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Industry news focusing on the people and organizations who work in the clinical trials profession.
• BBK Worldwide (Newton, MA) named four additional principals who, together, will assume a minority ownership in the company. Matthew Kibby, Rob Laurens, Liz Ritchie, and Matthew Stumm have played key roles in shaping the company. As principals, they will partner with BBK's founding principals Joan F. Bachenheimer and Bonnie A. Brescia to maintain the company's core mission and values.
• Pharmaceutical Product Development, LLC (PPD) (Wilmington, NC) announced the appointment of Jay Dixon as Senior Vice President, Global Quality and Compliance. Dixon's experience will enhance PPD's ability to deliver quality drug development services and high-quality data across the full spectrum of the research and development lifecycle. Dixon is a member of the Drug Information Association and the Society of Quality Assurance.
• Chiltern International Limited (London, UK and Wilmington, NC) announced the promotions of Stuart McGuire to the position of Vice President, Global Business Development, and Jim Szymeczek to the position of Vice President, Global Information Technology and Systems. McGuire has been with Chiltern for more than 12 years and has led the Global Business Development team since 2009. McGuire will also join Chiltern's Group Executive Board. Szymeczek has more than 22 years of data and analytical science experience and joined Chiltern in 2006. In Szymeczek's new role, he will oversee and provide strategy for the global IT team in its three structural areas: IT operations, clinical systems, and commercial systems. Additionally, Szymeczek will be involved with technology related partnerships and sponsor activities.
• Theorem Clinical Research (King of Prussia, PA), a full-service contract research organization that provides core clinical research and development services, announced the appointment of Sara Davis as Vice President of Global Business Development. Davis will be responsible for driving strategic business development growth plans for Theorem in all regions of the world.
• Cleveland BioLabs (Buffalo, NY), a clinical-stage biotechnology company leveraging deep mechanistic understanding of the cell death process, apoptosis, to develop a robust pipeline of compounds primarily focused on oncology applications and mitigation of radiation injury, announced the appointment of key clinical development and regulatory affairs executives. Jean Viallet, MD, has joined the company as Chief Development Officer, and will be responsible for overseeing CBLI's clinical strategy, trials and operations, regulatory affairs, and preclinical development. Gillian Miller, PhD, was appointed as Senior Director of Regulatory Affairs, and Judith Schnyder, MBA, joined as Director of Clinical Operations.
• ACM Global Central Lab (Rochester, NY) announced that Timo Jackle has joined the executive management team as Vice President of Clinical Trials Operations. Jackle will be responsible for overseeing project management, data management, study support, specimen management, and logistics activities for all of ACM Global's US-based clinical trials, as well as developing and implementing its strategy for operations globally.
• DAC Patient Recruitment Services, (Dallas, TX) an Imperial company in patient recruitment and retention for global clinical trials, appointed Gwen Welty as Director of Project Operations. Welty will be responsible for identifying new business opportunities, building strategic partnerships, and managing existing client relations. A seasoned biopharmaceutical professional, she brings more than 16 years of regulatory, preclinical, clinical, and sales experience to the DAC team.
• Aptuit, LLC (Greenwich, CT) announced the appointment of two new members to its Executive Leadership team. Kurt Dinkelacker has been named Executive Vice President and Chief Financial Officer, and Kevin Duffield has been named Vice President, Sales and Business Development.
• The Avoca Group, (Princeton, NJ) a consulting and research organization specializing in clinical outsourcing and alliance management, announced the appointment of Danya Burakoff as Senior Manager of Member and Client Engagement. In her new role, Burakoff will focus primarily on member recruitment and engagement for The Avoca Quality Consortium and be an integral part of the Consortium and Summit planning team.
• Premier Research (Philadelphia, PA) has appointed Kimberly Hunsicker to spearhead the global expansion of its D-TARGET medical devices and diagnostics unit. D-TARGET was formed in 1997 and acquired by Premier Research in 2007. Since then, it has conducted more than 340 clinical research projects and recruited 35,000 patients.
