Immunogenicity Assessment & Clinical Relevance
Assay strategy and risk assessment for safe and efficacious products
Part of the Sixth Annual Immunogenicity and Bioassay Summit
November 17-18, 2014 | Hyatt Regency Bethesda | Bethesda, Maryland
The impact of Immunogenicity on efficacy is costing the industry vast amounts every year and denying patients much needed treatment. Moreover the danger of adverse reactions is ever present. Assessment of immunogenicity continues to be hampered by complications such as pre-existing antibody and interfering drug, while the interpretation of data is complicated. Immunogenicity Assessment & Clinical Relevance will enable investigators to work out a risk assessment immunogenicity strategy for their product that satisfies themselves and the regulatory authorities that their product is safe and efficacious.
I am looking for case studies and practical experience of the following:
Practical Application of Immunogenicity Preclinical Risk Assessment
- Features of the risk analysis and risk mitigation plan
- Immunotoxicology studies
Immunogenicity Strategy and Assay Methodology for Various Products
- Case studies on: Conjugates, bispecifics, novel constructs, gene therapy products, etc.
- Experiences with assay validation, setting cut points, interpreting the data
Challenges in Developing Neutralizing Antibody (Nab) Assays
- New technologies and comparison of methods
- Interpretation and handling of drug interference
Regulatory Expectations Regarding Immunogenicity Assessment
- How much assessment is necessary? How much is too much? What is the essential strategy?
- Proper validation and characterization of assays
Handling Pre-Existing Antibody
- Means of detection and of distinguishing them from potential immune responses to the drug
- Examples seen in the clinic and their relevance
Focus on Immunogenicity of PEGylated Proteins
- Experiences regarding pre-existing anti-PEG antibodies and how this affects efficacy
- How to overcome this challenge
Detection of Immune Complexes and their Impact on Immunogenicity Assessment
- Potential dangers of immune complexes in terms of toxicity
- Methods for detection and characterization
Case Studies on Clinical impact of Immunogenicity
- Real examples of immunogenicity in the clinic
- Relationship between immunogenicity assay results and PKPD
Risk Management in the Clinic
- Management in the clinic of products with low and high risk of immunogenicity
- Immunogenicity risk assessment as a function of the clinical condition: acute, chronic, malignant, autoimmune etc.
- Immunogenicity Prediction and Mitigation
Proposed Short Courses:
- Basics of Immunogenicity
- Overcoming the Challenges of Immunogenicity Assessment
- Immunogenicity Risk Assessment and Regulatory Strategy
If you would like to submit a proposal to give a presentation at this meeting, please click here.
Deadline for submission is May 2, 2014
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, contact:
Nicole Lyscom Ph.D.
Cambridge Healthtech Institute (CHI)
Tel: +44 7791 866489
For details on sponsoriship and exhibit opportunities, contact:
Business Development Manager
Cambridge Healthtech Institute
For details on media and association partnerships, contact:
Senior Marketing Manager
Cambridge Healthtech Institute (CHI)