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

Day 1

15 November 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

22 November 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

29 November 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.