Business and News Update September 2010

People

• S2 Statistical Solutions (Cincinnati, OH), a provider of data mining and economic analysis for medical device, diagnostic, and biopharmaceutical companies, has appointed Tina Hunter, PhD, as Senior Director of Analytics.

• Jonathan M. Fishbein has been appointed Vice President and Global Head for the Infectious Diseases Therapeutic Area Group at ICON (Dublin, Ireland) where he will oversee the growth and management of the infectious disease portfolio.

Tina Hunter, PhD

• Laurie Heilmann has been appointed ACR Image Metrix's (Philadelphia, PA) new Director of Business Development and Elena Kachanova has been appointed Clinical Project Manager.

• Joining MediciGlobal (King of Prussia, PA) is Judy Berwick as Account Executive.

• With 10 years of experience in the biopharmaceutical industry, Bill Kane has joined Almac (Craigavon, Northern Ireland) as Director of Quality Assurance and Regulatory Compliance. He will be responsible for supporting internal, client, and agency audits, as well as improving internal Quality and Compliance programs.

Jonathan M. Fishbein

• ACM Global (Rochester, NY) has added several new people to its team including Zoe Denham as Project Manager, Barnaby le Clercq as Business Development Director, and Ros McCabe, PhD, as Analytical Scientist. In addition, ACM Global has appointed Hua-Kang Wu, PhD, as Director of Molecular and Cellular Diagnostics, Cholpady P. Kamath, MD, Director of Anatomic Pathology, and promoted Tracy Hendershott to Executive Director, Global Operations.

• The Patient Recruitment Organization Steering Committee (Washington, DC) has elected Robert Loll as Vice Chairman.

• Mary Spellman, MD, will lead Integrium's (Tustin, CA) new Dermatology Clinical Research Group.

Laurie Heilmann

Pharmaceutical Research and Manufacturers of America (Washington, DC) has hired John J. Castellani as President and Chief Executive Officer.

• Virtify (Cambridge, MA) has promoted John P. Murgo to the role of Chief Operating Officer. He will manage the integration of people and processes within sales, marketing, product implementation, and customer support in addition to his existing responsibilities as Executive Vice President/Chief Financial Officer.

Judy Berwick

• With more than a decade of drug development experience, John Q. Kamerud, PhD, will lead Covance's (Princeton, NJ) North American principal investigator teams, providing large molecule bioanalytical services as Associate Director of Immunochemistry Services.

• TRAC (Corwnall, UK), a regulatory affairs specialist, has made several new additions including Debbi Finlay and Mike May as members of the Regulatory Affairs Team and Natalie Grogan as Marketing Manager.

Alliances

• To create online educational offerings for biotechnology, pharmaceutical, academic, and regulatory professionals around the world, Kaplan EduNeering (Princeton, NJ) and the Drug Information Association (Horsham, PA) has created a strategic alliance.

• The Global Alliance for TB Drug Development (New York, NY) and Drugs for Neglected Diseases Initiative (DNDi) (Geneva, Switzerland) have entered into a royalty-free license agreement that gives DNDi the right to develop a class of potential anti-TB compounds that also show promise for treating other neglected diseases that largely affect the world's poor.

• Aris Global (Stamford, CT) has selected invivodata (Pittsburgh, PA) as its preferred partner for ePRO solutions.

• PPD (Wilmington, NC) and Lovelace Biomedical and Environmental Research Institute (Albuquerque, NM) have entered into a collaboration focused on future service opportunities for biopharmaceutical and government clients across a range of therapeutic areas.

• Target Health (New York, NY) and LifeOnKey (New York, NY) have formed an alliance that allows Target Health to provide health care companies with an electronic clinical trial record that can manage and monitor the care of clinical trial patients from Phase I through Phase IV post-marketing surveillance.

• Extending its operations, Ockham Development Group (Cary, NC) has formed a partnership with Russlan Clinical Research (East Yorkshire, UK), a specialist CRO conducting clinical trial activities in the Eastern European countries of Russia, Ukraine, Latvia, Lithuania, Estonia, as well as some other Commonwealth of Independent States.

Awards

• Almac's (Craigavon, Northern Ireland) late founder, Sir Allen McClay, was posthumously honored at Northern Ireland's first ever Craigavon Business Awards with the "Special Recognition Award." A second award, "Young Business Person of the Year" was named in Sir Allen's honor. In addition, Almac was awarded "Best Export Initiative" in recognition of the company's efforts to expand its customer base and increase international competitiveness.

• Quintiles (Research Triangle Park, NC) has been named the 2010 Asia Pacific Contract Research Organization Company of the Year by Frost & Sullivan for the third time in the last five years. The award honors the company that exhibited excellence in innovation, growth strategy, and implementation, as well as overall customer and market leadership.

• Copernicus Group IRB's (Research Triangle Park, NC) CGIRB Connexus Solution has been named a finalist in the Records Management and Compliance category of the 2010 ACE Awards. Presented by ECM Connection magazine, the awards honor the vendors and solutions providers that have gone above and beyond the call of duty to help their clients achieve the best results possible from their enterprise content management implementations.

• Pfizer (New York, NY) has won a CIO 100 award based on their successful deployment of DecisionView's (San Francisco, CA) StudyOptimizer. The Web-based patient enrollment optimization solution automates the planning and tracking of subject enrollment for global clinical trials.

The newest additions to TRAC's staff pictured with company Directors Sarah Trethowan and Jonathan Trethowan. From left to right: Sarah Trethowan, Mike May, Debbie Finlay, Natalie Grogan, and Jonathan Trethowan.

Company News

• Imaging Endpoints (Scottsdale, AZ), a core medical imaging lab focused on accelerating the clinical trial process for pharmaceutical and medical device manufacturers, has officially launched.

• A group of clinical trial professionals consisting of medical imaging experts has launched Intrinsic Imaging (San Antonio, TX). The biopharmaceutical services organization provides image management and radiological review services to global pharmaceutical, biotechnology, and medical device organizations.

• L2FU (King of Prussia, PA), a company specializing in helping clinical trial sites and biopharma companies locate, contact, and collect data from patients deemed 'Lost to Follow-Up,' has reported a successful recovery of 100 percent of a recent study's lost clinical trial subjects.

Products

• TCN e-Systems (Boston, MA) has introduced a Smartphone Application for its TrialCentralNet that provides immediate access to study-goal information, enrollment numbers, key dates, country information, and media metrics in 11 different languages.

• CenterWatch (Boston, MA) has launched Grant Notification Service, a service designed to match clinical research sponsors with currently active, experienced investigative sites and provide an effective study grant generation tool for research professionals.

• Ricerca Biosciences (Concord, OH) has released Foresight, its similarity analysis service that allows compound assay results to be compared against the assay results of a large reference set of pharmacologically active compounds and helps predict in vivo effects from in vitro pharmacology data.

• MedNet Solutions (Minnetonka, MN) has made several enhancements to EMPOWER, the company's investigator initiated sponsored research management solution. Updates include an increase in the standard functions available in each of the system's core modules, expansion of the configurability of the system to meet each customer's unique requirements, and new standard reports and metrics.

• PharmaVigilant (Westborough, MA) has unveiled I-Vault 2.5, the enhanced version of its electronic Trial Master File system which offers enhanced e-mail, document tracking capabilities, improved reporting function, and separated signed and approval status.