What’s New

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New Healthcare-related Products, Services, and Companies

Scientific Advantage Launches MSL Outsourcing Subsidiary The new division addresses client requests for MSL professionals. Scientific Advantage LLC has formed MSL Advantage LLC to fill MSL staffing positions within pharmaceutical, biotech, and medical-device companies. Scientific Advantage launched the new business in response to requests from clients in the biopharmaceutical and device areas seeking to contract high-level MSL professionals. MSLs are the specialists charged with maintaining an open exchange of complex scientific information between drug and device companies and medical thought leaders. Like its parent company, MSL Advantage is based in Bernardsville, N.J., and operates internationally. “With the creation of MSL Advantage, we can now offer flexible and customized contracting solutions that complement the extensive expertise and portfolio of services already provided by Scientific Advantage,” says Robin Winter-Sperry, M.D., president and CEO of Scientific Advantage. “The synergy of both companies working together will enable us to provide the broadest and most professional range of customized MSL staffing, training, management, and operational services available anywhere in the world.” Keith Morris, a 21-year industry veteran with extensive experience in the MSL and medical-communications fields, has been appointed executive VP of MSL Advantage. Previously, he was executive VP of the Network for Medical Communications and Research (NMCR). As Executive VP of MSL Advantage, Keith Morris spearheads Scientific Advantage’s new MSL outsourcing company. Healthcare Educational Outcomes Journal is Launched CE Measure has been launched as the first peer-reviewed journal dedicated specifically to the art and science of healthcare educational outcomes measurement. Published by Carden Jennings Publishing (CJP) and the University of Medicine and Dentistry of New Jersey (UMDNJ), CE Measure establishes an educational connection among academic, public, and private sectors interested in increasing educational outcomes awareness. The journal covers a variety of topics that are of interest to anyone involved in advancing disease-management educational outcomes or researching more effective ways to do so. CE Measure is edited by Robert F. Orsetti, a 30-year veteran of the CME industry, who also serves as assistant VP of continuing and outreach education at UMDNJ. The journal, whose inaugural issue was June 2006, is published quarterly in print and electronic formats and is distributed to 10,000 professionals in academia, industry, specialty societies, and commercial organizations. Robert F. Orsetti, a 30-year veteran of the CME industry, has been appointed Editor of CE Measure. Publicis Selling Solutions Reorganizes Business Development Publicis Selling Solutions Group (PSSG) has reorganized to better serve the growing demand from its clients. The four companies within the Publicis Selling Solutions Group — Publicis Selling Solutions, Arista Marketing Associates, Total Learning Concepts, and Pharmaceutical Corp. of America — have fully integrated their business development teams to provide more comprehensive and integrated selling-solution offerings for their clients. As part of the company restructuring, Don Overcash, R.Ph., has been named executive VP of PSSG business development. He is spearheading the coordinated business development effort for all four companies. Additionally, Mr. Overcash retains the title and responsibilities he has held for five years as president of Arista Marketing Associates. Don Overcash, R.Ph., Executive VP, Business Development, Publicis Selling Solutions Group, is leading the company’s reorganized effort to coordinate business development across its four divisions. Quintiles Creates Strategic Biostatistics Unit Quintiles Transnational Corp. has created the Strategic Biostatistics Unit to help customers cut the time and reduce the costs of drug development through the “adaptive design” of clinical trials and other innovative statistical approaches. The unit aims to provide input to sponsors on innovative statistical approaches to increase chance of success for individual studies or for whole programs. A study design is called adaptive if it allows modification of an essential design feature — for example sample size reassessment, randomization ratio, number of treatment arms — based on accruing data from within that clinical trial, with the possible adaptations fully prespecified for confirmatory trials, and in all cases carried out without compromising the integrity of the trial. New Collaboration to Speed Product Development Battelle, BattelleCRO Inc., and Accium BioSciences Inc. have formed a collaboration to support and service pharmaceutical and biotechnology clients. The effort combines Accium’s expertise in accelerator mass spectrometry-based study design and in-house bioanalytical services, Battelle’s preclinical and toxicology capabilities, and BattelleCRO’s clinical-trial experience to provide clients with comprehensive Phase 0 (microdosing) and low-radiation Phase I clinical services. The high cost and financial risk associated with developing new drugs and biological products highlights the need to reduce product development cycle times. The