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An Introduction to Cell and Gene Therapies: A Beginner’s Guide

28 October 2022 | Short Online Course

£236.00

1 day live online training | Starts 10 AM UK Time

Are you new to Cell and Gene therapies?  Do you work in a non-technical role?

Understand the basics of cell and gene therapies to support you in your role.

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Enrol before 30 September to save 20%

Discount is applied to the price above. VAT, if applicable, will be added.

 

 

Course Overview

 

Scientific advances have led to a new generation of innovative therapeutic products. These new therapeutics are called many things: cell therapies, stem cell therapies, CAR-T, gene therapies, advanced therapies, Advanced Therapeutic Medicinal Products (AMTPs). This new and exciting areas of treatments are growing year on year. But what are they? What makes them so effective? What makes them so expensive? How are they different from biopharmaceuticals and pharmaceuticals?

 

This training course will provide you with a comprehensive overview of how cell and gene therapies products are developed and manufactured. The course is designed for professionals who require a basic understanding of the science and technology. Once completed, you will understand what each advanced therapy is, how it is made and the challenges that must be overcome. You will also appreciate the major challenges of developing and manufacturing an ATMP including regulatory, clinical and quality issues.

Learn more about how we deliver live online training.

 

What is Included?
  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 2 weeks after the session

Key Learning Objectives

  • Understand the science behind cell and gene therapies to support you in your role
  • Gain a comprehensive overview of cell and gene therapy development and manufacturing
  • Understand the basics of cell and gene development and manufacturing
  • Improve your understanding of the key techniques used by the sector
  • Appreciate the major differences between cell and gene therapies and biopharmaceuticals
  • Examine the major challenges when developing/manufacturing a cell and gene therapy product which can impact timelines and costs

Learn more about the course by toggling through the tabs below (trainer, who should attend?)

 

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 (1st to 4th 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.

 

This course is specifically designed for professionals who are not technical experts but wish to have a high level understanding of cell and gene therapies. It is also ideal for technical professionals who are new to cell and gene therapies. It will provide you with comprehensive overview of the sector to support you in your job.

Sectors and job roles this course is most suited for include:

  • Technical professionals starting out in cell and gene therapies who require a comprehensive overview
  • All supporting functions such as marketing, finance and IT
  • Investment Professionals
  • Recruitment Professionals
  • Legal and IP Professionals
e-learning options

Want to train your team, department or whole organisation? This course can be developed into on-demand e-learning and hosted by Educo Life Sciences or on your own LMS platform.

Email [email protected] for more information.

Could your team benefit from this course?

We can customise this course to meet the requirements of your organisation, delivered as a classroom and/or online course.

For more information you can email us at [email protected] or call +44 (0) 203 111 7357.

 

Complete our contact form by following the link. Get in touch.

*

• This course is delivered online
• For live online courses, module durations are approximate
• You will have full access to the training portal and the recordings for 2 weeks after the training