Business and People Update September 2009

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-09-01-2009, Volume 0, Issue 0

Industry news focusing on the people and organizations who work in the clinical trials profession

People

Gráinne Forrest

• Currently a member of BARQA and the Institute of Clinical Research, Gráinne Forrest will now serve as the head of quality assurance at Clintec's (Glasgow, UK) Glasgow-based headquarters, where she will manage the global quality assurance team and further develop and deliver a quality strategy for the company.

Annette Doherty

• Being recognized for her services to the pharmaceutical industry for the past 20 years, Annette Doherty, PhD, the senior vice president and head of worldwide pharmaceutical sciences for Pfizer (New York, NY) has been made an Officer of the Order of the British Empire in the Queen's Birthday Honors celebrations.

Karen Bateman

Karen Bateman will bring with her quality assurance background in both pharmaceutical manufacturing and R&D to her new position as head of quality assurance for LCG Bioscience (Cambridgeshire, UK).

Jonathan Andrus

• The Vice President of Clinical Data Management and Regulatory Operations for BioClinica's (Newtown, PA) eClinical Service Division, Jonathan Andrus, has been elected as the Drug Information Association North American Special Interest Area Communities eClinical Chair.

• Bringing with him more than 25 years of experience in the areas of scientific computing, biostatistics, bioinformatics, programming, and global data management, Monte Jarvis will oversee Covance's (Princeton, NJ) data management and biostatistics for Phase IIIb/IV clinical trials, patient registries, and observational studies as he serves as the new vice president of global data management and biostatistics for peri-approval services.

• Previously the senior director in clinical research operations specializing in patient recruitment at Merck & Co. (Whitehouse Station, NJ), Lars-Olof Eriksson, PhD, is now serving as the vice president of Parexel's (Boston) Start-up and Accelerated Recruitment Team (START).

• Being an accomplished senior executive and having developed several life sciences companies throughout his career, Hervé de Kergrohen, MD, will now serve as the new chief executive officer and director of Anavex Life Sciences (Geneva, Switzerland).

• Joining MMG (Rockville, MD) as the new Senior Strategist and Vice President of General Medicine, Nikki Fink will utilize over 10 years of provider and sponsor experience designing and directing patient recruitment programs.

• Now leading the customer delivery group as the Chief Operating Officer, John Jordan will be responsible for global operations within the services branch of CRF Health (Lansdale, PA).

• Upon the opening of a new office in Brussels, Chiltern (London, UK) has appointed Maurizio Passinisi as the new country manager for Belgium and The Netherlands.

• As the new Senior Vice President of Neuropsychiatry to INC Research's (Raleigh, NC) Central Nervous System team, Tom Zoda, PhD, will be responsible for providing senior level oversight of all psychiatry and neurology projects on a global basis.

Alliances

  • Six academic medical centers and research institutions—the University of Texas M.D. Anderson Cancer Center, Columbia University, Duke University, University of Kansas, University of Miami, and UT Southwestern Medical Center—will form an advisory group that will collaborate with Velos (Fremont, CA) to develop a Service-Oriented Architecture for the company's eResearch CTMS deployed at each of the institutions.

  • A collaboration between to-BBB (Leiden, The Netherlands) and Dr. Olaf van Tellingen from the Department of Clinical Chemistry of the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital (Amsterdam, The Netherlands) will begin development of a potential therapy for brain tumors.

  • Following an agreement from November 2008, Eli Lilly (Indianapolis, IN) has signed another strategic partnership with ICON (Dublin, Ireland), which will have the company manage Lilly's clinical trial set up and monitoring in Europe.

  • To launch and manage the ImproveCareNow Collaborative, which allows selected practice sites to work together to improve the care of Crohn's disease and ulcerative colitis, Clinipace (Morrisville, NC) and Improve Care Now have extended a partnership.

  • Mortara (Milwaukee, WI) has welcomed Biotrial (Rennes, France) as a certified partner, making it one of only a few partners around the world that are recognized by Mortara for adhering to the HL7 annotated ECG standard used by the FDA to manage its data warehouse.

  • With many top pharmaceutical companies having a presence in Saudi Arabia and in order for the region to attract more commercial attention, group delegates from some of the leading institutions and pharmaceutical companies based in the country participated in the Institute of Clinical Research's (Bourne End, UK) clinical trials and clinical trials practice course.

  • Working closely together for over a year, Genotronix Limited (Manchester, UK) and Apredica (Watertown, MA) have entered into an alliance to reduce the failure rate of drugs in late development, particularly due to toxicology.

  • To develop a purpose built translational medicine facility, ICON (Dublin, Ireland) has entered into a collaborative agreement with the Central Manchester University Hospitals Foundation (CMFT).

  • PFC India, a full-service CRO specializing in clinical monitoring and data management services, has been launched by Excel Life Sciences (Chicago) and PFC Pharma Focus (Zurich, Switzerland) in response to a growing demand by European and U.S. pharma companies for clinical trial support services in India from already established providers.

