Skip to main content
search

Conference: 2026 ISPE Annual Meeting

Date: August 29 - September 2, 2026

Location: Milan, Italy

Booth: 406

Learn more about Certara’s innovative approach to studying rare diseases

Addressing the complex challenges of rare disease drug development and evidence generation requires an innovative approach. Visit Certara at booth #406 at the 2026 ISPE Annual Meeting to connect with our real-world evidence and pharmacoepidemiology experts and learn how we’re linking rare disease registries with national health claims databases to overcome issues related to limited and incomplete data to help our customers assess the burden of illness.

Linking data to solve common yet complex challenges in studying rare disease

Certara’s experts help you overcome:

  • Limited data caused by inherently small patient populations
  • Fragmented, hard-to-find patients dispersed patient populations
  • Incomplete data sources that capture some outcomes and resource utilization but lack granular clinical measures or quality of life data

Join our poster presentations and spotlight posters on rare disease

Monday, August 31
12:00PM – 1:30PM CEST
Identifying Fit-for-Use Real-World Data for Regulatory Decision-Making – A CAR-T Cell Therapy Initiative

Presenting Author: Stephanie H Read, PhD

Using the EMA Data Quality Framework, this study illustrates a structured, reproducible approach to assessing the fitness-for-use of three real-world data sources for regulatory-grade CAR-T cell therapy research.

Tuesday, September 1
11:30AM – 1:00PM CEST
Interim Results from A Post-Authorisation Safety Study of the Utilization and Prescribing Patterns of Xeljanz® (tofacitinib) Using an Administrative Healthcare Database in France

Presenting Author: Stephanie H Read, PhD

This post-authorization drug utilization study leverages nationwide French claims data (SNDS) to characterize real-world tofacitinib prescriber adherence to dosing, screening, and monitoring recommendations, supporting ongoing evaluation of this Janus kinase inhibitor’s risk minimization measures.

Wednesday, September 2
12:00PM – 1:30PM CEST
Economic Burden of Eosinophilic Esophagitis in the United States (2017–2023): Healthcare Resource Utilization and Costs in ICD-10 Identified and Undiagnosed Patients.

Presenting Author: Alekhya Lavu, PhD, PharmD

The study evaluates the healthcare resource utilization and economic burden of EoE using real-world EMR and claims data. It highlights substantial healthcare utilization and costs among patients with documented and potential undiagnosed EoE, underscoring the burden of EoE and potential gaps in diagnosis.

Wednesday, September 2
12:15 PM – 1:15 PM CEST
SPOTLIGHT SESSION: Spotlight Poster Rare Disease
Clinical Outcomes of IgA Nephropathy: Insights from Multisource Real World Data Before and After Delayed Release Budesonide Approval

Presenting Author: Giancarlo Pesce, PhD

This work triangulates three independent US real-world data sources — the CureGN Registry, the TriNetX EHR network, and a single-center chart review — to characterize IgAN disease course, treatment patterns, and clinical outcomes before and after FDA approval of delayed-release budesonide (Nefecon). Together, the three sources capture complementary views of the same disease — long-term natural history, comparative safety and cost, and early post-approval outcomes — that no single data source could provide.

Wednesday, September 2
12:15PM – 1:15PM CEST
SPOTLIGHT SESSION: Spotlight Poster Rare Disease
Type 2 Inflammation and Comorbidities in Eosinophilic Esophagitis: US population-based cohort study

Presenting Author: Alekhya Lavu, PhD, PharmD

This study characterizes the burden of type 2 inflammatory conditions and other EoE specific comorbidities among patients with documented and potential EoE using real-world US data.

Wednesday, September 2
12:15PM – 1:15 PM CEST
SPOTLIGHT SESSION: Spotlight Poster Rare Disease
Development of a Novel Data Linkage for Rare Disease Research: Identifying Myotonic Dystrophy Type 1 in the French SNDS using the DM-Scope Registry

Presenting Author: Stephanie H Read, PhD

This study establishes a novel data linkage between the DM-Scope registry and the French SNDS claims database to develop and validate the first predictive algorithm for distinguishing between Myotonic Dystrophy Type 1 and Type 2 patients in administrative healthcare data.

Explore Certara's RWE Services

  • Outcomes Research and Surveys: Analyzing treatment patterns, patient outcomes, and unmet needs in niche populations to inform development and market access strategies
  • Data Source Selection: Identifying and selecting the most appropriate real-world data sources (e.g., patient registries, medical records, claims data) to address specific research questions
  • Advanced Analytics and Modeling: Applying sophisticated analytical techniques to RWE to extract meaningful insights, including comparative effectiveness studies, cost-effectiveness analyses, and safety evaluations.
  • Regulatory Support: Providing regulatory writing, strategy, and submission expertise to support rare disease drug approvals.
  • Market Access Strategies: Developing strategies to optimize pricing, reimbursement, and market access for rare disease therapies.