Healthcare Industry News: Savient Pharmaceuticals
News Release - January 24, 2014
PTC Therapeutics Expands Management TeamSOUTH PLAINFIELD, N.J., Jan. 24, 2014 -- (Healthcare Sales & Marketing Network) -- PTC Therapeutics, Inc. (PTCT) today announced an expansion of 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, Dr. 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. Prior to joining PTC, Dr. Spiegel was Chief Medical Officer of Schering-Plough and was involved in the filing of New Drug Applications and interacting with regulatory authorities in the U.S. and globally on a regular basis. He also served on the executive committees overseeing research projects and drug licensing activities. Dr. 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. He received his undergraduate degree, cum laude, from Yale University and his medical degree from the University of Pennsylvania. He is currently an Associate Professor at Weill Cornell Medical Center and serves on the Board of Directors and Scientific Advisory Committees of a number of companies.
In his role as Vice President of Global Regulatory Affairs, Mr. 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. Prior to PTC, Mr. Husain was Vice President, Regulatory Affairs at Savient Pharmaceuticals, Inc. He has led numerous worldwide regulatory teams for drug and biologics development and registration while at Pfizer, Hoffman-La Roche, 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. He received his M.S. in Pharmaceutical Marketing from St. John's University and his Masters and Bachelors in Pharmacology from the University of Dhaka.
Joseph M. Colacino, Ph.D. joined PTC in March 2003 as Vice President of Drug Discovery. Dr. 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. Dr. Colacino joined PTC after 14 years at Eli Lilly and Company, where he held positions as Research Acquisition Advisor, Director of Virology, and Head of Biology for Infectious Diseases Research. Dr. Colacino has served on special emphasis panels for the review of grant applications in oncology and virology. He is widely published and serves on the editorial board of Antimicrobial Agents and Chemotherapy and is an expert reviewer for Journal of Virology, Virology, Virology Research, Antiviral Research, Journal of Medicinal Chemistry, and Proceedings of the National Academy of Science. From 2010-2012, he was the president of the International Society for Antiviral Research and is currently past president of the Society. Dr. Colacino received his Ph.D. in Virology from the Cornell Graduate School of Medical Sciences, New York City.
As Senior Vice President of Quality, Mr. Ernest 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 served as President of DRE Enterprises, Inc., a consulting company that provided services to the pharmaceutical industry in areas of quality, manufacturing, validation, regulatory and business development. Prior to DRE Enterprises, he held various roles in Quality and Manufacturing at Pliva, Inc. and Hoffmann-La Roche, Inc. Mr. Dietel holds an MBA in management from Farleigh Dickinson University and a BA in Chemistry from Bloomfield College.
"We are excited that Dr. Spiegel will expand his role at PTC. His expertise has been valuable in the development of ataluren and our other clinical programs," stated Stuart W. Peltz, Ph.D., CEO of PTC Therapeutics. "I would like to welcome Mr. Husain to our senior management team. Mr. Husain's global regulatory experience will be a valuable contribution to the company. In addition, I am proud to announce the promotions of Dr. Colacino and Mr. Dietel. They have served important roles in our drug discovery and our quality assurance functions. These important additions to our management team will enable PTC to advance our clinical and research programs consistently with our goal of becoming a global fully integrated discovery, development and commercial company."
About PTC Therapeutics, Inc.
PTC is biopharmaceutical company focused on the discovery and development of orally administered, proprietary small molecule drugs that target post-transcriptional control processes. Post-transcriptional control processes regulate the rate and timing of protein production and are essential to proper cellular function. PTC's internally discovered pipeline addresses multiple therapeutic areas, including rare disorders, oncology and infectious diseases. PTC has developed proprietary technologies that it applies in its drug discovery activities and which form the basis for collaborations with leading biopharmaceutical companies. For more information on the company, please visit our website www.ptcbio.com.
PTC THERAPEUTICS, INC. FORWARD LOOKING STATEMENTS:
Any statements in this press release about future expectations, plans and prospects for PTC, the development of and potential market for PTC's product candidates, our clinical trials, our current and planned regulatory submissions, our earlier stage programs, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan" "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Forward-looking statements involve substantial risks and uncertainties that could cause our future results, performance or achievements to differ significantly from those expressed or implied by these forward-looking statements. Such risks and uncertainties include, among others, those related to the initiation and conduct of clinical trials, availability of data from clinical trials, expectations for regulatory approvals, our scientific approach and general development progress, the availability or commercial potential of our product candidates and other factors discussed in the "Risk Factors" in the most recent Quarterly Report, which is on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent PTC's views only as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing PTC's views as of any date subsequent to the date of this press release.
Source: PTC Therapeutics
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