Developing and Validating Bioassays to Advance the Development of Biotherapeutics
ABOUT THIS CONFERENCE:
Bioassays play a vital role in the characterization, comparability, stability and potency testing of large molecule therapeutics. The inaugural Biossays for Biologics will bring together key individuals from across CMC, Bioanalytical Sciences, and Bioprocessing to share strategies and methods for developing and validating bioassays to advance the development of biotherapeutics.
CHI’s Inaugural
Bioassays for Biologics
March 21 – 22 | Intercontinental Harbor Court | Baltimore, Maryland | Healthtech.com/Bioassays
Bioassays for Biologics
March 21 – 22 | Intercontinental Harbor Court | Baltimore, Maryland | Healthtech.com/Bioassays
Agenda-at-a-Glance
Wednesday, March 21
BIOASSAYS FOR BIOSIMILAR DEVELOPMENT
Featured Presentation: Bioassays Empower Biologics Development
Patrick Liu, M.D., Ph.D., Senior Director and Global Head of Bioassays, Teva Pharmaceuticals, Inc.
International Bioassay Standardization
Michael Tovey, Ph.D., Director of Research, Biotechnology & Applied Pharmacology at ENS Cachan
Michael Tovey, Ph.D., Director of Research, Biotechnology & Applied Pharmacology at ENS Cachan
Functional Bioassays as Tools for Biosimilar Development
Cornelius Fritsch, Ph.D., Fellow, Technical R&D Biologics, Analytical R&D, Novartis Pharma AG
THE CHALLENGE OF DEVELOPING RELEVANT POTENCY ASSAYS
Featured Presentation: Cell Based Therapeutics: The Challenges of Developing Relevant Potency Assays
Alice Grebanier, Ph.D., Director, Bioassay Method Development, Janssen Research & Development
Alice Grebanier, Ph.D., Director, Bioassay Method Development, Janssen Research & Development
Bioassay Development and Validation: Challenges to Identify “Platform” Approaches for Unique and Complex Bioassays
Karen Blank, Senior Scientist, Analytical Research & Development, Pfizer
The Road from Potency to Neutralizing Antibody Assays: Twists, Turns and Bumps
Renuka C. Pillutla, Ph.D., Associate Director, Bioanalytical Sciences, Bristol-Myers Squibb
Bioassay Development – Challenges along the Way from Research Method to Quality Control Test
Jeffrey Glenn, Ph.D., Associate Director, Large Molecule Method Development, Pharmaceutical R&D, Johnson & Johnson
Complementary Role of Bioassays and Analytical Assays to Characterize Antibody-Maytansinoid Conjugates
Sonia Connaughton, Ph.D., Bioassay Development Group Leader, Translational Research, ImmunoGen, Inc.
REGULATORY AND REFERENCE STANDARDS
Use of Reference Standards in Bioassays
C. Jane Robinson, Ph.D., Principal Scientist, Biotherapeutics, National Institute for Biological Standards and Control, UK
Understanding Differences in Approaches in Bioassay Analysis
Timothy Schofield, Managing Director, Arlenda, Inc.; former Director, US Regulatory Affairs, GlaxoSmithKline
Featured Presentation: Reference Standard for Assessment of Therapeutic Monoclonal Antibody Products Potency – A Regulator’s Perspective
Carla R. Lankford, M.D., Ph.D., Quality Reviewer, Monoclonal Antibodies, OBP / OPS / CDER
Thursday, March 22
BIOASSAYS FOR COMPARABILITY STUDIES
Application of a Well-Diversified Bioassay Toolkit as a Key Component of Comparability Assessments
Max L. Tejada, Ph.D., Senior Scientist, Biological Technologies, Genentech, Inc.
Addressing Method and Process Change in Early Stage Development
Xu-Rong Jiang, Ph.D., Associate Director, Analytical Biochemistry, MedImmune LLC
A Case Study of Biological Assays for Biosimilar Monoclonal Antibody Development
Philip A. Krasney, Ph.D., Senior Scientist II, Bioassays, Teva Pharmaceuticals, Inc.
Strategies for Potency Assessment for Biotherapeutic Antibodies
Velvizhi R. Heine, Senior Scientist, Analytical Development, Biogen Idec
Development of Multiplexed Cell-Based Potency Assays: Potential for Simultaneous Characterization of Therapeutic Antibodies
Sarah Ronan, M.S., Associate Scientist I, Analytical Biochemistry, MedImmune
Development and Comparability Assessment of Cell-Based and Biochemical Assays for Potency Determination of a Therapeutic Antibody
Anaelle Dos Santos, Bioanalytics Lab Manager, BioProcessing, NovImmune SA
Part of CHI’s Third Annual Characterization & Comparability for Biologics
RECOMMENDED SHORT COURSES* Click here for complete details.
Pre-Conference Short Course* MEASUREMENT, CHARACTERIZATION AND IMPACT OF IMPURITIES
Monday, March 19, 9:00 am – 12:30 pm
Post-Conference Short Course* SETTING UP A COMPARABILITY PROTOCOL FOR INNOVATOR PRODUCTS AND BIOSIMILARS
Thursday, March 22, 1:30 pm – 5:00 pm
