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New Healthcare-related Products, Services, and Companies Featured Briefs: TGaS Model Helps Solve Managed Markets Staffing Dilemma Razorfish Launches Independent, Dedicated Health Division FDA, NIH Collaborate to Speed Release of Medical Innovations Sidebar: On The Shelves PSKW Adds Loyalty Relationship Portfolio PharmaTelevision Expands Biopharma Media Service Offerings Sidebar: Around the Globe Follow Up THE FOOD AND DRUG ADMINISTRATION is the federal agency responsible for ensuring the safety of foods, cosmetics, human and veterinary drugs, biological products, and medical devices sold in the United States. For more information, visit fda.gov. THE NATIONAL INSTITUTES OF HEALTH, part of the U.S. Department of Health and Human Services, is the federal agency for conducting and supporting medical research. For more information, visit nih.gov. PHARMATELEVISION LTD. is an online biopharma-focused TV channel that offers daily television news, analysis, and feature interviews with industry leaders. For more information, visit pharmatelevision.com. PSKW AND ASSOCIATES is a loyalty-relationship marketing company serving the pharmaceutical industry. For more information, visit pskw.com. RAZORFISH, part of Publicis Groupe, is an interactive marketing and technology company. For more information, visit razorfish.com. TGAS ADVISORS provides benchmarking and advisory services to the pharmaceutical and biopharma industries. For more information, visit tgas.com. ACM GLOBAL CENTRAL LABORATORY is expanding its lab services for clinical trials in the Asia Pacific region by partnering with area labs to conduct clinical testing and to gather the data. These trials are overseen by Nandan Rao, who has been named general manager, Asia Pacific, based in Mumbai, India. Mr. Rao also is responsible for building ACM Global’s Asia Pacific infrastructure and team to meet the increased demand in the region. For more information, visit acmgloballab.com. KENDLE INTERNATIONAL, a global, full-service clinical research organization, has received approval from Indian authorities to proceed with development of a new operations center in a special economic zone (SEZ) in the upcoming Ahmedabad-Gandhinagar Knowledge Corridor. The high-end, world-class center of excellence focuses on quality delivery of clinical data management, medical writing, pharmacovigilance/safety, biostatistics/programming, and other knowledge processing-related services. Kendle’s SEZ center is initially housing 50 associates and is expected to scale up to about 300 associates in the near term. For more information, visit kendle.com. Global public relations agency KETCHUM has entered a joint venture with affiliate TBWARAADPR, a fast-growing communications network in the Middle East, to deliver enhanced capabilities to clients in the region and internationally. The new firm formed under the venture, Ketchum Raad Middle East, operates in 14 cities spanning 12 countries throughout the Middle East and northern Africa. Hania Tabet leads Ketchum Raad Middle East as managing director. For more information, visit ketchum.com or tbwa.com. Global biopharmaceutical services provider PAREXEL INTERNATIONAL has opened a new early-phase unit in Port Elizabeth, South Africa, adding more than 40 beds to Parexel’s global early-phase capacity. In addition to providing the capability to conduct a variety of studies in healthy volunteers, the core focus of the Port Elizabeth unit is on early-phase studies in patients, from first-in-human to proof-of-concept studies. For more information, visit parexel.com. PPD has opened offices in Manila, Philippines, and Bangalore, India, as the global CRO continues its expansion efforts to meet growing demand in the Asia Pacific region. Both offices are providing Phase II to IV clinical development and management services in key therapeutic areas. The company also has officially opened its contract research facility in Athlone, Ireland, which includes an 18,000-square-foot analytical testing laboratory and clinical supplies business. The facility expands PPD’s global scientific expertise, laboratory capacity, and supplies network to meet growing client demand for these services in Europe, the Middle East, and Africa. For more information, visit ppdi.com. QUINTILES has made a number of recent expansions to its international operations, including the opening of an office in Nairobi, Kenya. The team of Nairobi-based clinical professionals is responsible for monitoring throughout East Africa, enhancing Quintiles capability to provide clinical research services across the continent. In London, Quintiles has opened an expanded research facility, increasing its Phase I capacity and extending its ability to drive progress in translational medicine. With capacity for 35 patients and healthy volunteers, the extension brings the total number of Phase I beds in London to 105 and globally to 385. And in China, Quintiles has announced the availability of anatomic pathology services through its central laboratory in Beijing, aimed at helping biopharmaceutical companies develop more effective cancer treatments. These services complement assay development, digital pathology, and core lab offerings available through the facility to help customers comply with China’s restrictions on tissue import/export. For more information, visit quintiles.com. TGaS Advisors has developed a new, customizable account manager sizing model to help pharmaceutical companies tailor their managed market account strategies. Using industry data and information specific to an organization’s products, the sizing model is designed to help managed markets leadership plan for the future needs of the organization. It provides fact-based information to support staffing and resource investment requests as heads of managed markets seek to manage the changes transforming healthcare. TGaS Advisors can advise companies on staffing needs now and in the future based on a company’s own scenarios, including such issues as launches, loss of patent exclusivity, complexity of products in medical benefit reimbursement, sales force downsizing, and company mergers and acquisitions. The account manager sizing model provides an outside-in perspective to predict a company’s needs based on current conditions and future outlook, according to Brian Bamberger, managed markets practice leader. “We developed the account manager sizing model to meet the need for an instrument equal to the complexities of managed markets environments while maintaining statistical significance,” Mr. Bamberger explains. The FDA and the National Institutes of Health (NIH) have unveiled an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies. As part of the effort, the agencies have established a joint NIH-FDA leadership council to spearhead collaborative work. The council works to help ensure that regulatory considerations form an integral component of biomedical research planning and that the latest science is integrated into the regulatory review process. In addition, the NIH and the FDA