What’s New

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NEW HEALTHCARE RELATED PRODUCTS, SERVICES, AND COMPANIES

The American Heart Association has launched the last of its updated cardiology subspecialty journals published under the banner of Circulation: Journal of the American Heart Association by Lippincott Williams &Wilkins, part of Wolters Kluwer Health. Circulation: Cardiovascular Genetics is edited by Ramachandran Vasan, M.D., D.M., of Boston University School of Medicine and The Framingham Heart Study. “The field of cardiovascular genetics is exploding, with exponential increases in scientific investigations and manuscripts,” Dr. Vasan says. “ These rapid advances bring with them the urgent need for continuous education of cardiologists, scientists, and practitioners.” Circulation: Cardiovascular Genetics mainly focus es on original research on population genetics and biomarkers, as well as clinical trials in the burgeoning field of pharmacogenetics. The journal also features current and comprehensive reviews in the areas of advances in molecular genetics, genomics, proteomics, metabolomics, and systems biology; methods in genetics and clinical interpretation; and controversies in cardiovascular genetics. The new title completes the updated Circulation portfolio of journals, designed to meet the need for tightly focused information at the cutting edge of cardiology. Vox Medica has revamped its traditional health care marketing agency model in an effort to address the changing healthcare and communications environment. Led by industry veteran George Glatcz, Vox Medica’s president and chief branding officer, the agency’s cuttingedge structure and sixstep brand communications model known as PEER has demonstrated early success with clients. “Internally, we have taken down business unit barriers to allow us to readily bring together talent from across our organization so our clients gain early access to experienced insights, while also streamlining duplicative support services,” Mr. Glatcz says.“ Externally, PEER supports our efforts to look across audiences in new ways to find common mindsets and build solutions around diverse audiences rather than physicians only,patients only, payers only, etc. The net result is a more effective model that doesn’t waste time or money.” PEER supports our efforts to look across audiences in new ways to find common mindsets and build solutions around diverse audiences rather than physicians only, patients only, payers only, etc., say George Glatcz, President and Chief Branding Officer (left), and Ross Thomson, Executive VP, Chief Ideation Officer, Vox Medica. Octagon Joins CDISC for EDUCATION INITIATIVE FOR FDA REVIEWERS Octagon Research Solutions is partnering with the Clinical Data Standards Interchange Consortium (CDISC) to provide continuing education on electronic data standards to regulatory submission reviewers at the U.S. Food and Drug Administration. The FDA recently awarded CDISC and its member partners with a two year contract to provide electronic data standards training to their reviewers. Octagon is conducting the training sessions and developing the appropriate training materials to support the curriculum,which includes courses such as CDISC Basics, Study Data Tabulation Model (SDTM), Analysis Data Model (ADaM), and Advanced Topics of CDISC Standards. “This opportunity will give us the ability to help facilitate the bidirectional flow of information between sponsors and reviewers,” says Fred Wood, principal consultant and lead of the data standards consulting group at Octagon. “We are pleased to collaborate with CDISC on such an important project,”adds Octagon Chairman and CEO Jim Walker. AHA Lippincott Completes Update of CIRCULATION JOURNAL PORTFOLIO Vox Medica Changes its AGENCY BUSINESS MODEL The new model addresses the changing healthcare environment. A new enterprise formed by Science Oriented Solutions (SOS) and Scientific Advantage offers a one stop package of medical affairs strategies and applications for every phase of the product life cycle. Robin WinterSperry, M.D., founder and president of Scientific Advantage, leads the combined entity. SOS provides contract medical science liaisons (MSLs) and medical communications support services. Scientific Advantage provides medical affairs management consulting, training, and strategic operations. “This partnership serves as a medical affairs resource center for companies,” Dr. WinterSperry says. “Providing medical affairs departments with flexible options allows them to pick and choose the specific customized services they need at any point in time to match the natural ebb and flow of business.” Combined Enterprise Offers MEDICAL AFFAIRS SERVICES SUITE Providing medical affairs departments with flexible options allows them to pick and choose the