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.


PRE-CLINICAL BIOASSAYS

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

UNDERSTANDING MECHANISM-OF-ACTION

Bioassays for Checkpoint Inhibitors

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

CLINICAL STAGE ASSAYS

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
Email: kwaters@healthtech.com
For exhibit & sponsorship opportunities, please contact:
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Tel: 781-972-5412
Email: cbenton@healthtech.com

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