Business and News Update November 2010

People

• Chief Operating Officer of Chesapeake IRB (Columbia, MD), Jeff Wendel, was appointed to the Association for the Accreditation of Human Research Protections Programs' Board of Directors.

• Rod Roderick was named Vice President of Business Development at BioPharm Systems (San Mateo, CA).

• Praxis (Brentwood, TN) has hired Robert J. Loll as the Vice President of Business Development—he will lead the company's business development team in building sponsor relationships and providing sponsors with customized global recruitment solutions.

• Jane Clarke will lead Phlexglobal's (Buckinghamshire, UK) new eTMF Consulting Group where she will provide the expertise for companies in all aspects of records management, with a specific focus on TMFs, electronic TMFs (eTMFs), and the migration from paper to electronic.

• Garry D. Johnson joins BioClinica (Newtown, PA) in the newly created position of Senior Vice President and Chief Technology Officer in order to support the company's growth initiatives and emphasis on current and future technologies across the organization.

• IntegReview (Austin, TX) has made several new appointments including Rick J. Clemens as Vice President of Business Development and Melissa Meyer as Vice President of Operations.

• With nearly 30 years of pharmaceutical manufacturing experience, Patrick D. Walsh has been appointed AAIPharma Services' (Wilmington, NC) Chief Executive Officer. Philippe M. Maitre has been appointed Executive Vice President and Chief Financial Officer.

• JL Shapiro Clinical Support Services (Edison, NJ) has hired three new members to its team including Doretta Imperial as Project Director, Matthew Cohen as Project Manager, and Gregg Jones as Senior Account Executive.

• BioProcess Technology Consultants (Woburn, MA) has opened a European office in Denmark and appointed Lars Skriver, PhD, to lead its operations as Senior Consultant.

• TranScrip Partners (Reading, UK), a pharmaceutical development company providing advice and hands-on support to pharmaceutical and biotechnology companies, has appointed Gareth Walters as its new partner.

• Previously the Global Program Manager at Warner Chilcott, Brian Johnston has been hired as CTI Clinical Trial and Consulting Services' (Cincinatti, OH) Assistant Director, Clinical Trials.

• Velesco Pharmaceutical Services (Plymouth, MI) has made several additions including Shirley Smith as Director of Quality and Yuan Chen as Senior Pharmaceutical Scientist.

• Adding to its team, Image Solutions (Eschborn, Germany) has appointed James Hendry and Natalie Herbert as Regulatory Process Consultants.

Rod Roderick

• INC Research (Raleigh, NC) has appointed Hans-Peter Guler, MD, as Vice President, Clinical Development of Endocrine, where he will be responsible for providing therapeutic and clinical development oversight with internal and customer teams.

• Vice President of Global Clinical Strategic Resourcing at Wyeth, Dianne Kikta, PhD, was appointed Executive Vice President, by ClinTec International (London, UK).

Rod Roderick

Alliances

• South Korean CRO MediCROstar (Seoul, South Korea) has joined Medidata's (New York, NY) channel partner program for CROs and other service providers.

• Copernicus Group IRB (CGIRB) (Research Triangle Park, NC) has entered into a strategic alliance with IRB Services (Aurora, Canada) that will allow CGIRB to offer institutional review services to its clients whose clinical research protocols include Canadian sites.

• Eli Lilly and Company (Indianapolis, IN) is transferring select activities to support its US clinical trials, including biostatistical services, to i3 (Ann Arbor, MI).

• Parexel (Waltham, MA) has established a strategic functional service provider relationship with Eli Lilly and Company (Indianapolis, IN) to support study start-up and site monitoring of clinical trials throughout the Asia/Pacific region.

• The partnership between Ricerca Biosciences (Concord, OH) and Instem has resulted in the development of a new approach to eliminating potential misdosing during drug safety studies using Instem's Provartis software suite.

• The European Medicines Agency (London, UK) and the US Food and Drug Administration (Silver Spring, MD) have extended their confidentiality arrangements related to medicinal products for human and veterinary use, following the positive experience gained since the initial arrangements were signed in September 2003.

