All Events

2025 ISPE Annual Meeting

  • Start Date:

    22 Aug 2025

  • End Date:

    26 Aug 2025

  • Location:

    Washington, DC

  • Region:

    Global

  • Booth #:

    200

Request a meeting

Join us in Washington, DC for the 41st ISPE Annual Meeting on Pharmacoepidemiology and Therapeutic Risk Management. 

Stop by our booth (#200) to learn more about our commitment to driving excellence and innovation in pharmacoepidemiology through market-leading real-world data (RWD) and real-world evidence (RWE) solutions. Backed by a multi-disciplinary team with deep therapeutic and methodological expertise, our customizable solutions generate impactful evidence and insights to accelerate drug development and ensure patient safety.  

Request a meeting

ISPE 2025 conference website

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Pregnancy & lactation solutions
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Posters & Presentations 

Sunday, August 24 

Oral Session  

10:30AM – 12:00PM ET 
Using Aggregate Historical Control Data to Assess the Effects of New Treatments: An Illustrative Example of Population Adjusted Indirect Comparisons

Speaker: Jack Ishak
Time: 11:30-11:45am ET 

3:30PM – 5:00PM ET
Benefits of Machine Learning Methods for Identifying Clinical Features and Patient Characteristics Associated with Treatment Outcomes in Autoimmune Conditions

Speaker: Heather Litman
Time: 4:00 – 4:15pm ET 

Poster Session A

12:00PM – 1:30PM ET 

  Nominated for ISPE Spotlight Session

Vaccine-Related Studies Listed in the Heads of Medicines Agencies-European Medicines Agency (HMA-EMA) Catalogue of Real-World Data Studies: What Can We Learn from Study Characteristics?

Sarah Rosen, Maria-Angeles Natividad-Sancho, Sara Angleman, Ariel Berger, Alice Rouleau

Post-Approval Real-World Studies of RNA Therapies in the EU: What Can We Learn from Study Characteristics?

Sara Angelman, Elizabeth Donahue, Mai Duong, Nelson Ndegwa Gichora, Nahila Justo, Alice Rouleau

Mandated Long-Term Follow-Up Studies of Patients Treated with Gene and Cell Therapies Approved in the European Union (EU): An Analysis of Commonalities and Variations

Nahila Justo, Mai Duong, Pingling Zeng, Sara Angleman, Alice Rouleau, Elizabeth Donahue

An Alternative to Non-Responder Imputation for Study Participants with Missing Outcomes in Single-Arm Drug Effectiveness Studies: A Case Study in the CorEvitas Psoriasis Registry

Oksana Pugach, Michael Singleton, Wanyi Chen, Robert R. McLean, Nicole Middaugh, Heather J. Litman, Leslie R. Harrold

Interpretable Machine Learning Models: Describing Treatment Patterns of Healthcare Providers Selecting Rheumatoid Arthritis Therapies to Evaluate Treatment Policies

Heather Litman, Leslie Harrold, Zachary Margolin

Safety Profile of Vaxzevria® COVID-19 Vaccine in the COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER)

Janelle Gravesande, Deborah Layton, Andrew Lee, Jennifer Wu, Joseph Kim, Cheryl Renz, Syd Phillips, Susan A. Oliveria, Diego F. Wyszynski

An Evidence Base to Support the Establishment of a Fit-for-Purpose Quality Management System for Secondary Data Pharmacoepidemiological Studies

Susan Oliveria, Deborah Layton, Antonella Porta, Donny Patel, Tzuyung Douglas Lou, Sarah A Friese, Asieh Golozar, Andrea Splendiani, Yola Moride, Efe Eworuke, Christina D Mack, Darmendra Ramcharren

Monday, August 25 

Oral Session  

4:15PM – 5:45PM ET
Comparison of Propensity Score Matching vs. Inverse Probability Treatment Weighting: A Simulation Study in the CorEvitas Psoriasis Registry

Speaker: Sarah Mansfield
Time: 4:45-5:00pm ET

Poster Session B

11:30AM – 1:00PM ET  

Random Patient Selection in Retrospective Chart Review Studies: Cases, Considerations and Insights

