Comparability and Biosimilarity


Always an important consideration in late-stage development for QC and release testing, comparability is now even more of a concern particularly with ADCs and other complex multi-component, combination products, where batch-to-batch comparability poses a huge challenge. In addition, more and more biosimilars are expected to enter the foray of drug approvals in the coming years, giving more angst to companies trying to ensure analytical comparability of their biosimilars to the originators.

The Comparability and Biosimilarity conference aims to open up communication within the industry to discuss the expectations, requirements, acceptable criteria, methodologies and reality concerning analytical comparability and biosimilarity, particularly on protein higher-order structure analysis and interpretation, forced degradation and stability testing, as well as comparability assessment for the heterogeneous antibody-drug conjugates.

Priority Confirmed Topics and Speakers include:


HIGHER ORDER STRUCTURE ANALYSIS FOR COMPARABILITY AND BIOSIMILARITY

Choosing the Right Tools for the Job: Higher Order Structure Methods for Comparability and Biosimilarity

John P. Gabrielson, Ph.D., President, Elion Labs

Application of NMR and Biophysical Techniques to Higher Order Structure Comparability Studies

Desiree Tsao, Ph.D., Associate Director, Analytical Development, Momenta Pharmaceuticals


CQA AND STABILITY COMPARABILITY OF BIOLOGICS

Application of Differential Scanning Calorimetry in Biotherapeutic Comparability Analysis

Simon Yeung, M.S., Research Associate II, Protein Biochemistry, Regeneron Pharmaceuticals, Inc.

Assessment of Critical Quality Attributes in Biopharmaceuticals and Their Impact on Different Stages of Product Development

Robert Mayer, Ph.D., Scientist, Characterization Group, Sandoz GmbH

Comparability of Biologics – A Stability Perspective

Nila Das, Ph.D., Senior Research Investigator, Bristol-Myers Squibb


BIOSIMILARS – ANALYTICAL REQUIREMENTS AND ROLE OF STATISTICS

Analytics for Biosimilars: The Inverted Rhino Paradigm

Nadine M. Ritter, Ph.D., President and Senior Analytical Advisor, Global Biotech Experts, LLC.

Forced Degradation Study of a Therapeutic Protein and Reference Product: Comparability Assessment in Support of Biosimilarity

James Prescott, Ph.D., Associate Director, Analytical Development, Momenta Pharmaceuticals

The Role of Statistics in Biosimilarity Evaluation

Harry Yang, Ph.D., Senior Director, R&D, MedImmune


COMPARABILITY OF ANTIBODY-DRUG CONJUGATES

Characterization and Comparability of an Antibody-Drug Conjugate and Its Parent IgG2 Antibody Intermediate

Adam Fung, Ph.D., Principal Scientist, Analytical Development, Agensys, Inc.

Bioassays for Comparability Assessment of ADCs

Jodi A Pegg, Ph.D., Scientist, Pfizer




For questions about the meeting, please contact:
Mimi Langley
Sr. Conference Director
Cambridge Healthtech Institute
Phone: 816-472-0701
Email: mlangley@healthtech.com

For partnering & sponsorship information, please contact:
Jon Stroup
Sr. Business Development Manager
Cambridge Healthtech Institute
Phone: 781-972-5483
Email: jstroup@healthtech.com