2026 ISPE Annual Meeting

A-007

Self-Selected and Self-Served: Does Patient-Led Digital Enrollment Predict Downstream Data Completeness in Real-World Evidence Studies?

Susan Oliveria, Christine Varner

A-037

Leveraging R to Accelerate and Enrich Real-World Evidence Analyses: Lessons from Modernizing Analytics for a Large Observational Registry Network

Heather Litman, Leslie Harrold, Richard McCoy, Melissa Moore-Clingenpeel, Adam Sima

A-047

Identifying Anti-VEGF Treatment Response Heterogeneity in Neovascular AMD Using LLM-Based NLP of Unstructured Clinical Notes

Ashwin Rai, Ariel Berger, Nick Boucher, Josee Winsor, Victoria Ikoro (Mai Duong presenting)

A-069

Why Harmonization Matters: A Lesson Learnt from Designing and Implementing a Bespoke Common Data Model and Quality Framework Across Registries for a Long-term, Post-authorization Efficacy Study (PAES)

Ines Akhamilich, Mai Duong, Noami Berfeld, Hai Nguyen

A-165

The Role of Early Access to Medicines Scheme (EAMS) Data in NICE Technology Appraisals in the UK

Ivana Sestak, Alice Rouleau, Martin Parkinson, John Sampalis, Alban Fabre

A-274

A Framework for Bespoke Data Harmonization and Privacy-Preserving Methods to Enable Analysis of Pooled Individual-Patient Level Data Across Different Real-World Data

Yi Lu, Divya Shridharmurthy

A-317

Cross-regulatory Differences in Pregnancy and Lactation Postmarketing Requirements: Implications for Real-World Evidence Generation

Ronna Chan, Ivana Sestak

A-356

Review and Insights Into the Evolution of the FDA’s Postmarketing Requirements for Clinical Lactation Studies: 2010 to 2025

Chelsea Crepeau, Neil Brett, Darin Brimhall, John Sampalis

A-357

Review of the Evolution of the FDA’s Postmarketing Requirements and Commitments for Pregnancy and Lactation Studies of IBD Therapies

Chelsea Crepeau, Neil Brett, Darin Brimhall, John Sampalis

A-380

Estimating Live Birth Rates for Enrollment Planning in Pregnancy Exposure Registries

Laura Sayegh, Yassaman Vafai, Brittany Gonyeau

A-384

A Prospective, Registry-based, Observational Study to Evaluate the Safety of Rimegepant Exposure During Pregnancy: Data from the Fourth Interim Report

Ivana Sestak, Ronna Chan, Courtney Norris, Lindsey Radenbaugh

B-067

Area Deprivation Index (ADI) and its impact on disease severity and patient reported outcomes (PROs) among US patients with psoriasis (PsO): The PPD CorEvitas Psoriasis Registry

Robert McLean, Thomas Eckmann, Taylor Blachley, Scott Henderson

B-068

Progression From Psoriasis (Pso) To Psoriatic Arthritis (Psa) and the Role of Pso Therapy: Novel Insights from the PPD™ CorEvitas™ Psoriasis Registry

Robert McLean, Michael Singleton, Maya Marchese, Alicia Beeghly, Jean Choi, Alvin Li, Taylor Blachley

B-128

Designing Registries to Enable Interventional and Noninterventional Studies: The PPD CorEvitas Obesity Registry Experience

Leslie Harrold, Heather Chubb, Alicia Beeghly, Paul Lakin, Andrea Austin, Heather Litman, Erin Masterson

B-212

A Practical, Scalable Quality Control Approach for Retrospective Chart Review Studies: Operational Insights from a Multi-Study Re-Abstraction Process

Neil Brett, Elizabeth Donahue, Marielle Bassel

B-247

Are Cross-sectional Cohorts an Efficient Alternative to Prospective Cohort Design in Real-world Studies?

Neil Brett, Marielle Bassel, John Sampalis

B-259

The Fidelity Gap: A Systematic Review of Specification versus Emulation in 208 Target Trial Emulation Studies

Alban Fabre, Yassaman Vafai

B-285

Beyond Traditional Feasibility: The Value of In-Depth Feasibility Assessments for Observational Studies

Laura Sayegh, Marielle Bassel

B-288

What Do Oncology Real-World Studies Tell Us? Lessons from the HMA-EMA Catalogue

Ivana Sestak, Sarah Rosen

B-390

Advancing Fit-For-Purpose Post-Authorization Safety Evidence-Generation Through Registry-Based Pharmacovigilance and Scientific Partnership

Melissa Moore-Clingenpeel, Christine Barr, Gaby Tayeh, Jeff Greenberg, Dimitrios Pappas, Peter Wahl, Heather Litman

B-415

A Post-Marketing Safety Study Using Data From a Pregnancy Registry to Evaluate the Safety of Respiratory Syncytial Virus (RSV) Vaccine (ABRYSVO™) Exposure During Pregnancy: Interim Report #3

Ronna Chan, Andrew Fitzgibbon

B-440

Respiratory Syncytial Virus (RSV) vaccine-related studies listed in the HMA-EMA Catalogue of Real-World Data (RWD) studies: Regulatory drivers and design patterns of RSV vaccine real-world studies?

Sarah Rosen, Maria Angeles Natividad Sancho, Alice Rouleau

C-017

Impacts of a Biostatistician-Led Cross-Disciplinary Data Quality Initiative

Richard McCoy, Heather Litman, Scott Kreider, Alina Onofrei

C-019

Study Designs and Characteristics of Post-Authorization Safety Studies Assessing the Implementation and Effectiveness of Additional Risk Minimization Measures (Armms) in the HMA-EMA Catalogue of Real-World Data

Alice Rouleau, Sara Angleman, Nicola Barnes, Sarah Rosen

C-233

Gene Therapies Approved During 2023-2025: What Does the Recent Landscape of Recent Approvals Look Like?

Sara Angleman, Yassaman Vafai, Alice Rouleau, Sarah Rosen, Elizabeth Donahue

C-315

Impact of Weighted Cumulative Exposure Methods for Determination of Risk Windows when Evaluating Long-Latency Malignancy Events

Heather Chubb, Melissa Moore-Clingenpeel, Robert Magner, Heather Litman

C-326

Feasibility of a Prevalent New User Design (PNUD) for Effectiveness Outcomes in the PPD CorEvitas Psoriatic Arthritis (PsA)/Spondyloarthritis (SpA) Registry

Samantha Kerti, Maya Marchese, Adam Sima, Melissa Moore-Clingenpeel, Robert McLean, Heather Litman

C-328

Use of Real-World Data to Support Clinical Studies: Contextualization vs. External Control Arm

Heather Litman, Melissa Moore-Clingenpeel, Leslie Harrold

C-332

When Switching Is Censoring: Why Time-Varying Inverse Probability of Treatment Weighting (IPTW) Collapses to Inverse Probability of Censoring Weighting (IPCW) in Strategy-Based Target Trial Emulation

Melissa Moore-Clingenpeel, Michael Singleton, Nathan Rubin, Robert Magner, Heather Litman

C-336

A Review of Analytical Methods to Correct for Left Truncation Bias When Assessing the Risk of Spontaneous Abortion (SAB) in Pregnancy Exposure Registries

Maria Angeles Natividad Sancho