Optimizing Bioassays for Biologics
Merging Biology and Statistics for Successful Biological Assay Development
Part of the Seventh Annual Immunogenicity and Bioassay Summit
November 18-19, 2015 | Hilton Baltimore | Baltimore, Maryland
Bioassays are a critical component of biologics drug discovery and development. With increasingly complex biologic modalities coming to market, including those with multiple mechanisms, accurate biological measurements are crucial. Cambridge Healthtech Institute’s Third Annual Optimizing Bioassays for Biologics will showcase strategies for biologics with multiple modes of action while bridging two perspectives on bioassay development: biology and statistics. At this event, industry leaders will showcase strategies for assay selection, validation, transfer, and maintenance, with an emphasis on molecules with complex mechanisms. Health authorities 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
- Reporter assays
- Bioassays for cell and gene therapies
- Statistical design for assay development and validation
- Assay comparability case studies
- Characterization assays in support of characterization of antibody therapeutics
- Characterization and methods for ADCs and bispecifics
- Selecting the relevant method of action
- Method transfers to other groups or CROs
- Monitoring change and variability
- New technologies or formats for bioassays
- Expectations of health authorities
Proposed short courses:
Basics of Immunogenicity
Overcoming the Challenges of Immunogenicity Assessment
Immunogenicity Risk Assessment and Regulatory Strategy
Strategic Bioassay Design and Analysis
If you would like to submit a proposal to give a presentation at this meeting, please click here.
Deadline for submission is May 7, 2015.
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:
Cambridge Healthtech Institute
For exhibit & sponsorship opportunities, please contact:
Business Development Manager
Cambridge Healthtech Institute