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NEW HEALTHCARERELATED PRODUCTS, SERVICES, AND COMPANIES

Doctors+Designers has changed its company name to HealthEd to reflect a change in business strategy focusing on developing patient-centered health education programs. “With noncompliance costing the pharmaceuti cal industry $15 billion to $20 billion each year, according to the National Pharmaceutical Council, the need for patientcentered health education is more important now than ever,” says Roy Broadfoot, president and CEOof HealthEd.“To address this enor mous communication gap between doctors and patients we’ve created a new category called `Educa tional Marketing.’Our new name now appropriately reflects our expertise in the field of educational mar keting and our rededicated efforts to help our phar maceutical clients develop effective patientcen tered health education tools that improve patient adherence andpersistency,and helps clients realize a direct benefit to their return on investment.” HealthEd recently has taken a more active role in meeting the needs of the pharmaceutical industry by helping them better understand the problem of low health literacy and how it affects patient compliance. “As an industry, we need to smarten up a bit and think about the effectiveness of the materials we put out there and begin to recognize that 90% of the so called health education material currently produced may be irrelevant or inappropriate,” says Joseph Lof tus, HealthEd’s VP of sales and marketing. “We know educated patients are better patients, and effective patient education can make the difference between a brand’s stagnation and success.” Some of the core prod ucts and services offered by HealthEd include: patient centered health education programs,professional edu cation programs, physician support programs, patient compliance and persisten cy programs, ehealth pro grams, and database mar keting programs. “Critical to the success of any health education and compliance program is the application of proven health literacy principles in the design and execution of customized educational tools,” says Stephanie MazzeoCaputo, HealthEd’s VP of health education.“This encourages patients to take a more active role in their healthcare.” With the rebranding of the company, a new Web site, www.healthed.com, was created to offer useful information on the latest research, trends, and best practices in the field of patient and professional health education pro grams. Doctors+Designers Becomes HEALTHED New name reflects change in business strategy to more closely focus expertise on developing patientcentered health education programs “With noncompliance costing the pharmaceutical industry $15 billion to $20 billion each year, the need for patientcentered health education is more important now than ever. To address the enormous communication gap between doctors and patients we’ve created a new category called `Educational Marketing,”’ says Roy Broadfoot. Grey Healthcare Launches CONSULTING AND BRANDING GROUP Grey Healthcare Group Inc. has intro duced Brand Care, a strategic branding and consulting group focused on global branding, portfolio, lifecycle, and corpo rate strategy, as well as naming and logo development for pharmaceutical prod ucts. The team uses quantitative and qualitative research, customer insights, and proven principles from consumer marketing to accelerate and reinvigorate brand sales. Brand Care has tools to help clients formulate clinical plans and opti mize labeling,and develop course correc tion plans for products that have stalled. One of Brand Care’s products is a political marketing model that gives pharmaceutical companies specific tools to unseat “incumbent” products by taking advantage of all windows of opportunity, making appropriate course corrections as the campaign unfolds, and by actively engineering product suc cess step by step. Brand Care takes a predictive look at a product or portfolio. Based on these analyses, the group helps clients organize products in a more marketable and profitable way throughout their lifecycles. “Fewer blockbusters, increased competition, and more mergers mean that pharmaceutical companies mayhavenew competitiveor disparate product lines,” says Cindy Machles, president of Brand Care. “Making the right decisions about how to market and finance those products is critical to a company’s success.” Cindy Machles heads up Grey Healthcare’s new strategic branding and consulting group — Brand Care. Insight Interactive Group has launched Knowl edge Reporting Services, a proprietary analysis ser vice that allows marketing and brand managers to gauge the impact their online marketing efforts are having on a targeted audience.Although previously available to Insight Interactive clients, this is the first time KRS is available as an unbundled service. Insight Interactive works with a client to define a core set