What’s new New healthcare-related products, services, and companies
PRA forms Global Medical and Safety Services Division
The new business unit consolidates PRA’s risk-management activities across the company. PRA International, a clinical research organization, has formed Global Medical and Safety Services (GMSS) to provide drug safety surveillance, pooling and analysis of global databases, medical monitoring and support of clinical trials, and risk-management consultancy services. The new business unit is headed by Monika Pietrek, Ph.D., M.D., M.Sc., senior VP of PRA. “Regulatory authorities worldwide are requiring more formalized strategies to minimize safety risks throughout the drug product life cycle,” Dr. Pietrek says. “PRA is well positioned to integrate appropriate measures for assessing both benefits and risks during an individual clinical study as well as for the entire drug-development program.” To bolster its expertise in risk management, PRA has obtained the services of Dr. Robert Nelson and Rosalind Coulson. Dr. Nelson spent 20 years at the U.S. Food and Drug Administration (FDA) and held a number of high-profile positions, including associate director of the Office of Epidemiology and Biostatistics for the Center for Drug Evaluation Research. Ms. Coulson spent more than 20 years at the Medicines Control Agency in the United Kingdom and has particular expertise in pharmacovigilance. PRA’s Global Medical and Safety Services include a large staff of physicians, epidemiologists, statisticians, analysis programmers, nurses, and other drug safety professionals. Dr. Monika Pietrek, head of PRA’s Global Medical and Safety Services unit, says as more global clinical development is conducted, it is important to link drug safety management expertise with medical oversight. Psychiatric Times to Publish Second Annual Issue on Global Mental Health CMP Healthcare Media is publishing its second annual Psychiatric Times: Global Watch, a bonus mid-April issue devoted exclusively to the global state of psychiatry. The publication tackles such mental health issues as depression, alcoholism, schizophrenia, and obsessive compulsive disorder, which are leading causes of disability worldwide. “We’re excited to extend our coverage to global issues once again,” says Marcy Holeton, publisher of Psychiatric Times. “The response to the issue underscores the need to develop a greater awareness of the challenges that face psychiatric professionals around the globe.” Psychiatric Times: Global Watch is being delivered to Psychiatric Times’ circulation of more than 39,000 psychiatric professionals. Psychiatric Times is a monthly tabloid newsmagazine covering clinical and treatment updates, practice-management insights, and policy and legislative issues. Slack Inc. has relaunched Orthopedics with the March 2004 issue. Throughout its 27-year history, Orthopedics has provided orthopedic professionals with the clinical information they need to apply to their practice and will maintain this tradition in its new and improved format. Each month the journal is distributed to more than 27,500 orthopedic surgeons and rheumatologists throughout the United States. “The editors, editorial board, and I have continued to keep Orthopedics current, as well as respond to the changing needs of our loyal readers,” says Robert D. D’Ambrosia, M.D., editor-in-chief. “After extensive reader research and a year of planning, we are relaunching Orthopedics in a colorful magazine format. Each of the new design and content updates are based directly upon feedback from our readers.” In an effort to better serve readers, Orthopedics now features a more graphic, reader-friendly format; Tips & Techniques, a step-by-step instruction of surgical procedures; Pharmacology Update, a new column that examines timely therapeutic issues in orthopedics, including new drug approvals, indications, and pre- and postoperative treatment plans; and monthly review articles that offer physicians the credits they need with CME quizzes. “Orthopedics will continue to be the peer-reviewed publication of choice for busy orthopedic surgeons,” says Richard N. Roash, executive VP of Slack. “In its new format, Orthopedics combines the trusted science of a peer-reviewed journal with the easy-to-read layout of a magazine. It’s the format of the future, and we’re proud to be the first orthopedics publication to bring it to the field.” Orthopedics was relaunched in March at the Annual Meeting of the American Academy of Orthopedic Surgeons in San Francisco. Thomson CenterWatch and Integrated Clinical Trial Services to Offer New CME Symposia to Complement Patient-Recruitment Initiatives Thomson CenterWatch, a part of The Thomson Corp., and Integrated Clinical Trial Services (ICTS) are collaborating to provide educational symposia, including CME credits, designed to inform practice-based physicians and allied health professionals about the importance of communicating clinical-trial information to their patients. The difficulty in recruiting patients for clinical trials continues to cause substantial delays in getting new drugs and devices to market. It is estimated that only 10% of eligible people who suffer from severe and chronic illnesses participate in clinical trials. Biopharmaceutical companies have increasingly turned to community-based physicians and allied health professionals for assistance in referring eligible patients to their studies. At this time, CenterWatch estimates that only one in five volunteers learns about a clinical trial from his or her physician or nurse practitioner. “These CME programs fill an unmet need for biopharmaceutical companies looking to build a more effective referral network of community-based physicians and allied health professions as part of a comprehensive recruitment strategy,” says Paul Molinari, manager of business development at Thomson CenterWatch. “The programs will also greatly raise patients’ awareness of clinical trials that are actively seeking volunteers.” According to Tom Sturgis, president of ICTS, the ability to provide community-based physicians and their staff with an accredited educational opportunity coupled with increased exposure to the clinical research industry is another tool that ICTS can use in the process of identifying the patients that are required by ever more complex study protocols. What’s New on