Cambridge Healthtech Institute’s Inaugural Symposium

Bioassays for Immuno-Oncology

Biological Assay Selection, Development, and Standards to Ensure FDA Approval of Novel Immunotherapies

October 23, 2017 | The Westin Alexandria | Washington, DC

Biological assays demonstrating drug characteristics such as potency, mechanism-of-action, and stability, are one of the most critical components of an FDA biologic submission. However, with more complex mechanisms-of-action, immunotherapies add a layer of difficulty to bioassay selection and development. At Cambridge Healthtech Institute's Inaugural Bioassays for Immuno-Oncology symposium, experts in bioassays for immuno-oncology therapies will discuss selection, development, and standards for bioassays and immunoassays. Special attention will be given to understanding the mechanism-of-action for immunotherapies, whether they be antibody- or cell-based. Overall, this one-day immersive symposium will outline a product life cycle approach for developing and implementing biological assays from preclinical studies to clinical development.


In vitro Bioassays to Accelerate Immuno-Oncology Drug Development

Sofie Pattijn, CTO, ImmunXperts

Measurement of Fc Effector Function Using Binding Assays for Product Characterization

LeeAnn Machiesky, Scientist, MedImmune


Bioassays for Checkpoint Inhibitors

Ulrike Herbrand, Ph.D., Scientific Supervisor Research & Development, Biosafety & Bioassay Services, Charles River Labs


Host Cell Protein Immunoassays: The Case of Excess Antigen and Non-Linearity of Dilution

Matthew Roberts, Ph.D., Investigator, Biopharmaceutical and Analytical Sciences, GlaxoSmithKline

Flow Cytometric Assessment of Therapeutic Targets and Immune Responses in Immuno-Oncology

Steven J. Kussick, M.D., Ph.D., Associate Medical Director, Director, Contract Research and Flow Cytometry, PhenoPath

Panel Discussion: Challenges in Bioassay Design for Immuno-Oncology

Moderator: Steven J.Kussick, M.D., Ph.D., Associate Medical Director, Director, Contract Research and Flow Cytometry,PhenoPath

Panelists to be Announced

For more details on the conference, please contact:
Kaitlyn Waters
Associate Conference Producer
Cambridge Healthtech Institute
Tel: 781-247-6282
For exhibit & sponsorship opportunities, please contact:
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Tel: 781-972-5412



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Celebrating 25 years