Business and People Update June 2008

Article

Applied Clinical Trials

Applied Clinical TrialsApplied Clinical Trials-06-01-2008
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Issue 0

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

People

• Münster, Germany's blue inspection body, an audit service provider, added Dr. Wolfgang Heisig to its team of pharmaceutical inspectors, where he will serve as chief GMP auditor for active pharmaceutical ingredients.

Dr. Wolfgang Heisig

Pamela Ring will oversee and manage e-meeting, medical education, and communication services for clients of MedPoint Communications (Evanston, IL) as the company's new vice president and senior director of account management. Before accepting a position with MedPoint, Ring served as senior business unit director for Discovery Chicago (Chicago, IL).

Heather Balcarcel joined Excel Life Sciences (Chicago, IL) as director of marketing, having previously served as marketing manager for CenterWatch (Boston, MA).

Pamela Ring

Norbert Clemens, MD, is CRS Andernach Group's (Andernach, Germany) new head of clinical development and will be based out of Mannheim, Germany.

• Having been executive chairman at Ricera Biosciences (Concord, OH) since 2006, R. Ian Lennox was recently appointed as the company's chairman of the board and chief executive officer.

Parexel (Boston, MA) strengthened its team with a few new hires. Larry Ereshefsky and Malek Bajbouj, MD, both joined the company as vice presidents of clinical pharmacology consulting services. Ereshefsky will be based in Los Angeles, CA, while Bajbouj will work out of Berlin, Germany. Additionally, Dr. Imogene Grimes is the company's new vice president of data sciences strategic services, having served as vice president of statistics, data management, and informatics at Regeneron Pharmaceuticals (Tarrytown, NY).

Heather Balcarcel

Stephen Johnson was promoted from OmniComm Systems' (Fort Lauderdale, FL) executive vice president of business development and professional services to his new role as chief operating officer.

Dr. Dimitri Goundis has accepted the position of project director of clinical development for Anavex Life Sciences, based in Geneva, Switzerland. Prior to Anavex, Dr. Goundis was managing director at Speedel Experimenta (Basel, Switzerland).

John Rogers will lead Octagon Research Solutions' (Wayne, PA) process consulting team as the director of process solutions, with nearly 30 years of life science and technology experience under his belt.

Dr. Norbert Clemens

• Having already served as one of the leaders of the Siebel Clinical group for Accenture's (New York, NY) Health and Life Sciences division, Parambir Singh recently joined BioPharm Systems (San Mateo, CA) as director of the Siebel Clinical Practice.

Clinsys Clinical Research (Bedminster, NJ) recruited a bevy of staffers to compose the company's newly developed Therapeutically-aligned Program Strategists (TPS) teams. Linda Miller, MD, was promoted to vice president of clinical development and chief scientific officer, and will aid in the development, growth, and success of the teams. Senior Director of Clinical Development Chris Gregory—who specializes in Alzheimer's disease, Parkinson's disease, and multiple sclerosis—and Director of Clinical Development Nermina Nakas, MD—who has extensive research experience in dermatology, pediatrics, and respiratory disease—will support the teams, along with Daniel Wood, senior clinical research scientist. John Oh, MD, director of clinical development, will develop TPS programs in the areas of pain, spinal cord injury, stroke, and traumatic brain injury. For more on the Clinsys TPS teams, please see Applied Clinical Trials' new CRO eNewsletter, now available on our Web site at www.appliedclinicaltrialsonline.com.

Business & Commerce Excellence Jewel Award winner Dr. Rabinder Buttar (middle) with Lloyds TSB Business Development Director Andrew Horner (left) and Asian Marketing Director Kamel Hothi.

Ciaran Cooper is M2S's (West Lebanon, NH) new general manager of clinical trials services after being promoted from vice president of clinical trials services.

Laurie Sterling takes on the role of chief financial officer for Clinical Resource Network (CRN; Deerfield, IL). Sterling joins CRN after leaving her position as chief financial officer of global business services for Hewitt Associates (Lincolnshire, IL).

Alliances

  • In response to increasing demand for cardio-pulmonary safety and efficacy in clinical studies, eResearchTechnology (Philadelphia, PA) and nSpire Health (Longmont, CO) will jointly provide a combined solution for cardiac safety and pulmonary core laboratory services to clinical trials professionals.

  • Premier Research Group (Philadelphia, PA) and Octagon Research Solutions (Wayne, PA) have entered into an alliance that will enable Premier to incorporate Octagon's expertise in electronic submissions into their regulatory affairs services, as well as allow Octagon to utilize Premier's regulatory capabilities.

