BioPharma Services USA, Inc. (BioPharma) announced it has been awarded a five-year, $20 million contract with the Center for Drug Evaluation and Research (CDER), a division of the US Food and Drug Administration (FDA). The contract is to conduct in vivo studies of generic drug products in human subjects over a period of five years, from 2016 through to 2021.
"We are very proud to work with the FDA in support of their Generic Drug programs," said Renzo DiCarlo, CEO at BioPharma Services, Inc. "This award is a great example of BioPharma’s capabilities as a leading industry expert in Bioequivalence and Early Stage clinical research."
The FDA studies conducted by BioPharma will allow CDER to proactively address scientific questions in developing generic approval standards and ensure postmarket safety and efficacy of approved generic drug products. Ultimately, the outcome of these studies will help improve the generic review practice within CDER.
As part of this contract, BioPharma will provide the FDA with a full service offering from study design inception to clinical conduct, bioanalysis and final report.
"I am certain that our outstanding regulatory history with the FDA and our team’s extensive expertise in the conduct of Bioequivalence trials played a major role in landing this important contract with the FDA,” said Brent Matthews, COO at BioPharma Services Inc.
REDI worked with BioPharma Services to attract its first U.S. site to Columbia in 2014. BioPharma USA. opened in Columbia with 48 beds. It expanded to 70 beds last year and expects to expand again to between 100 and 120 beds next year. BioPharma began with 10 full-time and 30 part-time workers, and now employs 35-45 full-time and 15 part-time employees and continues to recruit additional employees.