Cambridge Healthtech Institute’s Fifth Annual

Optimizing Bioassays for Biologics

Merging Science and Statistical Methods for Successful Biological Assay Development

October 25-26, 2017 | The Westin Alexandria | Washington, DC


Bioassays, at their core, spring from a fusion of biological and statistical sciences, and are used to measure activity or function of a compound or group of compounds in samples. The biological aspect is based on finding or creating a living system that responds to the compound with most development effort focused on how to make the response larger, more consistent, and more selective. The statistical aspects involve the design of the assay system, techniques for constructing measures of the relative activity (or potency) of preparations of the stimulant, tools for improving the assay system, and methods for demonstrating the properties of potency estimates. 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. At Cambridge Healthtech Institute’s Fifth 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. Health authorities will weigh in on new guidelines as well as provide insight into what they consider a well-characterized and well controlled bioassay. Finally, new technologies and bioassay formats will be presented along with recommendations for implementation to ensure a steady drug development pipeline.


Who should attend: Members of bioanalytical R&D, those who work in quality control or CMC for biological products, statisticians and biologists who are new to biological assays, and members of industry regulatory groups that support biological products.


  • Signal to noise, best practice in dose response selection
  • Sample size selection per dose, number of plates
  • Outlier detection and removal in curve fitting
  • Outlier detection and removal for immunoassays and establishing cut points
  • Outlier detection and removal for immunoassays and establishing cut points
  • Dose masking for curve saturation (parallel line analysis)
  • Curve Weighting based on examination of the residuals
  • Systems Suitability and Validity criteria selection
  • Tests and approach for parallelism and constraining the curves
  • Study designs for bioassay validation
  • Selecting acceptance criteria for bioassay validation
  • Reference stability and bioassay control
  • Change in reference and the impact to relative potency

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:
Samantha Drinkwater
Senior Conference Director
Cambridge Healthtech Institute
Tel: 781-972-5461

For exhibit & sponsorship opportunities, please contact:
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute
Tel: 781-972-5412



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Conference at a glance

Celebrating 25 years