Camargo Presents at the International Conference of the Korean Society of Pharmaceutical Services and Technology
Cincinnati, Ohio, December 16, 2009; – Ruth Stevens, Ph.D., CSO and executive vice president of Camargo Pharmaceutical Services, has presented her research on the Food and Drug Administration’s (FDA) 505(b)(2) drug approval registration process at the International Conference of the Korean Society of Pharmaceutical Services and Technology, November 19-20, 2009, in Daegu, South Korea. Camargo is a full-service clinical research organization (CRO) specializing in the continuum of drug development.
During her presentation, Dr. Stevens spoke about Camargo’s depth of experience and expertise in the 505(b)(2) regulatory submission pathway and its importance in enhancing one’s portfolio of drug products. She addressed the main factors driving the increase in the 505(b)(2) submission program and the potential opportunity for Korean pharmaceutical companies.
In 2008, well over 50% of US FDA New Drug Applications (NDAs) were approved through the 505(b)(2) regulatory pathway. Based on Camargo’s projections, it is expected that, by 2012, more than 80% of the NDAs approved in the US will come from the 505(b)(2) submission process.
“Strategically, the US 505(b)(2) regulatory pathway provides an exciting opportunity for drug development companies that specialize in drug delivery platforms to broaden their product portfolio base and optimize therapeutics to patients,” Dr. Stevens said.
Extending its world-wide reach into South Korea, Camargo continues to provide its valued, world-wide expertise within the biopharmaceutical industry.
“The 505(b)(2) regulatory pathway is certainly a way for companies seeking to leverage new drug delivery systems and technologies with known drug substances. Since this is a different approval pathway than the more familiar 505(b)(1), it is imperative to develop a program that meets the regulatory needs for submission via a 505(b)(2),” stated Dr. Stevens.
Camargo is focused on world-wide end-to-end drug development through the 505(b)(2) process and provides a full spectrum of services to the drug development industry from discovery through each phase of clinical development.
About Camargo Pharmaceutical Services
Camargo Pharmaceutical Services is a full-service CRO for the continuum of drug development. With more than 150 FDA approvals, Camargo works with companies to develop comprehensive programs, managing every facet of the plan from formulation and testing the drug product, conducting clinical studies and FDA application submissions. Visit www.camargopharma.com for more information.
Posted: December 2009