  • Servier's (Neuilly-sur-Seine, France) two core discovery research facilities—specializing in brain disease, cardiovascular, neuropsychopharmacology, and oncology—in Suresnes and Croissy-sur-Seine, France, are slated to receive Definiens (Munich, Germany) Enterprise Image Intelligence Suite, which automates the image analysis process.

  • Criterium (Saratoga Springs, NY) is now a member of OmniComm Systems' (Fort Lauderdale, FL) CRO Preferred Program, which enables Criterium to offer its clients access to TrialMaster, OmniComm's EDC solution. In more OmniComm news, the company announced plans to work with Logos Technologies (London, UK) to create an enhanced EDC solution for Phases I–IV by integrating TrialMaster and Logos' ALPHADAS, a Phase I EDC product.

  • In a new agreement between LCG Bioscience (Cambridge, UK) and The Harley Street Clinic (London, UK), an HCA International hospital, sponsors will have access to clinical trials expertise, a variety of patient populations, intensive care facilities, and teaching hospital specialists. The alliance came about in an effort to facilitate first-in-human studies.

  • The Association of Perioperative Registered Nurses (Denver, CO) is partnering with Computer Sciences Corporation (Falls Church, VA) to create the Standardized Perioperative Record, which will allow for the creation of new perioperative data in a format compatible with existing electronic health record programs.

  • GlaxoSmithKline (GSK; London, UK) is utilizing Insightful's (Seattle, WA) S-PLUS, a data analysis and predictive analytics platform, as well as a clinical graphics solution designed by the company. GSK hopes to better understand and communicate statistical data with the use of Insightful's software.

  • Clinical Resource Network (Deerfield, IL) will use Chandler Group (Evanston, IL) as its agency of record for marketing. Chandler Group will develop a communications campaign, which includes an enhanced Web site, a more streamlined logo, public relations, trade advertising, and trade show materials.

  • A new alliance will pave the way for LabVantage Solutions (Bridgewater, NJ) to integrate its SAPPHIRE laboratory information management suite with InforSense's (London, UK) integration and analytics workflow infrastructure.

  • Image Solutions (Whippany, NJ) will provide biopharmaceutical company NovaRx (San Diego, CA) with its regulatory submissions package, which includes the electronic submission software eCTDXPress and ISIWriter, a set of global authoring templates.

  • ClinPhone (Nottingham, UK) is partnering with invivodata (Pittsburgh, PA) to deliver an electronic patient reported outcomes solution to their clients. Additionally, ClinPhone will become a member of invivodata's PROPartner Program, which allows invivodata's clients to utilize the services of affiliate companies.

  • Under the terms of a new agreement, Dedicated Clinical Research (Litchfield Park, AZ) will establish clinical research centers at all Integrated Medical Services (Phoenix, AZ) facilities.

Awards

  • Winners from the health care, pharmaceutical, and medical sectors were recently announced at the Lloyds TSB (London, UK) Northern Jewel Awards held in Manchester, UK. Dr. Rabinder Buttar, president and chief executive officer of ClinTec (Glasgow, Scotland), won the Business & Commerce Excellence Jewel Award.

  • Medidata Solutions (New York, NY) received Bio-IT World magazine's Best of Show award in the clinical trials and research category for Medidata Designer because of the product's ability to deliver excellent quality and consistency of clinical protocols.

  • Athena (La Jolla, CA), an organization for female executives in the business, health care, life sciences, and technology communities in the San Diego area, awarded Synteract's Vice President and Chief Executive Officer (Carlsbad, CA) Ellen Morgan the Pinnacle Award for an Individual in Services at the organization's 10th award anniversary.

  • Covance (Princeton, NJ) took home the Best Contract Research Organization (CRO) award from the 2008 World Vaccine Congress in Washington, DC. The judging panel selected Covance based on the quality of its customer relations, facilities, and vaccine services.

  • Healthcare Marketing Report magazine recently sponsored the 25th Annual Healthcare Advertising Awards, where SCORR Marketing (Kearney, NE) earned three awards. The company received a gold medal for a campaign called "Who Says You Can't Teach an Old Dog New Tricks?" designed for Cincinnati, OH-based Camargo Pharmaceutical Services; a bronze award for one of Cognitive Drug Research's (Oxfordshire, UK) trade show booths; and a merit award for a television commercial series created for Kearney Eye Institute (Kearney, NE).

  • An independently conducted study of European clinical investigator sites, covering 300 European investigators in 18 different countries, ranked Quintiles Transnational (Research Triangle Park, NC) number one in overall satisfaction, with 84% of surveyed sites saying they were either satisfied or extremely satisfied with the company.

