Business and News Update October 2010

October 1, 2010
Kayda Norman

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-10-01-2010, Volume 0, Issue 0

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

People

Kevin K. Gordon

Michael J. Gallagher, MD

Judith Teall

Tita Jeter

• With over 25 years of experience, Kevin K. Gordon has been appointed Chief Financial Officer of Quintiles (Triangle Park, NC).

Michael J. Gallagher, MD, has been named Vice President and Global Head, Medical Affairs, at Kendle (Cincinnati, OH) where he will provide global leadership for the company's medical affairs organization. Jeffrey M. Zucker has been appointed as Senior Director and Global Head, Patient Recruitment.

Exco InTouch (Hertfordshire, UK) has hired Judith Teall to fill its newly-created position of Director of Patient Recruitment.

Copernicus Group IRB (Raleigh, NC) has made four additions to its team including Bill Van Nostrand as Vice President and Chief Business Development Officer, Tim Schuckman and Marcie Goodale as Regional Directors of Business Development, and Tita Jeter as Manager of Quality Assurance and Regulatory Compliance.

PPD (Wilmington, NC) has appointed Henrietta Ukwu, MD, as Senior Vice President of Global Regulatory Affairs.

• As Health Decisions' (Durham, NC) Chief Technology Officer, Bryan Minihan will strengthen the company's proprietary HD360° technology platform.

• Previously the Senior Therapeutic Director for Oncology at i3, Jane Bentley, PhD, has joined Novella Clinical (Research Triangle Park, NC) as Vice President, Clinical Operations.

CRF Health (Plymouth Meeting, PA) has hired Bonnie Teschendorf, PhD, as Patient Reported Outcomes Scientific Advisor where she will lead CRF Health's PRO consulting initiative providing scientific insight and guidance to clients and internal staff, as well as to the global clinical trial sector.

Anthony Maida, PhD, will lead PharmaNet Development Group's (Princeton, NJ) oncology team in his new role as Vice President, Clinical Research.

Carlos Martínez Manchado has joined Ricerca Bioscience's (Concord, OH) Analytical Chemistry department.

• Leading sales, marketing, and business development strategies for late stage business, Evelyn Graham will use her previous drug development experience as Worldwide Clinical Trials' (King of Prussia, PA) Executive Vice President, Global Business Development.

Biomedical Systems (St. Louis, MO) has promoted Shanin Hagene to the position of Director of Contracts and Budgets where she will supervise a team of contract specialists in the St. Louis and Brussels offices, and Steven De Hertefelt has been hired to the position of Business Development Director, Europe.

Synexus (Manchester, UK) has made several changes to its executive management team with the appointment of Christophe Berthoux, MD, as Chief Executive.

• Bringing with her more than 20 years experience, Julie Heneghan has been appointed Vice President of Advanced Clinical (Bannockburn,IL).

Stuart Mudge, PhD, has been appointed Global Regulatory and Clinical Affairs Manager by HalcyGen Pharmaceuticals (Melbourne, Australia).

CTI Clinical Trial and Consulting Services (Blue Ash, OH) promoted Nick Schatzman to Business Development Associate. Timothy Bockerstette has joined as Director, Business Development Operations.

Alliances

  • PPD (Wilmington, NC) and Microsoft (Redmond, WA) have entered into an agreement to jointly implement a technology solution designed to improve efficiency in managing Risk Evaluation and Mitigation Strategy programs by using Microsoft Amalga Unified Intelligence System and Microsoft HealthVault.

  • BioClinica (Newtown, PA) has created strategic partnerships with Axio Research Corporation (Seattle, WA) and Beardsworth Consulting Group (Flemington, NJ) to strengthen the BioClinica Certified Partner Program and provide customers with additional support in therapeutic areas of study and data monitoring and management.

  • Anavex Life Sciences (Califon, NJ) has signed a master services agreement with Genesis BioPharma Group (Hoboken, NJ) and ABX-CRO Advanced Pharmaceutical Services (Dresden, Germany) to begin clinical studies and regulatory filings for ANAVEX 2-73, its lead compound for the treatment of Alzheimer's Disease.

  • Clearstone Central Laboratories (Toronto, Canada) has created a global collaboration with LabCorp through its Esoterix Clinical Trials Services (Cranford, NJ) division, providing clients with access to CAP-accredited laboratories across both. Under the agreement, clients of each company will be able to access LabCorp's assay portfolio and Clearstone's central laboratory protocol management system: APOLLO CLPM.

