Business and News Update August 2011

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-08-01-2011, Volume 20, Issue 8

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

People

Phlexglobal (Bucks, UK) has announced the addition of Jerold Grupp as Vice President. Grupp will also head up the organization's recently launched Philadelphia office which opened in May.

Jerold Grupp

Biomedical Research Alliance of New York (Lake Success, NY) has added Robert L. Van Nostrand as a biotechnology expert to its Board of Directors.

ACM Global Central Lab (Rochester, NY) announced that Todd Meyers has joined the executive management team as Vice President of Sales and Marketing and will be responsible for global business development efforts.

Robert L. Van Nostrand

INC Research (Raleigh, NC) has appointed Erik Deurell, MD, as Medical Director of Pediatrics, where he will be responsible for maintaining the scientific integrity of the CRO's pediatric clinical trials and providing medical oversight and therapeutic training to its project teams in the United States.

Advanced Clinical (Bannockburn, IL) has made several new additions including Christina Fleming, PhD, to its leadership team as Executive Vice President, Scientific and Medical Affairs, and Tony Crone as Senior Director of Business Development.

Todd Meyers

Lee Shapiro, President of Allscripts, has been elected to Medidata Solutions' (New York, NY) board of directors.

Worldwide Clinical Trials (King of Prussia, PA) has appointed Gerald Messerschmidt, MD, as Vice President, Oncology Medical Affairs.

• The European Medicines Agency's (EMA) (London, UK) Management Board has nominated Guido Rasi as new Executive Director of the Agency. Rasi has been Director-General of the Italian Medicines Agency since 2008, and a member of the EMA's Management Board since 2010. The management board also elected Kent Woods, Chief Executive of the Medicines and Healthcare Products Regulatory Agency of the United Kingdom, as chair for a three-year mandate.

Richard Staub

• With more than 20 years of leadership experience in the life sciences, medical, pharmaceutical, and biopharmaceutical sectors, Neil Rotherham, MD, will join Cmed Group's (Horsham, England) board of directors.

ERT (Philadelphia, PA) has appointed Jeffrey S. Litwin, MD, its new President and Chief Executive Officer and a member of the board.

William Irish, PhD, has been appointed to the editorial board as Statistical Editor of the American Journal of Transplantation (Cincinanati, OH).

Alliances

  • PharmaNet Development Group's (Princeton, NJ) subsidiary, PharmaNet Canada and Maisonneuve-Rosemont Hospital and its research center have agreed to collaborate and conduct pharmacokinetic studies in patients with impaired renal function.

  • PharmaNet Development Group (Princeton, NJ) is collaborating with the Cancer Immunotherapy Trials Network (CITN) (Seattle, WA) in order to help identify trials with immunotherapy agents prioritized by the CITN as having high potential for cancer therapy.

  • ICON (Dublin, Ireland) has formed a strategic partnership with Pfizer (New York, NY) which will see it serve as one of two preferred providers of clinical trial implementation services. The partnership will enable Pfizer to focus internally on its core capability in clinical trial design, while leveraging the strengths and scale of ICON to implement clinical development programs with greater efficiency and rigor.

  • Anoto Group (Lund, Sweden) and ExpeData (Miamisburg, OH) announced that writeresult (Cranford, NJ) has committed to use their technologies for another global clinical trial, their sixth of 2011. ExpeData partner writeresult is a provider of data management solutions for clinical research to the pharmaceutical/life sciences industry, and is automating the process of capturing patient-reported outcomes during clinical trials with digital pen and paper technology.

  • PatientsLikeMe (Cambridge, MA) and BBK Worldwide (Newton, MA) have formed an alliance to jointly offer their services to pharmaceutical companies and other industry stakeholders interested in enhancing patient recruitment and retention for ongoing and upcoming clinical research studies.

  • Medidata Solutions (New York, NY) announced Clinverse (Raleigh, NC) as the 13th partner to join its Technology Partner Program, for solution providers that have leveraged Medidata products for data sharing with their clinical systems.

  • Exco InTouch's (Cheshire, UK) eDiary technologies have been selected by Pfizer (New York, NY) as part of the first ever Participatory Patient-Centered trial.

