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New healthcare-related products, services, and companies
FDA Anticounterfeiting Draft Focuses on Chemical Identifiers The FDA has issued a draft guidance on the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) by manufacturers of solid oral dosage forms, which include pills and capsules, to make drug products more difficult to duplicate by counterfeiters and to make it easier to identify the genuine version of the drug. Drug counterfeiting is a serious public health concern, notes Commissioner of Food and Drugs Margaret Hamburg, M.D. We look forward to working with industry to help ensure that consumers are not exposed to products containing unknown, ineffective, or harmful ingredients. A PCID is a substance or combination of substances possessing a unique physical or chemical property used to identify and authenticate a drug product or dosage. In addition to inks, pigments, and flavors, specific chemicals may be used as molecular tags in a PCID. In some cases, the PCID may be easily detected by wholesalers or pharmacists to determine if they have authentic products. In other cases, special analytical instruments may be necessary to identify whether the PCID is present. In the draft guidance, the FDA anticipates that many of the potential PCID ingredients are already used as food additives, colorants, or other types of inactive ingredients with established safety profiles. To minimize adverse effects, the draft guidance recommends using the lowest level of PCID that ensures identification of the product. It also recommends that the PCID be a substance with no medicinal effect and placed within the dosage form so that it does not interact with the drug s active ingredient. New Healthcare-related Products, Services, and Companies Featured Briefs: FDA Anticounterfeiting Draft Focuses on Chemical Identifiers Lewin Group Forms Comparative Research Center Scientific Collaboration Aims to Improve Drug Safety imc2 Launches Health and Wellness Agency FDA Enhances Speed and Transparency of Actions Taken Against investigator Misconduct Wolters Kluwer Health Offers Forecasting Service ScopeMedical Establishes U.S. Operations TogoRun Opens Washington, D.C., Office Sidebar: Around The Globe Follow up THE FDA is the federal agency responsible for ensuring the safety and accurate representation of foods, cosmetics, human and veterinary drugs, biological products, and medical devices sold in the United States. For more information, visit fda.gov. THE HAMNER INSTITUTES FOR HEALTH SCIENCES is a nonprofit research organization. For more information, visit thehamner.org. IMC2 HEALTH & WELLNESS is an imc2 agency specializing in marketing for clients in the healthcare and wellness industries. For more information, visit imc2healthandwellness.com. THE LEWIN GROUP is a healthcare policy and management consulting firm. For more information, visit lewin.com. SCOPEMEDICAL is a provider of medical education and marketing services to the pharmaceutical industry. For more information, visit scopemedical.com. TOGORUN, part of Omnicom Group Inc. s Diversified Agency Services (DAS) network, is a global healthcare communications agency in healthcare, pharmaceutical, and consumer wellness public relations and public affairs. For more information, visit togorun.net. WOLTERS KLUWER HEALTH, a division of Wolters Kluwer, provides information and business intelligence for students, professionals, and institutions in medicine, nursing, allied health, pharmacy, and the pharmaceutical industry. For more information, visit wkhealth.com.?? New center provides data and analysis to help set priorities and support fact-based healthcare decisions. The newly formed Lewin Group Center for Comparative Effectiveness Research has the goal of meeting the growing need for fact-based, comparative effectiveness research (CER) for use by policymakers, researchers, healthcare providers, and others to improve patient care and optimize resources. The center has unique capabilities for conducting and supporting CER, combining The Lewin Group s independent analysis of health information technology, evidence-based medicine, healthcare policy, and other issues; affiliate company i3 s expertise in clinical trials and study design, drug safety, health economics, and outcomes research; and Ingenix data. Through Ingenix, the center has access to robust longitudinal, de-identified patient data sets, including integrated medical, disability, laboratory results, and pharmacy claims data. The Lewin Group Center for Comparative Effectiveness Research offers development and management of data sets and registries; data analysis, including linked data sets and electronic health records; tools for analysis of longitudinal health outcomes for treatment effectiveness and drug safety; services to conduct and