Business and News Update August 2012

People

• Drug Safety Alliance, Inc., (Research Triangle Park, NC) a pharmacovigilance services provider, has announced the addition of industry veteran Michael Pierce, MBA, RAC, as Chief Compliance Officer. In his new role, Pierce will oversee DSA's Quality and Regulatory Compliance and Risk Management teams. Pierce has more than 35 years of government and industry experience in regulatory and quality compliance.

Michael Pierce

• ACM Global Central Lab (Rochester, NY) announced that Mark Engelhart has joined the executive management team as Chief Commercial Officer. Engelhart will be responsible for leading business development, proposals and contracts, marketing, and sales activities worldwide. Prior to joining ACM Global, Engelhart was Chief Commercial Officer at Cryoport, Inc. a provider of leading-edge cold chain logistics services.

Mark Engelhart

• ICON (Dublin, Ireland)has made two senior appointments in Early Phase and Epidemiology & Risk Management departments. Pui Man Leung, MD, has joined ICON as Senior Clinical Research Physician at the Clinical Pharmacology Unit in Manchester, UK. Leung joins the company with over 23 years of hospital and pharmaceutical industry experience in a variety of medical specialties including diabetes, endocrinology, and general medicine. Susan Anton has been appointed Director, Epidemiology and Risk Management Practice, ICON Late Phase & Outcomes Research. Anton has over 25 years of experience leading international epidemiologic, health economic, and outcomes research, and other market access initiatives.

• Camargo Pharmaceutical Services (Cincinnati, OH), an end-to-end drug development service provider specializing in the 505(b)(2) process, has appointed K. Gary Barnette as Vice President of Drug Development. Barnette will be responsible for the growth of the company and excellent customer service utilizing his experience within the drug development industry and his knowledge of FDA regulations. He will be stationed in the Durham, NC office.

K. Gary Barnette

• Nathalie Doize has joined REGISTRAT-MAPI (Lyon, France) as Vice President, Clinical Operations for REGISTRAT-MAPI EU. Working as a key member of the organization's executive leadership, Doize will assume responsibilities for clinical operations in Europe and affiliated territories. She will be responsible for the strategic development and functioning of international operations to ensure that growth, profitability, quality, and customer service goals are achieved.

Acquisitions

• CROMSOURCE (Verona, Italy), an international full-service CRO has acquired Pleiad, an established international CRO with offices in the United States (Cambridge,MA) and the United Kingdom (Stirling, Scotland). Pleiad was launched in 1999, supporting clients in multiple therapy areas and with dedicated medical device and ophthalmology divisions. Additionally, Pleiad also possesses strong capabilities within statistics and data management.

Alliances

• A consortium of investors led by Frontier Capital (Wilmington, NC) has funded the strategic merger of Inclinix, Inc. with PMG Research Inc., creating an organization designed to accelerate clinical trial enrollment from beginning to end: Inclinix-PMG Holdings, Inc. The company will be led by J. Tobin Geatz, President and CEO, and Jeffrey Reiniche, CFO. The company will operate in the short term as two divisions.

• Anderson Packaging (Rockford, IL), a pharmaceutical, clinical, and commercial contract packager in the United States, and Brecon Pharmaceuticals (Hey-On-Wye, UK), a leading supplier of pharmaceutical commercial packaging and clinical supply services in the United Kingdom, are further aligning their businesses to become a global end-to-end pharmaceutical packaging company. AndersonBrecon will feature 12 facilities across two continents, and more than 1,500 dedicated associates who will work to provide medications to patients in more than 100 countries around the world.

Awards

• Greenphire (King of Prussia, PA), a provider of payment technologies for the clinical trials industry, has been awarded the Philadelphia Alliance for Capital and Technologies Enterprise Award in the Technology Startup Division. Greenphire and other Enterprise Award winners and finalists were recognized at the 19th Annual Enterprise Awards gala in front of 1,200 prominent business leaders in May in Philadelphia. The Enterprise Awards honor exceptional technology and life sciences companies and entrepreneurs in the greater Philadelphia region each year.

