Webinar: Biosimilars: Nonclinical and Clinical Development Challenges and Considerations
Sponsored by: Covance
Focused on:
Date: 27th September
Days old: 4514
Time: 4PM London/11AM New York
Analyzing the key issues effecting Biosimilar drug development timelines in nonclinical and clinical environments
With many blockbuster biological drugs now, or soon to be off patent, there has been great interest in developing follow-on versions, termed biosimilars. Biosimilars have emerged as one of the fastest growing development opportunities in the biopharmaceutical sector. Unlike generic small molecule drugs creating an exact copy of a therapeutic protein is impossible. As a result regulatory agencies evaluate this category of biologics based on their level of similarity to, rather than the exact replication of the innovator drug.
Biosimilars represent a new category of biological medicine – one that is fraught with risks but ripe with opportunity. Biosimilar development presents challenges at every level, from selection of a manufacturing platform, to analytical assays demonstrating comparability, to in vitro and in vivo testing, clinical testing, market access, and post-marketing surveillance.
This webinar will explore key considerations in biosimilar development:
• The current regulatory environment for biosimilars
• Nonclinical aspects including in vitro characterizations as well as in vivo study
considerations
• Key Phase I and Phase III issues in the biosimilars debate
Presented by
Raymond Donninger, MBChB, MBA,
Senior Program Manager, Molecule Development Group
After obtaining his Honours degree in Biochemistry and Microbiology at the University of Cape Town (South Africa), Raymond switched fields to pursue a medical degree. In 2002 he joined South Africa's largest Biotechnology Company as the company's Medical Officer responsible for all clinical aspects of product development. He was responsible for preparing Investigato's Brochures, designing study protocols and preparing Regulatory submissions. His role expanded to include early product development and general business strategy.
Raymond joined the Covance Program Management group in 2008 and has particular experience with large molecule drug development. He has been responsible for the provision of expert advice to Clients in the design and execution of effective strategies for biotherapeutic development through pre-clinical and early clinical studies. Raymond also has specific expertise in the field of biosimilar drug development and has been responsible for the successful design, execution and management of early biosimilar drug development projects for both therapeutic proteins and monoclonal antibodies.
Download Slides
Please login to download the slidesKey Learning Objectives
- The current regulatory environment for biosimilars
- Nonclinical aspects including in vitro characterizations as well as in vivo study considerations
- Key Phase I and Phase III issues in the biosimilars debate
Audience
- CEO/President/Chairman/Executive Director
- R&D Executives
- Nonclinical and Clinical Development Personnel focused on Biosimilars