Immunogenicity Summit


Optimizing Bioassays for Biologics
Strategies for Assay Selection, Validation, Transfer, and Maintenance
Part of the Sixth Annual Immunogenicity and Bioassay Summit
November 18-19, 2014 | Hyatt Regency Bethesda | Bethesda, Maryland

In biologics drug development, a reliable bioassay is crucial to the approval of the final product. However, when developing new drugs, a lack of data on the relevant mechanism-of-action can slow progress. This can become especially complex with new biologic modalities such as bispecifics and antibody-drug conjugates. At Cambridge Healthtech Institute’s Second Annual Optimizing Bioassays for Biologics, industry leaders will showcase strategies for assay selection, validation, transfer, and maintenance with an emphasis on molecules with multiple mechanisms. Health authorities, including the FDA and USP, will weigh in on new guidelines as well as provide insight into what they consider a well-characterized biologic. Finally, new technologies and bioassay formats will be presented along with recommendations for implementation to ensure a steady drug development pipeline.

Who should attend: Optimizing Bioassays for Biologics will bring together key individuals from bioanalytical R&D, cell and antibody engineering, immunology, pharmacology, and preclinical and clinical development.

Topics may include, but are not limited to: 

  • Working with different assay types: 
    • Potency assays, 
    • Alpha screen assays
    • Fluorescence-based proximity assays
    • Octet assays
    • Biacore assays
    • Reporter assays
  • Selecting your bioassay
  • Assay comparability case studies
  • Characterization assays in support of characterization of antibody therapeutics
  • Characterization and methods for ADCs and bispecifics
  • Method transfers to other groups or CROs
  • Monitoring change and variability
  • Maintaining assay consistency
  • Expectations of health authorities
  • New technologies or formats for bioassays
  • Strategies for molecules with multiple mechanisms
  • Selecting the relevant method of action
  • Moving from non-cell-based to cell-based assays
  • Statistical design for assay development or validation
  • Bioanalytics for new biologic modalities

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

Deadline for submission is May 2, 2014 

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, contact:
Samantha Lewis
Conference Producer
Cambridge Healthtech Institute (CHI)
Tel: 781-972-5461
Email: slewis@healthtech.com

For details on sponsorship and exhibit opportunities, contact:
Carolyn Benton
Business Development Manager
Cambridge Healthtech Institute (CHI)
Tel: 781-972-5412
Email: cbenton@healthtech.com

For details on media and association partnerships, contact:
James Prudhomme
Senior Marketing Manager
Cambridge Healthtech Institute (CHI)
Tel: 781-972-5486
Email: jprudhomme@healthtech.com 

2013 Brochure Cover

Download Brochure 


Podcast 

IMN Podcast iconReducing and Monitoring Bioassay Variability 

2013 Speaker: Janet L. Lathey, Ph.D., Director, Immunology and Assay Development, BioDefenseDivision, Emergent BioSolutions