George McCormick, #Teva Pharmaceuticals on the biggest challenges in #drug safety

drug safety, pharmacovigilance, clinical, assessment, regulation, epidemiology, risk management, biostatistics, product safety, surveillance, conference, strategy, event, drug safety

In the run up to the #WorldDrugSafety congress 2012 we asked #drug safety expert George McCormick, Vice President : Head NCS Small Molecules at Teva, the biggest change he is seeing in pharma's drug safety strategies currently.

"From a nonclinical safety perspective, a significant challenge is to enhance or replace the existing in vitro / in vivo models in use for predicting the occurrence of potential adverse effects of drugs or chemicals in humans. Currently, FDA has proposed a ‘modernization concept' toward improving predictability in nonclinical testing such as the use of animal models of disease in toxicity evaluations, the employment of new measurement technologies, promoting better understanding of molecular mechanisms of toxicity, and expending efforts to identify and evaluate biomarkers that are highly-concordant between animals and humans."

George will be presenting at the World Drug Safety Congress Americas in April on "Preclinical safety considerations in support of clinical safety" in April- please visit our website for more information.