Cambridge Healthtech Institute’s 13th Annual
Immunogenicity Assessment and Management
Assay Development, Clinical Relevance, Regulatory Landscape and Predictive Studies
May 12-13, 2021
As the immunogenicity field is moving forward, closing the gap between clinicians and assay developers is essential in the success of biologic development and accelerating the adoption of new biologic therapies in patient treatments. In addition, understanding
and controlling immunogenicity-related risks are critical in the development of biotherapeutics to ensure they meet regulatory requirements. This conference brings together leading industry, regulatory and academic experts to share best practices
in immunogenicity assessment and management of both novel and traditional biologics.
Coverage will include, but is not limited to:
- Clinical Relevance of ADA, NAb and PK Assays: Cost of developing assays and new techniques, collecting good data, detecting ADA and the FDA perspective
- Recent Advances with Novel Modalities: Including but not limited to cell therapy (e.g. CAR T and edited stem cell), gene therapy (e.g. AAV vectors, re-dosing), peptides, bispecifics, trispecifics, biosimilars, immunotherapies and ADCs
- Regulatory Perspectives: Critical feedback from the FDA on new/updated guidance and recent submissions
- Assay Development and Validation: Selecting the optimal format for your assay, overcoming technical challenges, data reporting and cut point calculations
- Managing Assay/Drug/Target Interference and Drug Tolerance: Strategies to improve drug tolerance and manage interference including double acid association
- Translation into the Clinic: How can the data generated be used in the clinic? What is the true value of the pre-clinical assays and how can this be proved?
- Risk Assessment: Overcoming issues with impurities and aggregation, what do the FDA want to see?
- Predictive Assays, Studies and Tools: How can these be improved? Examples include but not limited to T cells, MAPPS and Abirisk
- Immune Tolerance: Immunosuppression, tolerance induction, check point inhibitors and cytokine therapies
- Informatics and Statistics: Successful implementation of algorithms and mathematical models
If you would like to submit a proposal to give a presentation at this meeting, please click here.
The deadline for priority consideration is December 11, 2020
All proposals are subject to review by session chairpersons and/or the Scientific Advisory Committee to ensure the overall quality of the conference program. Additionally, as per Cambridge Healthtech Institute’s policy, a select number of vendors and consultants who provide products and services will be offered opportunities for podium presentation slots based on a variety of Corporate Sponsorships.
For more details on the conference, please contact:
Senior Conference Director
Cambridge Healthtech Institute
Phone: (+44) 7754-518-131 Email: email@example.com
For partnering and sponsorship information, please contact:
Senior Manager, Business Development
Phone: 781-972-5452 Email: firstname.lastname@example.org
Manager, Business Development
Phone: 781-972-1340 Email: email@example.com