Awards

  • Celerion's (Lincoln, NE) clinical research operations in Belfast, Northern Ireland, and its clinical research and bioanalytical services operations in Lincoln have been certified by the Brazilian National Health Surveillance Agency (ANVISA). ANVISA provides regulatory approval for drugs and other products seeking to enter the Brazilian market.

  • Novella Clinical (Research Triangle Park, NC) has announced President and CEO Richard Staub is a 2011 Ernst & Young Entrepreneur of the Year Award Carolinas winner. The awards celebrate entrepreneurs who transform economies, drive innovation, and change communities.

Company News

  • Pfizer (New York, NY) announced that it is conducting the first-ever randomized clinical trial under an investigational new drug application that manages study participation entirely using electronic tools and allows patients to participate in the clinical trial regardless of their proximity to clinical sites. The pilot project uses mobile phone and web-based technology to collect the necessary data for the trial without clinic visits.

  • BioConvergence (Bloomington, IN), a contract solutions provider for the life sciences industry, celebrated its fifth year of operations recently. BioConvergence expanded its facilities after one year, and strives to create an environment where its employees and its clients collaboratively plan new product development.

  • Clinilabs (New York, NY) has been selected to conduct a Phase II clinical research study of an investigational medication in patients with Major Depressive Disorder.

  • In order to better serve its clients, DaVita Clinical Research (Minneapolis, MN) has recently invested in its Central Laboratory, servicing pharmaceutical, biotechnology, and medical device industries.

  • Almac's (Souderton, PA) Clinical Services business unit have increased its presence in the Asia Pacific region. It has extended its reach by adding five new depots located in Japan, Thailand, Hong Kong, and Taiwan to its extensive global depot network.

Mergers/Acquisitions

  • Laboratory Corporation of America Holdings (Burlington, NC) has entered into a definitive agreement to acquire Clearstone Central Laboratories (Toronto, Canada). The transaction, which is subject to customary closing conditions, is expected to close in the second quarter of 2011.

  • INC Research (Raleigh, NC) has acquired Trident Clinical Research (Austin, TX) to expand its clinical trials outsourcing footprint and expertise in Australia, New Zealand, and India. Under the terms of the agreement, Trident will become a wholly owned affiliate of INC Research and will operate as Trident Clinical Research, an INC Research company, through its offices in Sydney, Brisbane, Melbourne, Adelaide, Auckland, and Mumbai.

New Facilities

  • Advanced Clinical (Chicago, IL) has added a Scientific and Medical Affairs Division to its core client offerings. New divisional service offerings include Pharmacovigilance, Regulatory Affairs, Clinical Pharmacology/Translational Medicine, Medical Monitoring, and Quality Assurance.

  • IDDI, an eClinical and Biostatistical service provider headquartered in Louvain-la-Neuve, Belgium, has opened a new office in Houston, TX to enable access to clients on both the East and West coasts.

Products

  • ICON (Dublin, Ireland) announced that its medical imaging division has made MIRA, ICON's medical image review and analysis software, available to clients in an Application Service Provider (ASP) model. ICON Medical Imaging is the first medical imaging provider to offer clients an ASP solution for their image management needs.

  • invivodata (Pittsburgh, PA) announced the availability of DiaryPRO Web, its Web-based electronic PRO data collection solution. DiaryPRO Web provides all of the scientific design and ease-of-use features necessary for capturing valid, reliable patient data in a web interface.

  • CRF Health (Plymouth Meeting, PA) announced new medical device integrations to support both spirometers and glucometers used in Phase I-IV respiratory and diabetes clinical trials. CRF Health's eDiary TrialMax platform now integrates with Entra Health Systems' Bluetooth-enabled MyGlucoHealth Wireless Meter and Vitalograph's Asma-1 electronic Peak Flow Meter.

  • OpenClinica (Waltham, MA) has launched the production release of OpenClinica 3.1. The software is freely available for download at https://community.openclinica.com.

  • Covance (Princeton, NJ) launched Xcellerate, a proprietary methodology designed to help optimize clinical trial performance in order to assist biopharmaceutical companies in improving quality, reducing waste, and decreasing trial timelines.

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