In the lifecycle of a biotech product, manufacturing changes (process, site, equipment) to the drug substance or drug product are to be expected. When such changes occur, manufacturers need to demonstrate sufficient and appropriate comparability between pre-change and post-change to ensure that the safety and efficacy of the product remains intact. The biggest challenge therein, lies in what constitutes “sufficient” and “appropriate”? How do you know what may/may not be affected and what needs to be tested? When do you need to conduct such assessments? How much information is sufficient? What techniques should you use to obtain the best possible comparison? These and many other questions are on the minds of many analytical scientists as the products move along the development pathway, from early stage to formulation.
The Comparability for Biologics conference brings together scientists and engineers from core analytical lab, drug development, process sciences, formulation, manufacturing, QA/QC and regulatory affairs to share strategies, approaches and technologies that will help overcome these comparability questions and challenges.
An FDA Perspective on Risk-Based and Phase-Appropriate Comparability
Marjorie Shapiro, Ph.D., Chief, Laboratory of Molecular and Developmental Immunology, Monoclonal Antibodies, CDER, FDA
An Industry Regulatory Affairs Perspective on Managing Complex Changes
Allison Wolf, MSc, Research Scientist, Regulatory Affairs CMC Biotechnology, Eli Lilly and Company
Risk-Based Comparability Assessment of a Monoclonal Antibody Post Manufacturing Process Change during Early Clinical Stage: General Considerations and Case Study
Veronique Bailly, Ph.D., Bioprocess Development CMC Team Leader, Biogen Idec
Risk-based Comparability Strategy for Clinical Development of Therapeutic Proteins
Methal Albarghouthi, Ph.D., Senior Scientist, Regulatory Sciences & Strategy, MedImmune, Inc.
Comparability Approaches during Clinical Development and Post-Approval
Matthew Kalo, Ph.D., Senior Group Leader, Protein Analytical Chemistry, Genentech, Inc.
Talk Title to be Announced
Elizabeth Potocka, Ph.D., Oncology Clinical Pharmacology, Novartis Institutes for Biomedical Research
New Analytical Approaches to Probe the Interrelationships between Protein Higher-Order Structure and Pharmaceutical Stability as Applied to Comparability Assessments
David B. Volkin, Ph.D., Takeru and Aya Higuchi Distinguished Professor, Director, Macromolecule and Vaccine Stabilization Center, Pharmaceutical Chemistry, University of Kansas
Characterization of Fusion Proteins by Mass Spectrometry: Challenges to Analysis and Data Interpretation
James Bourell, Ph.D., Senior Scientist, OncoMed Pharmaceuticals
Quantitative Analysis of Site-Specific Glycosylation of Recombinant Therapeutic Glycoprotein as a Tool to Support Drug Development
Joanne Cotton, Ph.D., Staff Scientist I, Genzyme Corp
Application of Spectral Similarity Analysis for Product Comparability Exercise
Qin Zou, Ph.D., Senior Principal Scientist, Analytical Research and Development, Pfizer, Inc.
State-of-the-art Analytical Tools for Comparability and Biosimilarity Assessment
Horst Bierau, Ph.D., Scientific Advisor and Relation Manager, Pharmaceutical & Analytical Development, Biotech Products, Merck Serono
Current Regulatory and Scientific Issues with Biosimilars in the US
Emily Shacter, Ph.D., Consultant, ThinkFDA
How Similar Does a Biosimilar Have to Be?
Christopher Holloway, Ph.D., Group Director, Regulatory Affairs & CSO, ERA Consulting Group
Demonstrating Biosimilarity from the Aspects of Functional Characterization
Patrick Liu, MD, Ph.D., Senior Director, Global Bioassays and Technologies, Teva Pharmaceuticals
Establishing Biosimilarity and Comparability with Process and Manufacturing Changes
Jennifer Liu, Ph.D., Director, Analytical Sciences, Biosimilars Process Development, Amgen Inc.
For questions about the meeting, please contact:
Sr. Conference Director
Cambridge Healthtech Institute
For partnering & sponsorship information, please contact:
Manager, Sponsorship & Exhibits
Cambridge Healthtech Institute