Singlicate ADA analysis
Insights into the current thinking around immunogenicity analysis in single wells.
With the adoption of ICH M10, many sponsors are embracing single-well analysis for ligand-binding PK assays. The wide support of singlicate analysis for PK assays has fed the discussion of single-well analysis in ADA assays. This webinar will discuss the benefits of such an approach and provide examples of where singlicate ADA analysis was successfully applied.
Who this may interest?
• Bioanalytical scientists in pharma, biotech and CRO organizations
• Scientists participating in preclinical and clinical immunogenicity analysis
• Chief Scientific Officers managing therapeutic program schedules including immunogenicity assessments
• Scientific Group Leaders managing bioanalytical technologies for development programs
Speakers
Paul Bolliger
Manager, Bioanalytical Services
ICON plc
With over 15 years of CRO experience, Paul has collaborated on many novel and innovative LBA projects. He currently serves as the Manager of the ligand binding method development group and oversees the development and transfer of PK, PD and immunogenicity assays at ICON’s bioanalytical laboratory in Lenexa, Kansas. He has several years of experience as a Scientist and Principal Investigator, overseeing method development and validation for large molecule assays via ELISA and ECL techniques.
Alissa Cornacchia
Manager, Bioanalytical Services
ICON plc
Alissa Cornacchia’s CRO career began approximately 9 years ago when she joined ICON as a Scientist I, specializing in pharmacokinetic analysis. Over the last 3 years, her experience has expanded to both pharmacokinetic and immunogenicity method development, transfer and validation activities. She currently holds the position of Manager of the Immunoassay Validation Team at ICON’s Bioanalytical Laboratory in Whitesboro, NY.
This webinar was recorded on Wednesday 11 September 2024
In association with:
