Sadhale will manage all aspects of formulation development and manufacturing of a client’s clinical trial materials.
Dec. 4, 2017, Greenville, N.C.: Metrics Contract Services , the contract pharmaceutical development and manufacturing division of Mayne Pharma, has appointed Yogesh D. Sadhale, Ph.D., as associate director of pharmaceutical development.
Sadhale will manage all aspects of formulation development and manufacturing of a client’s clinical trial materials. This includes guiding a team of formulation scientists who develop oral solid-dose formulations for Phase I through Phase III clinical trials, and then scale up and support validation and commercialization for those products.
“Dr. Sadhale is a proven leader in formulation and process development, and his addition strengthens our scientific depth, customer service, and product development expertise,” said Kimberly McClintock, executive vice president of Metrics Contract Services. “Metrics is growing significantly, thanks to our facility expansion, and Yogesh will help our team continue delivering the thoughtful scientific expertise we’ve always invested in our work.”
Sadhale will provide planning and budgeting for operations within the pharmaceutical development area as well as hire, train and manage pharmaceutical development staff.
With 20 years of experience in the pharmaceutical industry, Sadhale most recently managed pharmaceuticals and process technology at Patheon Manufacturing Services in Greenville, N.C. There he was responsible for pharmaceutical development of oral solid dosage forms and ensured cGMP compliance for a team of scientists. He holds a doctorate in pharmaceutical sciences from the Medical University of South Carolina.
As a full-service contract development and manufacturing organization, Metrics Contract Services has delivered proven scientific and operational excellence for oral dosage forms to clients worldwide for more than 20 years. Its areas of expertise include quality pharmaceutical formulation development; first-time-in-man formulations; Phase I-III clinical trial materials manufacturing; and analytical method development and validation services leading to commercial-scale manufacturing.
Metrics’ technical capabilities include potent and unstable compounds; Schedule II-V controlled substances; and products with poor bioavailability, for which the organization offers an impressive portfolio of advanced delivery methods.
The parent company of Metrics, Mayne Pharma, has completed construction of an $80-million, 126,000-square-foot solid oral-dose commercial manufacturing facility in Greenville, N.C., that will quadruple the company’s U.S. manufacturing capacity. When the facility becomes fully operational in January 2018, Metrics will be able to offer development clients “concept to commercialization” solutions in one contiguous location under one site registration.
A highlight of the expansion includes commercial-scale manufacturing capability with solvent-based, fluid-bed processing and film coating — a first for Mayne Pharma operations in the United States. To learn more about Metrics Contract Services and its capabilities, visit online at www.metricscontractservices.com (http://www.metricscontractservices.com) .