Industry news focusing on the people and organizations who work in the clinical trials profession.
Patrice Hugo, PhD, will lead the development of biomarkers through Phases I-IV in his new role as vice president of scientific affairs at MDS Pharma Services' (King of Prussia, PA) global central lab network.
Quintiles (Research Triangle Park, NC) senior management team has two new players: Millie Tan, senior vice president of global marketing and chief marketing officer, and David Coman, senior vice president of communication and patient recruitment.
Praxis (Brentwood, TN) hired three new staff members. New hires include Chris Layfield, marketing director; Craig Carson, marketing communications research specialist; and Kristin Saliski, patient recruitment coordinator.
Parexel International (Boston, MA) promoted 11-year company veteran Mark Goldberg, MD, to chief operating officer. Dr. Goldberg previously served as president of two of Parexel's three business segments: Clinical Research Services and Perceptive Informatics, which he will continue to oversee in his new role.
After 17 years with the Center for Drug Evaluation and Research, Stephen Moore, PhD, is joining Kendle (Cincinnati, OH) to serve as principal CMC consultant in the company's regulatory affairs and quality group.
Rho, Inc. (Chapel Hill, NC) announced the election of Dr. Katherine Monti, director of its Massachusetts office and senior statistical scientist, to the Biopharmaceutical Section of the American Statistical Association (ASA). Dr. Monti will serve a three-year term as ASA's Chair-Elect in 2009, Chair in 2010, and Past-Chair in 2011.
Terek Peterson, MBA, is the new director of clinical programming at Octagon Research Solutions (Wayne, PA), where he will oversee all statistical programming projects and initiatives.
Movetis, a Turnhout, Belgium-based biopharmaceutical company formed in 2007, appointed two new members to its senior management team: Catherine Moukheibir as chief financial officer and Dirk Van Broekhoven as general counsel.
ACR Image Metrix (Philadelphia, PA) named Brenda Young senior director of clinical operations and Yi Zhu clinical research project manager. Both women bring years of management experience to their new positions.
According to Prometrika (Cambridge, MA), "one of the most experienced clinical research professionals in the field" has joined the company with the recent addition of Faith Haines Kolb as senior director of clinical operations and data management.
Seasoned industry veteran Thomas Wells joined eClinical solutions provider OmniComm Systems, Inc. (Ft. Lauderdale, FL) as vice president of technical operations. He most recently served as director of research & development informatics at Amgen (Thousand Oaks, CA).
A new Cardiac Scientific Advisory Board made up of global experts will advise ICON's (Dublin, Ireland) Warrington, PA-based Medical Imaging division. Members include Professor Nelson Schiller, MD, of the University of California, San Francisco; C. Michael Gibson, MD, chief of clinical research in cardiology at Harvard's Beth Israel Deaconess Medical Center; Harald Becher, MD, PhD, of John Radcliffe Hospital in Oxford and Oxford professor of cardiac ultrasound; and Scott Solomon, MD, associate professor of medicine at Harvard Medical School and director of noninvasive cardiology at Brigham and Women's Hospital in Boston.
Canadian biotech company Allon Therapeutics (Vancouver) credits Nextrials' (San Ramon, CA) Prism software for being able to publish results from a nine month, Phase IIa Alzheimer's trial in less than seven weeks after last patient visit.
In a new public–private partnership, New York's Rochester Medical Center and FDA (Rockville, MD) will develop a national data repository of thousands of ECG recordings for use by academic and industry researchers. The goal of the Telemetric and Holter Electrocardiogram Warehouse (THEW)—as it will be known—is to improve cardiac safety monitoring in R&D through more precise measurement methods.
West Lafayette, IN-based BASi (Bioanalytical Systems, Inc.) and Swiftwater Group (Tucson, AZ) announced they have formed an alliance that will increase the number of service offerings available to both companies' clients.
Phase Forward (Waltham, MA) is integrating its InForm integrated trial management system with AG Mednet's (Boston, MA) imaging transport network to create a solution that removes the post office from the process of shipping trial images to core labs. With the new solution, sponsors can track, manage, and send images electronically and labs can enter their analysis data directly into the Inform system.
Novo Nordisk (Bagsvaerd, Denmark) has implemented Aris Global's (Stamford, CT) Register, a Web-based regulatory solution that streamlines the management and tracking of global product submissions. And now—as the result of a recent comarketing deal—Register users have the option to use A4L (ALiCE for Labeling), i4i's (Toronto, ON) XML-based global labeling solution.