  • Argint International (Budapest, Hungary) and Brookwood International Academy (Surrey, UK) have entered into a strategic partnership giving Argint exclusive distribution rights for the Academy's training courses throughout Central and South Eastern Europe.

  • The Institute of Clinical Research (Buckinghamshire, UK) has entered into a collaboration with the Pan-Asian Clinical Research Association (PACRA) (Singapore), which allows ICR to expand its global presence in the Asia Pacific region by letting the company provide research and training to PACRA members research professionals across the region. As part of the agreement, the ICR's members' journal CRfocus will be produced quarterly and rebranded as "Silk Route" for the Asia Pacific members via the PACRA website.

Awards

  • MedNet Solutions (Minnetonka, MN) and Nextrials (San Ramon, CA) have been named to the Inc. 5000 list, a listing compiled annually by Inc. Magazine, recognizing America's fastest-growing private companies, for the fourth year in a row.

  • Rho (Chapel Hill, NC) has been designated as one of the 50 most family-friendly places to work in North Carolina for 2010 by Carolina Parent Magazine.

  • PPD (Wilminton, NC) has established preferred provider relationships with a network of sites including Commonwealth Biomedical Research (Madisonville, KY), CNS Network (Los Angeles, CA) and Lovelace Scientific Resources (Albuquerque, NM), in order to conduct Phase I trials to meet growing client demand for these services.

Company News

  • A new clinical service provider, FlexCare Clinical Research (Chicago, IL), has formed to provide study visits in the home or other alternate site settings through a network of clinicians.

  • CRF Health (Plymouth Meeting, PA) has launched an Inventory Management Program that offers device buyback options, third-party brokerage services to transfer devices between clients, new equipment for long-term investment, reconditioned equipment to reduce the upfront costs, refurbishing services on both client owned devices and newly acquired devices, and leasing options. The company has also recently completed the ePRO vendor certification program for use with the EXAcerbations of Chronic Pulmonary Disease Tool, a patient-reported outcome measure designed to standardize the method for evaluating the frequency, severity, and duration of acute exacerbations of chronic obstructive pulmonary disease and chronic bronchitis in the United States, as well as international based studies and clinical trials.

  • Quay Pharma (Derby, UK) has been appointed by a Japanese pharmaceutical company to handle the clinical trial drug manufacture of two NCEs for UK trials, which marks the first time the Japenese company has outsourced clinical trials manufacture to a European company.

  • US Oncology (Woodlands, TX) has played a role in the development of 42 novel cancer therapies approved by the US Food and Drug Administration, assisting most recently with Tasigna capsules, a medicine developed by Novartis.

Mergers/Acquisitions

  • To expand its biopharmaceutical development services globally, the Halifax Group (Washington, DC) and SV Life Sciences (Boston, MA) have made a series of acquisitions including ClinResearch (Nordrhein-Westfalen, Germany), ADDPLAN (Cologne, Germany), and Fulcrum Pharma (Hertfordshire, UK).

  • Medco Health Solutions (Franklin Lakes, NJ) acquired United BioSource (Bethesda, MD) for approximately $730 million.

  • Oracle (Redwood Shores, CA) has completed its acquisition of Phase Forward (Waltham, MA).

New Facilities

  • Expanding its services in Asia, Marken (London, UK) has opened a branch in Tokyo, Japan.

  • CRF Health has opened a new 4,200 square foot warehousing facility in Philadelphia, PA, coinciding with the relocation of the U.S. corporate offices to Plymouth Meeting, PA.

  • Cetero Research (Cary, NC) has expanded multiple Clinical Dermatology and Transdermal Delivery System services to four Cetero clinical facilities located in Miami, FL; St. Louis, MO; Toronto, Ontario; and Fargo, ND.

Products

  • Schreiner MediPharm (Munich, Germany), a provider of specialty pharmaceutical labeling solutions, has introduced a translucent, self-adhesive film to neutralize color differences between placebo and drug solutions used in clinical trials.

  • Cytel (Cambridge, MA), a provider of adaptive clinical trial design services and software, has released Compass, a software package for adaptive dose-finding studies based on frequentist or Bayesian methods.

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