A Guide to the Main Challenges When Developing a Cell and Gene Therapy (ATMP)
Advice from a range of Educo Life Sciences' trainers
Getting a cell and gene therapy developed, manufactured, and approved on the market is challenging. There are numerous hurdles to overcome such as supply chain issues, aseptic working, patient access, efficacy and safety.
Below are short interviews with a range of Educo Life Science Trainers who work in different areas of cell and gene therapies. They share their main challenges of developing a cell and gene therapy.
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.
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.
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
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