Business and People Update January 2009

People

• Joining WorldCare (Boston, MA) as director of regulatory affairs and associate medical director, John Tomera will become responsible for managing all quality assurance and regulatory affairs operations.

John Tomera

• Upon taking on the role as director of research services at Camargo (Cincinnati, OH), Elaine Taylor will have the responsibility of performing all scientific research writing activities, providing full life cycle support from clinical study protocols through regulatory submission as well as post approval activities.

Elaine Taylor

• Previously serving as the director of the Office of Human Subjects Research and a bioethicist at the NIH, Jerry A. Menikoff, MD, JD, has been appointed as the director of the Office for Human Research Protections (OHRP; Rockville, MD).

Jerry A. Menikoff

• Now leading the INC Research (Raleigh, NC) pediatric team in the development of program strategies and consideration for clinical trials in neonates, children, and adolescents is Renee Simar, the new principle pediatric strategist.

Renee Simar

• MorphoSys (Munich, Germany) has appointed Arndt Schottelius, MD, as the company's first chief development officer, allotting him the responsibility of coordinating the group's expanding therapeutic antibody development activities.

• With more than 18 years of experience in heading financial and operational management efforts in other organizations, James Thomasell has been appointed as The Association of Clinical Research Professional's (ACRP; Alexandria, VA) acting president and chief executive officer.

• Nigel McBean will become the new vice president of operations for IndiPharms' (Mumbai, India) headquarters located in Mumbai, India.

• After recently serving as chief executive officer for PhenoTech (Philadelphia, PA), Guy Maestre will now serve as Kayentis' (Gif sur Yvette, France) vice president of U.S. operations.

• As the new director of business development for Eurofins (Portage, MI), Jeff Moran will lead the business development team and work toward improving client relations.

• Ricera (Concord, OH) has named Thomas Davidson to the position of director, toxicology and pharmacology, where he will be responsible for all work conducted by the company's study directors, as well as the peer review process and delivery of toxicological reports.

• Ellen McDonald has been appointed to Regado Biosciences' (Basking Ridge, NJ) new senior vice president of business operations position, as well as chief business officer, in which she will bring with her almost 20 years of biopharmaceutical industry experience.

• To expand on global growth initiatives, Sparta Systems (Holmdel, NJ) has added Tom Dalle-Molle, vice president of North American sales, and Nathan Birtle, vice president of EMEA and APAC sales, to its sales team.

• Joining Phlexglobal (Amersham, UK) as the new head of global resourcing, Paul Westnedge, also vice-chair of ICR's Resourcing Special Interest Group, brings with him over 25 years of experience, which includes working in sales, sales management, marketing, and as a senior resourcing consultant.

Alliance News

• One of the largest CROs in Japan, CMIC (Tokyo) has joined Medidata's (New York, NY) ASPire to Win partnership program and will be implementing Medidate Rave into its existing services.

• Upon a recent collaboration, Roche (Basel, Switzerland) was able to provide TQT data, which was acquired, analyzed, and formatted by Cardiocore (Bethesda, MD) for submission into the Telemetric and Holter ECG Warehouse's (THEW) international repository.

• Bio-Imaging Technologies (Newtown, PA) has partnered with AG Mednet (Boston, MA) to provide a complete imaging service for clinical trials.

• In an attempt to improve GCP in China and after entering into an alliance with the Association of Clinical Research (ACRP; Alexandria, VA), Shanghai Clinical Research Center (SCRC; Shanghai, China) will promote the U.S.-based organization's training programs nation-wide in China.

• With a new business unit that focuses on clinical trial data management and plans to further expand into the clinical trial market, Sermes (Madrid, Spain) has implemented Oracle (Redwood Shores, CA) Clinical applications to support its initiatives.

• NTT Data (Tokyo, Japan) has begun its first self-designed project using Datatrak's (Cleveland, OH) eClinical platform in a Japanese clinical trial.

Awards

• Among 320 companies, evaluated by 44 global technology experts, Phase Forward (Waltham, MA) emerged as The World Economic Forums' selection for Technology Pioneer of 2009.

• Steven Nichtberger, MD, cofounder, president, and chief executive officer of Tengion (East Norriton, PA), a biotechnology company, has been awarded the Ernst & Young national Entrepreneur of the Year within the emerging company category.

• In recognition of its research of genetic techniques in cancer treatment, Horizon Discovery (Cambridge, UK) has been awarded the "Best Business Proposition Award" at the UK-based Medical Futures Innovation Awards.

• After completing the necessary requirements, John Suedbeck of Metrics (Greenville, NC) has been named an ASQ-Certified Manager of Quality/Organizational Excellence, which is administered by the American Society of Quality (Milwaukee, WI).

• ProTrials (Mountain View, CA) was awarded "Best Overall Company of the Year," for service businesses with up to 100 employees, at the 5th annual Stevie Awards for Women in Business.

Company News

• The U.S. Department of Defense (DoD) has contracted with Phase Forward (Waltham, MA), requiring its support in the FDA's sponsored drug safety initiative, which sets out to access DoD health care data for a more rapid assessment of drug safety issues.

• Proving its GMP compliance, Almac (Durham, NC) has completed its voluntary inspection that covered the group's main sites including, Craigavon, UK, Audubon, PA, and Durham, NC. All inspections returned with no major failure notices.

• Launched by ex-Lilly executives, William McGinnis and Michael Smiricky, Centurion (Indianapolis, IN) is the only commercial clinic to host Phase I trials in Indianapolis.

• ICON's (Dublin, Ireland) medical imaging division has launched a cardiac echocardiography (ECHO) analysis software solution, which now allows ECHO images to be utilized in clinical trials.

• Marking its 30th anniversary of the Annual Spring Conference and Exhibition, ICR (Bourne End, UK) has updated the events' format to include featured speakers across the specified topics of therapeutics, raising standards, shaping knowledge, and developing professionals.

• With a new name and business model, Domain Therapeutics (Strasbourg, France), formerly Faust Pharmaceuticals, will allow companies access to its G Protein-Coupled Receptors (GPCRs) technology and will also be conducting early development of its products.

• In response to the dropout of two U.S. competitors from the European market as well as the closing of a German lab facility, INTERLAB (Munich, Germany) has increased its European project and data management team by 30% in preparation of an expected rise in business.

• To ensure timely and secure data communication, QED (Milton Keynes, UK) has chosen to utilize IT Farm's Web-based IT, which allows the company, including its offices in Russia, India, and China, to access all of its programs, files, and share data through a secure Web site.

New Facilities

• Adding to the research and development core that is Research Triangle Park, in North Carolina, Patheon (Research Triangle Park, NC) is opening its new U.S. headquarters and analytical lab facilities in the area.

• Metroplex Clinical Research Center (Dallas, TX) has expanded its services by adding a Phase I unit to its already existent Phase II-IV facility.

• Marking its fifth location in Latin America, Parexel (Boston, MA) has opened an office in Lima, Peru, where it will provide regulatory consulting and clinical research capabilities.

• Further developing its worldwide presence, DIA (Horsham, PA) has made another addition to its regional offices by opening one in Beijing, China.