The cell and gene therapy (ATMPs) industry has grown significantly. The number of therapies reaching clinical trials and market approval has increased. To fuel its growth, a skilled workforce is required in all areas of development such as regulatory, clinical, manufacturing (process), analytical and commercialisation. As a result, large numbers of professionals from biotech and small molecules are moving into cell and gene therapies, adapting and applying their skillsets to advanced therapies.

Below are three short interviews with a range of Educo Life Sciences Trainers who work in different areas of cell and gene therapies. They share their advice for those looking to transition into CGT products.

Melody Janssen

Dr. Janssen is an expert in bioanalysis and immunogenicity testing of biopharmaceuticals with in-depth experience as a project leader, trainer and senior expert in CROs and biotech companies.

Melody delivers the course An Introduction to Cell and Gene Therapies: A Beginner’s Guide.

Melody’s top tips include:

1. You need to be more tolerant and accept development takes longer and it is likely not go to plan.
2. You need to be able to think outside of the box as cell and gene therapies are unique and specialised.
3. From a regulatory perspective, be able to adapt and mould the regulations for your product.
   
   

Olivier Negre

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.

Olivier delivers the course Fundamentals of Cell and Gene Therapies.

Olivier’s top tips include: 

1. To be up-to-date in a fast evolving field. Be sure to read a lot of publications and guidelines.
2. To be ready for the complexity of the products, in particular the characterisation.
3. Think differently in development and clinical. It is best to take a risk-based approach.

 

Margit Holzer

Dr Margit Holzer has over 25 years of experience in the industry and worked on more than 50 different products. She is a specialist in process, product and analytical method development for biopharmaceuticals. She has extensive expertise in bioprocess in all phases of development including preclinical production, clinical production and large-scale commercial supply.

Margit delivers the following courses:

• Biopharmaceutical Process Qualification and Validation
• Upstream Process Development for Biopharmaceuticals
• Continuous and Intensified Biomanufacturing

 

Margit’s top tips include:

1. Make sure you understand the expression systems being used.
2. Understand the different technologies used which are much more complex.
3. Be cautious in quality and characterisation are far more complex, as well as supply chain. 

 

 

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View our Cell and Gene training courses