Cambridge Healthtech Institute Training Seminars offer real-life case studies, problems encountered and solutions applied, along with extensive coverage of the academic theory and background. Each Training Seminar offers a mix of formal lecture and interactive discussions and activities to maximize the learning experience. These Training Seminars are led by experienced instructors who will focus on content applicable to your current research and provide important guidance for those new to their fields.
TS8C: INTRO TO IMMUNOGENICITY
THURSDAY, September 3 - FRIDAY, September 4
DAY 1: THURSDAY
1:40 - 5:20 pm Seminar Sessions
DAY 2: FRIDAY
8:30 am - 3:40 pm Seminar Sessions
12:30 - 1:30 Lunch Provided
Exhibit Hall Refreshment Breaks also provided.
Instructors:
Bonnie Rup, PhD, Independent Consultant
Sofie Pattijn, CTO, ImmunXperts
All protein drugs generate an immunogenic response. This 1.5-day training seminar provides a practical, comprehensive overview of immunogenicity – the causes, how to assess, predict and prevent, and what to do if you observe immunogenicity during
preclinical, clinical and post-market approval. The seminar begins by detailing the science behind immunogenicity, the latest international guidances, followed by assay and bioanalytical assessment strategies for traditional and emerging biologics.
Other topics include predictive models and how to report immunogenicity incidents both internally and externally.
Part 1: Sources and Causes of Immunogenicity
- What is immunogenicity?
- Immunology and major mechanisms affecting immunogenicity
- B cell development
- Clinical consequences of ADA
- Risk-based approach
- Immunogenicity in the clinic
- Regulations and Guidance governing immunogenicity
Part 2: Assay Methodologies
- Assay methodologies
- Comparison of different methods
- Screening, Confirmation
- Characterization of anti-drug-antibodies
- Cut-points
- Immunogenicity of complex biologics (e.g. multi-domain, biosimilars)
- PK/PD and Safety and Efficacy - as a measure.
- Immunogenicity in the clinic – how to report
Part 3: Pre-Clinical and Clinical Considerations, Predictive Tools
- Pre-clinical prediction and assessment
- Predictive tools – in silico, in vitro tools, humanized models, artificial lymph node
Instructors:
Bonnie Rup, PhD, Independent Consultant
Sofie Pattijn,
PhD, CTO, ImmunXperts
Sofie Pattijn (CTO and founder, ImmunXperts) has over 20 years of experience in the field of immunogenicity assessment (vaccines and biotherapeutics) and in vitro assay development. She has extensive hands-on lab experience and has managed and coached
several In Vitro teams over the last decade. From 2008 till 2013 she was Head of the In Vitro Immunogenicity group at AlgoNomics (Ghent, Belgium) and Lonza Applied Protein Services (Cambridge, UK). Prior to that, she worked at Innogenetics, Belgium
for over 15 years.
WHAT IS A TRAINING SEMINAR?
Each CHI Training Seminar offers 1.5 days of instruction, refreshment breaks, exhibit hall functions, and lunch for all registered attendees on the full day of the class. Each person registered for the Training Seminar will be provided
with a hard copy handbook for the Training Seminar in which they are registered. A limited number of additional handbooks may be available for other delegates. CHI encourages track hopping between conference programs, and we ask
that Training Seminars not be disturbed once they have begun. We ask that attendees commit to attending the entire 1.5-day training, and not engage in track hopping once the class has started.
