Biomarkers in early drug development
The EMA glossary defines a biological marker, or biomarker, as ‘an objective and quantifiable measure of a physiological process, pathological process or response to a treatment (excluding measurements of how…
Evaluation of drug safety does not start at candidate nomination: Create value by de-risking early
Drug development is a daunting and difficult task where all the puzzle pieces need to click to result in an efficacious and safe treatment for patients. It is a…
Unleashing the Power of Drug Repurposing
Drug repurposing, also called drug repositioning, reprofiling or retasking, is the process of identifying a new use for an existing medicine/active substance outside the scope of the original indication(s). It…
Cell Therapy: Towards a First-in-Human Trial
The proof-of-concept studies have shown promising results and bring a therapy a step closer to the clinic. But what is needed before this therapy can show its efficacy in a…
How Is The Minipig Used In Drug Development?
The Göttingen Minipig was developed at the University in Göttingen, Germany to meet the demand for a non-rodent model with many similarities to humans as genetic management is required to…
How To Create Science-Based PDEs
The 4 pivotal questions you have on PDEs answered: A shared concern on how to create scientifically-based PDEs. From a safety perspective, all companies with multifunctional pharmaceutical and chemical production…