combination of the three companies’ capabilities provides an opportunity to move products from discovery to clinical studies performed at subtherapeutic doses to the commercial market more quickly and effectively. “Our collaboration with Accium allows us to offer our clients an expanded scope of services — including our analytical chemistry, toxicology, and clinical services — with the ability to obtain early human bioavailability and pharmacokinetic data earlier than conventional Phase I studies,” says Mark Gritz, VP of Battelle’s health and life-sciences division. MS&L Creates New Global Division Manning Selvage & Lee (MS&L) has formed a global healthcare issues management and litigation communications practice to address the changing business environment for healthcare and pharmaceutical companies. The new practice brings together MS&L’s substantial issues management and litigation communications expertise under the leadership of MS&L’s crisis expert and North American President Larry Kamer. The practice, which will expand in the future with country-specific leaders in Europe, includes the following four senior MS&L executives who are experts in media, healthcare, and issues management: Paul Gallagher, senior VP and director of media strategy; Peter Pitts, senior VP, global health affairs and former associate commissioner for external relations at the Food and Drug Administration (FDA); Don Hannaford, senior VP and managing director of MS&L’s Washington, D.C., office; and Pal Jebsen, chairman of MS&L Sweden and partner in the JKL Group, one of the leading corporate communications consultancies in the Nordic region. Around the Globe Averion Inc., a Framingham, Mass.-based provider of clinical-trials support services, has expanded into Europe with the creation of Averion GmbH. Offering Averion’s full range of services, the European subsidiary will work to develop relationships with international clients as well as run European studies for existing North American clients. The wholly owned subsidiary is based in Germany and headed by John Shillingford, Ph.D., who has been named president of Averion GmbH. Dr. Shillingford has 25 years of pharmaceutical and CRO experience, both in the United States and Europe. He most recently held positions in clinical operations and project management at PRA International and ImForm GmbH. For more information, visit averioninc.com. Covance Inc., Princeton, N.J., a drug-development services company, has further strengthened the laboratory testing capabilities provided by its Covance Central Laboratory Services unit in the Asia-Pacific region. Covance’s dedicated laboratory in Singapore, as well as its laboratory service provider in Shanghai, China — Huashan Hospital Center of Laboratory Medicine — have both achieved certification by the College of American Pathologists (CAP). Additionally, Covance has forged agreements with Japan’s two largest central laboratories: Mitsubishi Kagaku Bio-Clinical Laboratories Inc. (MBC) and SRL Medisearch Inc. Under the agreements, these laboratories are servicing the company’s clients’ clinical trials in Japan, through the unique Covance Virtual Central Laboratory service. Covance also has expanded its kit production facilities in Sydney, Australia, and quadrupled its laboratory testing facilities in Singapore, including expanded quantitative PCR testing. For more information, visit covance.com. After recently expanding its HealthCare division with offices in Hong Kong, Singapore, China, and Thailand, GfK HealthCare Asia has made four senior-level additions to its executive team. GfK HealthCare Asia, Beijing, is a specialist division of The GfK Group that handles information services within the region’s healthcare markets. Scott Davies has been appointed healthcare director for Asia. Alan John has been named director of healthcare, Thailand. Clive Marshall has been appointed managing director, China. And Keren Priyadarshini has been named director of healthcare, Singapore. The group also has established a new division to focus on syndicated work in Asia. The new division is headed up by Ken Walsh, the newly appointed director of syndicated and services. For more information, visit gfk.com. The Institute of Clinical Research (ICR), Buckinghamshire, United Kingdom, an international association supporting and promoting clinical research organizations, has expanded its global presence by signing up its first China-based member. Dr. John Hooper, CEO of ICR, recently visited Shanghai, China, where he delivered a lecture on the Global Dynamics of Clinical Research in India and China at the 10th International Exhibition on Biotech and Pharma. For more information, visit instituteofclinicalresearch.org. Publicis Groupe, Paris, has acquired the BOZ Group, a leading French healthcare communication agency. BOZ has developed a new integrated approach to medical communications, extending from the scientific research environment and market studies, to training for medical professional salesforces, specific training for doctors, and management of pathology observatories — all indispensable services to pharmaceutical groups. This approach thus fits in well with Publicis Groupe’s holistic approach to communications, especially in healthcare. For more information, visit publicishealthcare.com. New Company Aims to Improve Clinical-Trial Process Likelihood methodology