Business and News Update September 2011

People

• ERT (Philadelphia, PA) has appointed Robert Kleiman, MD, to the role of Chief Medical Officer in addition to his current role as Vice President of Global Cardiology.

Robert Kleiman, MD

• Eman Albazzaz has been hired as Executive Director of Regulatory Affairs at Advanced Clinical (Deerfield, IL) to lead the company's regulatory and pharmacovigilance efforts.

Eman Albazzaz

• Joel Posener, MD, has joined PharmaNet (Princeton, NJ) as Executive Medical Director, Neuroscience. The company has also appointed George Scott, PhD, as Vice President, Bioanalytical Services.

Joel Posener, MD

• Cmed Group (Horsham, UK) has announced that Neil Rotherham, MD, co-founder of ClinPhone, will join its Board of Directors.

• Bringing with him more than 30 years of experience in preclinical safety, and testing, Paul C. Barrow has joined CiToxLAB (Evreux, France) as Director of Scientific Projects and Client Consulting.

• INC Research (Raleigh, NC) has hired Chris Smyth, PhD, to its oncology leadership team as Senior Vice President, Clinical Development, where he will leverage his extensive oncology expertise to support the company's oncology development and service delivery efforts in Europe and Asia Pacific.

• Synteract (San Diego, CA) has appointed Wendel Barr, formerly Chief Operating Officer and Executive Vice President at Covance, as the company's new Chief Executive.

• PPD (Wilmington, NC) has appointed Edward Ian as Vice President of Clinical Development for Asia Pacific. He will be based in Singapore and will provide strategic leadership and operational oversight for PPD's Phase II-IV business in the region.

• With over 30 years of experience in the contract research organization and pharmaceutical industries, Raymond Farmen, PhD, has been appointed Vice President of Global Bioanalytical Services at Celerion (Lincoln, NE).

• Biotec Services International (Brigend, UK), has appointed two new Project Managers, Clare Aubrey and Nicola Jenkins, to strengthen the company's team.

• Genticel (Toulouse, France) has named Didier Hoch, MD, as a member of the company's supervisory board to help the company position its strategic assets.

Alliances

• Greenphire (Philadelphia, PA) has formed a partnership with Mytrus (San Francisco, CA) to deliver efficient web-based solutions for clinical trial patients.

• OpenClinica (Waltham, MA) has contracted with the SAFE-T Consortium (Salt Lake City, UT) to enable quicker and safer evaluations of potential new medications in patients.

• Chiltern International Limited (London, UK) made an additional financial investment in Endpoint Clinical, (San Francisco, CA) to strengthen its strategic partnership with the company established in April 2009.

• Clinilabs (New York, NY) has entered into a strategic alliance with Ambulatory Monitoring (AMI) (Ardsley, NY) to bring together AMI's instrumentation with Clinilabs' core laboratory.

Awards

• Covance (Princeton, NJ) announced that Joe Herring, Chairman and Chief Executive Officer, received the Ernst & Young Master Entrepreneur of the Year Award at the 2011 New Jersey program's 25th anniversary gala.

Joe Herring

• Vetter (Ravensburg, Germany) has received the Frost & Sullivan 2011 European Prefilled Injection Systems Customer Service Leadership Award for best practices in its collaboration with global customers.

• The Association for the Accreditation of Human Research Protection Programs (Washington, DC) has awarded five organizations with full accreditation including Beijing YouAn Hospital, Capital Medical University (Beijing, China); McLean Hospital (Belmont, MA); Mount Sinai School of Medicine and The Mount Sinai Hospital (New York, NY); The Medical College of Wisconsin, Inc. and Froedtert Memorial Lutheran Hospital (Milwaukee, WI); and Veterans Health Administration Central Office Human Research Protections Program (Washington, DC).

Company News

• IntraLinks (New York, NY) announced the results of the IntraLinks Global Investigator Site Survey which highlights the need for the adoption of web-based clinical trial document exchange tools to drive efficiencies and increase productivity.

• Industry Standard Research (Cary, NC) announced the availability of its 3rd Annual CRO Quality Benchmarking Report. The 2011 version of the report profiles 169 pharmaceutical and biotechnology professionals and their experiences with dozens of small, mid-size, and large CROs.

