Business and News Update April 2011

People

With over 20 years experience in computer compliance, business development, and consulting within the pharmaceutical industry, Colin Goddard has been appointed General Manager at the newly opened Plexys facility in Amsterdam, The Netherlands.

Colin Goddard

INC Research (Raleigh, NC) has made several new appointments including Patrick Melvin as Executive Director of Oncology, and Bruce Wakeman as Vice President of Alliance Development. David Gill, formerly of Transenterix, has also joined the company's executive team.

Jeffrey Freitag, MD, Senior Vice President, PharmaNet Consulting, will expand his role to become Chief Medical Officer of PharmaNet Development Group (Princeton, NJ) where he will be the senior medical representative for the company and provide guidance to physicians who are involved in designing and monitoring Phase I through Phase III clinical trials.

David Gill

CTI Clinical Trial and Consulting Services (Cincinnati, OH) has promoted Catherine Close to Director, Business Development and Client Management and has promoted Meredith Boley to Regulatory Specialist I. David Flick has also joined as an Information Technology Support Specialist.

Jeffrey Freitag, MD

Bringing with him over 10 years of recruitment experience, Quanticate People (London, UK) has appointed Richard Ellis as General Manager.

The European Federation of the Pharmaceutical Industries and Associations (Brussels, Belgium) has selected Richard Bergström as its new Director General.

Bruce Wakeman

Ockham (Cary, NC) has promoted Michael Enright from Chief Financial Officer to President of its OckhamCROTM division where he will provide senior-level leadership and perspective to pharmaceutical, biotechnology, and medical device clients for the company's Phase I-IV clinical operations globally.

Dmytro Razborov has been appointed Regional Director of Synexus' (Manchester, UK) Ukraine with responsibility for operations and business development.

Kendle (Cincinnati, OH) has announced that beginning May 1, Senior Vice President and Chief Operating Officer Stephen Cutler, PhD, will become the company's next President and Chief Executive Officer. Chairman and CEO Candace Kendle, will continue to serve as Chairman. In addition, Jamie Macdonald will take on the position of Senior Vice President and Chief Operating Officer.

Accelovance (Rockville, MD) has made two additions to its senior management team including Joseph W. Angle, Jr. as Chief Financial Officer and Lisa Beth Ferstenberg, MD, as Chief Medical Officer.

Robert DiLaura, PhD, Eliot Siegel, MD, and Kiyoteru Takenouchi, PhD, have been appointed Board of Directors for CDISC (Round Rock, TX), each for a three-year term.

ClinTec International (Glasgow, UK) has promoted Stuart Grant, PhD, into the newly created role of Associate Director of Regulatory Affairs and Medical Writing.

Cytel (Cambridge, MA), a provider of clinical trial design and implementation services and software, has announced the addition of Jim Baker, formerly Senior Director at Study Standards Implementation at Millenium, as the company's Vice President, Clinical Research Services.

Alliances

• Elan (Dublin, Ireland) and PPD (Wilmington, NC) have formed a global business collaboration focused on the advancement, progression, and execution of Elan's development portfolio.

• Samsung Group (Seoul, South Korea) has formed a $266 million venture with Quintiles Transnational (Durham, NC) to make biologic drugs as it seeks new businesses to drive growth.

• Ricerca Biosciences (Concord, OH) and Fulcrum Pharma (Morrisville, NC) have entered into a collaboration to provide value-added capabilities to biopharmaceutical companies by creating a streamlined and efficient process to move a candidate from development to clinical evaluation.

• Medidata Solutions (New York, NY) and ViroPharma (Exton, PA) have extended their agreement to use the Medidata Rave electronic data capture and clinical data management platform for another multi-year period.

Awards

• Quintiles (Research Triangle Park, NC) has been recognized as one of the top organizations in the world for workforce training and development excellence with its inclusion in Training Magazine's "Training Top 125" for the third year in a row.

• The staffs of Chiltern International (Wilmington, NC) and Spectratox (Dundee, UK) celebrated the 25-year mark of working together using a validated and regulatory accepted in vivo human study method for the assessment of drug phototoxicity.

• Eight organizations have been awarded full accreditation from the Association for the Accreditation of Human Research Protection Programs including Central Arkansas Veterans Healthcare System (Little Rock, AR), Children's National Medical Center (Washington, DC), Guthrie Healthcare System (Sayre, PA), Mayo Clinic (Rochester, MN), Minneapolis Medical Research Foundation (Minneapolis, MN), The Rockefeller University (New York, NY), Wake Forest University Health Sciences (Winston-Salem, NC), and William Beaumont Hospital (Royal Oak, MI).

Company News

• German Federal Minister of Economic Cooperation and Development toured Vetter's (Ravensburg, Germany) South facility during a regional tour.

• Almac's (Craigavon, Northern Ireland) Diagnostics business unit today announced the launch of its Bioinformatics Consultancy service that will support discovery and development of biomarkers as well as enable an in-depth understanding of biology by partnering with customers in the pharmaceutical, biotech, and diagnostics setting from the initial study design through to the interpretation of data results. The company has also added two fully automated inline wallet press machines to its Craigavon and Pennsylvania locations to reduce the timelines associated with the use of blister card packaging.

• Health Decisions (Durham, NC) has received Safe Harbor Certification that recognizes that Health Decisions meets or exceeds directives of the European Union for data privacy and protection.

• Max Neeman International (Research Triangle Park, NC) has established a team of experts specialized in carrying out rare disease trials in response to sponsor demand.

• Celerion (Lincoln, NE) has completed a clean room and pharmacist certification to comply with USP 797 guidelines that enables in-house preparation for microtracer studies providing an alternative to the requirement for GMP manufacturing of the IV solution.

• Association for Assessment and Accreditation of Laboratory Animal Care has awarded full accreditation to Covance's (Princeton, NJ) early development research facility in Shanghai, China.

New Facilities

• INTERLAB (Munich, Germany) is opening a new lab facility in Shanghai, China, mid 2011.

• ClinPharm Consulting has moved into new offices in Research Triangle Park, NC and is hiring more employees to accommodate an expanding portfolio of clients and projects.

• Marken (London, UK) has opened a directly owned clinical trial supply depot in Singapore.

• ACM Global Central Laboratory's (Rochester, NY) specimen processing department at its US site has moved into a new 7,200 square feet facility.

Products

• Phlexglobal (Buckinghamshire, UK) has announced the launch of PhlexEview version 3, the third generation of its electronic Trial Master File solution. The new version features an enhanced client-interface platform, system integration, and the option of a "software as a service" model.

• Comprehend Clinical (San Francisco, CA) released version 1.0 of its first product Comprehend Clinical, a new enterprise reporting and visualization software package specifically for clinical trials that runs against multiple databases in real time, while leaving the data in place.

• Oracle (Redwood Shores, CA) has announced the availability of Oracle Health Sciences Central Coding Release 3.0. The third generation of the web-based clinical trial data coding and dictionary management application includes expanded query management and automated workflows that help clinical trial sponsors and contract research organizations improve the efficiency and consistency of the coding process.