Our round-up of the week's hires begins with Beatrice Setnik, INC Research's new VP of Clinical Pharmacology.
The contract research organisation has appointed Beatrice Setnik as VP, Clinical Pharmacology. She will work in INC Research’s Early Phase business unit, directing its abuse liability work.
Setnik moves from Pfizer, where she was most recently senior director, Medical Development and Neuroscience, leading evaluation of the abuse potential of opioid products.
INC claims to have conducted more abuse liability studies than any other CRO, at its purpose-built facility in Toronto, Canada. Dr Setnik explained her abuse-potential work to Outsourcing-Pharma.com:
“In summary, regulatory agencies require an assessment of abuse potential of drugs that have CNS activity and may potentially be abused or misused when marketed. During drug development, sponsors are required to collect and organize safety data from preclinical (animal) and clinical studies to determine if there are any safety signals of concern.
“When signals do appear, or when drugs in development are related to those that are abused, the agencies (FDA, Health Canada) will generally require additional studies to be conducted in recreational drug users. These types of studies are what we refer to as abuse potential studies.
“Our Early Phase unit specializes and is one of very few centers with the capability of conducting these studies.”
The FDA in January 2013 issued a draft guidance for industry on deterring opioid abuse. Study of these drugs is needed “to support specific claims in their label regarding the formulations’ ability to deter abuse,” continued Setnik.
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