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Bioassays 2020: Scientific Program
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To view the preliminary program, including speakers and talk titles, click here.
              

Program Agenda

Sunday, April 26, 2020

13:00 – 17:00    Workshop: Taking Your Bioassay to the Next Level: Phase Appropriate Validation of Bioassays for Use in GMP Sample Analyses
(Additional ticket required.  Visit the workshop page for more information.)

Monday, April 27, 2020

08:30 – 08:45    Welcome and Introduction

08:45 – 12:30    Session I: Technical Aspects of Bioassays throughout the Product Lifecycle

13:30 – 14:00    Lunch and Learn: Vendor Showcase

14:00 – 17:00    Session II: Bioassays for Cell and Gene Therapy

17:00 – 17:55    Vendor Showcase

18:00 – 19:30    Exhibitor and Poster Reception

Tuesday, April 28, 2020

08:30 – 09:15    Keynote Presentation

09:30 – 12:45    Session III: Bioassays for Bispecifics – Double the Trouble or Double the Fun?

12:45 – 14:00    Hosted Lunch

14:00 – 14:45    Poster Session

14:45 – 17:45    Session IV: Bioassays for New Therapies

17:45 – 18:00    Closing

 

Sessions

Technical Aspects of Bioassays throughout the Product Lifecycle
Session Chairs: Evangelos Bakopanos, Health Canada; Katrin Buss, Federal Institute for Drugs and Medical Devices, Germany; Mike Merges, Emergent BioSolutions; Adelheid Rohde, F. Hoffmann-La Roche AG

The technical aspects of bioassay strategies are essential as ever while the biotech industry launches new biologics including modified proteins, DNA, RNA and cell-based therapeutics.  The focus of this session will reinforce the importance of those bioassay technical features that contribute to the successful performance of a bioassay from assay development through to the post-marketing stage.  Some of the common threads intersecting bioassay applications and strategies that will be discussed during this session include bioassay design considerations, critical reagents (e.g. reference standards), data analysis approaches, and control measures used throughout the product lifecycle.


Bioassays for Cell and Gene Therapy
Session Chairs: Thomas Millward, Novartis Pharma AG; Bhavin Parekh, Eli Lilly and Company; Michael Sadick, Catalent Biologics

With increasing numbers of cell and gene therapy products in development and entering commercialization, more and more sponsors are facing a unique set of challenges of developing bioassays for cell and gene therapy products. Developing appropriate bioassays for cell and gene therapy products tends to be significantly more difficult than for conventional biologics due to a number of different factors, including

   •   the difficulty of adequately modelling the clinical mode(s) of action in a simple cellular system
   •   the challenge of defining, assessing suitability and generating sufficient quantity of, reference substances
   •   non-linear or non-sigmoidal dose response relationships in some bioassays; qualitative or only semi-quantitative responses in others
   •   a need for rapid analytical turnaround times in some cases
   •   an evolving understanding of clinical mode(s) of action in some cases, which may require a close interplay between analytical and clinical development
   •   and finally, the challenge of selecting the best bioassay(s) for release and stability testing vs. characterization/comparability testing.

This session will focus on case studies and regulatory feedback that we hope will be beneficial to all sponsors faced with the daunting task of developing a comprehensive control strategy for a cell or gene therapy product.

Bioassays for Bispecifics – Double the Trouble or Double the Fun?
Session Chairs: Jill Crouse-Zeineddini, Amgen Inc.; Stephen Hartman, AbbVie, Inc.; David Cirelli, Pfizer, Inc.

The structures and functions of modern biotherapeutics are becoming increasingly complex. A new generation of diverse multi-modal molecules has quickly emerged, where single molecules can bind multiple targets, harbor multiple activities, have combinatorial/synergistic activities, or all of the above. The complexity of multi-modal biotherapeutics brings about new challenges for bioassay development, as well as exciting opportunities for the application of novel assay formats and technologies.


Bioassays for New Therapies
Session Chairs: Thomas Arroll, Seattle Genetics, Inc.; Chana Fuchs, CDER, FDA; Max Tejada, AstraZeneca

Abstract coming soon.

 

 
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