  • In an effort to enhance discovery and development of affordable and effective therapies for visceral leishmaniasis (kala azar), the Drug Discovery Unit of the University of Dundee (Dundee, UK) and Drugs for Neglected Diseases Initiative (Geneva, Switzerland) have decided to collaborate.

Awards

  • The data management division of Quintiles (Research Triangle Park, NC) has won the 2008 Pfizer Development Operations' Strategic Supplier Excellence Award for demonstrating consistent and excellent performance in the areas of quality, service delivery and reliability, innovation and business processes, and customer service and responsiveness.

  • Computerworld magazine has named Quintiles (Research Triangle Park, NC) to its "100 Best Places to Work in IT," for its second year in a row, moving from 37th to 16th place.

  • Frost & Sullivan's 2009 Clinical Trials Management Product Innovation of the Year Award has been awarded to Nextrials (San Ramon, CA), recognizing the company's EDC and CTMS platform, Prism.

The Institute of Clinical Research's Education Manager Sue Fitzpatrick shaking the hand of Abdullah Aljoudi, MD, after he completes one of the organization's clinical trial courses recently made available in Saudi Arabia.

Company News

  • The latest software addition to TOPAZ Technology's (Austin, TX) product line is the Biosafety Solution, which automates the medical research study protocol process, from protocol inception to approval, as is required by the Institutional Biosafety Committee.

  • The Association of Clinical Research Organizations (Washington, DC) has lent its support to the "Patient-Centered Outcomes Research Act," which was introduced by Senator Max Baucus (D-MT) and Senator Kent Conrad (D-ND). ACRO also supports a related House bill introduced by Kurt Schrader (D-OR), H.R. 2502.

  • Through an Internet Web browser, Winchester Business Systems (Woburn, MA) now provides instant access to its Protocol Manager Version 8.0.

  • In the Medidata ASPire to Win program, Omnicare Clinical Research (King of Prussia, PA) has achieved Rave Accredited status, enabling the company to build Rave EDC databases independently and provide other Rave EDC programming related tasks for clients.

  • Metrics (Greenville, NC) surpasses what it refers to as a significant industry milestone, which is its 100th first-in-man Phase I study.

  • With the launch of a new, redesigned Web site, Rho (Chapel Hill, NC) has changed the look of its site, but the Web address remains the same, www.RhoWorld.com.

  • Version 3.6 of NextDocs' (King of Prussia, PA) Regulatory Document Management System will be built to support and validate documentation for the DIA Electronic Document Management Reference model.

  • Health Decisions (Durham, NC) has launched a new Web site, www.healthdec.com, that now allows visitors to converse about clinical trial efficiency while simultaneously experiencing the company's Agile Clinical Development platform.

  • Working closely with the American College of Radiology Imaging Network (ACRIN), the American College of Radiology (ACR) Image Metrix (Philadelphia) conducts Positron Emission Tomography (PET) trials, which allows sites to participate in multicenter research trials once its quantitative data of PET scans and images are reviewed.

  • Demand for hands-free, speech-directed workflows for today's mobile warehouse has prompted TAKE Supply Chain (Austin, TX) to launch the new Gemini Simplified Interface Voice, a voice-enabled user interfacing system that supports the company's Gemini Oracle Process Manufacturing and Oracle Discrete Manufacturing mobile data collection applications.

  • BioClinica's (King of Prussia, PA) Express EDC platform has been certified by the Clinical Data Interchange Standard Consortium (CDISC; Austin, TX) for its compliance with the Operational Data Model (ODM) standard.

  • Phase Forward has relaunched its (Waltham, MA) Clinical Trials Signal Detection product, now called Empirica Study, which will complete the company's Empirica Suite.

New Facilities

  • Velesco (Plymouth, MI) has opened a new facility and office in Kalamazoo, MI, and has also moved its Ann Arbor, MI, laboratories to the Michigan Life Science and Innovation Center in Plymouth, MI.

  • Providing what the company refers to as much needed office space to accommodate growth, ACR Image Metrix (Philadelphia) has opened a new headquarters that is still in Philadelphia, however, is no longer within the ACR Clinical Research Center, but now is located adjacent to the ACR imaging and radiation therapy quality assurance core laboratories.

  • Expanding its European operations, Chiltern (London, UK) has opened a new office in Brussels, Belgium.

  • Quintiles' (Research Triangle Park, NC) opening of a new office facility in Accra, Ghana, is intended to improve efficiency and expand capacity to monitor the clinical studies being conducted in Western Sub-Saharan Africa.

  • To meet a growing demand of its services in Singapore, ICON plc (Dublin, Ireland) has moved its Singapore central laboratory to a new and larger one that is located at Loyang Way in Eastern Singapore.