• Nice Insight (New York, NY) has published its Q2, 2011 marketing intelligence report for the pharmaceutical and biotech CRO/CMO industry. The release of this second quarterly report enables companies buying the research to see developing trends from the Q1 report, as well as the overall key survey research that provides benchmark metrics for customer perception and customer awareness in the industry.

• CenterWatch (Boston, MA) has released the first edition of Global Regulatory Systems: A Strategic Primer for Biopharmaceutical Product Development and Registration, a guide to the complexities of drug approval and regulation.

• DecisionView (San Francisco, CA) has announced that a number of pharmaceutical industry leaders including GlaxoSmithKline and Roche have agreed to participate in the creation of a set of industry patient enrollment benchmarks based on real-world clinical performance data. Each of the initial sponsors will contribute their historical enrollment data, which will be anonymized, aggregated, and made available to all participants via DecisionView's StudyOptimizer for use in benchmarking, planning, and forecasting clinical trial enrollment.

• PharmaNet Development Group's (Princeton, NJ) bioanalytical laboratory in Quebec City, Canada, has received formal recognition from the Standards Council of Canada for its compliance with the Organization for Economic Co-operation and Development Principles of Good Laboratory Practice.

• Bordeaux (Chicago, IL) has established Bordeaux Clinical Research Network, a service platform dedicated to clinical trials in the healthcare industry. It aims to fulfill the increasing requirements of CROs and healthcare professionals to boost and speed up patient inclusion in phase I to IV clinical trials, while still ensuring compliance with all applicable quality standards.

• A paper, "Practical Considerations for Clinical Trial Sites Using Electronic Health Records Certified for Clinical Research," was released by the EHRCR Project (Friesenheim, France) that speaks directly to clinical research investigative sites regarding the use of electronic health record systems.

Mergers/Acquisitions

• ICON (Dublin, Ireland) has acquired Firecrest Clinical (Limerick, Ireland), provider of technology solutions that boost investigator site performance to enhance investigator site performance and quality.

• INC Research (Raleigh, NC) has completed the acquisition of Kendle International (Cincinnati, OH) in an all-cash transaction with a total equity value of approximately $232 million or $15.25 per share. The combined company will operate as INC Research, LLC and will be led by James T. Ogle, Chief Executive Officer.

• Bracket, United BioSource Corporation's (Chevy Chase, MD) pre-approval specialty services division serving pharmaceutical, CROs, and biotech and medical device sponsors, has completed the acquisition of Arrowhead Electronic Healthcare (Austin, TX).

New Facilities

• ClinTec International (Glasgow, UK) has continued its international expansion by opening fully registered offices in China, Singapore, and Thailand.

• Sherpa Clinical Packaging, a privately held provider of clinical trial material management services, has opened a state-of-the-art, CGMP production facility in San Diego, CA.

• Advanced Clinical has moved its headquarters from Bannockburn, IL, to the Parkway North Center at 10 Parkway North, Suite 350, Deerfield, IL in order to accommodate its recent growth and expansion of service offerings, including medical writing, clinical monitoring, safety operations, regulatory affairs, and biometrics.

• Vince & Associates Clinical Research has opened its new Neuropsychiatric Research Center in Overland Park, KS. This research facility provides study recruitment, medical management, and oversight in study volunteers for neuropsychiatric disorders including acute and chronic schizophrenia.

Products

• Covance (Princeton, NJ) announced the launch of Xcellerate, a proprietary methodology designed to help optimize clinical trial performance in order to assist biopharmaceutical companies in improving quality, reducing waste, and decreasing trial timelines.

• ClearTrial (Chicago, IL) has released ClearTrial 4.2. The new version introduces the ClearTrial Web Services Application Programming Interface (API). The ClearTrial Web Services API streamlines the integration of ClearTrial with any system that utilizes a web service.

• Octagon Research Solutions (Wayne, PA) has introduced two additions to its Quantum Regulatory Information Management platform. Content Manager and Document Publisher join Submission Manager as the next applications built on Octagon's Quantum Platform.