i3 Creates Drug Safety Business
The new business unit is responding to the industry’s need for greater vigilance regarding the safety of drugs. i3 has introduced i3 Drug Safety, a new business unit created to unite all of the organization’s epidemiology and drug-safety resources into one unit to enhance the delivery of safety services to the industry. Clients benefit from a cohesive approach to support decision making across the pharmaceutical life cycle. Led by Terri Madison, Ph.D., MPH, an epidemiologist from sister business i3 Statprobe, i3 Drug Safety includes a staff of drug safety coordinators — nurses, medical doctors, and doctors of pharmacy — as well as respected pharmacoepidemiologists. Alec Walker, M.D., Dr.P.H., continues as senior VP of epidemiology. These experts support a full spectrum of safety services, including premarket clinical trials, safety surveillance studies, and pharmacovigilance activities. “Over the last several years, the industry has recognized the value of epidemiology as a crucial internal discipline to monitor and assess the safety of its products,” Dr. Madison says. “Our epidemiologists have been conducting important pharmacoepidemiology work for more than 25 years and are renowned for their deep experience in this area.” i3 Aperio, the drug experience registry launched in April to help researchers identify potential safety signals in new drugs faster, also resides within i3 Drug Safety under the direction of Arnold Chan, M.D., Sc.D. i3 Magnifi, which formerly housed epidemiology, now is focused on health economics and outcomes. This business unit uses its proprietary healthcare claims and laboratory results database on information from more than 11 million consumers, primary data collection from consumers and physicians, and sophisticated statistical analytic methods to understand the business of healthcare. Also residing within i3 Magnifi is its suite of data products drawing on robust information assets. i3 Magnifi is led by William Crown, Ph.D., who has been leading i3’s outcomes business for several years. Over the last several years, the industry has recognized the value of epidemiology as a crucial internal discipline to monitor and assess the safety of its products, says Terri Madison, Ph.D., MPH, head of the new i3 business unit. ICTS Introduces Patient Recruitment Training For Study Coordinators Integrated Clinical Trial Services (ICTS) has introduced a new service, patient recruitment training for study coordinators. ICTS’ programs are customized to build study coordinators’ working knowledge of patient-recruitment activities. The ultimate goal of these sessions is to energize, empower, and motivate study coordinators to devote focused time and energy into accelerating patient enrollment. The training sessions generally last one day and are best done in person, but they can be conducted through active Web or an interactive CD-ROM. “Study coordinators are the backbone of clinical-trial patient-recruitment activities,” says Tom Sturgis, president of ICTS. “Even the best inquiry development program can face serious difficulty if the coordinators are unable to meet the demands of participant management. We are pleased to offer this new service to help study coordinators better understand their role in patient recruitment.” We are pleased to offer this new service to help study coordinators better understand their role in patient recruitment, says Tom Sturgis, President of ICTS. Slack Launches Medical-Education Company Slack Inc. has launched Vindico Medical Education Inc., which is devoted to providing continuing medical education (CME), including symposia and printed and electronic materials, with delivery through the specialty journals and newspapers published by its sister company, Slack. “This new company will further our corporate goal of providing high-quality and immediately relevant educational programs and activities that will ultimately result in improved patient care,” says Peter N. Slack, president of Slack. Vindico is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. Slack has been an ACCME-accredited provider since 1996. Vindico operates as a wholly separate company from Slack, with separate staff and management. Wayne McCourt, former VP of U.S. sales for Slack, has been named VP of Vindico. Working under the leadership of Mr. Slack and Executive VP Richard N. Roash, Mr. McCourt directs content development, program development, and meeting services for the new company. While CME programming and accreditation will shift to Vindico, Slack continues to publish medical books, journals, and newspapers; develop innovative Internet-based projects; and handle sales and management for a number of exhibit clients. The creation of Vindico Medical Education provides an outstanding opportunity for us to maximize our ability to deliver continuing medical education to healthcare professionals, says Peter N. Slack, President of Slack Inc. Elsevier Introduces Two Publications Elsevier Society News Group is launching a bimonthly publication, Vascular Specialist, beginning with the September/October 2005 issue. Vascular Specialist, targeted to 9,200 vascular medicine specialists, includes news and meeting coverage critical to vascular medicine specialists, as well as updates on new devices and surgical equipment, expert commentary, and coverage of the business and politics of vascular medicine. The publication represents the latest venture between the Society for Vascular Surgery and Elsevier. In addition