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 biological assays 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.

 

Who should attend: Bioassays for Immuno-Oncology will bring together key individuals from immunotherapy R&D, bioanalytical R&D, cell and antibody engineering, immunology and oncology, pharmacology, and preclinical and clinical development.

 

Topics may include, but are not limited to:

  • Bioassay and immunoassay selection and development
  • Cell-based assay types, including:
    • Potency, including assays for antibody-based and cell-based therapies
    • Reporter
  • Immunoassays
  • Qualification and validation case studies
  • Standardization of performance and output
  • Reflecting the correct mechanism-of-action
  • FC Effector function
  • Regulatory expectations for Biologic License Application (BLA)
  • Benefits and disadvantages of in vitro vs. in vivo assays

 

If you would like to submit a proposal to give a presentation at this meeting, please click here.

 

Deadline for submission is April 14, 2017

All proposals are subject to review by the Scientific Advisory Committee to ensure the highest quality of the conference program. Please note that due to limited speaking slots, preference is given to pharmaceutical and biotech companies, regulators and those from academia. Additionally, vendors/consultants who provide products and services to these biopharmaceutical companies are offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.

 

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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