Business and News Update May 2011

People

• Quay Pharma (Derby, UK) has promoted Mark Powell, PhD, to Scientific Manager where he will take on wider technical responsibility and seek to further raise the scientific profile of the company.

Mark Powell

• The International Society for Pharmaceutical Engineering (ISPE) (Tampa, FL) has selected Bryan Wright to join ISPE as European Regulatory Affairs Advisor. In his new capacity, Wright will act as liaison between ISPE and European regulatory authorities to help expand relationships between regulatory bodies and ISPE, shape ISPE educational offerings, and keep ISPE members informed of relevant regulatory developments originating from European regulatory authorities.

Bryan Wright

• Donna E. Beardsworth, Founder, President, and Chief Executive Officer of Beardsworth Consulting (Flemington, NJ) passed away unexpectedly in late March. Michael O'Brien has been appointed as the new President and Chief Executive Officer.

Donna E. Beardsworth

• Chiltern International (London, UK) announced that it has opened a new office in the Netherlands and has appointed Angela Pasma as the Netherlands' Country Manager.

Angela Pasma

• Clinilabs has appointed Richard Johnson, MD, head of Hudson Global, to its Advisory Board.

• David Iklé, PhD, RHO Principal Investigator, has been invited to join the American Journal of Transplantation (AJT) (Chapel Hill, NC) Editorial Board as a Statistical Editor based on his contributions to transplantation literature in general, contributions to AJT in particular, and his reputation as a thought leader in the field of transplantation, specifically as it applies to statistical methodologies.

• President and Executive Medical Director of PMG Research (Winston-Salem, NC), Thomas W. Littlejohn, III, MD, passed away in a plane crash on Wednesday, March 30, 2011. Littlejohn helped PMG Research grow from a single research site in Winston-Salem to a nationally recognized multi-site clinical research organization.

• With more than 15 years experience in marketing, communications, and business consulting, Jessica Cunningham has been appointed Director of Marketing of Novella Clinical (Research Triangle Park, NC), where she will have executive oversight of all global marketing and communication for both Novella Clinical and Novella Clinical Resourcing.

Outside Almac's new 240,000 square foot headquarters in Souderton, PA. The lab provides support for clinical packaging operations as well as standalone analytical services. The new facility also offers polymorph and salt screening and solid form development.

Alliances

• Almac's (Souderton, PA) Clinical Technologies business unit has formed an exclusive integrated patient management alliance with Exco InTouch (Cary, NC). The alliance will be focused on the integration of both technology and processes by both firms to deliver patient management, compliance, retention, and ePRO service offerings to sponsors of clinical trials.

• C3 Research Associates (Seattle, WA) has selected StudyManager's (Seattle, WA) Evolve software to manage its largest clinical study.

• A National Bureau of Economic Research (Cambridge, MA) project will use industry benchmark cost data from Medidata Solutions (New York, NY) Grants Manager and Medidata CRO Contractor to investigate the major causes of increasing drug development costs.

• GlaxoSmithKline (London, UK) has decided to implement Medidata (New York, NY) Designer to optimize study design and expedite clinical development.

• ICON (Dublin, Ireland) has selected the Oracle Health Sciences (Redwood Shores, CA) LabPas solution, delivered via the Oracle Health Sciences Cloud, to support subject recruitment, data capture, and analysis, and enhance clinical workflows for its Phase I clinical trials.

Company News

• Phlexglobal (Carlsbad, CA) has launched a new research nurse bank to supply skilled nursing staff on a temporary basis to both commercial and NHS clients. The nurses will be available for all phases of clinical trials.

• The European Medicines Agency (London, UK) launched the EU Clinical Trials Register to give public access for the first time to information on interventional clinical trials for medicines authorized in the 27 EU member states and Iceland, Liechtenstein, and Norway. The database also allows the public to search for information on clinical trials authorized to be carried out outside the EU if these trials are part of a pediatric investigation plan.

• To better reflect its diverse therapeutic expertise, Comprehensive NeuroScience (Miramar, FL) has changed its name to Comprehensive Clinical Development.

• In response to increased client demand for cold and dedicated frozen storage capacity for biopharmaceuticals, Almac's (Souderton, PA) Pharma Services business unit has expanded its commercial facilities to include an additional 6,124 square feet of cold and frozen storage.

• Celerion (Lincoln, NE) has been accepted for membership of the Belfast facility within the UK Respiratory Therapeutic Capability Cluster. Celerion will work with key decision makers and thought leaders in the UK to develop and execute Phase I and IIa studies with targeted patient populations.

• Oncodesign (Dijon, France) acquired exclusive commercialization rights to distribute the world's most comprehensive collection of human colorectal cancer models directly developed from patient's tumors.

• Clinical Research Management (Hinckley, OH) has changed its name to ClinicalRM to support the company's strategic business growth and to better differentiate itself among providers of clinical trial and research services for both pharmaceuticals and medical devices. ClinicalRM has also launched a new website designed to increase communication to sponsors and partners regarding their range of capabilities and sponsor services.

• Comprehensive Clinical Development (Miramar, FL), formerly operating as Comprehensive NeuroScience, has acquired Charles River Clinical Services Northwest, including its 250-bed, 77,000-square-foot, Phase I-IIa facility located in Tacoma, Washington.

New Facilities

• Almac has new headquarters in Souderton, PA. The 240,000 square foot facility delivers full-service, integrated clinical packaging, drug supply management, and technology solutions to pharmaceutical and biotech clients. Almac's Diagnostics business unit has also opened its CLIA registered laboratory in Craigavon, Northern Ireland to support the company's ongoing biomarker discovery and development strategy by enabling the use of novel tests to stratify and enrich prospective clinical trails.

• Novotech (Sydney, Australia) has opened an office in Taiwan as part of its ongoing Asian expansion. The Taipei office will complement existing operations in India, South Korea, Thailand, Malaysia, and Singapore.

• Camargo Pharmaceutical Services (Cincinnati, OH)has expanded into Research Triangle Park, NC with the opening of a new office to offer additional service offerings, as well as streamlining client service.

Products

• Perceptive Informatics (Boston, MA) unveiled the new release of its DataLabs Electronic Data Capture (EDC) solution, which provides richer functionality to further streamline the clinical trial process. The DataLabs 5.0 EDC solution enables clinical trial sponsors to more efficiently manage the clinical development process from study design to collection and reporting of study data.

• GE Healthcare (Barrington, IL) has released Centricity Research, a new clinical research management solution. Centricity Research will help improve the efficiency and efficacy of clinical research studies, enterprise-wide, by driving better management of treatment plans, processes, and protocols while supporting research billing compliance.

• Oracle (Redwood Shores, CA) has launched Oracle Health Sciences Clinical Development Center 3.1, a centralized solution for integrating, managing, and analyzing clinical trial information. The release provides new integration and expanded data standardization to enable accelerated processing of clinical trial data from multiple sources and increased user productivity from capture through submission.

• CIT (Evreux, France) is offering a new range services, grouped under the name LeadScreen, that offer an extensive array of tests designed to give an early evaluation of safety of drugs thought to have development potential.

• OpenClinica (Waltham, MA) is launching a program designed to match its Enterprise technology with CRO services to deliver enhanced customer offerings.

Correction: In March 2011's "Partnerships in Clinical Trials" supplement Radinder Buttar"s e-mail was incorrect. The correct e-mail is rbuttar@clintec.com.