Laureate Pharma, Inc. has entered into a cGMP contract manufacturing agreement with Enobia Pharma, a biotechnology company developing an enzyme replacement therapy for the treatment of hypophosphatasia. Under the agreement, Laureate will produce Enobia's fusion protein for treatment of hypophosphatasia, a rare, and potentially fatal metabolic bone disease characterized by skeletal hypomineralization. Terms of the agreement were not disclosed.

"We are delighted by the confidence Enobia has shown by continuing to utilize our specialized experience in the manufacture of fusion proteins," said Robert J. Broeze, president and chief executive officer of Laureate. "We have a successful relationship with Enobia and will work with them closely to help them achieve their manufacturing objectives."

"Our partnership with Laureate is an important component of our manufacturing strategy. We look forward to our partnership with Laureate and advancing our hypophosphatasia program into the clinic," said Robert Heft, president and chief executive officer of Enobia.

Robert M. Haggerty has been appointed to the newly created position of vice president of quality, Hyaluron Contract Manufacturing (HCM). Mr. Haggerty will be responsible for overseeing quality and regulatory compliance at the company’s Burlington, MA facility.

“Mr. Haggerty’s extensive experience will enhance our ability to provide our clients with the best possible products and services,” Shawn Kinney, president of HCM explained. “We are especially pleased with his knowledge of global quality practices as our business continues to grow both in the U.S. and abroad.”

Mr. Haggerty has more than thirty years of experience in quality and regulatory compliance in the pharmaceutical/biopharmaceutical industries. Most recently, he was the director of quality assurance at Alexion Pharmaceuticals where he was responsible for all quality assurance start-up activities at its new biotech facility. Prior to that, he held positions of increasing responsibility at Ben Venue, Dupont Merck, and Transkaryotic Therapies (now Shire). Throughout his career, Mr. Haggerty has been involved in the successful launch of multiple drug products and has achieved numerous NDA and sNDA approvals.

As vice president of quality, Mr. Haggerty will oversee the quality of products and services, as well as on-time delivery and courteous, professional communication. He will also be responsible for overseeing compliance with FDA and ISO regulations, as well as facilities and engineering validations.

PPD, Inc. plans to expand its operations in Bellshill, Lanarkshire, in an effort to meet the increasing demand for its drug development services. The company expects to invest as much as $30 million to expand its offices in this location during the next three years.

The expansion will create approximately 390 additional jobs in biostatistics, data management, pharmacovigilance, product development, and clinical trial management and monitoring. PPD currently employs more than 350 professionals in Scotland at its Strathclyde Business Park.

This investment will include the construction of a new 34,000-sq.-ft facility to be built next to the company's existing Fleming House offices, which were opened earlier this year and also comprise 34,000 sq.-ft. PPD will continue to retain space at Avondale House in Strathclyde Business Park until the new facility is completed.

"With the biopharmaceutical industry increasingly relying on global outsourcing to speed drug development and reduce costs, demand for our services continues to grow," said Fred Eshelman, chief executive officer of PPD. "Scotland offers both intellectual and technical resources that make it an important hub for our global clinical research operations."

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