Business and News Update September 2012

Applied Clinical Trials

Applied Clinical Trials, Applied Clinical Trials-09-01-2012, Volume 21, Issue 9

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

People

• SAFE-BioPharma Association (Fort Lee, NJ) has elected Karen Bien to the board of directors. Bien, Director, Business Technology in Pfizer's Acquisition, Collaboration, and Divestiture team, will participate in leading SAFE-BioPharma's global expansion involving industry partners in governments, research institutions, and the US healthcare system in this volunteer board position.

John M. Blakeley

• Mytrus (San Francisco, CA) announced the promotion of Anthony J. Costello to CEO. He replaces Steve Cummings, MD, who is now the company's new Chief Scientific Officer and who will remain as Chairman of the Board of Directors. Costello is one of the founding members of Mytrus and previously served as its Chief Operating Officer.

G. Lynn Miesel, MD

• Ricerca Biosciences (Concord, OH) announced G. Lynn Miesel, MD, as new Technical Director. In her new role, Miesel will utilize her more than 13 years of industry experience in anti-infectives to lead projects.

• Greenphire (Philadelphia, PA) announced the appointment of John M. Blakeley to the role of Chief Commercial Officer. Blakeley will lead Greenphire's global marketing and sales strategy as the company continues to expand the adoption of its clinical payment technology platforms, the ClinCard System and the eClinicalGPS, to the pharmaceutics, medical device, and contract research markets.

Stephen Huang

• DaVita Clinical Research (DCR) (Minneapolis, MN) has hired four individuals to help expand DCR's latest clinical research facility in Denver, CO. The new team members include: Christopher Galloway, MD, Medical Director; Chad Jaeger, Senior Director of Clinical Operations; Amy Denvir, Director of Operations-Denver; and Michael Kreuter, Director of Data Management.

Jay Rothe

• Inclinix-PMG Holdings (Wilmington, NC and Winston-Salem, NC) announced changes to the executive management team. John Rubio, MD, of Raleigh Medical Group (RMG) has been appointed Medical Director of Inclinix-PMG Holdings, Inc. and will also serve as the head of the Principal Investigator Advisory Board. Jennifer Byrne has been named President and Chief Operating Officer of PMG Research, Inc. Denise Robinson has been named President and Chief Operating Officer of Inclinix, Inc.

• HRA Pharma (London, UK) has appointed Stephen Huang, MD, to the role of Medical Director for their UK and Irish Operation. Huang will be responsible for overseeing all essential medical activity such as medical information, pharmacovigilance, product quality, and code compliance.

• CRF Health (Plymouth Meeting, PA), a leading global provider of eCOA solutions for the life sciences industry announced that Mark Maietta, MBA, has been appointed as Senior Vice President for Global Business Development and as a member of the executive team. Maietta comes to CRF Health with over two decades of experience in business development, strategy, and marketing in the clinical research and pharmaceutical sectors.

• PharmaNet/i3 (Princeton, NJ), inVentiv Health's clinical segment and a provider of clinical development services to pharmaceutical, biotechnology, generic drug, and medical devices companies, announced that Robert Lasser, MD, MBA, has been appointed Vice President and General Manager, Neuroscience, overseeing the management of all clinical projects handled by PharmaNet/i3's Neuroscience group and the Rater Training Services team.

• Sitrof Technologies (Princeton, NJ) a provider of IT, consulting, and technology solutions for life sciences companies announced the addition of Jay Rothe as Vice President of Business Development.

Acquisitions

• ERT (Philadelphia, PA) announced the acquisition of invivodata, Inc., (Pittsburgh, PA) a provider of electronic patient reported outcomes (ePRO) solutions and consulting services. The transaction was facilitated by the San Francisco-based private equity group, Genstar Capital, LLC who announced that they had completed the acquisition of ERT.

Alliances

• Quintiles (Research Triangle Park, NC) and Allscripts (Chicago, IL) have entered a strategic partnership to jointly develop software solutions to enable improvements to the drug development process and demonstrate the value of biopharma products in the real world. Areas of focus include late-phase research, recruiting for and monitoring of clinical trials, and post-market surveillance.