of analysis points and analyzes them on a regular basis, reporting how the campaign is per forming, complete with relevant industry bench marks and competitive activities. “Brand managers are frustrated with current Inter net statistics because there is no connection to busi ness strategy, too much data, and not enough valu able information,” says Lee Mikles, Insight Interactive’s chief innovation officer. “In addition, it is difficult for them to consolidate all the data coming from various sources in different formats into a meaningful report.” Historically, companies use a combination of branded and unbranded Websites, banner and pop up ads, direct email, and search engine rankings to get their message across. It is difficult, however, for brand managers to tell if these strategies are work ing. A 2001 survey revealed that 77% of brand man agers reported dissatisfaction with how they were measuring the success of their online activities. The KRS system can let a client know on a real time, monthtomonth basis, if specific online mar keting objectives are being met. One of KRS’s fea tures is the ability to let a company know which search words caused the most valuable interactions. “Effective online marketing is about quality of leads and access to a target audience, not mass quantity of hits,” Mr.Mikles says.“What is really critical is for the brand manager to have the ability to under stand the impact of the entire interactive campaign, regardless of the outlet, and find connections across these different sources that strengthen the online marketing message.” Insight Interactive Helps Gauge Impact of ONLINE MARKETING ACTIVITY ANDROI WHAT’S new Electronic ClinicalTrial Leaders ETRIALS AND ARACCELTO JOIN FORCES In a move that will bring together two leaders in the electronic clinicaltrial market, etrials Inc. and Araccel Corp. have agreed to a merger. The new company will operate under the name etrials World wide Inc. Fred Nazem, chairman of Araccel, will assume the role of executive chairman of the com bined entities, while John Cline, former president of etrials,will take the CEO role.The merger wasexpect ed to take place on or before Nov.30,2002,pending shareholder approval. The two companies will join forces to further develop and market comprehensive eclinical tech nology and service capabilities for the entire clinical trial process undertaken by pharmaceutical,biotech nology, and medicaldevice companies. The merged companies will be wellpositioned to take the leader ship position in a market that is expected to more than double by 2004. Paperbased processes and systems are used in more than 90% of all clinical trials. Efficiencies and costsavings from managing clinicaltrial data elec tronically and the need for pharmaceutical,biotech, and medicaldevice companies to more rapidly develop their new product pipelines are forcing research organizations to rethink their use of paper based trial processes. As a result, the electronic clini cal trial technology market is expected to explode during the next three years. etrials Worldwide will be able to provide an inte grated platform of eclinical technologies from elec tronic patient diaries (EPD) to EDC to the backend Oraclebased clinical database management sys tem.The combined and enhanced product lines will allow the company to compete for a market 5 to 10 times larger than EDC/EPD alone. “It had become clear to everybody in the industry that the timing was right for an aggressive, strategic initiative to capitalize on an enormous market oppor tunity,”Mr.Cline comments.“This merger provides etri als customers an immediate base of operations in Europe, and Araccel customers with additional key products and technologies.We believe this merger is the logical next step toward our longheld goal of building a truly great company that can lead the mar ket in endtoend eclinical solutions for clinical trials. etrials Worldwide will continue to look for opportuni ties to build or acquire technology that will strength en its marketleading eclinical solutions platform.” “This deal makes sense at every level,”Mr. Nazem says. “The current market among EDC/EPD vendors is highly fragmented with no companies offering a fast, robust, and completely integrated eclinical solution. This merger instantly places our new com pany as a clear market leader.” The newly formed biodistribution division of Pharmaceutical Profiles will serve the growing radio pharmaceuticals market by building on the compa ny’s established experience in the area of gamma scintigraphy. Radiopharmaceuticals are used in diagnostic imaging and therapeutic applications in nuclear medicine, and biodistribution investi gations determine the safety and effectiveness of radiopharmaceuticals in Phase I/IIa clinical trials. “These services and facilities have been established by Pharmaceutical Profiles to provide rapid initiation and completion of comprehensive