Challenging the Current Paradigm for ADA Testing21-22 September 2023, NH Málaga, Spain
Submit an Abstract
For this Focus Workshop, we look forward to your contributions, which should fit with the areas we plan to include in the workshop:
- Challenges of the current ADA testing paradigm and opportunities for alternative approaches to ensure meaningful immunogenicity assessment and getting safe and efficacious medicines to patients. When does the confirmatory tier add value? Can it be omitted? Should we be using a risk-based approach for this tier?
- How far should immune responses be characterized for multidomain biotherapeutics and does it add value?
- What are community examples of when we are doing “too much”? Presentations of ideas, recommendations and/or case studies for appropriate lean(er) approaches?
- Other case studies that show how we can streamline our immunogenicity assessments in the clinic?
- Examples of regulatory acceptance of alternative scientific approaches
You can submit your abstract before 31-MAY-2023 using the attached form. Inclusion into the program will be evaluated by the organising committee and is based on its fit with the meeting goals. We will communicate acceptance of your abstract before 15-JUN-2023.