Australian CRO Novotech (Sydney) received Frost & Sullivan's Australian CRO of the Year award as part of its Excellence in Healthcare Awards series for the Asia Pacific Region. According to Frost & Sullivan, Novotech won the award based on its significant revenue increase between 2005 and 2007, investments in IT capabilities, and its geographic expansion.
Praxis (Brentwood, TN) took home three awards at the Healthcare Communication & Marketing Association's (HCMA) annual conference. From a pool of 900, HCMA selected the company as Best of Show for its "Have Patients!" campaign, for which it also won a Gold award—one of two it received.
ProTrials Research (Mountain View, CA) is one of the Top 50 Women Owned Businesses in Silicon Valley according to the Silicon Valley/San Jose Business Journal. The CRO ranked 7th on the list, up two spots from last year's 9th.
At the 2008 annual meeting of the Center for Information & Study on Clinical Research Participation (CISCRP; Dedham, MA), PharmaNet (Princeton, NJ) received the award for "Supporting the Development of Educational Materials" for its collaboration with CISCRP on brochures about the risks and benefits of clinical trial volunteerism.
Thermo Fisher Scientific (Waltham, MA) and AstraZeneca (London, UK) walked away from the 44th DIA Annual Meeting with Microsoft's (Redmond, WA) 2008 Pharmaceutical and Life Sciences Award in the category of Discovery & Product Innovation. The award recognized the pharma company's success with Thermo Scientific's Nautilus Laboratory Information Management System, which is built on Microsoft's Visual Studio.NET.
Quintiles (Research Triangle Park, NC) made Computerworld magazine's 2008 list of 100 Best Places to Work in Information Technology. It was a first for Quintiles, which gave credit to the company's IT staff and its own efforts to attract whom it described as the best in the field.
Formalized training in the use of medical imaging in clinical trials is what the new Blinded Reader and Investigator Training Institute (BRITI) offers. Training and testing modules are provided online and locally to individuals or groups (blind readers, CRAs, clinicians, etc.) and cover topics such as clinical development, evaluation criteria, and regulatory requirements.
Octagon Research Solutions (Wayne, PA) celebrated a milestone last month when StartingPoint—its global submission document authoring template suite—gained its 100th user. The company also recently outlined the integration strategy for ViewPoint Quantum, the next version of its enterprise process management system. The strategy: Connect data that support electronic submissions by connecting widely used document management systems to ViewPoint Quantum.
Pharsight (Mountain View, CA) has entered a new business market and broadened its suite of services available to existing clients with the expansion of its reporting and analysis service offerings to include preclinical & statistics, and data management.
Dr. Shaun Holt launched the first site management organization (SMO) in New Zealand, Clinicanz. The new SMO will conduct late phase studies for most diseases outside of cancer.
SMI (King of Prussia, PA), a physician-owned marketing firm that traditionally works with pharma on point-of-care branding applications, has expanded to include a patient recruitment division: SMI Clinical Trials. Barry Crescenzi will spearhead the division as director of patient recruitment.
Almac Group (Craigavon, UK) announced the establishment of a new division. The new company, Almac Discovery, will focus on early discovery and development of both cancer therapies and biomarkers, and plans to out license or partner on projects before or at proof-of-concept stage.
A paper on the use of mobile technology in capturing osteoarthritis patient data is now available from Exco InTouch (Harlow, UK) and the Centre of National Research on Disability and Rehabilitation Medicine (Queensland, Australia). "Electronic Data Capture Using the WOMAC NRS 3.1 Index: A Pilot Study of Cellular Technology in OA" can be downloaded as a PDF for free at www.excointouch.com.
ePRO provider CRF Inc. (London, UK, and Waltham, MA) recently welcomed new members to its Clinical Advisory Board. Five clinical and scientific experts now make up the board, including CRF Inc.'s own Rachael King, who chairs it.
SGS Life Science Services (Geneva, Switzerland) is moving its American headquarters to a larger office in Gaithersburg, MD, to accommodate both its growing staff and U.S. service offerings, which now include medical monitoring and pharmacovigilanc services.
Symbio (Port Jefferson, NY) opened a 62-bed Phase I clinical unit that takes up an entire floor inside Saint Anthony Memorial Hospital in Michigan City, Indiana. With this addition, the CRO can now provide services from Phase I through Phase IV.
Xceleron (York, UK), a British biotech firm that calls itself a leader in human microdosing, joined the local biotech cluster in Germantown, MD, when it opened lab headquarters there back in July. In an article on washingtonpost.com, company cofounder Colin Garner said the goal is to "persuade big pharma to adopt the microdosing technique."