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. 

• Display of Biologics
• Engineering Antibodies
• Machine Learning - Part 2

• Antibody-Based Therapies
• Emerging Targets & Approaches
• Membrane Protein Targets

• Safety & Efficacy of Bispecifics
• Advancing Bispecifics
• Engineering Bispecifics

• Tumour Microenvironment
• Innovations in CAR Therapy
• Next-Gen Immunotherapies

• Optimisation & Developability
• Analytical Characterisation
• Protein Stability & Formulation

• Cell Line Engineering
• Expression Platforms
• Protein Process Development

• Intro to Machine Learning
• Machine Learning - Part 1
• Machine Learning - Part 2

• Intro to Machine Learning
• Intro to Bispecific Antibodies
• Intro to Protein Engineering