for measuring statistical evidence provides a low-cost solution because it maximizes a clinical trial’s efficiency, flexibility, and accuracy from a statistical perspective, says Arthur Blume, CEO and President, Analytical Edge Inc. Analytical Edge Inc. has formed to develop and commercialize a revolutionary statistical methodology with the potential to reduce the time and costs of performing clinical trials for new drugs and medical devices. Analytical Edge, in partnership with Brown University, uses a flexible, efficient, and accurate statistical approach to design clinical trials and analyze their results. The approach is based on a methodology referred to as Pure Likelihood, a new technique for measuring the strength of statistical evidence in data, which presents significant advantages for both standard and adaptive clinical-trial designs. The new firm is backed by the Slater Technology Fund. It is headed by Arthur Blume, Ph.D., CEO and president, a 35-year industry veteran with experience in biotechnology and pharmaceutical research and development. Jeffrey Blume, Ph.D., serves as Analytical Edge’s chief scientific officer. “Both the pharmaceutical and medical-device industries must stretch their current resources for development and discovery programs in order to maintain their competitive advantage,” Dr. Arthur Blume says. Aptuit Consulting is Launched Aptuit Inc. has launched Aptuit Consulting Inc., a business unit dedicated to offering counsel and services in all aspects of drug development and helping clients move efficiently from IND-enabling chemistry and biology to proof-of-concept clinical studies. The formation of Aptuit Consulting coincides with the company’s recent acquisition of Pharma Consulting Inc., Harvard, Mass. Pharma Consulting has merged with Aptuit’s existing team to form a group with more extensive expertise and geographic coverage. The new business has offices in major life-sciences centers around the globe, serving both large and small biotech and pharmaceutical companies. William D. Kerns, D.V.M., former CEO of Pharma Consulting, has joined Robert G. Burford, Ph.D., and Leslie Patmore, Ph.D., as a managing director of Aptuit Consulting. New Pharma Company is Created Cabrellis Pharmaceuticals Corp. has launched operations following a successful spinout from Conforma Therapeutics Corp. Cabrellis, a specialty pharma company committed to developing therapies to treat cancer, was formed by members of the Conforma management team that executed the sale of Conforma to Biogen Idec Inc. Cabrellis’ lead product, Calsed, is expected to enter Phase II clinical testing during the third quarter of 2006. The new company is led by President and CEO Thomas M. Estok, along with his Cofounders, John E. Crawford, chief financial and administrative officer, and Christopher C. LeMasters, chief business officer. Cabrellis’ initial investors include the former Conforma shareholders, including Domain Associates, Forward Ventures, Lilly Ventures, Novo A/S, ProQuest Investments, RBC Capital Partners, RiverVest Venture Partners, and S.R. One Ltd. “Cabrellis is fortunate to have a strong partner in Dainippon Sumitomo Pharma,” Mr. LeMasters says. “Since the inception of the partnership with Conforma in June of 2005, they have been extraordinarily supportive. Both of our companies are looking forward to continuing this successful relationship.” Scienta Launches Neurology CME Program Scienta Healthcare Education has announced the launch of Issues in Neurology, a new educational network of programs designed for physicians who practice in the field of neurology. The program offers evidence-based continuing medical education (CME) presented by recognized neurology experts through a combination of live events, Web-based content, and CD-ROMs. Issues in Neurology is guided by an education advisory board of recognized educators and clinicians in the field of neurology. This board is responsible for creating and reviewing educational content, participating in live Web events, and presenting at Issues in Neurology live events. The Issues in Neurology Website launched in June. Along with original CME content, the Website offers updated neurology news, information about upcoming neurology events, and discussion boards where members can interact with peers and top neurology thought leaders. The Issues in Neurology program will be exhibiting at several conferences this fall to give neurologists the opportunity to learn about its CME content. This new CME initiative offers a robust source of educational content for practicing neurologists, says Sherri Foster, Director of Medical Education for Scienta. Stressgen Changes Name to Nventa Biopharmaceuticals Stressgen Biotechnologies Corp. has changed its name to Nventa Biopharmaceuticals Corp. Nventa is developing innovative therapeutics for the treatment of viral infections and cancer, with a focus on diseases caused by the human papillomavirus (HPV). “So much has changed during the past year that we decided to rebrand the company and create a new corporate identity that coincides with our recently announced new corporate vision and clinical strategy,” says Gregory M. McKee, Nventa’s president and CEO. “With a new management team now in place, a more open and dynamic corporate culture, and a new strategic development plan to resume clinical development of our lead