Abbott has officially opened its new state-of-the-art biologics manufacturing facility in PR to support the long-term supply Humira and other future biologics. The facility, Abbott Biotechnology Limited (ABL), received FDA approval in February to commercially produce Humira for the U.S. market. This new plant has significantly more production capacity than Abbott’s Bioresearch Center (ABC) in Worcester, MA, where the drug was previously manufactured.

"This new facility is a key milestone for Abbott as we move to focus our resources and future growth on biologic and potent-drug manufacturing," said Lawrence Kraus, vice president of manufacturing, global pharmaceutical operations, Abbott. "The advanced, high-quality infrastructure of ABL can meet the exceptionally challenging and stringent processes of biologic manufacturing. With this state-of-the-art facility, we can supply HUMIRA to the growing number of patients who have come to rely on this breakthrough product."

The new plant cost Abbott approximately $450 million and is the company’s largest capital investment to date. In addition to producing Humira, the 330,000-sq.-ft. facility is designed for large-scale production of future products in Abbott's pipeline that will require advanced manufacturing technologies.

Parexel Consulting, a business unit of Parexel International has appointed five new consulting experts to support its growth. The consultants are based in Parexel's new Washington, D.C.-area office, in Bethesda, MD. The team of consultants is led by Carolyn Finkle, vice president of Parexel Consulting.

"Our clients require a fusion of scientific, regulatory and business expertise to help them develop products for worldwide bio/pharmaceutical markets," said Alberto Grignolo, Ph.D., Corporate Vice President and General Manager of Parexel Consulting. "Our expanding team of consultants in Washington, D.C., many of whom have in-depth experience as former regulators, will assist our clients in gaining regulatory approval for important products."

Ms. Finkle has more than 24 years of experience in drug development, regulatory affairs, GMP, pharmacology, drug product safety evaluation, clinical development, post-approval requirements, and scientific research. She is responsible for management of the product development and regulatory consulting team in North America, focused on helping clients optimize all aspects of the development process for drugs, biologics, devices and combination products. Prior to joining the company, Ms. Finkle was vice president of regulatory affairs at Celsion Corp.

Lawrence Grylack, M.D., was appointed principal consultant. Prior to joining the company, Dr. Grylack served as medical officer in the Division of Pediatric Drug Development in the Office of Counterterrorism and Pediatric Drug Development, and the Division of Pulmonary and Allergy Drug Products at the FDA Center for Drug Evaluation and Research (CDER). In this role, he handled reviews of adverse event reports, INDs and NDAs, and performed consultations for other CDER Divisions and other FDA Centers.

David Morse, Ph.D., has been appointed as a principal consultant. Dr. Morse has more than 20 years of experience in pharmacology and toxicology. Prior to joining the company, he worked as a supervisory pharmacologist for CDER, where he provided strategic regulatory oversight for all phases of product development and safety testing for new therapeutics.

Sally Hargus, Ph.D., was appointed senior consultant. Dr. Hargus has more than 15 years of combined research, industry, and regulatory experience in pharmacology and toxicology aspects of drug development. Prior to joining the company she held senior positions in toxicology, including with 3M Pharmaceuticals and with the FDA's Center for Biologics Evaluation and Research (CBER), where she reviewed pharmacology and toxicology sections of IND, pre-IND, and BLA submissions for vaccines and allergenic products.

Patrick Guinn has been appointed manager. Prior to joining the company, Mr. Guinn served as Consumer Safety Officer/Regulatory Health Project Manager at the FDA's CDER. He has more than 10 years of FDA experience, including preparation and facilitation of regulatory meetings and negotiations, coordination of activities for multi-disciplinary review teams, management of the drug review process, and development of several regulatory Guidance documents for the industry.

Robert Bradway has been named executive vice president and chief financial officer, Amgen. He will be responsible for the company's finance, strategy and investor relations operations. Mr. Bradway replaces Richard Nanula, who is leaving the company to pursue other opportunities.

Mr. Bradway joined the company in 2006 as vice president, operations strategy. Prior to that, he spent 18 years at Morgan Stanley in New York and London, where he was a managing director in investment banking.

"Bob brings nearly 20 years of corporate finance experience to his new role and we are delighted to have him as part of our executive team," said Kevin Sharer, Amgen's chairman and chief executive officer. Mr. Nanula will remain at Amgen for the next 90 days to assist in the transition. "Richard has played an important role in Amgen's growth during the past six years, and I deeply appreciate his service to the company," said Mr. Sharer.

Cardinal Health has completed the sale of its Pharmaceutical Technologies and Services (PTS) segment to The Blackstone Group for approximately $3.3 billion. Cardinal Health announced in November of last year that it planned to divest PTS to focus resources on its four remaining segments serving healthcare provider customers.

"We are pleased to begin this new chapter in our history," said John Lowry, chief executive officer of PTS. "We have a long heritage of providing customers with creative solutions and consistent service, and we expect to create even more value for our customers in the future with Blackstone as our partner."

Commenting on the acquisition, Chinh Chu, senior managing director of The Blackstone Group, said, "We believe the pharmaceutical outsourcing sector is in its early stages of growth as pharmaceutical and biotechnology companies of all sizes will increasingly rely on third parties for the development, manufacture, and packaging of pharmaceutical and other products. Blackstone is pleased to be partnering with the existing PTS management team, led by John Lowry, who will be significant investors in PTS alongside Blackstone."