INDUSTRY NEWS


allow CRF Health to confidently provide customers with reliable global end-to-end solutions for clinical trials to ensure the highest quality outcomes. Working together with CRF Health, we can achieve their goal of a seamless global experience and greater operational efficiency.” For further information on CRF Health, please visit www. crfhealth.com


PBOA Supports FDA SOS Act


The Pharma & Biopharma Outsourcing Association (PBOA) praised Representatives Leonard Lance (R-NJ) and Anna Eshoo (D-CA) for introducing the FDA Safety Over Sequestration Act, or FDA SOS Act (H.R. 1078). The Act would exempt privately paid user fees paid to the FDA from any future sequestration.


PBOA President Gil Roth made the following statement: “The PBOA commends Representatives Lance and Eshoo for their bipartisan efforts taking the lead on this important issue. User fees comprise nearly half of the FDA’s budget and help the Agency reach performance milestones for regulatory review, thorough and timely inspections, and IT implementation.


"PBOA's members provide the services that help the pharma and biopharma industry develop and manufacture drugs, biologics, vaccines, and other treatments safely and cost-effectively. User fees, whether paid by their clients or by them directly, are integral to advancing this mission and ultimately bringing those treatments to patients. While recent budget deals have restored cuts through FY15, the FDA SOS Act would provide a permanent fix and remove the threat and uncertainty that sequestration would create for the Agency.


“We look forward to working with Congress, industry, and other stakeholders to address this issue and preserve FDA’s access to the user fees it collects."


For more information on regulatory and legislative issues affecting pharma and biopharma outsourcing providers, please visit www. pharma-bio.org.


Catalent Expands European Clinical Packaging Capabilities, Highlights Growing Industry Need for Specialty Handling


Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics, and consumer health products, has announced several expanded capabilities within its European Clinical Supply Services network. The expansions have been implemented in response to increased customer demand for specialty clinical packaging, where the proportion of highly potent or temperature-sensitive investigational medical products continues to increase.


At its Schorndorf, Germany, facility, Catalent tripled its frozen storage (-18°C) capacity and has added a second automated Inova® packaging line for pre-filled syringes, with capabilities including plunger-rod insertion, application of single panel labels, finger flanges, and safety device mounting. At its controlled substances facility in Deeside,


UK, the company has expanded its clinical storage capacity with the addition of a third vault, bringing the combined controlled substance storage capacity to over 14,000 cubic feet. The Bathgate, UK facility’s cold storage capabilities have been updated to include a cryogenic storage service, suitable for stem cells, regenerative therapies, and other clinical materials.


Finally, at Catalent’s primary packaging facility, in Bolton, UK, the company installed two new energy-efficient chiller units that increase output capacity by more than 10%.


“As with our recent investments in our US capabilities, we are committed to offering comprehensive clinical supply solutions throughout our European network,” commented Gerry Hepburn, Chief Operating Officer, Vice President, and General Manager of Catalent’s Clinical Supply Services business. “A key part of that commitment is ensuring that our facilities are well aligned with the current, emerging and future needs of our customers, as evidenced by our recent investments in Europe and the harmonization of key systems across all Catalent sites.”


The 60,000-sq.-ft. Schorndorf facility offers primary and secondary packaging for oral dose solids and pre-filled syringes; cold, frozen, and controlled drug clinical storage; and EU-GMP audit, importation, release, and consulting services. The 125,000-sq. ft. Deeside facility provides comprehensive primary and secondary packaging services, with extensive capabilities in the cold storage of temperature- sensitive and controlled drug substances handling. The 141,000-sq.-ft. Bathgate facility provides primary and secondary packaging services and returns and destruction management. The 61,000-sq.-ft. Bolton facility offers state-of-the-art clinical supply services and is capable of supporting a range of primary and secondary packaging projects, from early-stage clinical studies to specialty commercial packaging needs, including cold storage or highly potent drugs handling. All 4 sites provide end-to-end clinical supply solutions that also include clinical supply management and comparator sourcing.


Theorem Clinical Research and Biomedical Systems Form Strategic Partnership to Expand Contract Services


Theorem Clinical Research, a prominent global contract research organization, and Biomedical Systems, a leading provider of comprehensive centralized diagnostic services, have formed a strategic partnership to expand the suite of services available to clients worldwide.


“Theorem’s business strategy is to offer our clients the very best available services in every research area,” said John Potthoff, Theorem president and CEO. “Biomedical Systems is one of the true pioneers in our industry, supervising breakthrough research innovations in centralized cardiac safety, pulmonary function, imaging, scientific affairs, and electronic clinical outcome assessment (eCOA). The company’s broad range of capabilities and global scale are a complement to Theorem studies being conducted around the world.”


Pharmaceutical Outsourcing | 64 | March/April 2015


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