Cambridge Healthtech Institute’s 7th Annual

Optimizing Bioassays for Biologics  

Case Studies Demonstrating Successful Bioassay Development

October 17-18, 2019


As the bioassay field continues to move forward, new technologies and software are changing the way scientists view experimental design and data analysis. The health authorities and USP have provided guidance for the design and validation of a bioassay; however, they do not discuss solutions to common problems springing from this revolution in technology. At Cambridge Healthtech Institute's Seventh Annual Optimizing Bioassays for Biologics, leaders working in bioanalytical and bioassay development will come together to provide case studies and best practices for handling the most common issues in biological assay development, validation, transfer, and maintenance. There will also be a focus on new modalities including cell therapies (encompassing immunotherapies), gene therapies and antibodies. In addition, new technologies and bioassay formats will be presented along with recommendations for implementation to ensure a steady drug development pipeline.


Coverage will include, but is not limited to:


  • Innovative bioassay design

        - Design of experiments

        - Multi-targeted bioassays

  • Lifecycle management of bioassays
  • Assay bridging, analytical bridging
  • Study designs for bioassay validation
  • Method transfers to other groups or CROs
  • Change in reference and the impact to relative potency
  • New bioassay technologies and formats to increase speed and sensitivity
  • Automation and robotics in bioassay development
  • Bioassays for emerging modalities

        - Cell & gene therapy, immuno-oncology

        - Antibody therapy

  • Cell-based bioassay development
  • Bioassay quality by design (QbD)
  • Bioassays to understand a drug’s mechanism-of-action

        - Working with multiple mechanisms-of-action

  • Setting equivalence bounds for similarity in bioassays


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


All proposals are subject to review by session chairmen and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.


For more details on the conference, please contact:
Kaitlyn Barago

Associate Conference Producer

Cambridge Healthtech Institute

Phone: 781-247-6282


For partnering and sponsorship information, please contact:

Carolyn Cooke

Business Development Manager

Cambridge Healthtech Institute

Phone: 781-972-5412