Company News

  • Medidata Solutions' (New York, NY) EDC product Medidata Rave received certification from the Clinical Data Interchange Standard Consortium for complying with the Operational Data Model.

  • Computer Sciences Corporation (Falls Church, VA) introduced its new health care sector, which aims to help clients improve processes such as clinical trial management, claims processing, document management, revenue cycle management, and supply chain management by leveraging core intellectual property.

  • Octagon Research Solutions (Wayne, PA) noted that business dealing with the Clinical Data Interchange Standards Consortium Study Tabulations Model has boomed in recent months, citing a trend toward standardization as a probable reason.

  • A new advancement in drug development could lead to more rapidly produced and cost-effective drugs. Researchers at College Park, MD-based University of Maryland's A. James Clark School of Engineering and the University of Maryland Biotechnology Institute recently confirmed that their biological microfactories can create the chemical reactions required to test developmental drugs. An enzyme placed on a biochip designed to copy the environment in the human body behaved as it normally would, which means that researchers can likely test new drugs with this laboratory tool.

  • Biotechnology and Pharmaceutical Patents: Law and Practice is a new resource from Wolters Kluwer Law Business (Amsterdam, The Netherlands) that includes comprehensive, step-by-step instructions to help companies successfully make biopharmaceutical patent decisions.

  • ClinPhone (Nottingham, UK) announced year end results of 15% revenue growth on a constant currency basis, with the last four months of the year—ending February 29, 2008—responsible for 60% of the Normalized Profit.

  • In an effort to increase the company's drug development and trial design capabilities, Clinsys Clinical Research (Bedminster, NJ) created Therapeutically-aligned Program Strategists made up of teams of experts in a number of therapeutic areas, who will work through the development through protocol finalization of sponsor projects.

  • The European Forum for Good Clinical Practice (EFGCP; Brussels, Belgium) is now offering new corporate membership packages to organizations involved in biomedical research. Benefits include exposure at EFGCP conferences and on marketing materials, free conference and event registration, complimentary training modules, and participation in stakeholder policy roundtables and the annual corporate members dinner, as well as the chance to forge relationships with key stakeholders.

  • Perceptive Informatics (Boston, MA) is now offering IMPACT MySites, the company's clinical site management and monitoring software, on a portable USB drive.

Mergers/Acquisitions

  • i3 Research (Basking Ridge, NJ) expands its global clinical research capabilities with the acquisition of clinical research organization Lege Artis (Moscow, Russia). Tatjana Zwereva, MD, founder and chief executive officer of Lege Artis, will lead the company, which boasts capabilities in Belarus and Ukraine as well as Russia.

  • PeerView (Newtown, PA) will complement PubSTRAT, its comprehensive publication planning suite, with the recently purchased Veritas Clinical Trials Register (VCTR) platform from Veritas Medicine (Cambridge, MA). VCTR features integration of new compliance requirements, automated posting to registry Web sites, online clinical trial subject response services, and more.

  • Aida Pharmaceuticals (Santa Monica, CA) now has a controlling interest in Jiangsu Institute of Microbiology (Wuxi City, China), a leading microbiology research institute currently testing several drugs, with a few new drugs in the pipeline.

New Facilities

  • ClinPhone (Nottingham, UK) announced the opening of a new office in Paris, France, which will be led by Damien Tremolet, director of operations.

  • In light of Eurofins Medinet's (Herndon, VA) positive experience opening a central laboratory in Singapore last year, the company chose Suzhou, China, as the location for its newest central lab. This year the lab, named Eurofins Medinet Shanghai, will reportedly support multiple studies spanning more than 80 investigator sites in eight cites.

  • SGS Life Science Services (Geneva, Switzerland) opened three new facilities in Prague, Czech Republic; Bucharest, Romania; and Warsaw, Poland. The offices will offer clinical trial monitoring, site selection, and study feasibility services to aid clients who want to conduct studies in Central and Eastern Europe.

  • The Woodley Equipment Company's clinical trial division has moved from its Old Station Park Buildings location to Locomotive House, Locomotive Industrial Estate, Horwich, Bolton, BL6 5UE, UK.

  • As a new subsidiary of DSG (Malvern, PA), Uttar Pradesh, India-based India Document Solutions Private Limited will serve as a site for research, development, and quality control for DSG software.

  • EMD Serono (Rockland, MA), an affiliate of Darmstadt, Germany-based Merck, looks to increase its U.S. presence with a $50 million investment in its Billerica, MA, facility. The money will allow for the establishment of a center of excellence in discovery as well as the creation of about 100 new jobs.
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