Jalpa Patel
Scientific Director- Specialty Pipeline & Global Medical Affairs Abbvie
Seminars
Tuesday 19th August 2025
Innovating Endpoints in IPF: Including & Beyond FVC to Determine Clinical Efficacy
8:00 am
FVC remains the standard endpoint for IPF clinical trials, yet its variability poses challenges for trial reliability, cost, and regulatory approval. As the field advances, there is a growing need to refine clinical trial endpoints by integrating additional, more predictive measures. This workshop will explore innovative approaches to endpoint selection, incorporating lessons from other respiratory diseases and data-driven strategies to enhance trial sensitivity and efficiency.
Get ready to explore:
Addressing the Limitations of FVC
- Understanding the variability of FVC, its impact on trial design, and the need for complementary or alternative measures to improve accuracy and trial success
Learning from Composite Endpoints in Pulmonary Arterial Hypertension
- Evaluating how composite endpoints, including six minute walk distance, respiratory hospitalizations, and imaging biomarkers, can provide a more robust efficacy assessment
Advancing Clinical Trial Design
- Leveraging quantitative, data-driven approaches to define novel composite endpoints that enhance sensitivity, support regulatory approval, and transform the future of IPF clinical trials
Thursday 21st August 2025
Designing Clinical Trials with Patients in Mind to Align Scientific Goals with Real-World Needs
11:30 am
- Integrating fatigue, cough, and other patient-centered outcomes into clinical trial design – How can we better capture the true impact of therapies on quality of life?
- Developing endpoints that go beyond regulatory approval to deliver meaningful data for patients and clinicians
- Leveraging Insight from Patient Organizations to improve recruitment, retention and relevance
