PTC Therapeutics has expanded its senior management team with the appointment of Robert J. Spiegel, M.D., FACP, to chief medical officer and Murad Husain to vice president, Global Regulatory Affairs. PTC also announced the promotions of Joseph Colacino, Ph.D., to senior vice president, Drug Discovery and Ernest R. Dietel to senior vice president, Quality. In addition, Jay Barth, M.D., senior vice president of Clinical Development, is leaving PTC to pursue other opportunities.

In 2011, Spiegel joined PTC on a part-time consulting basis as chief medical officer. In his new role, he will be responsible for all aspects of clinical development. Previously, Spiegel was chief medical officer of Schering-Plough and was involved in the filing of New Drug Applications (NDA) and interacting with regulatory authorities in the U.S. and globally on a regular basis. He also worked on the executive committees overseeing research projects and drug licensing activities. Spiegel joined Schering-Plough in 1983 as director, Clinical Research, progressing through clinical operations as vice president of Clinical Research, senior vice president of Worldwide Clinical Research and then becoming chief medical officer in 1998.

In his role as vice president of Global Regulatory Affairs, Husain will lead the regulatory efforts to support PTC's lead product candidate, ataluren, and other clinical programs. He brings to PTC more than 25 years of pharmaceutical industry experience, with 20 years in regulatory affairs.

Previously, Husain was vice president, Regulatory Affairs at Savient Pharmaceuticals. He has led numerous worldwide regulatory teams for drug and biologics development and registration while at Pfizer, Hoffman-La Roche, EMD Serono, AstraZeneca and Forest Laboratories. He achieved approvals of original NDAs, BLAs and new indications for drugs and biologics in pulmonary, oncology, CNS, rheumatology and anti-infective therapeutic areas.

Joseph M. Colacino, Ph.D., joined PTC in March 2003 as vice president of Drug Discovery. Colacino oversees drug discovery activities across therapeutic areas including genetic disorders, oncology and infectious diseases programs. He has actively participated in PTC's business development and grant efforts from government and other funding agencies, has served on steering committees for a number of our collaborations and has been the principal investigator on a number of scientific grants. Colacino joined PTC after 14 years at Eli Lilly, where he held positions as research acquisition advisor, director of Virology and head of Biology for Infectious Diseases Research. Colacino has worked on special emphasis panels for the review of grant applications in oncology and virology.

As senior vice president of Quality, Dietel is responsible for GxP quality management operations at PTC. He joined the company in 2009 and became vice president of Quality Assurance in 2012. From 2005 to 2009, he was president of DRE Enterprises, a consulting company that provided services to the pharmaceutical industry in areas of quality, manufacturing, validation, regulatory and business development. Previously, he held various roles in quality and manufacturing at Pliva and Hoffmann-La Roche.