• inVentiv Health (Burlington, MA) announced a strategic alliance with Bell Medical Solutions, one of Japan's clinical research organizations with more than 700 clinical research associates serving the growing Japanese market. Bell, a preferred service provider to some of Japan's top pharmaceutical companies, offers CRO services that cover Phases I-IV, post-approval studies, and patient access. Together, inVentiv and Bell aim to offer comprehensive global drug development services to Japanese and international clients conducting studies in Japan.
• The Association of Clinical Research Professionals (ACRP) (Orlando, FL) and the Academy of Physicians in Clinical Research (APCR) presented their respective 2013 Annual Awards recognizing individual excellence in a variety of clinical research enterprise settings at the ACRP 2013 Global Conference & Exhibition in Orlando, FL during a joint reception. The award for Outstanding Leadership in Clinical Research recognizes individuals who are active as clinical research coordinators, clinical research associates, and/or project managers, and who have made exceptional leadership/practice contributions that have furthered the vision and mission of ACRP. One award recipient has been chosen in each of the Outstanding Leadership categories for 2013: Leadership as a CRC was awarded to Ann Rutledge, MA, CCRC, Manager of Quality Assurance and Senior Clinical Research Coordinator for Benchmark Research in Austin, TX. Leadership as a CRA was awarded to Leslie Ann Kemp, RN, BSN, BA, CCRC, CCRA, Senior Clinical Trial Monitor for Roche in Reisterstown, MD. Leadership as a Project Manager was awarded to Wendy Boone, RN, MPH, CCRC, CCRA, Remote Project Manager and Clinical Research Associate II for ClinicalRM in Delta, OH. Innovation in Clinical Research was awarded to AprilMayberry, RAC, CCRP, CFPHW, CCRA, Vice President for Regulatory Affairs, International Services Fund in Research Triangle Park, NC. Advancing Public Awareness in Clinical Research was awarded to Debbie A. Waldrop, MSN, RN, CCRC, Professor in the Tyler Junior College Associate Degree in Nursing Program and part-time Research Consultant, Ben Wheeler in Texas. The APCR awarded Outstanding Physician Leadership in the Profession to Jonathan Seltzer, MD, MBA, FACC, President and CEO of Applied Clinical Intelligence, LLC, in Bala Cynwyd, PA.
• ERT (Philadelphia, PA) announced a series of upcoming industry conferences and company-sponsored events that will feature presentations by members of the company's scientific and regulatory teams. For information on these events and other opportunities to meet with the ERT teams, visit www.ert.com/news-events.
• Radiant Research (Cincinnati, OH) launched a new website with full details of its services, including dermal safety patch testing, cumulative irritation studies, and phototoxicity and photoallergy studies. Visit the new site at http://bit.ly/YZQm1U.
• ICON, plc, (Dublin, Ireland) in conjunction with the University College of Dublin announced the launch of the ICON Business Academy. Developed with the UCD Michael Smurfit Graduate Business School, the ICON Business Academy offers a number of tailored, university-accredited programs to ICON staff, the first of which is the Certificate in International Business Management which launched in April. The Certificate Program focuses on areas of increasing importance for companies operating in global markets such as managing and motivating teams across international boundaries and promoting a culture of innovation. Having launched the Academy in Dublin, future plans for the ICON Business Academy include expansion to other locations such as Asia Pacific and the United States
• BioClinica, Inc. (Newtown, PA) announced the immediate availability of BioClinica Express EDCplus. Through the web-based EDCplus program, sponsors and CROs personnel can now directly build their own Express EDC (electronic data capture) studies. The program aims to offer full access to the same system that BioClinica created to build thousands of studies over 15 years, without compromising on power or performance.
• Pharmaceutical Product Development, LLC (PPD) (Wilmington, NC) introduced PPD InVision, a data solution that consolidates and standardizes data from multiple sources, giving clients real-time access to their clinical trial data. PPD InVision's complete, end-to-end clinical data management capabilities provide clients increased visibility to study data, creating time and cost efficiencies. The dashboards provide interactive visualizations of operational and patient data, giving clients and PPD teams the ability to identify trends and drill down into the data for detailed information.