Business and News Update July 2011

People

• Michael Lytton, Biogen Idec's former EVP of Corporate and Business Development, was appointed as EVP of Corporate Development and Strategy and General Counsel at Patheon (Research Triangle Park, NC), a global provider of contract development and manufacturing services to the global pharmaceutical industry.

Michael Lytton

• Copernicus Group IRB (Research Triangle Park, NC) has appointed Yvonne Higgins as the newest addition to the senior management team as Director, Quality Management.

Yvonne Higgins

• Bringing with him more than 25 years of experience in all operational aspects of clinical trial planning, execution, and delivery, Ronald Kershner, PhD, was named Premier Research Group's (Philadelphia, PA) Vice President, Biostatistics and Data Operations for North America.

Ronald Kershner, PhD

• ICON has appointed Elizabeth Thomas as Vice President and General Manager of ICON's Bioanalytical Operations in Manchester, UK.

Elizabeth Thomas

• The European CRO Federation (Rome, Italy) has elected a new executive board for a two-year term and includes Stefano Marini, MD (Italy), President; Dagmar Chase, PhD (Germany), Vice-President; Ana Jurczynska, PhD (Spain), Treasurer; Tanja Hoffman (The Netherlands), Secretary; and Hubert Mechin, MD (France), Board Member.

• Craig Lipset has been appointed Pfizer's (College-viille, PA) Head of Clinical Innovation where he will work across Development Operations' stakeholders to help define Pfizer's vision for the future of clinical trials.

• Almac's (Craigavon, Northern Ireland) Clinical Technologies business unit announced that Todd Kole has joined the company as Vice President of Clinical Project Services and as a member of the Executive Leadership Team where he will oversee clinical project management and drug supply services globally.

• Succeeding Gerard Barba, Wesley P. Wheeler was selected as Chief Executive Officer for Marken (London, UK). Barba will remain the Chairman of the Marken Board of Directors.

• Novella Clinical (Research Triangle Park, NC) has hired Nick Dyer as Executive Vice President, Global Business Development.

• Synexus (Manchester, England) has appointed Alison Martin as Vice President, International Projects.

• TAKE Solutions (Princeton, NJ) has strengthened its leadership team with the addition of two new executives including Matt Walker as Executive Vice President of Supply Chain Business, and Mike Lewis as Vice President of Sales.

• John Larson has joined CRF Health (Plymouth Meeting, PA) as Chief Operating Officer. In this role, Larson will be responsible for global operations and lead the client services, logistics and help desk functions.

• With over 14 years of experience in developing and directing a variety of drug and device development programs, Harman Dubé has been selected as Vice President of Ockham's (Cary, NC) Pre-Clinical and Regulatory Affairs group within the OckhamCRO division.

Alliances

• ICON (Dublin, Ireland) has formed a strategic alliance with Boston Clinical Research Institute (BCRI) (Boston, MA) that will combine BCRI's leadership in clinical strategy, study planning, and academic relationships with ICON's experience in the execution of global clinical trials.

• Velos (Fremont, CA) has entered into an agreement with The University of Texas MD Anderson Cancer Center (Houston, TX) where the center will use Velos eResearch for its clinical studies.

• Evofem (San Diego, CA) chose Health Decisions' (Durham, NC) strategic development division for a global female contraceptive study that will involve 60 sites and 2,800 patients.

• Medidata Solutions (New York, NY) announced Logos Technologies (London, UK) as a Medidata Technology Partner.

Awards

• At the 2011 Association of Clinical Research Professionals (ACRP) Annual Awards, ACRP (Seattle, WA) awarded the Outstanding Leadership in Clinical Research Leadership as a Clinical Research Coordinator to Deborah Sibley, Clinical Research Coordinator for Emergency Medicine at Louisiana State University Health Sciences Center (Shreveport, LA), the Leadership as a Clinical Research Associate award to Paul Below, ACRP Credentialed Trainer, Clinical Research Consultant, and GCP Trainer with P. Below Consulting (Burnsville, MN), and the Leadership as a Project Manager award to Shada Sayegh, ClinArt International (Dubai, United Arab Emirates). In addition, James DeSanti, Chief Executive Officer and Founder of PharmaVigilant (Westborough, MA) won the Innovation in Clinical Research Award, and Laurin Mancour, Program Director and Clinical Trials Research Associate with the Durham Technical Community College (Durham, NC), was awarded the Advancing Awareness in Clinical Research award. William C. Waggoner, former Chair of the ACRP Association Board of Trustees, posthumously won the Chairperson's Award.