to Vascular Specialist, Elsevier also publishes Journal of Vascular Specialist, the official journal of the society. In addition, Elsevier is launching Thoracic Surgery News, the official newspaper of the American Association for Thoracic Surgery. The bimonthly publication premieres with the September/October 2005 issue. The newspaper has a circulation of 5,500 thoracic surgeons, including all members of the association. Editorial content includes clinical news, meeting coverage, expert commentary, clinical-trial results, reports on new devices, and updates on the business and politics of medicine. Sections are devoted to the news of general thoracic surgery, adult cardiac surgery, transplantation, and congenital heart disease. Blackwell to Publish Cardiology Journal In January 2006, Blackwell Publishing will launch Congenital Heart Disease: Clinical Studies from Fetus to Adulthood, a specialized clinical journal that addresses the latest research developments in congenital heart disease in children and adults. “The editorial mission of the journal is to better educate cardiologists, researchers, and nurses on the developments in this discipline,” says Dr. Douglas Moodie, editor of Congenital Heart Disease. “This in turn will help develop more effective treatments for patients with congenital heart disease.” The journal will cover all specialized studies in the field, such as fetal, infant, and child-based care, as well as adult care. It also will explore the growth of technology in treatment for congenital heart disease. The editorial content will include clinical studies, state-of-the-art reviews, video clips, case reports, articles focusing on the history and development of congenital heart disease, and continuing medical education material. M&A Activity Dendrite International Inc., Bedminster, N.J., a provider of sales, marketing, and clinical solutions for the pharmaceutical industry, has agreed to acquire Optas Inc., a provider of privacy-safe, relationship marketing solutions for patients and physicians aimed at improving patient acquisition and therapeutic compliance by providing higher levels of support services. The resulting integrated patient and prescriber-based marketing programs will enable pharmaceutical companies to reach physicians and consenting patients with consistent messages while maintaining adherence with federal and state regulations surrounding privacy. The Optas acquisition is valued at $12 million and will be funded by cash. Optas, formerly a private company with headquarters in Woburn, Mass., will be branded as Optas: a Division of Dendrite International. For more information, visit dendrite.com. etrials World Inc., Morrisville, N.C., which provides fully integrated, easy-to-use e-clinical software for the clinical-trial process, and CEA Acquisition Corp., Tampa, Fla., a special purpose acquisition corporation, have agreed to merge. After the completion of the merger, etrials Worldwide will be a wholly owned subsidiary of CEAC, and etrials shareholders will own a majority interest in the parent company CEAC, a public reporting company. Additionally, upon conclusion of the merger, etrials will become a publicly traded company and receive up to $21 million in cash from CEAC, depending upon the number, if any, of CEAC shares that may be converted to cash in accordance with CEAC’s charter as a result of being voted against the merger. For more information, visit etrials.com. Oracle Corp., Redwood Shores, Calif., a leader and innovator in the global software industry, has agreed to buy Siebel Systems Inc., Los Angeles, a provider of customer-facing solutions, for $10.66 per share. The offer is valued at about $5.85 billion, or $3.61 billion net of Siebel’s cash on hand of $2.24 billion. Company officials say the acquisition makes Oracle the No. 1 CRM applications company in the world. For more information, visit oracle.com. Phase Forward, Waltham, Mass., a provider of data-management solutions for clinical trials and drug safety, has entered into a definitive agreement to acquire privately held Lincoln Technologies, Wellesley, Mass., in an all-cash transaction valued at $11 million, plus up to an additional $6 million based on achievement of certain financial targets in 2005 and 2006. Lincoln Technologies, a software technology company, provides products and services for strategic pharmacovigilance, clinical-trial safety signal detection, and applied data standards. Together, Phase Forward and Lincoln Technologies will provide customers with a more powerful set of solutions for managing clinical data and drug safety throughout the product life cycle. For more information, visit phaseforward.com. Wolters Kluwer, a multinational publisher and information services company with headquarters in Amsterdam, has agreed to acquire the information management business of NDC Health Corp. (NDC-IM), Phoenix, a provider of healthcare information solutions. NDC-IM is expected to have revenue of about $165 million and adjusted EBITDA of $36 million in calendar year 2005. The purchase price of $382 million will be paid in cash. This is a multiple of 2.3 times revenue and 10.5 times adjusted EBITDA. The transaction, which is expected to be completed in the fourth quarter of 2005, strengthens Wolters Kluwer’s position in the growing pharmaceutical, biotech, and medical-device market by expanding its business intelligence offerings. NDC-IM will become part of Philadelphia-based Wolters Kluwer Health’s Pharma Solutions unit, creating overhead