Training Seminars

THURSDAY, APRIL 11 - FRIDAY, APRIL 12
DAY 1: 1:40 - 5:20 PM | DAY 2: 8:30 AM - 3:40 PM (Federal Complex)

TS8C: INTRO TO IMMUNOGENICITY

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 pm Lunch Provided


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

Instructor Biographies

Rup BonnieBonnie Rup, PhD, Independent Consultant


Pattijin SofieSofie Pattijn, 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 Training Seminar offers 1.5 Days of instruction with start and stop times for each day shown above and on the Event-at-a-Glance published in the onsite Program & Event Guide. Training Seminars will include morning and afternoon refreshment breaks, as applicable, and lunch will be provided to all registered attendees on the full day of the class.

Each person registered specifically for the training seminar will be provided with a hard copy handbook for the seminar in which they are registered. A limited number of additional handbooks will be available for other delegates who wish to attend the seminar, but after these have been distributed no additional books will be available.

Though CHI encourages track and symposia hopping between conference programs, we ask that Training Seminars not be disturbed once they have begun. In the interest of maintaining the highest quality learning environment for Training Seminar attendees, and because Seminars are conducted differently than conference programming, we ask that attendees commit to attending the entire program, and NOT engaging in track hopping, as to not disturb the hands-on style instruction being offered to the other participants.


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