New Early Phase Clinical Trials Paradigm - 6th Biopharm Day Seminar

It is with great pleasure that SGS invites you to the 6th Biopharm Day Seminar. This Research & Development seminar will address the new early phase clinical trials paradigm.

Global drug development in the 21st century is facing increasing costs, a decline in drug approvals and a shift from small molecular entities towards large biological drugs. Supported by key industry experts, this event will introduce topics such as:

• PK/PD
• Innovative and complex sampling (PBMCs analysis and monitoring within a clinical trial)
• Adaptive study design
• Regulatory environment
• Modeling and simulation
• Human challenges trials
• T-cell biomarkers

These topics, and more, will be introduced through short presentations, then discussed and challenged with Q&A and thematic Round Tables.

• Session 1 – How to Choose the Right Early Phase Clinical Study Design
• Session 2 – Empowering Early Phase R&D with Human Challenge Trial Solutions

This ‘new look’ seminar has evolved in its format to include a forum for direct exchanges regarding concrete solutions to early phase issues. In two, informal, interactive sessions you will have the opportunity to exchange thoughts with your peers on the latest early phase clinical trials initiatives and industry endeavors to revitalize the global drug pipeline.

Agenda

Speakers

• Maikel Raghoebar, Senior Director and Head of Janssen Clinical Pharmacology Unit (CPU)
• K. Lemmens, MD, Medical Director Early Phase, SGS
• Stephan Chalon, VP R&D, Experimental Medicine & Clinical Pharmacology, Medicines for Malaria Ventures (MMV)
• Adrian Wildfire, Project Director - Infectious Diseases & Viral Challenge Unit, SGS

Free of charge seminar, registration is mandatory.

Event location: Lindner Hotel, Lange Kievitstraat 125, 2018 Antwerpen, Belgium

For further information, please contact:

Wendy Crauwels
SGS Clinical Research
t: +32 (0)15 40 50 82