2017 Archived Content
THURSDAY, 16 November | 17:30 - 20:30 | DINNER
SC10: New Analytical Approaches & Strategies for Comparability and Biosimilarity
Instructors:
Hans-Martin Mueller, Director, BioProcess Development, Biologics and Vaccines, MSD
David Wylie, Principal Scientist, Sterile Process and Analytical Development, MSD
Introduction:
Providing convincing comparability/similarity studies is a key success factors for the filing of novel biologics. This is even more important for the steadily growing new field of biosimilars and biobetters. In this case, comparability studies are combined
with demonstrating similarity. For a proper planning of novel or biosimilar development programs, it is important to understand the development costs, timelines and the authoring of CMC regulatory sections. The analytical characterization of comparability
and similarity studies will form the cornerstone for each successful marketing authorization application of these products. This short course will be about analytical development and its challenges, technical hurdles, BLA authoring, timelines and
costs. Participants will be introduced to state-of-the art analytical comparability/similarity strategies, which anticipate occurrences of non-identity, leading to a smooth and efficient IND/BLA application and approval.
Course Agenda:
- Cost and resource management
- Strategic use of the analytical database
- Optimal application of modern analytical tools (e.g., Forced Degradation)
- Preparation of strong and convincing files
- Health agency expectations for biosimilars
- Attributes important to similarity
- When attributes differ between biosimilar and originator
- Case studies
Instructors Bio:
Hans-Martin Mueller, PhD, Director, BioProcess Development, Biologics and Vaccines, MSD
Martin Mueller, Ph.D., Biotech Engineer, started his career at a Biotech startup in Berlin. Following this he joined a globally acting CRO headquartered in Basel, Switzerland (RCC, today: Harlan Labs). There he worked as a GLP study director for close
to hundred clients from the agrochemical industry and from big pharma companies. With this experience he joined Schering-Plough’s biotech division and built-up the new Global GMP Labs. In 2012, Martin relocated to New Jersey, U.S., and accepted
a position within Merck’s BioProcess Division responsible for development and commercialization of biological key products. Today, he manages a biotech team co-located in Europe and in the U.S.
David Wylie, PhD, Principal Scientist, Sterile Process and Analytical Development, Merck Research Labs
A protein chemist by training, David Wylie has been involved in the purification development and analysis of over 25 novel and biosimilar drug candidates ranging in size from peptides to large multi-domain fusion proteins. He was instrumental in overseeing
the design, execution, analysis and reporting the analytical similarity studies incorporated in the successful filing of Lusduna, a biosimilar to Lantus insulin glargine. Through his direct participaton with biosimilar drug development and work with
partners of Merck, he has gained firsthand knowledge of EU and US agency expectations for multiple biosimilar drugs since 2012. David received his PhD from Duke University.