biodis tribution studies, expediting the early clinical development of radiopharma ceuticals,” says Dr. Dennis Heller, VP of biodistribution business develop ment for Pharmaceutical Profiles. The company can conduct stud ies at a cGMP facility for manufactur ing radiolabeled dosage forms that specializes in earlyphase clinical stud ies with radiolabeled pharmaceuti cals, and conducts studies to cGCP standards.The company’s biodistribu tion division has established proce dures for subject recruitment and study conduct, integrated QA study audits,a highly trained team of profes sionals experienced in the handling of radiolabeled dosage forms, and com prehensive clinical trials incorporating key study objectives into a single integrated study design.The service also allows the incorporation of common study objectives into a single comprehensive study, in either normal healthy subjects or patient populations, to include: whole body imaging for dosimetry and effi cacy;assessment of subject safety; col lection and analysis of excreta for mass balance and metabolic profiling; and blood collection for pharmacokinetic and safety endpoints. Recently revised FDA guidelines have sought to clarify and expand the scope of earlyphase clinical trials required for new diagnostic agents. These regulations place increased emphasis on the pharmacological and toxicological response of both the radionuclide and the ligand (carrier) components, in addition to the evalu ation of the radiation absorbed dose and biodistribution. “Despite revisions to the FDA regu lations in this area,there is much confu sion and uncertainty within the design of earlyphase clinical trials,” Dr. Heller says. “Our experience during the past several years in assisting clients with the optimization of clinicaltrial objectives, to address the concerns set forth by regulatory agencies such as the FDA, sets us apart from other centers.” International PGR Study Group Formed to FOCUS ONDIABETES MANAGEMENT A group of international diabetes experts has formed the International PGR Study Group to provide new insights and recommendations for the manage ment of diabetes. The team of North American, Euro pean, and Japanese specialists are focusing on the emerging,overlooked concept of prandialglucose reg ulation as a key component of diabetes management. The three most common measurements of blood glucose are fastingprandial glucose — the measurement of glucose in the blood 12 hours fol lowing a meal; hemoglobin A1c — the measure ment of the average glucose concentration in the blood during a period of time,usually 3 months to 4 months; and postprandial glucose — the measure ment of glucose in the blood two hours following a meal. Prandial glucose regulation is the active con trol andmanagementof that glucose concentration. The group is advocating a fundamental change in the diagnosis and treatment of diabetes to reduce the burden of cardiovascular disease and other diabetes related complications. The goal is to achieve prandial glucose regulation as part of the tradi tional diabetes management mix. The group of physicians and scientists has come together to further the under standing of PGRand its role in predicting disease outcome. “ The role of the International PGR Study Group is quite simple,” says Pro fessor Antonio Ceriello, chair of internal medicine at the University of Udine, Italy, and the group chair.“Many people with diabetes are dying from cardio vascularrelated outcomes. It’s clear that traditional treatment approaches need to be updated and PGR is the next step in diabetes management.” The group is funded through an unrestricted educational grant from Novo Nordisk. Pharmaceutical Profiles’ biodistribution service determines the safety and efficacy of radio pharmaceuticals in Phase I/IIa trials. The role of the International PGR Study Group is to ensure that healthcare professionals around the world have the most current information and tools for treating diabetes. Antonio Ceriello Pharmaceutical Profiles is first CRO to offer a TAILORMADEBIODISTRIBUTIONSERVICE PharmaVOICE WHAT’S new PharmaVOICE Michael S. Jabbour, a healthcare industry veteran with more than 25 years of experience, and former president of Lewis Gace Bozell Healthcare World wide, has established MSJ Healthcare Consulting. Providing strategic and creative insights and solu tions to advertising agen cies, pharmaceutical com panies,and publicrelations firms, Mr. Jabbour func tions in a variety of roles, including troubleshooter, lecturer, workshop leader, facilitator, mentor, strate gist, and business development consultant. Mr. Jabbour has experience in sales, sales man agement, product management, strategic plan ning,advertising,public relations, and new business development. He has held senior positions on domestic and international levels with indepth experience in positioning, strategy, creative, marketing, and branding. ARACCEL