Seeger of Harvard University, will teach a pre-conference workshop on propensity score methods, an essential tool for controlling confounding in pharmacoepidemiologic studies. In the Applied Sensitivity Analysis course, Jeremy and Head of Scientific Research, Liz Garry, will present a range of approaches for contextualizing and testing the robustness of findings from non-interventional studies. As part of the Intermediate/Advanced Topics in Vaccine Safety and Effectiveness skills course, Katie Mues (VP, Science) will discuss applications of the target trial emulation approach for the valid design of vaccine effectiveness studies.

Optimizing Study Validity Through Novel Methods

Real-world data (RWD) is increasingly recognized as a powerful tool for conducting pharmacoepidemiologic research. To generate valid findings using RWD, researchers must carefully consider every aspect of their study design and analysis to identify and mitigate potential sources of bias. Aetion scientists will share their experiences with and approaches to producing robust real-world evidence (RWE). On Monday, August 26th, Jeremy Rassen will moderate a session entitled “Don’t Be Biased!” (5:15-6:45 p.m. CEST) in which several speakers will discuss methods for both detecting and addressing bias in pharmacoepidemiologic studies. On Wednesday, August 28th, Chief Scientific Officer, Nicolle Gatto, will contribute to the session “Orchestrating the Data Symphony: Harmoniously Combining Diverse Datasets in External Control Arm Studies in Oncology” (10:30 a.m.-12:00 p.m. CEST) by presenting an objective, phased approach to external control arm study design and implementation that employs published frameworks to assess the fitness of heterogeneous datasets, and allows data-driven decisions while maintaining objectivity. On Wednesday afternoon, Andrew Weckstein will build on this theme, sharing a novel approach to protocol development that uses pre-specified, but adaptive design elements as part of the “Methods Mischung” symposium (1:30–3:00 p.m. CEST). Aetion scientists will also present several posters highlighting methodological and study design approaches, including work on target trial emulation (Natalie Levy, Poster Session B, Poster 201); use of real-world data in oncology regulatory submissions (Veronica Frajzyngier, Poster Session B, Poster 007); preventing bias in pregnancy safety studies (Natalie Levy, Poster Session B, Poster 285); and applications of transportability methods to real-world data (Patrick Arena, Poster Session C, Poster 017).

Vaccine Effectiveness and Safety

The COVID-19 pandemic highlighted the importance of generating reliable and timely evidence on the effectiveness and safety of novel vaccines and the vital role of RWD in this process. Aetion scientists will share their broad experience conducting vaccine effectiveness and safety studies across several therapeutic areas using RWD through several presentations and posters. On Wednesday, August 28th, Liz Garry will present a real-world study of the effectiveness and safety of the Modified Vaccinia Ankara Bavarian Nordic (MVA-BN) vaccine against Mpox in at-risk individuals in the United States (US) (8:30-10:00 a.m. CEST). Later that day, Christopher Bush will share the results of a real-world study comparing adverse events following receipt of the Spikevax bivalent vaccine versus routine influenza vaccination in the US (1:30-3:00 p.m.). Neloufar Rahai will showcase two other COVID vaccine studies in posters on the safety of Moderna’s mRNA-1273.222 bivalent omicron-containing vaccine (Poster Session A, Poster 129) and a descriptive analysis of early use of Moderna’s mRNA-1273.815 monovalent vaccine (Poster Session C, Poster 341).

COVID-19 Data Capture and Treatments

Aetion scientists have also led work in collaboration with the U.S. Food and Drug Administration investigating and highlighting several other aspects of the challenges and opportunities for studying COVID-19 using RWD. On Wednesday, August 28th, Liz Garry will share an evaluation of the impact of data standardization on the quality of data capture for patients diagnosed in outpatient settings (1:30-3:00 p.m. CEST). This work highlights differences in the capture of key data elements important in COVID-19 research using administrative healthcare data after applying the Sentinel common data model (SCDM) compared with native formats and has broader implications for data standardization efforts. Liz will also present a poster characterizing the completeness of laboratory data in two administrative healthcare datasets (Poster Session A, Poster 091) and Veronica Frajzyngier (VP, Science) will share findings from a RWE study of the outcomes of patients hospitalized with severe COVID-19 who were treated with add-on immunomodulatory agents (Poster Session A, Poster 117).

Safety of Medical Devices

Aetion’s pioneering work to transform the role of RWE in the evaluation and approval of medical devices will be presented in two posters on Tuesday, August 27th. Christopher Bush will share findings from a study using US National Burn Registry data to describe treatment and device utilization patterns of patients with deep dermal or full thickness burns (Poster Session B, Poster 150). Liza Gibbs will present the findings of a real-world comparative effectiveness study of overall survival after robotic-assisted versus non-robotic radical prostatectomy, completed as part of Aetion’s partnership with the National Evaluation System for Health Technology Coordinating Center (NESTcc) and in collaboration with US Food and Drug Administration (FDA). The findings of this RWE study resulted in a labeling revision for Intuitive’s da Vinci X and XI robots specific to radical prostatectomy and represents Aetion's first FDA device clearance and label change using RWD.

We hope you will join Aetion at #ICPE. In addition to the presentations and posters outlined above, you can meet our team on the Exhibition floor at Booth 404. If you’re interested in setting up a meeting with our experts at ICPE, please click here. We look forward to seeing you soon.