specific customized services they need at any point in time to match the natural ebb and flow of business, says Dr. Robin WinterSperry, Founder and President of Scientific Advantage. What’s new ON THE SHELVES Barnett Educational Services, Needham, Mass., has released the 2008 edition of Good Clinical Practice: A Question & Answer Reference Guide, a pocket training and reference guide that answers more than 500 of the most common questions regarding day-to-day interpretation and implementation of GCP standards for drugs and biologics. While the guide continues to focus on U.S. Food and Drug Administration standards, the 2008 version has expanded its information on international GCP issues in such regions as the European Union, Canada, India, Russia, and China, and added a new section on GCP in Latin America. For more information, visit barnettinternational.com. Informa Healthcare, New York, has released the second edition of FDA Regulatory Affairs: A Guide for Prescription Drugs, Medical Devices, and Biologics, an incisive, comprehensive guide to the most recent Food and Drug Administration regulations for the approval of pharmaceuticals, biological products, and medical devices. The guide provides users in the life-sciences fields with a road map for successfully navigating the pitfalls of the FDA approval process. For more information, visit informahealthcare.com. Consultant Mark Stinson’s new book, ForwardFast, The 6-Step Model to Accelerate Your Health, Science, and Technology Brand, offers readers the opportunity to improve their skills in medical marketing, advertising, education, and communications. This “workshop-in-print” provides practical brand innovation principles, as well as 17 worksheet templates that can be downloaded from the book’s Website. Published by Mr. Stinson’s consultancy, Stinson Brand Innovation, ForwardFast can be purchased as a hardcover or e-book; it is also available in the Amazon Kindle format. For more information, visit stinsonbrandinnovation.com or forward-fast.com. M&A Activity ARIAD PHARMACEUTICALS, Cambridge, Mass., has acquired the remaining interest in its 80%-owned subsidiary, Ariad Gene Therapeutics (AGTI), in a 2-for-1 stock transaction. Further details of the transaction were not disclosed. The deal grants Ariad the full potential economic benefits from AGTI’s portfolio, including the novel mTOR inhibitor drug deforolimus, which is in Phase III clinical trials to treat metastatic soft-tissue and bone sarcomas. Ariad discovers and develops medicines that treat cancer by regulating cell signaling with small molecules. For more information, visit ariad.com. Toronto-based specialty pharmaceutical company BIOVAIL has acquired privately held U.S.-based specialty firm Prestwick Pharmaceuticals, which recently obtained the U.S. and Canadian licensing rights to Xenazine (tetrabenazine tablets) from Ovation Pharmaceuticals. Biovail acquired Prestwick for an estimated $100 million in cash. Xenazine was recently approved by the U.S. Food and Drug Administration for the treatment of chorea associated with Huntington’s disease. The FDA also granted the product an orphan drug designation. For more information, visit biovail.com. BIOVITRUM, a Stockholm-based specialty pharmaceutical company, has agreed to buy three products from Thousand Oaks, Calif.-based biotechnology firm Amgen for about $130 million in cash and stock, expanding Biovitrum’s global presence to include North America, Europe, Australia, and New Zealand. Under the terms of the deal, Biovitrum acquires the biologic products Kepivance (palifermin) and Stemgen (ancestim) and obtains a worldwide exclusive license to Kineret (anakinra) for its current approved indication to treat inflammation associated with rheumatoid arthritis. For more information, visit biovitrum.com. Contract research organization CHARLES RIVER LABORATORIES INTERNATIONAL, Wilmington, Mass., has completed the acquisition of privately held NewLab BioQualty, a Dusseldorf, Germany-based provider of safety and quality control services to biopharmaceutical clients. NewLab joins Charles River Biopharmaceutical Services and further strengthens the company’s portfolio of products and services for accelerating drug development. For more information, visit criver.com. ELI LILLY, Indianapolis, has agreed to acquire New York-based ImClone Systems in a cash transaction valued at about $6.5 billion. The combined oncology portfolio of Lilly and ImClone targets a broader array of solid tumor types including lung, breast, ovarian, colorectal, head and neck, and pancreatic cancers, positioning Lilly to pursue treatments of multiple cancers. The deal also expands Lilly’s biotechnology capabilities through ImClone’s state-of-the-art development and commercial manufacturing facility, which provides significant flexibility to develop