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"Vince & Associates Clinical Research Awarded FDA Contract to Conduct Pharmacokinetic Study with Opioids"

News Release
FOR IMMEDIATE RELEASE
October 21, 2015
For more information contact:
Julie-Ann Cabana
(913) 696-1601
jcabana@vinceandassociates.com
Vince & Associates Clinical Research Awarded FDA Contract to Conduct Pharmacokinetic
Study with Opioids
Overland Park, KS – Vince & Associates Clinical Research today announced that it has been
awarded a contract with the U.S. Food and Drug Administration (FDA) Office of Generic Drugs
(OGD) to conduct a clinical pharmacology pharmacokinetic (PK) study of opioids manipulated via
milling procedures.
In this study-specific contract, Vince & Associates is responsible for conducting the opioid PK study
and providing the necessary support services including study design, protocol development,
clinical operations, data management, biostatistics, bioanalytical analysis and medical writing.
The objective of this study is to evaluate factors that affect the bioavailability of milled opioid drug
products following nasal snorting. The outcome of this study may help in determining critical study
design parameters when comparing deterrence of nasal abuse between a generic and its
Reference Listed Drug.
“We are eager to partner with the FDA to help address agency concerns about the manipulation of
opioid products. Vince & Associates is uniquely qualified to conduct this trial as our Principal
Investigators have extensive substance abuse clinical knowledge and are industry leaders in the
conduct of substance abuse trials,” said Dr. Brad Vince, CEO and medical director at Vince &
Associates Clinical Research.
“This type of study is ideally suited to the technical capabilities of Vince & Associates Clinical
Research. Our state-of-the-art pharmacy with facial recognition security is equipped with a
biosafety hood preparation area and controlled substance storage, which are essential for
completing complex clinical studies involving opioids,” stated Dr. Lorraine M. Rusch, Vice
President, Scientific Development.
This is not the first time Vince & Associates has worked with the U.S. Government on clinical
research trials. In 2012, Vince & Associates was awarded a five year, $10 million contract with the
National Institute on Drug Abuse as well as a separate five year, $5 million contract with the FDA.
The project described in this press release was supported by FDA-RFP-1155964. The content
above is solely the responsibility of the authors and does not necessarily represent the official
views of the FDA.
About Vince & Associates Clinical Research
Vince & Associates Clinical Research has provided clinical research services to the
biopharmaceutical industry for 15 years. The research professionals at Vince & Associates are
proud to be recognized in the industry as a “Center of Research Excellence.”
Vince & Associates currently operates a state-of-the-art, multimillion-dollar, 100-bed clinical
pharmacology unit that combines the ultimate in subject safety and luxury. This early development
unit has the upscale atmosphere necessary for the recruitment and retention of study volunteers in
both short- and long-term clinical trials. From the safety and security of the controlled access unit
to the added features of a movie theater and game rooms, no detail has been overlooked.
About Altasciences
Altasciences is the parent company of wholly-owned subsidiaries Vince & Associates Clinical
Research (Kansas, USA), Algorithme Pharma (Quebec, Canada) and Algorithme Pharma USA
(North Dakota, USA). All three organizations provide comprehensive early stage clinical services in
Phase I/IIa, including the necessary support services in this critical stage of drug development.
More Information
Additional background materials pertaining to Vince & Associates Clinical Research are located on
the corporate website at www.vinceandassociates.com.
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