• Horizon Discovery Ltd (Horizon) (Cambridge, UK) announced it has signed a collaboration agreement with Bayer Pharma AG (Bayer) to develop preclinical cell line models that will support Bayer's oncology research and development programs, using Horizon's prevision genome editing technology, GENESIS™. The aim of the collaboration is to deliver high quality cell lines that more accurately model the disease-relevant mutations found in human tumors.

• Pluristem Therapeutics, Inc. (Haifa, Israel) announced that in anticipation of initiating a Phase II study using PLX-PAD cells for the treatment of intermittent claudication (ic), the company has recently entered into a collaborative agreement with CPC Clinical Research for services related to enrolling and sustaining clinical sites. The partnership will leverage CPC's clinical study expertise, including patient recruitment, study monitoring, pharmacovigilance, site audits, quality assurance, biostatistics, data management, and medical writing.

• Clinipace Worldwide, (Morrisville, NC) a global research organization announced Prometheus Laboratories, Inc., a specialty pharmaceutical and diagnostic company, has awarded the company an oncology program. Immediate plans are commencing for two metastatic melanoma studies.

• ImageIQ, (Cleveland, OH) a clinic-founded contract research organization providing imaging analytics software and services, announces that it has been chosen by Histogenics, a regenerative medicine company, to provide imaging analytics for the Phase III IND clinical trial of the company's NeoCart implant. Through this multi-year partnership, ImageIQ is providing all imaging components of the trial including site training, site compliance, and image management.

Company News

• Clinical Financial Services (CFS) (Audubon, PA) will now be known as CFS Clinical. CFS Clinical has two service areas within clinical trial business management: contract and regulatory services and global payment services.

• Idis (Princeton, NJ) announced that the company has joined the RARE Corporate Alliance. As a member of the alliance, Idis will provide insight and expertise in addressing the challenges rare disease patients often face when seeking access to innovative new therapies.

New Facilities

• ExecuPharm (King of Prussia, PA) has expanded its locations to include Europe and Latin America. The new locations in Chichester, UK, and Buenos Aries, Argentina, will allow the company to meet increasing client demand on a global scale. The two new locations will serve as regional headquarters to manage a network of localized professionals.

Synexus (Pretoria, South Africa) has further expanded its global presence with the opening of a new in-patient facility in Pretoria, South Africa. The Nyeleti research facility has been developed for Phase II and III studies which involve 24-hour serial spirometry (lung function), mixed meal tolerance testing, and PK visits requiring an overnight stay or when infusion is required. The new site will support the existing Synexus clinical trial centers in Pretoria and Mamelodi.

• Patient Recruiters International, Inc. (PRI) (Carlsbad, CA) announced the opening of an office in Bangkok, Thailand. The new location gives PRI Asia central access to India, Singapore, China, Hong Kong, South Korea, Taiwan, Japan, and Indonesia.

CTI Clinical Trial and Consulting Services (CTI) (Cincinnati, OH) announces the formation of a new UK affiliate, CTI Clinical Trial and Consulting Services UK Ltd., and the opening of an office outside of London, England.

New Products

• Quintiles (Research Triangle Park, NC) introduced Allume™, a comprehensive go-to-market service to help biopharmaceutical companies launch new products and shorten timelines to peak sales, while retaining strategic and corporate control of their assets. Allume is designed to simplify and organize the complex and resource-intensive launch planning process; provides data-driven insights from 15 years of market entry experience across the globe; and taps Quintiles' local market and therapeutic category expertise.

• OmniComm Systems, Inc. (Fort Lauderdale, FL) announced the availability of TrialMaster version 4.1.2, its flagship product for electronic data capture. This latest version of TrialMaster introduces dynamic monitoring, a feature that allows organizations conducting clinical trials to reduce their monitoring costs, while showing compliance with the FDA's new draft guidance on risk-based monitoring.