compound HspE7, what better time to reflect on all of our recent accomplishments and refresh our corporate image.” We believe that our new tagline, ‘From Insight to Impact,’ communicates our mission well: the application of scientific insight to discover novel biopharmaceuticals that have a direct impact on patients suffering from difficult-to-treat diseases for which few, if any, treatments exist, says Gregory M. McKee, President and CEO, Nventa Biopharmaceuticals Corp. What’s New on the Shelves ABC of Asthma, Fifth Edition, by John Rees and Dipak Kanabar and published by Blackwell Publishing, is the latest edition of this best-selling book, updated to include the latest guidelines on the management of asthma. The book is essential for anyone dealing with the treatment of asthma in adults or children. For more information, visit blackwellpublishing.com. Encyclopedia of Heart Diseases, by M. Gabriel Khan and published by Elsevier, is a thorough and easy-to-navigate guide to the diseases that kill more than 12 million people worldwide each year. A valuable resource for sales teams, brand teams, and researchers alike, this text includes in-depth analysis of even the least common and rare heart conditions. For more information, visit books.elsevier.com. Health Care Politics and Policy in America, Third Edition, by Kant Patel and Mark E. Rushefsky and published by M.E. Sharpe Inc., provides a guide to the history of U.S. healthcare politics and policy as well as the origins of the Medicare and Medicaid programs, including a chronology of significant events. This latest version contains two new chapters addressing medical liability and the policy initiatives of the late 1990s. For more information, visit mesharpe.com. Pharmaceutical Operations Management: Manufacturing For Competitive Advantage, by Pankaj Mohan, Ph.D., Jarka Glassey, Ph.D., and Gary A. Montague, Ph.D., and published by McGraw-Hill, is a comprehensive guide to pharmaceutical operations management. The book focuses on policy execution, risk management, supply-chain modeling, advance process control, and Six Sigma for the pharmaceutical industry. The book offers an integrated approach to pharmaceutical product manufacturing life-cycle management by detailing process design, including the value of scale up and scale down, control strategy, and variability reduction. For more information, visit books.mcgraw-hill.com. Understanding Leukemias, Lymphomas, and Myelomas, by T. Mighal and J. M. Goldman and published by Taylor & Francis Group, is a practical, easy-to-use guide. The book is invaluable for anyone involved with treating leukemias, lymphomas, or myelomas or addressing this market. Discussions cover the different types of the disorders, diagnosis procedures, and the various treatments of leukemia and lymphoma, including blood and bone marrow transplantation. For more information, visit taylorandfrancis.com. Follow up Accium BioSciences Inc., Seattle, is the first company to fully commercialize accelerator mass spectrometry (AMS) services in the United States. For more information, visit acciumbio.com. Analytical Edge Inc., East Greenwich, R.I., provides software and services for measuring and interpreting the strength of statistical evidence in data. For more information, visit analyticaledge.com. Aptuit Inc., Greenwich, Conn., provides drug-development services to biotech and pharmaceutical innovators. For more information, visit aptuit.com. Battelle, Columbus, Ohio, develops and commercializes technology and manages laboratories for customers. For more information, visit battelle.org. BattelleCRO Inc., Newton, Mass., a wholly owned subsidiary of Battelle, supports Phase I-IV clinical programs for pharma, biotech, medical-device, nutraceutical, government, and biodefense efforts. For more information, visit battellecro.com. Cabrellis Pharmaceuticals Corp., San Diego, is a specialty pharmaceutical company committed to the development of therapies for the treatment of cancer. For more information, visit cabrellis.com. Carden Jennings Publishing Co. Ltd., Charlottesville, Va., is recognized for its print, CD-ROM, and online publications. For more information, visit cpj.com. Manning Selvage & Lee, New York, is a global public relations firm. For more information, visit mslpr.com. Nventa Biopharmaceuticals Corp., San Diego, develops therapeutics for the treatment of viral infections and cancer. For more information, visit nventacorp.com. Publicis Selling Solutions Group (PSSG), Lawrenceville, N.J., offers a range of strategic selling solutions to the pharmaceutical, biotech, and medical-device industries. For more information, visit psellingsolutions.com. Quintiles Transnational Corp., Research Triangle Park, N.C., provides quality professional expertise, market intelligence, and partnering solutions to meet the needs of the pharmaceutical, biotechnology, and healthcare industries. For more information, visit quintiles.com. Scienta Healthcare Education, Durham, N.C., is an ACCME-accredited provider dedicated to the development and dissemination of CME. For more information, visit scienta-edu.com. Scientific Advantage LLC, Bernardsville, N.J., develops and implements medical-affairs strategy, department architecture, training, and operations. For more information, visit scientificadvantage.com.

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