Immunogenicity Assessment & Clinical Relevance
Strategies, Overcoming Hurdles and Interpreting Results
Part of the Seventh Annual Immunogenicity and Bioassay Summit
November 17-18, 2015 | Hilton | Baltimore, Maryland
This is a conference for biotechs, biosimilar producers and now for Big Pharma as they take over biotechs to widen their portfolios. Understanding what the regulators want, especially with the case-by-case approach, remains a challenge. The industry wants to know if multiple assays are necessary, if their assays are over-sensitive, and if the challenging ones such as neutralizing antibody assays have to be included. The biosimilar industry and big pharma need advice on coordinating their findings with those obtained earlier. Increasingly, the non-clinical ADA assay strategy needs to be re-visited, and the experts are comparing the approaches to determine the best for their product. The challenge is interpreting the results and understanding the clinical relevance. Immunogenicity assessment is riddled with challenges such as target and drug interference which need to be understood and correctly handled. Moreover, pre-existing antibody clouds the interpretation. This conference will address all of these challenges and provide case studies in a clinical setting.
Who should attend: This conference on Immunogenicity Assessment & Clinical Relevance will bring together individuals from regulatory affairs, bioanalytical development, clinical and non-clinical immunology, PKPD, Pharmacology, toxicology safety and R&D.
I am looking for case studies and practical experience of the following:
- Regulatory expectations regarding immunogenicity assessment
- Case studies on meeting regulatory expectations with immunogenicity assessment
- Practical application of immunogenicity preclinical risk assessment
- Strategy for non-clinical ADA testing: How you interpret the results and understand the clinical relevance
- Different assay formats and technologies for immunogenicity assessment
- Experiences with neutralizing antibody (Nab) assays
- Interpretation and handling of drug interference
- Overcoming target interference in non-clinical studies
- Dealing with pre-existing positive ADA activity in study patients
- Critical issues in cut point determination and ADA assay validation
- Immunogenicity experiences with different products: MAbs, bispecifics, ADCs, peptides, etc.
- Clinical case studies on specific biotherapeutics
- Relationship between immunogenicity assay results and PK
- Immunogenicity assessment of biosimilars and non-innovator biologicals
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:
Nicole Lyscom, Ph.D.
Cambridge Healthtech Institute
Tel: +44 7791 866489
For exhibit & sponsorship opportunities, please contact:
Business Development Manager
Cambridge Healthtech Institute