Post Learning Implementation Plan (PLIP)

Pre-course

• Access to the Educo Training Portal
• Submit your needs analysis and objectives for training by completing a simple online form

Action Plan

• At the end of the training you will create an action plan to help you implement and develop your new skills and knowledge

Reinforcement Session

• Delivered 3 to 4 weeks after the training
• It is a 1 hour virtual session enabling the group to reinforce the key learnings from the training and cover subsequent questions and challenges

Introductory Online Module

FREE to Attend | Live & Recorded

29 January 2025  | 60 mins | 1:00 PM UK

Delivered Online

Overview of assays in biologics

During the first session we will explore the special nature of biologics and what makes them so complex. We will walk through the fundamentals of the clinical and manufacturing related assays we need to set up to ensure safety & efficacy of our biologics

• Large versus small molecules
• Clinical assessment of efficacy and safety
  • Fundamentals of PK/PD/Immunogenicity assays
• Manufacturing of clinical batches
  • Fundamentals of potency assays

Register For Online Session | Free

There are limited spaces on the introductory session. If demand is high you may not be able to attend the live session, however you will be sent the recording. Priority is given to full registrations.

Session 1

3 March 2025 | 120 mins | 1:00 PM (UK time)

Clinical Assessment of drugs – PK assay set up and development   

• Physicochemical properties of the plates
• Mechanism of how antibodies (or other capture molecules) are bound to the plate
• Blocking
• Detection antibodies
• Matrix/ excipients
• Development reactions such as with HRP
• Problems along the way

Session 2

4 March 2025 | 120 mins | 1:00 PM (UK time)

Immunogenicity

• Intro to Anti-Drug Antibodies (ADAs)
• Examine the clinical impact
• Anti-drug antibody assays and strategy

Practical exercises, group work and case studies

Interactive group exercises in the form of discussion and/or exercises are also included as part of the course to cement your knowledge.

Session 3

5 March 2025 | 180 mins | 1:00 PM (UK time)

Cell-based assays

• Cell-based endpoints
• The cell as the source of variability
• Special focus: neutralizing anti-drug antibody assays
• Cell banking for cell-based assay

Biostatistics

• Curve fitting in immune/bioassays
• Weighing the curves
• Cut point analysis Immunogenicity
• Design of Experiments (DoE)
• Screening vs optimisation

Session 4

6 March 2025 | 120 mins | 1:00 PM (UK time)

Qualification vs Validation

• Short history
• The GxP system
• Guidelines for bioanalytical method validation
• ICH M10, what’s new and different
• Core parameters
• Practical execution and acceptance criteria

Session 5

7 March 2025 | 120 mins | 1:00 PM (UK time)

The curious case of cell & gene therapy products

• A brief introduction to gene and cell therapies
• Clinical development
• Immunogenicity of viral-based gene therapies
• What do we need from a (bio)analytical point of view?
• Examine the CGT-specific guidelines

Practical exercises, group work and case studies

Interactive group exercises in the form of discussion and/or exercises are also included as part of the course to cement your knowledge.

Dr. Melody Janssen is an expert in bioanalysis and immunogenicity testing of biopharmaceuticals with in-depth experience as a project manager, trainer and senior expert in CROs and pharma/biotech companies. She worked predominantly on developing and validating ligand-binding and cell-based assays for PK/Tox and immunogenicity studies for biologics, biosimilars and vaccines and her work supported numerous regulatory filings. Dr. Janssen is experienced in the regulatory framework related to bioanalytical method establishment and validation including FDA, EMA, ICH guidelines and USP and Ph.Eur. monographs. She is frequently invited to speak at conferences on immunogenicity and bioanalytical testing, where she also leads conference specific workshops and seminars. She has shared her knowledge through trainings for over 10 years focusing on assay validation for bioanalytical, potency and immunogenicity assays. Recently she became a regular evaluator for the Swedish innovation agency, Vinnova, where her task is to assess the scientific rational and business proposals of start-up biotech companies competing for seed funding.

 

Based on her role as the head of non-clinical development at Mymetics, a viral vaccine company, she has gained experience on aspects related to the production of biologics and vaccines, potency assays and GMP.

 

For the last years, Dr. Janssen has been working as a freelancer for projects including non-clinical and clinical immunogenicity assessment, leading various late pre-clinical candidates to FIH, production of vaccines and biologics and teaching bioanalytical method validation workshops.

 

Her educational background is in infectious diseases and immunology, with a PhD in pharmaceutical sciences investigating the effect of protein aggregates on immunogenicity.