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…
webinar
9 Challenges During Cell and Gene Therapy Development in Europe, and How to Tackle Them
Developing gene and cell-based medicinal products (referred to as “Advanced therapy medicinal products” in Europe) still represents huge challenges. At…
publication
Cell and Gene therapies: European View on Challenges in Translation and How to Address Them
Advanced therapy medicinal products (ATMPs), i.e., cell and gene therapy products, is a rapidly evolving field of therapeutic development. A…
publication
Expedited access of cellular and gene therapy products: The EU versus the US
There is some variation in the eligibility criteria and features of breakthrough therapy designation (BTD), regenerative medicine advanced therapy (RMAT)…
publication
Cell and Gene Therapies: Addressing the Challenges in Translation
Advanced therapy medicinal products (ATMPs), i.e., cell and gene therapy products, is a rapidly evolving field of therapeutic development. A…
publication
Market Access for ATMPs Begins at the Bench
Despite their significant therapeutic potential, ATMPs face specific market access challenges compared to other therapeutic categories. These include high manufacturing…