and manufacture complex biomolecules. For more information, visit lilly.com. Stockholm-based specialty pharmaceutical company MEDA has acquired four products from Swiss pharma company Roche for an estimated 120 million euros (US $163.5 million), strengthening Meda’s position in the key therapeutic categories of cardiology, CNS, and pain and inflammation. The deal gives Meda worldwide rights to the anticoagulant Marcoumar (phenprocoumon); the loop diuretic Torem (torasemide); the NSAID Tilcotil (tenoxicam) for treating rheumatoid and osteoarthritis; and the antidepressant Aurorix (moclobemide). For more information, visit meda.se. NOVACEA, a privately held biopharmaceutical company based in South San Francisco, Calif., has agreed to merge with privately held specialty pharmaceutical company Transcept Pharmaceuticals, Point Richmond, Calif., in an all-stock transaction by which Novacea will issue new shares of its common stock to Transcept shareholders. The former Transcept shareholders are expected to own 60% of the combined company, with the former Novacea shareholders holding the remaining 40%. Once the merger closes, the combined company will operate under the name Transcept and be headed by Transcept President and CEO Glenn Oclassen. For more information, visit transcept.com. PHASE FORWARD, a provider of data management solutions for clinical trials and drug safety, has acquired privately held technology firm Clarix for $40 million in cash. Clarix continues to operate from its headquarters in Radnor, Pa., as part of Phase Forward. Clarix’s fully Web-integrated interactive response technology (IRT) is used for subject randomization, predictive medication inventory management, and operational management and reporting in clinical trials. For more information, visit phaseforward.com. Biopharmaceutical company SONUS PHARMACEUTICALS recently changed its name to OncoGenex Pharmaceuticals after its completion of the acquisition of OncoGenex Technologies and has cut 49% of its workforce as part of a subsequent restructuring. The new OncoGenex, Bothell, Wash., has a strong oncology pipeline addressing unmet needs in the treatment of cancer. For more information, visit oncogenex.com. SYMYX TECHNOLOGIES, Santa Clara, Calif., has closed its acquisition of Camarillo, Calif.-based Integrity BioSolution, a provider of contract formulation research and analytical services, as well as contract manufacturing services. The acquisition expands Symyx’s research service offerings in life sciences into biologic formulations, complementing its existing chemical formulations services. For more information, visit symyx.com. TRIPOS INTERNATIONAL, St. Louis, a privately held provider of drug discovery informatics products and services, has agreed to acquire Mountain View, Calif.-based Pharsight for an estimated $57 million in cash. Pharsight provides software, strategic, and regulatory services designed to optimize clinical drug development. The deal enables Tripos to offer software products and scientific services over an expanded market. For more information, visit tripos.com. Healthcare information and business intelligence provider WOLTERS KLUWER HEALTH, Conshohocken, Pa., has announced plans to acquire Waltham, Mass.-based UpToDate, publisher of an evidence-based electronic clinical information resource. Terms of the acquisition were not disclosed. The deal strengthens Wolters Kluwer Health’s portfolio in the growing point-of-care and electronic medical record (EMR) markets. UpToDate specializes in physician-driven products designed to improve healthcare at the point of care and integrate smoothly into EMRs. For more information, visit wkhealth.com. Follow up American Heart Association, Dallas, seeks to build healthier lives, free of cardiovascular diseases and stroke. For more information, visit americanheart.org. IDIS, London, develops and implements named patient programs (NPPs). For more information, visit idispharma.com. Octagon Research Solutions Inc., Wayne, Pa., provides software and services to the life-sciences industry. For more information, visit octagonresearch.com. Scientific Advantage LLC, Bernardsville, N.J., specializes in the development of medical science liaison divisions and strategic business development in the medical marketing arena. For more information, visit scientificadvantage.com. Science Oriented Solutions (SOS), Atlanta, is a full-service commercial-side medical affairs group and a member of the Publicis Healthcare Communications Group. For more information, visit scienceorientedsolutions.com. The Medical Affairs Company LLC, Kennesaw, Ga., provides outsourced medical science liaison services to the pharmaceutical, biotechnology, and medical-device industries. For more information, visit themedicalaffairscompany.com. Vox Medica, Philadelphia, is an