efficiencies and commercial synergies not previously available. The unit’s focus is to expand content for drug development and product management by offering more business intelligence databases and customized services. The NDC-IM acquisition complements this strategy. For more information, visit wolterskluwer.com. PharmaVOICE October 2005 Bridgetech and Amcare Labs Partner to Create CRO for China Bridgetech Holdings International Inc. has established a joint venture with Amcare Labs International Inc. to form a clinical research organization that will operate within China, Hong Kong, and Taiwan. The jointly owned CRO will assist biotechnology, pharmaceutical, and medical-device companies in the research, testing, and approval process with the SFDA (the Chinese equivalent of the U.S. Food and Drug Administration). Leaders from both companies believe this partnership will bolster their goals of becoming leaders in the overseas market. “We are very pleased to enter this new strategic relationship with Bridgetech,” says Dr. Mohan Chellappa, president of Amcare. “We believe this joint venture will play a significant role in allowing us to achieve our goal of becoming the leading provider of research and development services in markets outside of the United States.” “This joint venture is a significant milestone toward achieving our long-term goal of becoming a leading developer of commercialized healthcare products and services in Asia,” says Herbert Wong, chairman of Bridgetech. “By partnering with Amcare, an affiliate of the world renowned Johns Hopkins Medicine, we have a tremendous opportunity to become a leader in the CRO market.” Bridgetech executives also believe the success of this joint effort will position their organization to begin commercializing additional healthcare services and products in Asia. We believe that our relationships and resources in China, coupled with Amcare’s reputation within the international medical community, will allow us to become a leading developer of commercialized healthcare products and services in Asia, says Herbert Wong, Chairman of Bridgetech Holdings International Inc. Schering AG Opens Asia-Pacific Headquarters in Singapore Schering AG, a leader in fertility and contraceptive pharmaceuticals, has opened its Asia-Pacific headquarters in Singapore to meet the fast-growing contraception needs of women in Asia. The new company operates under the name of Schering Asia-Pacific Pte. Ltd. “With our new headquarters in Singapore, we are well positioned to serve women’s family needs in Asia, and it underscores our long-term commitment to the region,” says Klaus Wulf, managing director of Schering Asia-Pacific Pte. A new generation of women in Asia today are contributing to vast changes and economic growth in this region. They are increasingly better educated, more career and travel mobile, and important contributors to the economy of their country, as well as their individual families, says Klaus Wulf, Managing Director of Schering Asia-Pacific Pte. Ltd. New Company Offers Electronic Data Collection and Management Services Maaguzi, an innovative technology company that specializes in electronic data collection and data management for late-phase clinical trials, was launched in August. The company provides a software application that has been validated and used in multicountry registration trials and specializes in assisting with clinical studies that have a high level of patient involvement or that involve collecting data from multiple study roles. Maaguzi, which is a Swahili word for medicine or a device that brings healing, enables individuals to participate in clinical trials from either their own homes or their physician’s office in their own language. The technology is adaptable to virtually any type of trial and is available for pharmaceutical companies, medical-device manufacturers, CROs, research centers, hospitals, and managed-care companies. The Maaguzi system has been audited and complies with all of the relevant FDA and ICH guidelines. The system has been used successfully in an IND submission with data lock in 24 hours, device trials, and diagnostic trials. The Maaguzi technology is suited for collecting data from all participants — researchers, research sites, and subjects — in all types of late-phase research, including registries, naturalistic studies, post-marketing, safety surveillance, and observational studies, says John Larus, president and chief operating officer of Maaguzi. The Maaguzi technology is perfectly suited for collecting data from all participants — researchers, research sites, and subjects — in all types of late-phase research, including registries, naturalistic studies, post-marketing, safety surveillance, and observational studies, says John Larus, President and Chief Operating Officer of of Maaguzi. CPR Launches Managed-Care Contracting Service Complementing its traditional public relations and m rketing communications capabilities in healthcare and technology, CPR Strategic Marketing Communications has launched a service that forges contracts on behalf of disease management (DM) vendors, pharmaceutical companies, and medical-device manufacturers with self-funded labor unions, managed-care organizations, and other payers. For the initial phase of this program, CPR is providing contracting opportunities with more than 52 labor unions located in the New York metropolitan area, representing 7 million lives, as well as managed-care organizations located in the northeast