• ClearTrial (Chicago, IL) has been included in the list of "Cool Vendors" in the "Cool Vendors in Life Sciences, 2011" report by Gartner, Inc.

Company News

• Health Decisions (Durham, NC) has created a strategic development division that aligns the interests of pharmaceutical companies, medical device companies, physicians, and patients with a risk sharing model that accelerates clinical development through incentive-based performance and fixed-price investments.

• Biovista (Charlottsville, VA) announced that its EU affiliate has been awarded a prestigious grant worth $500,000 for research and development in the area of personalized medicine.

• DaVita Clinical Research (Minneapolis, MN) announced its Health Economics and Outcomes Research services. DCR's Health Economics and Outcomes Research services include strategic consulting, economic modeling, epidemiology, biostatistics, prospective study design, execution, analysis, disease management design, execution, and evaluation, among others.

• Clearstone Central Laboratories (Toronto, Canada) announced that SAS (Cary, NC) has recently published a customer success story that features the extensive history between the two companies working alongside each other to accelerate clinical trials with clean, on-time data.

Mergers/Acquisitions

• INC Research (Raleigh, NC) and Kendle International (Cincinnati, OH) jointly announced a definitive merger agreement under which INC Research will acquire Kendle in an all-cash transaction with a total equity value of approximately $232 million.

• Clinipace Worldwide (Morrisville, NC) and PFC Pharma Focus (PFC) (Zurich, Switzerland) jointly announced a definitive merger agreement under which Clinipace Worldwide has acquired all outstanding shares of privately-held PFC and its subsidiaries.

New Facilities

• CTI Clinical Trial and Consulting Services (CTI) (Cincinnati, OH) announced the formation of CTI Clinical Trial and Consulting Services Spain, SL. This new office location in Madrid will allow CTI to better meet the needs of its sponsors throughout Europe.

• Quotient Clinical has completed a major expansion of its clinical facilities in Nottingham, UK. The bed capacity has been increased by 50 percent and a dedicated sample processing laboratory for human ADME studies has been incorporated.

• Phlexglobal (Bucks, UK) has opened a new office in Philadelphia, PA to meet the growing demand for its services across the North American territory.

• Vetter's (Ravensburg, Germany) new facility, Ravensburg Vetter West, has been completed within 11 months of ground breaking.

• The Almac Group celebrated the official grand opening of its new North American Headquarters in Souderton, PA. The $120 million, 240,000-square-foot new North American headquarters houses more than 800 employees.

Products

• StudyManager (Seattle, WA) has released Reveal 3.2 with enhanced features that aim to provide greater ease of use and performance for research sites, academic medical centers, and hospitals.

• Oracle (Redwood Shores, CA) announced the availability of Oracle® Argus Safety 7.0, an integrated global adverse events management and regulatory reporting solution, that reduces the need for ongoing maintenance and features new capabilities, such as standardized configurations and rules management, as well as centralized coding-dictionary management.

• ICON (Dublin, Ireland) announced the release of a new version of NONMEM, ICON's non-linear, mixed effects modeling tool for Population Pharmacokinetic/Pharmacodynamic data analysis including new enhancements such as parallel computing of a single problem over multiple cores or computers. ICON also launched a new Cytometry Service offering clients two types of services to better support the testing requirements and development phase of a client's compound.

• Clinical Financial Services (Philadelphia, PA) has released Site Activation Services, a new service which includes regulatory document collection and management as well as global investigator budget and contract management, that will streamline and automate the trial activation process and minimize financial risk for clinical trial sponsors, CROs, and investigative sites.