have jointly issued a request for applications, making $6.75 million available over three years for work in regulatory science. The research supported through this initiative should add to the scientific knowledge base by providing new methods, models, or technologies that inform the scientific and regulatory community about better approaches to evaluating safety and efficacy in medical product development. “We’ve all been following the remarkable advances in biomedical sciences led by the NIH with great enthusiasm for years,” says U.S. Health and Human Services Secretary Kathleen Sebelius. “But much more can be done to speed the progress from new scientific discoveries to treatments for patients.” “The FDA plays an essential and unique role in how therapies are evaluated,” adds Commissioner of Food and Drugs Margaret Hamburg, M.D. “We now have a special opportunity — and responsibility — to harness advances in science and technology to support our efforts. We are working in collaboration with the best minds and research institutions available so that we can better develop and use new tools, standards, and approaches needed to properly assess the safety, effectiveness, and quality of products currently in development or already on the market.” “For more than two decades, the NIH and the FDA have been partners in multiple health initiatives designed to improve the health of millions of Americans,” notes NIH Director Francis Collins, M.D., Ph.D. “This collaboration, however, is the first of its kind and uses the NIH’s breadth of experience as a leader in biomedical sciences to help make the regulatory review process at the FDA as seamless as possible.” Razorfish has launched Razorfish Health, a dedicated health and wellness division that harnesses Razorfish’s technological expertise to develop brand campaigns with creativity, insight, and understanding of the sensitivities of health. Katy Thorbahn, who helped build Razorfish’s Philadelphia-based health practice, has been appointed to lead Razorfish Health as general manager. “Healthcare is a different industry from any other, and that’s why we’re making this dedicated effort,” Ms. Thorbahn says. “Both the healthcare industry and technology industry in general are experiencing landmark change, and that is opening up enormous opportunities to create direct connections with patients, caregivers, and healthcare professionals.” Razorfish Health clients put digital at the core of their ability to improve and transform their businesses. The company applies offerings that encompass digital advertising, Web site design, search, e-mail, and analytics. Razor?sh Health also advises clients on social influence marketing, the company’s approach for employing social media and in?uencers to achieve the marketing and business needs of an organization. Our experience with managed markets organizations showed us that a one-size-fits-all model won’t work, says Brian Bamberger. Both the healthcare industry and technology industry are experiencing landmark change, says Katy Thorbahn. We are working in collaboration with the best minds and research institutions available so that we can better develop and use new tools, standards, and approaches, says Dr. Margaret Hamburg. This collaboration uses the NIH’s breadth of experience to help make the regulatory review process at the FDA as seamless as possible, says Dr. Francis Collins. The Direct Marketing Association’s 2010 edition of its DMA STATISTICAL FACT BOOK: THE DEFINITIVE SOURCE FOR DIRECT MARKETING BENCHMARKS expands coverage of evolving digital media while still providing essential information on direct mail and other traditional channels. The latest edition includes new chapters on mobile marketing and social media, more data on consumer preferences, and expanded coverage on other digital media such as e-mail coupons, search-engine marketing, and Internet display. For more information, visit the-dma.org. The second edition of Informa Healthcare’s PHARMACEUTICAL COMPUTER SYSTEMS VALIDATION: QUALITY ASSURANCE, RISK MANAGEMENT AND REGULATORY COMPLIANCE has been thoroughly revised to include the latest industry developments in computer validation and verification principles and how to put them into practice. The guide provides the current best practice and guidance on identifying and implementing improvements for computer systems; extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology; and ensures that organizations move smoothly to the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system. For more information, visit informahealthcare.com. PSKW and Associates has acquired Triax Media Group, enhancing PSKW’s loyalty relationship marketing capabilities, as well as medical education and personal and nonpersonal promotional efforts. The addition of Triax’s marketing and communications solutions has enabled the integration of technology-driven loyalty relationship marketing programs with PSKW’s flagship LoyaltyRx CoPay Cards. “PSKW has long maintained a leadership position as a provider of prescription co-pay programs for the pharmaceutical industry,” says PSKW President Robert Previdi. “The acquisition of Triax broadens our offerings and enables us to offer a full array of loyalty relationship marketing program components.” PSKW has licensed the purchase of Triax to subsidiary Centricity Group. Chuck Morton and Paul Mastracchio, co-founders of Triax Media Group, have assumed senior business development roles within PSKW. PharmaTelevision, an online television channel dedicated to the biopharma industry, has added services to meet the growing demand for the production and dissemination of rich media content in the pharmaceutical and biotechnology sector. The new services include PharmaTelevision Production Services, which provides unique and powerful ways for companies to communicate to industry stakeholders, and PharmaTelevision Conference Services, which aims to better disseminate important communications from the many business partnering, logistical, and scientific conferences within the industry. A third service, PharmaTelevision Technical Services, helps pharma and biotech companies customize and integrate content into their existing infrastructure to drive value for their internal users. “The launch of these new services is a natural progression for us,” says PharmaTelevision CEO Fintan Walton. “We can deliver not only the highest production values, but also qualified audiences through our own media platform.” “Our industry is waking up to the impact of video, and PharmaTelevision is a showcase of how video should work in the new multimedia, multitasking, multiaccess environment,” adds Chief Operating Officer Anne Vindenes Allen. We can deliver not only the highest production values but also qualified audiences through our own media platform, says Fintan Walton. We have developed our technology platform carefully to offer a user experience that turns our video platform into an intelligence tool kit, says Anne Vindenes Allen. The alignment of PSKW and Triax Media provides leading-edge solutions, says Chuck Morton.