ATMPs definition
The advanced therapy medicinal products (ATMPs) represent a fast-growing field with a lot of potential in severe, rare, or chronic diseases for which no adequate conventional treatments exist. The ATMPs can be classified into three main types: gene therapy products, cell-based products, and tissue-engineered products. In addition, some ATMPs may contain one or more medical devices as an integral part of the product, which are referred to as combined ATMPs. An example of that is the cells embedded in a biodegradable matrix or scaffold.
Particularities of the ATMPs non-clinical development
Given the heterogeneity and the complexity of the ATMPs, the conventional strategies designed for robust non-clinical (NC) assessment of proof-of-concept (PoC), mechanism of action (MoA), toxicology and bio-distribution are not always directly transferable into the ATMP development.
hVIVO plc (formerly Open Orphan plc) is a rapidly growing specialist contract research organisation (CRO) and the world leader in testing infectious and respiratory disease vaccines and antivirals using human challenge clinical trials, providing end-to-end early clinical development services for its broad and long-standing client base of biopharma companies.