Robert J. Loll

Company News

• Charles River Laboratories (Wilmington, MA) now offers BlueScreen HC Screening services for the early detection of genotoxicity.

• Clearstone Central Laboratories (Toronto, Canada) is reporting HbA1c result values in International Federation of Clinical Chemistry units as well as the National Glycohemoglobin Standardization Program standard units. The company has also launched a new corporate website that provides clients with improved navigation, search capabilities, and multimedia content around the company's extended service offering and recent partnership with LabCorp.

• According to survey data released by Akaza Research, OpenClinica (Waltham, MA) has seen a surge in usage over the past year, with nearly 168,989 subjects involved in OpenClinica-powered clinical trials, a 224 percent increase from the prior year.

• CEDRA Corporation (Austin, TX), a division of Worldwide Clinical Trials, has a new company name, Worldwide Clinical Trials Drug Development Solutions.

• Almac's Clinical Technologies (Craigavon, Northern Ireland) division has successfully passed one of the UK's first joint routine GCP/GMP Medicines and Healthcare Products Regulatory Agency inspections at its Craigavon, UK site.

• In order to develop its position as an independent bioanalytical CRO in Europe, Unilabs Drug Development Services has changed its brand to York Bioanalytical Solutions (YBS) (York, UK).

• The Agency for Healthcare Research and Quality (AHRQ) (Rockville, MD) has published the second edition of "Registries for Evaluating Patient Outcomes: A User's Guide," a federal publication that provides information on designing, implementing, and evaluating patient registries including new methodological developments, emerging topics in registry science, technological advances, and operational examples and case studies from around the world. Outcome Sciences (Cambridge, MA) was selected by AHRQ to lead the effort to create the guide, and employees served as senior editors and authors for several chapters.

• Phlexglobal (Buckinghamshire, UK) has launched its enhanced resourcing solutions division to offer increased flexibility for both commercial and NHS clients. The resourcing solutions division now comprises four subdivisions covering recruitment, insourced services, task force, and clinical support services.

• Americas Clinical (Loveland, OH), along with seven other new business ventures, has won Xavier University's Launch-a-Business competition, a program designed to boost the economy by supporting promising new businesses in Greater Cincinnati.

• The US Food and Drug Administration (Silver Spring, MD) issued a final rule that clarifies what safety information must be reported during clinical trials of investigational drugs and biologics. The new rule requires that certain safety information that previously had not been required to be reported to FDA be reported within 15 days of becoming aware of an occurrence.

Jane Clarke

Mergers/Acquisitions

• A group of investors including The Halifax Group, SV Life Sciences, and the Comvest Group have merged Averion International (Southborough, MA), Trio Clinical Research (Raleigh, NC), Fulcrum Pharma (Morrisville, NC), and ClinResearch/ADDPLAN (Cologne, Germany), into a new global biopharmaceutical and medical device development services organization.

• Medco Health Solutions (Franklin Lakes, NJ) completed its acquisition of United BioSource Corporation (Bethesda, MD) in an all-cash transaction valued at approximately $730 million.

New Facilities

• PRA International (Raleigh, NC) plans to open their new bioanalytical laboratory facility, located in close proximity to PRA's US based Phase I clinic in Lenexa, KS. The facility will be equipped with state-of-the-art LC/MS/MS equipment.

• Covance (Princeton, NJ) and BML (Tokyo, Japan), a Japanese testing company, have opened the CB Trial Laboratory, a new central trial laboratory in the BML General Laboratory in Kawagoe City, Saitama Prefecture, to be used solely for the testing of clinical trial samples for studies being conducted by Covance in Japan.

• DaVita Clinical Research (Minneapolis, MN) has launched its clinical Central Laboratory services including green packaging for samples; a web-enabled data access system; and new equipment to provide fast, accurate results.

Products

• Virtify (Cambridge, MA) announced the upcoming release of its new software product Virtify PIM Enterprise. The product will be part of the Virtify Enterprise Content Compliance Software Suite.

• PharmaVigilant (Westborough, MA) has unveiled PaySite 2.0, a new site payment system that provides a complete dashboard to the sponsor, enabling them to program site payments based upon performance and individual site contracts.