manage institutional review board-approved comparative trials; and CER technical assistance, CER knowledge transfer, and consulting on CER methods and policies. Clifford Goodman, VP of The Lewin Group, is acting as interim director of the center and will continue as an adviser to the center once a permanent director has been appointed. In addition, Tina Brown-Stevenson, senior VP, healthcare innovation and information at Ingenix, and William Crown, Ph.D., president of i3 s Innovus health economics and outcomes research business, serve as advisers to the center. As the U.S. government and healthcare industry work together to transform healthcare delivery, CER is fundamental to making fact-based decisions to improve patient outcomes with efficient use of healthcare resources, says Lisa Chimento, Lewin senior VP. The investment of more than $1 billion in federal funding to be used for CER through the American Recovery and Reinvestment Act of 2009 underscores the important role this kind of research plays in setting priorities to improve access to care, care outcomes, and resource use across the nation, says Lisa Chimento. In consolidating access to our CER expertise, capacity, and capabilities from across Ingenix via this center, we are well-equipped to respond to market demands for CER as a better foundation for healthcare policy and decision making, says Clifford Goodman.The Hamner Institutes for Health Sciences and the University of North Carolina at Chapel Hill have announced the official launch of The Institute for Drug Safety Sciences. The nonprofit institute is led by Paul Watkins, M.D., an expert in drug-induced liver injury and the Verne S. Caviness Distinguished Professor of Medicine at UNC-Chapel Hill. As founding director for the Institute, Dr. Watkins has already assembled a core group of internal scientists and academic partners to develop new global drug safety initiatives in collaboration with the bio/pharmaceutical industry, the National Institutes of Health (NIH), and the FDA. The Institute s initial focus is developing new computational models and in vitro assays, starting first with evaluating liver toxicity and expanding into cardiovascular and kidney drug side effects. It now takes more than a decade and $1 billion from the time a new drug is discovered to the time it is approved by the FDA, Dr. Watkins says. Increasingly, these costs and delays relate to proving a drug is safe well after it has been shown to be beneficial. The Institute for Drug Safety Sciences is dedicated to using the latest scientific techniques to understand, predict, and avoid adverse events from drugs to speed delivery of important new drugs to the patients who need them, says Dr. Paul Watkins. imc2 has established imc2 Health & Wellness, an agency focused on the marketing and business challenges facing brands in the pharmaceutical, biotech, device, medical education, healthcare, and wellness industries. imc2 formalized its healthcare practice in response to the industry s challenging marketplace concerning healthcare reform, the evolving regulatory environment, and the shift toward fostering deeper relationships with healthcare professionals, consumers, payers, and other audiences. The new agency is led by Hensley Evans, who has been promoted to president, from her previous role as imc2 s senior VP of strategy. With the current state of the healthcare industry, we saw an opportunity to leverage our deep industry expertise to create an agency focused solely on the distinctive marketing needs of the health and wellness space, Ms. Evans says. The new agency s leadership team also includes Bonnie Sayers, VP, general manager; Karen Carr, VP, strategic growth and innovation; Amber Benson, VP, strategy; Renee McKeon, VP, creative; and Tom Donnelly, VP, Northeast. imc2 Health & Wellness allows us to better serve our clients, helping them to build more sustainable relationships between their brands and people, says Hensley Evans. European communications agency ScopeMedical has opened offices in Princeton, N.J., enhancing its ability to provide services to a growing base of clients in the United States, as well as offer U.S.-focused medical communications programs. Our mission is to deliver not only the very best quality service, but to innovate around our clients constantly evolving needs, while ensuring we operate within regulatory boundaries, says Jeremy Williams, CEO of ScopeMedical. In addition to strategic communication planning, ScopeMedical offers a full range of promotional medical education services, including publications planning, event management, thought leader development, product training, and e-healthcare solutions. We have operated extensively in Europe for almost 15 years and are now responding to demand from clients to expand our offering to the United States, says Jeremy Williams.