CORP.,Horsham, Pa.,provides validated, innovative,and proven eclinical solutions that capture,maintain,analyze, distribute, manage,and report clinicaltrial data,thereby expediting the clinicaltrial process.For more information, visit araccel.com. ETRIALS INC., Research Triangle Park,N.C., offers pharmaceutical and biotechnology clients efficient datamanagement prod ucts and services for collecting, monitor ing, and assessing quantitative and quali tative study data. For more information, visit etrials.com. THE FOODANDDRUGADMINISTRA TION,Rockville, Md.,promotes and pro tects the public health by helping safe and effective products reach the market in a timely way,and monitors products for continued safety after they are in use.For more information,visit fda.gov. GREY HEALTHCAREGROUP INC., New York,provides services in support of brand acceleration, including insightdriven brand strategy and branding,advertising, portfolio and franchise marketing, data based relationship marketing,medical education,public relations,Web initiatives, and meeting and symposia management. For more information,visit ghgroup.com. HEALTHED,Westfield,N.J., is a patient education agency focusing on developing patientcentered health education pro grams.For more information,visit healthed.com. INSIGHT INTERACTIVE GROUP,Philadel phia, is an interactive marketing agency that strategically builds brand loyalty with measured results. For more information, visit insightinteractive.com. THE INTERNATIONAL PGR STUDY GROUP, a virtual organization with global representation, is committed to producing evidencebased recommendations for integrating prandial glucose regulation into the management of diabetes.For more information,visit novonordisk.com. MSJHEALTHCARE CONSULTING,Boston, provides strategic and creative insights and solutions to advertising agencies, pharmaceutical companies,and public relations firms. For more information,e mail msjabbour@yahoo.com. THEPHARMACEUTICALRESEARCH ANDMANUFACTURERS OFAMERICA, Washington,D.C., represents the country’s leading researchbased pharmaceutical and biotechnology companies,which are devoted to inventing medicines that allow patients to live longer,healthier, and more productive lives. For more information, visit phrma.org. PHARMACEUTICAL PROFILES, Ruddington,U.K., is a global earlyphase development company.The company’s U.S.headquarters are in Princeton,N.J. For more information,visit pharmprofiles.co.uk. Follow up Former Agency Head launches MSJHEALTHCARE CONSULTING Michael Jabbour launches a consulting company to provide strategy and creative insights and solutions. FDA Consolidates Review Responsibilities for NewPharmaceuticals The Food and Drug Administration has consolidated the responsibility for review ing new pharmaceutical products into its Center for Drug Evaluation and Research. The work previously was performed in part by FDA’s Center for Biologics Evaluation and Research and in part by CDER. “FDA’s drug and biological product reviews have long been the gold standard for the world,” says Dr. Lester M. Crawford, deputy commissioner of the FDA.“By care fully combining part of our present biolog ics review operation responsibilities with our drug review operation, FDA will be optimally positioned to uphold that gold standard by continuing to review novel pharmaceutical products promptly and rigorously in an accountable and consis tent manner.” The consolidation will allow CBER to concentrate its scientific expertise and effort in the areas of vaccines and blood safety, and concentrate its expertise on cut tingedge biologic scientific areas, such as gene therapy and tissue transplantation. A working group,which will be chaired by Dr. Murray M. Lumpkin, senior associate commissioner, has been established to develop an implementation action plan and time line for the consolidation by Jan uary. The action plan will address issues related to the product andprocess logistics of the consolidation.Current FDA policy on generic biologics will not be affected by this decision. In the interim, the FDA advis es companies to continue to work with CBER andCDERuntil the FDA issues further guidance on any change in oversight responsibilities and practices. The FDA’s decision was met with approval from the industry’s largest organi zation. “Biotechnology is playing an ever increasing role in the development of new medicines by the pharmaceutical indus try,”says JohnT.Kelly,M.D.,Ph.D.,senior VP of scientific and regulatory affairs at the Phar maceutical Research and Manufacturers of America. “We applaud the FDA’s commit ment to enhance the effectiveness and efficiency of the review of therapeutic bio logics. As always,PhRMA’s prime concern is getting safe, effective, and innovative medicines to patients as quickly as possi ble. PhRMA looks forward to working with CDER in its augmented role.” INDUSTRY SNAPSHOT

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