Cambridge Healthtech Institute’s Ninth Annual
Immunogenicity Assessment & Clinical Relevance
Overcoming Challenges for Meaningful Evaluation
October 24-25, 2017 | The Westin Alexandria | Washington, DC
The generation of meaningful immunogenicity data with clinical relevance is beset with many challenges. Top of the list is management of drug and target interference in the assay in both clinical and non-clinical studies. Second, comes the challenge of assay validation and cut point determination. Last year, the FDA issued new guidance for establishing cut points, but the approach is seen by many to be idealistic and not entirely practical. The third is Nab assays, which continue to improve and evolve. There is uncertainty about when these should be implemented, their usefulness, how much time to devote to them and how to deal with all the variation. The fourth is the presence of pre-existing positive ADA activity in study patients, as investigators have difficulty distinguishing between these and potential immune responses to the drug. Finally, determining the relationship between assay data and the clinical outcome, particularly the impact on PK and efficacy is another major challenge.
This event will present industry case studies on how these challenges are addressed for a range of products, so that immunogenicity data can be assessed and presented to the regulatory authorities in a meaningful way.
Who should attend: Scientists, Project Managers, Team Leads and Senior Team Members from Departments in Bioanalysis, Toxicology, R&D, PKPD, Non-Clinical and Clinical, Immunology, Regulatory Affairs, etc.
I am looking for case studies on the following:
- Case studies on assay development: Experiences with managing the positive control, critical issues in ADA assay validation
- Experiences with neutralizing antibody assays: cell-based Nab assays and comparisons with ligand-binding assays; implementation of automation and DoE
- Managing drug and target interference/tolerance: Challenges facing the industry with drug tolerance and examples of how this is overcome
- Dealing with pre-existing positive ADA activity in study patients
- Experiences with anti-drug antibody immune complexes
- Immunogenicity assessment of specific products: e.g. bispecifics, ADCs, non-MAbs such as large proteins and peptides, enzymes, interferons, pegylated proteins, immunotherapies, etc.
- Case studies on determination of the relevance of clinical immunogenicity: Its relation to clinical PK, safety and efficacy
- Correlations between predictive immunogenicity and the clinical outcome
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:
Nicole Lyscom, Ph.D.
Senior Conference Director
Cambridge Healthtech Institute
Tel: +44 7791 866489
For exhibit & sponsorship opportunities, please contact:
Business Development Manager
Cambridge Healthtech Institute