The Physical and Chemical Characterization group at PPD is an internal support group which serves clients across the pharma spectrum by providing state-of-the-art testing expertise over a broad range of analyses supporting product development, stability and release.

Driscoll Scientific is a research driven company that develops new products for the nutritional beverage markets. By partnering with larger already established companies and universities we are able to leverage our expertise on product development and license those products and/or partner with organizations already having established sales, marketing and distribution infrastructure.

Developed and validated analytical assays to support pre-clinical and clinical studies, as well as product launches for injectible and soft-gel products. Managed technology transfers of analytical and synthetic procedures internally and to contract manufacturers. Managed the process development project for new route to doxercalciferol API with a contract manufacturer. Supervised teams of two to three people during the execution of analytical method validations and product problem-solving challenges. Lead authorship on several patents and affidavits. Developed new formulation of company’s (Bone Care) lead product (Hectorol Injection) as well as analytical assays. Discovered and characterized previously unknown polymorph of doxercalciferol. Designed and executed experiments in support of FDA requirements of company’s product lines, preformulation studies and NDA filings. Designed and synthesized several vitamin D analogues to provide a research pipeline of new drug candidates for development.

Bone Care acquired by Genzyme in July 2005

Designed and implemented multi-step organic syntheses of active drugs and metabolites for the pharmaceutical industry.

Managed Analytical Reference Standards Program