William Vincek is the founder of Pharma CMC Inc., which provides consulting to the pharmaceutical industry in the areas of regulatory affairs, quality assurance/control and CMC. His consulting skills draw from his 30+ years in pharmaceutical development: Merck, Sharp and Dohme, in human drug metabolism; SmithKline Beecham in dosage form development and analytical chemistry; Glaxo Welcome in quality assurance/control and regulatory affairs. He responsibilities included: SVP of development (CMC, clinical, & regulatory affairs) at Guilford Pharmaceuticals (Gliadel® wafer and LUSEDRA®); SVP of CMC, manufacturing, and distribution at MGI Pharma (Saforis™ and Amolimogene); and SVP of development and regulatory affairs at Alpharma Pharmaceuticals (EMBEDA® Extended-Release Capsules and Naltrexone Platform). Recently, he supported the development of a novel product with multiple actives using a combination of controlled release matrices and pH dependent enteric coatings compressed into a bilayer tablet. Currently, he is supporting the development of oral dosage forms from parenteral products. He has met with multiple divisions of the FDA both as the technical and regulatory expert. In addition, he filed an e-NDA for EMBEDA®, was the CMC presenter at a FDA Advisory Committee, and lead numerous CMC, quality, and regulatory due diligence teams.