independent healthcare agency that delivers inventive, cost-effective communications solutions to healthcare clients worldwide. For more information, visit voxmedica.com. Wolters Kluwer Health, Conshohocken, Pa., provides information and business intelligence to medical and pharmaceutical companies and institutions. For more information, visit wkhealth.com. Around the GLOBe Independent healthcare marketing firm HC&B HEALTHCARE COMMUNICATIONS, Austin, Texas, has opened an office in London, deepening its commitment to providing integrated global resources to a growing base of international clients. The new office is headed by industry veteran Michael Dumigan, who joins the agency as managing director from the same role at London-based Brand Create Limited. In addition to managing day-to-day operations in London, Mr. Dumigan oversees all current HC&B global accounts and is spearheading the agency’s new global business development efforts. For more information, visit hcbhealth.com. QUINTILES TRANSNATIONAL, Research Triangle Park, N.C., is expanding its Singapore operations to meet the surging demand for its drug development and commercialization services in the Asia-Pacific region. The company plans to double the size of its regional headquarters, making Quintiles the region’s largest clinical development organization. In addition to the Singapore expansion, Quintiles’ Asia-Pacific growth also has led to expansion of its offices in Manila, Taipei, Seoul, Kuala Lumpur, Bangkok, Sydney, and Hong Kong, as well as the addition of a new location in Jakarta, Indonesia. For more information, visit quintiles.com. IDIS Opens U.S. Office This expansion is critical for building our presence in the United States for all our global partners, says John Lagus, VP of Business and Corporate Development at IDIS. IDIS, a London-based firm that develops and implements prelaunch named patient programs (NPPs), has opened a regional office in Iselin, N.J., strengthening the company’s ability to support U.S.-based pharmaceutical companies in the implementation of programs to support early access to their medicines. The Iselin office is headed by John Lagus, VP of business and corporate development, who is leading the expansion of IDIS in the United States. “This expansion is critical for building our presence in the United States for all our global partners, as well as providing proximity to the pharmaceutical and biotechnology companies based in the United States,” Mr. Lagus says. “This new office demonstrates IDIS’ commitment to our clients, who requested we establish a U.S. presence, and helps the business to further deliver global market access for the pharmaceutical and biotechnology industry through named patient programs, as well as comparator drug sourcing.” NPPs provide drug developers worldwide with a legal and ethical way to make medicines available where appropriate when those medicines are not yet approved in their country or in late-stage clinical trials. The programs that IDIS establishes in partnership with pharmaceutical and biotechnology companies must adhere to the strict regulatory guidelines of the country from which the request originates to allow patients who have a genuine unmet medical need access to potentially life-saving medicines. Medical Affairs Veterans Form New Contract Medical Organization The TMAC team (left to right): David Hahn, Chief Operating Officer; Kyle Kennedy, Managing Director; Beth Price, Executive VP, Business Development; Evan Demestihas, M.D., R.Ph., CEO; and Jennifer King, Executive VP, Operations. The Medical Affairs Company (TMAC) is a full-service contract medical organization recently established by the same team that created the first contract medical organization more than a decade ago. TMAC’s leadership includes CEO Evan Demestihas, M.D., who founded Science Oriented Solutions in 1997; David Hahn, chief operating officer; Kyle Kennedy, managing director; and Jennifer King and Beth Price, both executive VPs. These executives also are principals in the organization. “Our new management team and the expertise we collectively possess provide a formidable array of unique medical affairs outsourcing capabilities, a true contract medical organization,” Mr. Kennedy says. Ms. Price notes that TMAC provides turnkey deployment of medical science liaisons teams and seamless access to a wide range of medical affairs services to help its clients create a medical science liaison team from the ground up, or optimize the performance of an existing team. “We are exceptionally well positioned to provide our clients with a wide range of medical affairs outsourcing activities including contract medical liaisons, medical liaison consulting and training, and medical communications services,” Dr. Demestihas adds.

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