Course Outline

Course Information

• The course begins at the time stated at the top of the page
• The course is broken up into modules outlined below
• There will be breaks between modules

Session 1

28 October | approx. 120 mins | 10:00 AM UK

Module 1: Introduction to the CGT industry

• Incentives for the development of these advanced therapeutics
• What is a cell therapy?
• What is a gene therapy?
• Diversity of CAR T cell generations (1^st to 4^th and beyond)
• Product development overview
• Examine the fundamental differences between biopharmaceuticals and CGTs

Module 2: Examine the science of CGTs

This module will provide you with an overview of how biopharmaceuticals are made and how their quality is ensured.  This will then be brought into perspective to the novel CGTs and highlight some fundamental differences in the approach to development and manufacture these unique products.

• Examine the biopharmaceutical life cycle
• Approaches to ensure clinical safety and efficacy
• How does that differ from Cell and Gene Therapies?
• Different CGTs may require different approaches for development

Session 2

28 October | approx. 120 mins | 1:00 PM UK

Module 3: The CGT manufacturing process

Now you know the science behind CGTs, this module will examine the manufacturing process from start to finish for selected products such as cell therapy and CAR T cells.

• Examine key terminology within manufacturing
• Autologous versus allogenic products
• What is a viral vector and why are they important in CGT?
• Selecting the right viral vector for delivery
• Analysis of the CGT for patient safety

Module 4: Examine major challenges during CGT development and manufacturing

In this module you will examine some of the major challenges faced by companies when developing CGT product such as manufacturing facilities, regulatory problems and bioanalytical issues.

• The need for specific equipment for production
• Overcoming regulatory hurdles
• Bioanalytical challenges of CGTs

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 biotech/CGT companies. She has worked on numerous biopharmaceutical products and is an expert on all areas of biopharmaceutical development and manufacturing.
Dr. Janssen has extensive experience of the regulatory frameworks (EMA, FDA etc.) for biopharmaceutical development/manufacturing. Ultimately Melody is aware of the many challenges biopharmaceutical companies face when developing a therapeutic product.

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.

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.