Industry Session
Beate Bittner, PhD
Global Head Product Optimization
F. Hoffmann - La Roche
Basel, Basel-Stadt, Switzerland
Gerard Bruin (he/him/his)
Director
Pharmacokinetic Sciences / Novartis
Basel, Switzerland
The workshop aims to provide an overview of the clinical development and regulatory pathways for subcutaneous (SC) administration of biologics. The content covers the overall SC clinical development program, clinical design choices, and endpoints. It addresses the industry perspective on bridging approaches from intravenous (IV) to SC administration and associated endpoints, the impact of targeted therapy on the selection of the study population, changes between clinical phases, and the use of high- volume devices. Case study presentations will be delivered by different pharmaceutical companies. The event concludes with a panel discussion, inviting audience participation and questions.