Lauren Gianchetti, Zaeem Khan, Christian Betz, Chris Colby, Patrice Venumiere, Laurence Callendret, Marielle Bassel, Neil R. Brett

The Inclusion of Dietary Data in Real-World Gastroenterology Studies: Insights from a Literature Review on Crohn’s Disease

Neil Brett, Garthiga Manickam, Naissara Dal Magro, Daniela Castano

Landscape and Study Design Characteristics of Prospective Observational Cohort Studies on Pregnant Women in China

Yufei Song, Alice Rouleau, Syd Philips

Policy Impact on Pregnancy Registry Participation and Reporting of Maternal/Infant Outcomes

Ronna Chan, Syd Phillips, Kathleen Shannon, Yao Yao

Differential Regulatory Approaches to the Implementation of Pregnancy Registries Between the United States and Europe

Ivana Sestak, Catarina Figueiredo, Ronna L. Chan

Methodological Considerations about Policy Impact on Studies of Pregnancy Registries and Maternal/Infant Outcomes

Kathleen Shannon, Yao Yao, Ronna L. Chan, Syd Phillips

Leveraging Complementary Study Designs to Enhance Drug Safety Assessment in Pregnancy: Benefits and Limitations

Dinci Pennap, Yassaman Vafai, Robert Corbé, Andrew Lee

Evolving Landscape of Post-Marketing Surveillance (PMS) Studies in Japan Utilising Secondary Real-World Data (RWD)

Ayumi Hamaguchi, Mari Kato, Tatsuo Sakashita, Tadashi Koga, Amanda Pulfer, Dimitra Lambrelli

Tuesday, August 26 

Oral Session

1:30PM – 3:00PM ET
Comparison of Performance of Common Exposure Episode Definitions in Long-Latency Outcome Studies

Speaker: Andrea Austin
Time: 2:30 – 2:45pm ET

Poster Session C

12:00 pm – 1:30pm ET  

  Nominated for ISPE Spotlight Session

Beyond Comparison: Target Trial Emulation (TTE) Principles Strengthen Observational Single-Arm (SA) Effectiveness Studies

Robert R McLean, Oksana Pugach, Melissa Moore-Clingenpeel, Adam Sima, Leslie Harrold, Heather Litman

Is There a Lack of Dietary Data Collection in Real-World Pediatric Rare Disease Studies? Literature Review and Future Considerations

Neil Brett, Galina Nesterova, Susan McCune, Elizabeth Donahue

Trends in FDA Comments on the Design, Conduct, and Analysis of Pregnancy Exposure Registries: A Summary of Findings at a Clinical Research Organization (CRO)

Laura Sayegh, Reem Masarwa, Alice Rouleau, Ronna L. Chan

Nuances of Risk Window Selection for Evaluation of Adverse Events

Heather Chubb, Elsie Grace, Melissa Moore-Clingenpeel, Nicole Foster, Christine Barr, Nathan Rubin, Bryan Cherry, Dimitrios Pappas

Review of Post-Authorization Safety Studies Submitted to the HMA-EMA Catalogue of RWD Studies Evaluating Cancer as an Outcome

Melissa Moore-Clingenpeel, Nicole Foster, Leslie Harrold, Heather Litman

Real-World Prospective Data Assessing the Long-Term Safety of Abrocitinib Treatment in Adults with Moderate to Severe Atopic Dermatitis (AD): Over Two years of Experience from the CorEvitas AD Registry

Sampada Gandhi, Bernice Gershenson, Heather Chubb, Bryan Cherry, Nathan Rubin, Christine J. Barr, Melissa Moore-Clingenpeel, Dimitrios A. Pappas, Haiyun Fan, Cristina Lumpan, Jen Weissert, Pinaki Biswas, Gary Chan

Longitudinal, Regulatory-Grade Registry Data Can Be Used to Emulate a Target Trial: An Application on Evaluating Treatments for Plaque Psoriasis

Heather Litman, Robert McLean, Oksana Pugach, Adam Sima, Melissa Moore-Clingenpeel, Leslie Harrold