Business and News Update August 2010

People

• BioStorage Technologies (Indianapolis, IN) has promoted Lori A. Ball to Chief Operating Officer.

• Working in the clinical trials industry for more than 25 years, Sandra Forman has been hired by C-TASC (Baltimore, MD) as a Senior Statistician.

• Previously President of Chiltern International, Aidan Nuttall, PhD, has been named U.S. Office President at Phlexglobal (Bucks, UK).

• Praxis (Brentwood, TN) has promoted Tracey J. Alderdice to Vice President of Operations, where she will lead the growth and expansion of Praxis' international recruitment operations.

Lori A. Ball

• Stephen Johnson has been promoted to President and Chief Operating Officer of OmniComm Systems (Ft. Lauderdale, FL).

• Ockham Development Group (Cary ,NC), a global CRO and functional service provider organization, has promoted Anthony J. Southers to the role of General Manager, Europe, where he will lead the continued expansion of Ockham's European operations.

• Making several new additions, CEDRA Corp-oration (Austin, TX) has appointed Thomas L. Lloyd Director of Automation for the Bioanalytical Group and John F. Pottier as Senior Director of Business Development in Generics.

Sandra Forman

• The European Personalized Medicine Association (Paris, France), has appointed Anne Bruinvels, PhD, as Executive Director and Board Member.

• In her new position as Director of Global Small Animal Development and Reproductive Toxicology (DART) at Covance (Princeton, NJ), Tacey E. White, PhD, will lead the small animal DART teams in North America and Europe.

Aidan Nuttall, PhD

• Joining PPD (Wilmington, NC) is Mike Wilkinson, PhD, as Executive Vice President and Chief Information Officer, and Paul Colvin as Executive Vice President of Global Clinical Development.

Tracey J. Alderdice

• The European Medicines Agency has unanimously re-elected Pat O'Mahony, Chief Executive of the Irish Medicines Board, as chair for a second three-year mandate.

Awards

• Rabinder Buttar, PhD, President and Chief Executive Officer of the CRO ClinTec International (Glasgow, Scotland), has won the Ernst & Young, Scottish Entrepreneur of the Year Award.

• Anne Tomalin, head of i3's (Basking Ridge, NJ) strategic regulatory services group, was honored with the 2010 Canadian Society for Pharmaceutical Sciences Leadership Award at a gala reception during the CSPS 13th Annual Symposium in Richmond, BC. This annual award is bestowed upon a scientist who has demonstrated leadership in advancing the cause of pharmaceutical research and development in Canada.

Alliances

• Australian CRO Novotech (Sydney, Australia) has joined Medidata Solution's (New York, NY) ASPire to Win channel partner program, allowing Novotech to offer sponsors a full range of services around the Medidata Rave electronic data capture and clinical data management solution.

• Royal Philips Electronics (Eindhoven, The Netherlands) and RXi Pharmaceuticals Corporation (Worcester, MA), a U.S.-based bio-pharmaceutical company, entered into a joint research agreement to explore the benefits of combining proprietary technologies from both companies for the targeted delivery of experimental therapeutics based on RNA interference.

• Chiltern International (London, UK) has formed a partnership with Tayside Academic Health Sciences Center (Dundee, UK)—a joint venture between UK's NHS Tayside and the University of Dundee—to conduct and support proof of concept and translational medicine studies.

Company News

• The FDA and the National Institute of Health launched the Safety Reporting Portal Web site, which features increased accessibility to submit reports concerning FDA-regulated products and allows the public to submit a safety report related to foods, drugs, and veterinary products.

• The Medicines and Healthcare Products Regulatory Agency (London, UK) has awarded the Surrey Clinical Research Center (Surrey, UK) at the University of Surrey standard accreditation for conducting clinical pharmacology Phase I trials.

• The Association for the Accreditation of Human Research Protection Programs (Washington, DC) has published a performance study on human research protection programs that is available in AAHRPP Advance and at www.aahrpp.org.

• Chiltern International (London, UK) has announced that Chiltern Early Phase Limited, based in Ninewells Hospital and Medical School in Dundee, Scotland, has achieved Supplementary Accreditation from the MHRA.

• Copernicus Group IRB (Research Triangle Park, NC) has received ISO 9001:2008 certification, affirming that the company's quality management system meets the strict qualifications for the globally accepted ISO standard.

• The European Medicines Agency and the European Network of Centers for Pharmacoepidemiology and Pharmacovigilance (London, UK) launched "ENCePP studies," a seal for EU-based, benefit/risk or risk studies that are carried out in compliance with the ENCePP code of conduct for independence and transparency and its methodological research standards and are entered into a publicly available electronic register before their start.

Blue Chip (Northbrook, IL) has launched Blue Chip Patient Recruitment, a division dedicated to serving pharmaceutical and biotech clients with clinical trial recruitment marketing.

Official groundbreaking ceremony for a new Ravensburg facility Vetter West with (from right to left): Wolfgang Kerkhoff, Bianca Vetter, Udo J. Vetter, PhD, Daniel Rapp, Thomas Otto, Peter Soelkner, Max Horn, and Gunther Strothe.

• Ricerca Biosciences (Concord, OH) has been granted a U.S. Drug Enforcement Administration license, allowing them to handle multiple kilos of agency-controlled Schedule II-V substances for research and development projects at its Concord facility. In addition, its Ricerca France, Lyon, facility has obtained the ISO 9001:2008 certification for all activities performed at the site.

New Facilities

• TKL Research (Rochelle Park, NJ ) a U.S.-based CRO that focuses on enrollment-driven Phase I-IV clinical trials, has expanded its presence in Europe by taking an equity position in proinnovera GmbH, a CRO based in Münster, Germany.

• Expanding for the first time outside of Europe, Phlexglobal (Bucks, UK) has opened an office in Carlsbad, CA.

• To allow the company to optimize both its control and logistical processes, which will enable safe and expeditious product delivery to customers, Vetter (Ravensburg, Germany) plans to open a new warehouse for cold-storage and room-temperature goods.

• Quotient Bioresearch (Cambridgeshire, UK) has opened a new facility in Cardiff, UK, where all staff have successfully transferred from the former site operated by Amersham Radiolabelling Services.

• Pharmaceutical outsourcing specialist Quay Pharma has opened its new headquarters in North Wales, UK, to bring together its services that were previously housed in two separate facilities.

Products

• Almac (Craigavon, Northern Ireland) has launched XCEL array, a biomarker discovery platform that enables the identification of biomarkers within multiple disease areas, as well as its IXRS 2.0 integrated, interactive voice and Web response technology that features enhanced Web function, such as smart menus and intuitive task management.

• IntraLinks (New York, NY) has released an enhanced version of its SaaS-based Safety Document Exchange that includes configurable rules-based automated workflow, intuitive organization and user-based views, and detailed compliance reporting.

• BBK Worldwide (Boston, MA) has introduced its Patient Recruitment Franchise Program and flagship product, FRANCHISE e-BINDER, a flexible communication platform that uses the Apple iPad for processes related to subject recruitment and management.

• BioClinica (Newton, PA) has introduced its eClinical technology suite as well as its integrated operations platform that uses Microsoft Office and SharePoint platforms for clinical operations.

Providing mobile access to patient data in clinical trial and health care settings, Nextrials (San Ramon, CA) launched an Apple iPad application for its clinical trial data management platform, Prism.

• PPD (Wilmington, NC) has launched Expert Community, an interactive area on the PPD Web site where industry professionals can engage in an exchange of ideas about important clinical research topics and trends.

Outside Quay Pharma's new laboratory and headquarters in North Wales.