region. Collectively, these groups represent about 12 million lives. Complementing its traditional public relations and marketing communications capabilities in healthcare and technology, CPR Strategic Marketing Communications has launched a service that forges contracts on behalf of disease management (DM) vendors, pharmaceutical companies, and medical-device manufacturers with self-funded labor unions, managed-care organizations, and other payers. For the initial phase of this program, CPR is providing contracting opportunities with more than 52 labor unions located in the New York metropolitan area, representing 7 million lives, as well as managed-care organizations located in the northeast region. Collectively, these groups represent about 12 million lives. What’s New on the Shelves The 2005/2006 Guide to Clinical Studies and Evidence-Based Medicine, published by Total Learning Concepts (TLC), a Publicis Healthcare Communications Group company, provides pharmaceutical sales representatives with an understanding of clinical studies and evidence-based medicine, as well as training on how to effectively use this information in sales situations. The guide incorporates TLC’s field-tested, reality-based training method and is designed to deliver real-world educational tools. It includes a fresh overview of clinical studies and the current evidence-based marketplace; an accessible curriculum design that makes it easier, quicker, and more fun to learn complex material; exclusive physician perspectives on clinical data; effective strategies for using the clinical data in the field; action-oriented “reality checks” to keep reps focused on practical applications, not just theory; and superior techniques for incorporating pertinent information from reprints into sales messages. For more information, visit tlconline.com. An updated training guide — Oncology Handbook has been released by Total Learning Concepts (TLC), a Publicis Healthcare Communications Group company. The training guide is designed to prepare sales professionals to participate in the decision-making dialogue. The learning tool captures the current understanding of cancer at the molecular level; outlines the therapeutic index of treatment, including efficacy, resistance, toxicities, multimodality approaches, and drug combinations; shows how scientific theory, clinical data, and experience combine to guide treatment decision-making; explores the emergence of economic value as a treatment decision factor; highlights the differences between various oncology practices, including hospital community and private practices; and elucidates the drug-development process so learners can intelligently participate in discussions about evidence-based patient-care decisions and optimal outcomes. For more information, visit tlconline.com. Follow up Amcare Labs International Inc., Baltimore, an affiliate of the Johns Hopkins Medicine International organization, provides specialized testing, laboratory medical education, and other related medical services derived from the skill, technology, expertise, standards, services, and resources owned by or associated with Johns Hopkins Medical Institutions. For more information, visit amcarelabs.com. Blackwell Publishing, Malden, Mass., has partnerships with more than 600 academic and professional societies and publishes more than 750 journals annually. For more information, visit blackwellpublishing.com. Bridgetech Holdings International Inc., Solana Beach, Calif., leverages an extensive network of relationships to capitalize on significant growth opportunities in the healthcare markets in the United States and China. For more information, visit bthi.com. CPR Strategic Marketing Communications, Elmwood Park, N.J., is a marketing and communications agency focused on the healthcare and life-sciences industries. For more information, visit cpronline.com. Elsevier, New York, is a publisher of scientific, technical, and medical information products and services; Elsevier Society News Group is its health and science publishing division, which offers products that specifically address the communications needs of medical associations. For more information, visit elsevier.com. i3, Basking Ridge, N.J., a global Ingenix company, provides integrated scientific strategies and solutions throughout the pharmaceutical product life cycle and comprises: i3 Research, i3 Drug Safety, i3 Statprobe, i3 Pharma Resourcing, i3 Magnifi, and i3 DLN. For more information, visit i3global.com. Integrated Clinical Trial Services (ICTS), Raleigh, N.C., is a full-service patient-enrollment firm that provides clinical-trial sponsors, contract research organizations, and site networks with a comprehensive resource for patient-recruitment expertise. For more information, visit integratedtrials.com. Maaguzi LLC, Indianapolis, is an electronic data collection and data management product and services company that offers technology solutions for the late-stage pharmaceutical clinical-studies market. For more information, visit maaguzi.com. Schering Asia-Pacific Pte. Ltd., Singapore, is a wholly owned subsidiary of Schering AG, Berlin, a research-based pharmaceutical company focusing on gynecology and andrology, oncology, diagnostic imaging, and specialized therapeutics for disabling diseases. For more information, visit schering.de/eng. Slack Inc., Thorofare, N.J., provides healthcare information, educational programs, and meeting and exhibit management services worldwide. For more information, visit slackinc.com.
