Part Three: Comparability for Biologics


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.


REGULATORY PERSPECTIVES ON COMPARABILITY ASSESSMENTS

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


COMPARABILITY ASSESSMENTS DURING CLINICAL DEVELOPMENT

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


ANALYTICAL TOOLS AND APPROACHES FOR COMPARABILITY STUDIES

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


ESTABLISHING BIOSIMILARITY

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:
Mimi Langley
Sr. Conference Director
Cambridge Healthtech Institute
Phone: 816-472-0701
Email: mlangley@healthtech.com 

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


Register Now 


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