Connect With Our Evidera and Corevitas Experts Specializing in Epidemiology, Drug Safety, and Real-world Data at ICPE 2024
We are participating in scientific sessions, presenting new and innovative research, and available to discuss how we can support your real-world evidence needs.
Check out our presentation list below and visit booth #401 to discover how our enhanced real-world evidence and data solutions and post-marketing safety study experts can help advance your drug development towards approval and market access.
Pre-conference Skills Course
Saturday, August 24 • 9:00am – 12:30pm
Risk Minimization and Communication: Scientific Approaches and Case Studies for Designing and Evaluating Interventions for the Safe Use of Medicines
Presenter: Meredith Smith
Oral Presentations
Session 3
Tuesday, August 27 • 8:00am – 9:30am
Performance of entropy balancing and covariate balancing propensity score methods for controlling confounding under challenging real-world conditions in observational studies: a simulation study
Presenters: Michael Singleton, Oksana Pugach, Melissa Eliot, Robert R. McLean, Adam Sima, Heather Litman
Development of the Reporting recommendations Intended for pharmaceutical risk Minimization Evaluation Studies-Standards for Reporting of Implementation Studies Extension (RIMES-SE)
Presenter: Meredith Smith
Symposia & Workshop Sessions
Session 3
Tuesday, August 27 • 4:15pm – 5:45pm
Novel Individualized Therapeutics: Challenges and Opportunities for the Use of Real-World Evidence in Rare Diseases
Presenter: Delphine Saragoussi
Why Real World Evidence (RWE) Studies Need Implementation Research: The Value Proposition
Presenter: Meredith Smith
Session 4
Wednesday, August 28 • 10:30am – 12:00pm
Back to the Source: A Review of the Current State of Social Determinants of Health in European and US Real World Data Sources
Presenter: Syd Phillips
Risk Minimization Programs for Teratogenic Drugs: How to Move from Art to Science
Presenter: Meredith Smith
Poster Presentations
Session A
Monday, August 26 • 8:00am – 6:00pm
Synthesized learnings and considerations from global historical cohort studies via retrospective chart review in oncology
Neil Brett, Laura Sayegh, Mariam Selvage, Celena Kent, Marielle Bassel
Adjuvant, 1L and 2L treatment patterns were described within metastatic non-small cell lung cancer (mNSCLC) patient populations across EU4, UK and USA during the years 2022 and 2023
Delphine Saragoussi, Ivana Sestak, Elvira Gomez, Kacy Emeanuru
Safety Results of Post-Marketing Surveillance Studies of B/F/TAF in China and South Korea
Javier Cid-Ruzafa, Harmony Omeife
Session B
Tuesday, August 27 • 8:00am – 6:00pm
Vaccine Cohort Event Monitoring: Enhancement of Safety Data Collection
Sarah Rosen, David Hillman, Delphine Saragoussi
A step-by-step guide for incorporating estimands in observational studies
Ivana Sestak, Maryse Kochoedo, Lindsey Radenbaugh, Yuliya Halchenko, Martin Ladouceur
Understanding the utility of historical cohort studies via retrospective chart review studies in inflammatory bowel disease: A review of global studies
Neil Brett, Christian Betz, Lauren Gianchetti, Zaeem Khan, Daniela Castano, Gustav Schellack, Marielle Bassel
Comparator cohort selection: a case study among review of prospective pregnancy registries for multiple sclerosis (MS) products
Kristin Veley, Reem Masarwa, Rebecca Buus, Yuliya Halchenko, Caitlyn Blum
Evaluation of digital data collection methods in a prospective pregnancy registry for a migraine product with both acute and preventive indications
Kristin Veley, MacDonald SC, Hardy JR, Huang Q, Ivans A, Norris CG, O’Donnell A, Yang R, Asomaning K
Effectiveness of awareness/recruitment activities for pregnancy registries
Kristin Veley, Courtney G. Norris, Lindsey Radenbaugh, Fang-Yi Lin
A hypothetical case study describing different intercurrent events in an observational prospective study: Differential interpretation of results
Ivana Sestak, Bree Newton, Yuliya Halchenko, Kathleen Shannon, Delphine Saragoussi
Real-world data collection in medical device for regulatory submissions: Considerations in epidemiology
Ronna Chan, Ken Butz, Christine Varner, Delphine Saragoussi
Methodological considerations for the design and implementation of real-world vaccine-related studies in low- and middle-income countries
Angela Carter, Annamaria Kiure, Sandra Okala, Sarah Rosen, Kat Downes, Delphine Saragoussi
Systematic Definition Development of Variables of Interest for Studies Using Administrative Databases
Mai Duong, Noami Berfeld, Mark Yates
Using Large Language Models with Real-World Data to Support Regulatory Decision-Making for Medicinal Products: Are We on the Road to Regulatory Convergence or Chaos?
Meredith Smith
Session C
Wednesday, August 28 • 8:00am – 1:30pm
Study Design Considerations for Real-world Observational Studies Supporting Pre-Approval Regulatory Decision-making in China
Yufei Song, Lu Ban, Jiang Li, Ziyi Li, Alice Rouleau
Retrospective chart review data collection to generate external comparator arm populations: Considerations and suggestions for reducing key biases
Neil Brett, Fang-Yi Lin, Elizabeth Donahue, Marielle Bassel, Martin Ladouceur
C&G therapy post-marketing commitments: review of designs, differences cell vs. gene therapy, EU vs. US, potentially other regions as well
Sara Angleman, Alice Rouleau, Bethany Gibson, Elizabeth Donahue , Delphine Saragoussi
A comparison of Regulatory Frameworks for real-world data (RWD) collection within Early Access Programs (EAP) in the US, EU and Japan
Alice Rouleau, Janneke Luijken, Zaeem Khan, Yufei Song, Pedro Inacio, Emily Speas, Ivana Sestak
Use of test-negative designs in pharmacoepidemiology: focus on vaccine effectiveness 2013-2023
Delphine Saragoussi, Aurelien Mantonnier, Amanda Pulfer, Martin Ladouceur, Jack Ishak, Susan Oliveria
Standardization of Coding Definitions for Sickle Cell Disease Complications: A Systematic Literature Review
Firas Dabbous, Rajrupa Gosh, Surbhi Shah
Estimation of period-based costs associated with individual chronic complications of rare inherited diseases, in the context of multimorbidity, using real-world data
Caoimhe Rice, Jennifer Davidson, Sara Carvalho