• Clinical Ink (Horsham, PA), a provider of eSource solutions for clinical trials, was named to the Gartner's prestigious 2012 Cool Vendor List for life sciences. Gartner cited the potential to eliminate errors, cut costs, reduce timelines, and simplify clinical trial processes as reasons to include Clinical Ink this year. Clinical Ink is the only company on the list to focus exclusively on clinical operations.

• PharmaNet/i3 (Princeton, NJ), inVentiv Health's clinical segment, and a leading provider of clinical development services to pharmaceutical, biotechnology, generic drug, and medical device companies has been named the recipient of the US Chinese Anti-Cancer Association (USCACA) Distinguished Partner Award for its support of oncology clinical trials and cancer research in China. USCACA is a non-profit organization that facilitates collaborations among cancer researchers and physicians in the United States and China.

Company News

• TransPerfect (New York, NY), a provider of eClinical technologies to the life sciences industry, announced that INC Research (Raleigh, NC), a therapeutically focused CRO, has selected Trial Interactive as its global electronic trial master file solution. Trial Interactive is a secure, web-based platform that reduces the redundancies inherent in paper-based TMF management. Trial Interactive's interface is available in more than 20 languages, which will enable INC Research to deploy the solution in the local language of the end user.

• The Ethical Standards in Health and Life Sciences Group (London, UK)has published a new series of Clinical Trial Transparency Principles and Facts. This is the first time that leading healthcare professional bodies and senior representatives of the pharmaceutical industry have agreed to a joint approach on this issue. This is a step forward in the ongoing move across the entire research community to drive best practice in clinical research reporting.

New Facilities

• Clinilabs (New York, NY), an early phase and specialty CRO that provides clinical drug development services to the pharmaceutical industry, has opened a second Phase I unit in Southern New Jersey. The 50-bed capacity, 15,000 square foot specialty pharma Phase I unit features semi-private rooms, a large PK sampling facility, a bioanalytic laboratory, pharmacy, and exam rooms.

• CTI Clinical Trial and Consulting Services (Cincinnati, OH) has announced the formation of a new, wholly-owned French subsidiary, CTI Clinical Trial and Consulting Services SARL, and the opening of an office in Paris, France. The new location continues the company's expansion throughout Western Europe. CTI has been working for more than a decade in the drug development industry in North America, Europe, and South America, specializing in clinical research programs involving critically ill patient populations.

• PRA (Raleigh, NC), a leading clinical research organization, announced the expansion of operations in the Netherlands and the United Kingdom to accommodate staff growth and strong client demand for Phase IIa-IIIb service offerings. Located in the thriving city of Utrecht, NL, the new Dutch facility will host 20-plus employees and is the first PRA office in that region to primarily support product registration trials.

• Roowin SA (Riom, France), a CRO that provides fine chemistry services, has moved into new premises in Riom, near Clermont-Ferrand, in the Auvergne region. The move will strengthen Roowin's position as one of the few companies in France that offers a comprehensive range of services, from early-stage research to the production of GMP batches for Phase I and II clinical trials.

Products

• MedPoint Digital (Evanston, IL), a digital services provider to the global biopharma industry, has released a new generation of eClinical technologies for mobile devices. The new mobile-friendly platforms deployed by MedPoint include: TriPort Clinical Trial Portal, a secure, fully validated technology that delivers study-specific information, training, and communications; TelePoint Virtual Meeting System, which simultaneously connects participants from desktop computers, smartphones, and tablets; ActivMedia Modules, which engages users for self-learning, real-world simulations, and training certification; SFX Site Feasibility Xelerator, can complete survey forms over mobile devices.

Correction: In the July news section, the article "Managing Budgets in Complex Times with Tight Variances" was published with inaccuracies. Please visit www.appliedclinicaltrialsonline.com/budgets for the correct version.