Case study
Key CMC Challenges for Innovative Healthcare Products
Have you encountered CMC challenges in the development of your innovative healthcare product? CMC includes all activities vital to product…
blog
Critical Materials considerations for Cell and Gene therapy product development – Part 2
In Part 1 of this blog, we covered the definitions of Starting Materials, Raw Materials, and Ancillary Materials. In Part…
blog
Critical Materials considerations for Cell and Gene therapy product development – Part 1
Raw and starting materials are an essential part of cell-based and gene therapy products (CGT). Frequently, the development of Cell…
webinar
Patient access to Advanced Therapies in Europe 2009-2021: from early access failures to current challenges
The recent announcement of BlueBirdBio to wind down its European commercialisation efforts due to access and pricing challenges for its…
blog
Advice on Non-clinical and Clinical Development for ATMPs from an Ex-CAT member
Gene Therapies and Cell-based products, referred to as Regenerative Medicine Advanced Therapy (RMAT) in the USA and as Advanced Therapy Medicinal…
blog
How to Successfully Manage The Challenges of Developing an ATMP
ATMPs (Advanced Therapy Medicinal Product), covering cell and gene therapy products, have a huge therapeutic potential to treat serious diseases.…
webinar
Advanced Therapy and Medicinal Products: How to overcome the hurdles from bench to clinic ?
We will review challenges in translation required to develop the ATMPs pharmaceutical product (cell and gene therapy products) from nonclinical…
webinar
Understand the Main CMC Challenges to Improve ATMP Development
Recent clinical successes in cell therapy and gene therapy have shown how fast this field is advancing. While the clinical…
