On January 28, 2020, the United States Food and Drug Administration (FDA) announced the release of six final guidances on gene therapy manufacturing and the clinical development of new products. In addition, they published a draft guidance on the interpretation of gene therapy products’ sameness under the orphan drug regulations. With these new guidance documents, the …
Skin Biopsy: A Complex Model Exploring Gene Expression
The heterogeneous presentation of clinical cases and the complex requirements by health authorities and care management contribute to making the development of innovative treatment options more challenging and complex. QPS recognizes these challenges and works together with clients to explore the possibilities of implementing and executing new research techniques in our Phase 1 units. QPS Netherlands …
Translational Medicine Now Bigger and Better at QPS
Goodbye boutique CRO, hello large study BIG PLAYER! For a long time, you’ve known us as THE high quality outfit that can stabilize difficult assays in the initial stages of clinical investigation. But we’ve been investing in additional technical personnel and laboratory capacity for translational medicine at our Flagship Delaware Technology Park facility. And now …
