CINCINNATI -- (BUSINESS WIRE) -- Camargo Pharmaceutical Services, the 505(b)(2) experts, is teaming with XenoTech, a leading contract research organization in the drug metabolism field, to present a webinar March 21 for drug developers who want to learn how to use the 505(b)(2) pathway to leverage preclinical studies to obtain regulatory approval faster and at a reduced cost.
The webinar, “Utilizing the 505(b)(2) Pathway to Streamline and Accelerate a Drug Development Plan,” will explain how to identify potential candidates and the best process to obtain approval from the U.S. Food and Drug Administration.
Andrea Hubbel, Camargo preclinical project manager, and Mark Horrigan, XenoTech senior mass spectrometry specialist and qualitative analytical chemistry group leader, will discuss how their team successfully developed an initial development plan using the 505(b)(2) program for a drug candidate designated for cardiovascular disease.
Camargo President and CEO Ken Phelps will moderate the webinar, which also will include panelists Stacey Ayres, Camargo director of research services, and Brian Ogilvie, XenoTech principal scientist, consulting.
“We will help developers reach the market faster using the 505(b)(2) pathway by demonstrating how to develop the preclinical studies that will generate the information needed for a successful drug development plan,” said Hubbel.
“We will discuss how metabolism studies established the appropriate species to build a toxicological bridge to existing data for the approved drug and how we successfully obtained the FDA’s endorsement at a pre-IND meeting,” added Horrigan.
About Camargo Pharmaceutical Services
Camargo Pharmaceutical Services is your full-service drug development partner specializing in the 505(b)(2) process. We manage your plan throughout your development continuum, from feasibility assessments, formulation and testing, to conducting preclinical and clinical studies, to final submission. Connect with Camargo on LinkedIn, the President’s blog or visit www.camargopharma.com.
About XenoTech, LLC
XenoTech is a contract research organization with unparalleled expertise evaluating drug candidates as substrates, inhibitors and inducers of cytochrome P450 enzymes and other drug metabolizing enzymes and drug transporters. The company offers a variety of in vitro contract studies and an extensive selection of products for drug metabolism research. Visit www.xenotechllc.com.