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Cell and Gene Therapies: Introduction to Manufacturing and Regulatory Processes

14 June 2023 | 3 Week Live Online Course

£995.00

The price is for all 3 days | Register for Module 1-Free

Understand how ATMPs are manufactured and regulated to help you navigate this evolving industry.

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Course Overview

 

The cell and gene therapy (or ATMP) market is set to grow as advances in technology bring new therapies to patients. Consequently, cell and gene companies are growing their workforce to meet demand. Developing an advanced therapy is a complex process and requires a high degree of skill and knowledge. These therapies differ considerably from pharma and biotech with major challenges in regulations, GMP and logistics.

 

This training course provides a complete overview of the cell and gene industry. It is designed to create a solid framework for anyone looking to embark on a career in the sector. You will learn key concepts in cell therapy manufacturing and gene therapy manufacturing. You will also examine the regulatory factors to get a CGT to market. Once completed, you will have the confidence to advance your career in cell and gene therapies.

 

With the Educo Post Learning Implementation Plan (PLIP) you will have the framework to apply and implement the knowledge acquired in the training, supporting you in your development. Learn more about how we deliver live online training.

What is Included in a Live Online Course?
  • Direct access to an expert trainer
  • Interactive and engaging sessions with exercises and discussions
  • Bitesize learning
  • Access to the Educo Life Sciences Training Portal
  • Unlimited access to the recordings for 4 weeks after the last session
  • Full access to the Educo Post Learning Implementation Plan (PLIP)
  • A validated certificate of attendance available for you to download and file
Register For Free Online Session

 

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.

Key Learning Objectives

 

  • Gain a broad overview of CGT manufacturing and development to support you in your role
  • Review definitions of cell and gene therapies
  • Understand cell therapy manufacturing to appreciate the complex nature of cell therapy development
  • Analyse a range of gene editing techniques used in gene therapies
  • Compare and contrast between core manufacturing principles for Cell and Gene therapies and consider the important logistical steps to get the treatment to the patient.
  • Explore the EMA and FDA regulatory landscape to appreciate the key regulatory challenges
  • Analyse common challenges for cell and gene therapies in manufacturing, scale-up, logistics and commercial models

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

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 Module 1

FREE to Attend | Recorded

Overview of cell and gene therapies

  • Introduction to CGTs and their history
  • Overview manufacturing
  • Overview of clinical development

Register For Module 1 | Free

Complete the form below and you will be sent the recording of the session.

 

 

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Day 1

14 June 2023 | 210 mins | 12:00 PM UK

Introduction to cell and gene therapies

  • Introduction to CGTs and their history
  • Cell therapy definition
  • Gene therapy definition
  • How CGT differs from traditional biopharmaceuticals
  • Review of products on the market

Cell therapy manufacturing – Part 1

This module will provide an overview of cell therapy manufacturing.

  • Understand the differences between autologous vs allogeneic
  • Important immunological concepts which impact cellular therapy
  • Outline the typical autologous manufacturing process
Day 2

21 June 2023 | 210 mins | 12:00 PM UK

Cell therapy manufacturing – Part 2

This module will provide an overview of cell therapy manufacturing.

  • Understand the differences between autologous vs allogeneic
  • Important immunological concepts which impact cellular therapy
  • Outline the typical autologous manufacturing process

Gene therapy manufacturing

This module will provide an overview of cell therapy manufacturing.

  • Review both ex vivo vs in vivo gene therapies
  • Outline the principle for gene therapy processing – methods for gene transfer and methods for gene editing
  • What is viral engineering?
  • Understand the difference between infective not replicative viruses
Day 3

28 June 2023 | 210 mins | 12:00 PM UK

Regulatory implications

This module provides an overview of the regulatory challenges that cell and gene therapies face.

  • Understand the differences between EMA and FDA regulations regarding these medicines
  • GMP for advanced therapies
  • Chain of custody and the importance of tracking where the product is at any time
  • Safety of gene therapy

Common challenges in CGT

This module will highlight common challenges that are preventing the large-scale manufacture of Cell & Gene Therapies, will cover issues such as:

  • Current lack of infrastructures to support an increasing number of large-scale manufacturing
  • Logistical challenges – timeframes, locations, manipulation methods and patient location are factors affecting CGTs
  • Lack of adequate reimbursement models – cost per patient is typically very high and an appropriate reimbursement model is yet to emerge.

Olivier Negre, PhD

Olivier developed his expertise in preclinical research and translational science through more than 20 years of experience in biotherapies.

 

After working at Inserm on macrophages and at Bioprotein Technologies on vaccines, he joined bluebird bio (formerly Genetix Pharm) to develop gene therapies. He was R&D team leader for 10 years in Paris and Director preclinical & translational research for 5 years in Cambridge MA, USA. He contributed to the development of the first approved gene therapy for beta-thalassemia (Zynteglo), from preclinical studies to clinical trials and marketing authorization.

 

In 2019, Olivier participated in founding Biotherapy Partners to foster drug developments in the field of cell and gene therapies. He is currently board member of the French Society and Gene and Cell Therapy, Co-President of the think tank Gene and Cell Therapy Institute in Paris, Head of R&D of a biotech company and Partner at Biotherapy Partners.

 

He contributed to several patents and scientific publications in the field of gene and cell therapy (Nature 2010, Blood 2011, Stem Cells 2013, Current Gene Therapy 2015, Human Gene Therapy 2016, New England Journal of Medicine 2017, New England Journal of Medicine 2018, Science Translational 2019, Molecular Therapy Methods & Clin Dev 2020, BioDrugs 2020, New England Journal of Medicine 2021). Olivier graduated from ENSTBB engineering school in Bordeaux and earned a PhD in cell and molecular biology from Paris 7 University.

 

Olivier has delivered many courses on cell and gene therapies and is fully versed in how they are developed and manufactured. When delivering training courses, he can draw upon his extensive experience and knowledge, supporting delegates with examples and case studies.

 

This course provides a comprehensive overview of CGT. It is aimed at technical professionals who are either new to the industry or thinking about a career move into CGT. If you are a someone with experience in small molecules or biologics this course is will suit you.

 

These include:

  • Regulatory Affairs Professionals
  • Production Personnel/Technicians
  • Quality Professionals
  • Clinical Professionals
  • Process Development
  • Personnel
  • Scientists involved in Development
Free First Module and Pricing
  • Free First Module and Pricing
  • Module 1 is free to attend and is delivered online and is recorded.
  • To enrol onto module 1, please submit your details in the form.
  • Module 1 is recorded so if you are unable to attend, you can catch up ahead of the course start date.
  • There are price tiers for this course. The dates of these are at the located above the course overview.

 

Frequently asked questions (FAQs)

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.

*

• The training course is delivered either online or in a classroom. Please check which course format you have booked.
• For live online courses, dates and times of modules are subject to change
• Please contact us for the module dates of future deliveries.
• For live online courses, module durations are approximate