the Shelves Getting Your Drug Approved – FDA’s Own Guidelines, Volumes I and II – a resource for shaving time and money from the application process by getting INDs and NDAs on the right track for FDA approval. Published by FDA News, the two-volume set includes the latest guidelines on the forms, regulations, and procedures that the FDA will use to determine whether a proposed new drug will make it to market, including guidelines for understanding the Part 11 final guidance, preparing NDAs, managing records, organizing clinical-trial results, and more. For more information, or to place an order, visit fdanews.com/wbi/bookstore. Subscribers will get a global perspective on depression, child psychiatry, psychotropic medications, and the role of human rights abuses in the development of psychiatric conditions, as well as psychiatry, healing, various global communities, and medical-education credits, says Marcy Holeton, publisher of Psychiatric Times. Medical Representation Company Launched The Watkins Representation Group, a medical representation company, was established in April 2004 by Ken Watkins III. The new company has BMJ USA, the U.S. edition of the British Medical Journal, as its inaugural client. BMJ USA is a monthly synopsis of the weekly BMJ that is distributed to primary-care physicians in the United States. Its circulation includes about 100,000 American physicians who specialize in family medicine, internal medicine, or general practice. Additionally, the Watkins Group will provide customized publishing programs to the healthcare community. Multimedia Healthcare/Freedom LLC and the Alzheimer’s Foundation of America (AFA) have teamed up to launch Vantage, a new publication aimed at caregivers of individuals with Alzheimer’s disease (AD) and other dementia-related illnesses. Vantage will be made available in the waiting rooms of high-prescribing neurologists, psychiatrists, and primary-care physicians, as well as to clients of AFA member organizations across the country. Vantage presents timely articles and departments that are written in a reader-friendly style. The publication will provide valuable advice and support to improve the quality of life for individuals and their caregivers. Topics will include managing stress; at-home cognitive therapies; handling difficult behaviors; coping with family issues; preventing AD; advice on legal, financial, and practical issues; and creative contributions from caregivers themselves. Vantage circulates to about 1,100 neurologists, 5,800 psychiatrists and geriatric psychiatrists, 1,500 American Association for Geriatric Psychiatry members, 41,000 primary-care physicians, and thousands of family caregivers through dementia-related organizations. Steve Kronenberg, founder and owner of RxAnalysts, and Don Paullin, founder and former president of Physicians Interactive, have teamed up to form BullsEye ROI Inc. The new company provides pharmaceutical companies and pharmaceutical suppliers with affordable marketing program return-on-investment (ROI) analysis. “With almost 50 years of experience in the pharmaceutical industry, Steve and I converged to help address the market demand for more efficient marketing spend,” Mr. Paullin says. “ROI hard data are now being demanded by pharmaceutical companies as evidence for maintaining and then increasing the promotional budget. We formed BullsEye ROI to help clients increase profitability through affordable ROI analyses, thereby improving their efficiency of their spend.” Mr. Kronenberg is the CEO and cofounder of BullsEye ROI. Mr. Kronenberg has provided ROI consulting for more than 11 years. Before founding RxAnalysts, he was research director at Walsh America where he designed the single largest ROI study in the history of the pharmaceutical industry. Mr. Paullin, cofounder and president of BullsEye ROI, brings 28 years of pharmaceutical sales and marketing experience. Mr. Paullin also founded Med-Smart and served 20 years at Searle Pharmaceuticals where he held several senior-management positions, including national director of Searle’s sales-development center. The Alzheimer’s Foundation of America, New York, is a nonprofit organization dedicated to meeting the educational, social, emotional, and practical needs of individuals with Alzheimer’s disease and related illnesses, as well as their caregivers and families, and to raise public awareness about the disease and lend expertise to healthcare professionals. For more information, visit alzfdn.org. BullsEye ROI Inc., Ft. Lauderdale, Fla., is a ROI analysis company. For more information, call 847-323-7308. CMP Healthcare Media, Irvine, Calif., delivers education, publishing, and marketing services that create meaningful connections among influential clinicians, leading healthcare researchers, marketers, and medical manufacturers. For more information, visit cmphealth.com. Integrated Clinical Trial Services LLC, Cary, N.C., provides solutions for patient recruitment, enrollment, retention, and compliance challenges. For more information, visit integratedtrials.com. MultiMedia HealthCare/Freedom LLC, Princeton, N.J., produces peer-reviewed, indexed journals that educate healthcare providers in all areas of medicine, with a core strength in knowledge about the diagnosis and treatment of the 50-and-older patient population. For more information, visit mmhc.com. PRA International Inc., McLean, Va., is a CRO with strong therapeutic expertise in oncology, central nervous system, allergy and respiratory, cardiovascular, and endocrine disorders. For more information, visit prainternational.com. SLACK Inc., Thorofare, N.J., is a provider of information to targeted healthcare specialties and a publisher of more than 30 journals and newspapers, including Orthopedics, and more than 200 medical and allied health books worldwide. For more information, visit slackinc.com. Thomson CenterWatch, Boston, is a publishing and information services company that provides business journalism, CME-accredited training and manuals, original research and analysis, and market intelligence services. For more information, visit centerwatch.com. The Watkins Representation Group, West Paterson, N.J., is a medical representation company. For more information, call 973-954-9300. Follow up Steve Kronenberg and Don Paullin join forces to improve marketing ROI for life-sciences companies.