Pre-Conference Workshop Day
Monday, May 15
9:00 – 12:00
Workshop A – Employing Biopsies as a Regulatory Endpoint – Present & Future
Synopsis
Join this interactive deep dive session to uncover the current regulatory perspective on biopsies through to endpoints to transform the pathway to regulatory approval. This session is dedicated to challenging and discussing the pros and cons of utilizing histology exclusively as the primary endpoint.
Key highlights covered in this discussion:
- Overview of the current position of using histology as a primary endpoint for phase II and III studies in patients with fibrosis and gastrointestinal diseases
- Exploring co-primary endpoints including a combination of non-invasive tests
- Understanding what the interpretation of histology is and what is the weight that is placed on the interpretation
1.00 – 4.00
Workshop B – Including Digital Pathology Alongside Conventional Pathology to Assess Fibrosis
Synopsis
Collaborate with key stakeholders to advance integration of multiple objective measurements of disease activity in fibrosis and gastroenterology. Be part of the groundbreaking discussion on how digital pathology can gain acceptance from industry pioneers.
Key highlights covered in this discussion:
- Integrating digital pathology to assess fibrosis alongside conventional pathology for enhanced quantitation of disease change
- Establishing a clearer understanding of the future utilization of digital pathology to enhance the current standard pathology applications
- Introducing diagnostic testing to understand disease regression specifically and what is needed in terms of therapeutic efficacy