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What’s new New healthcare-related products, services, and companies
RxPedite Established to Provide Solutions to Emerging pharma and Biotech Companies Cardinal Health and inChord joint venture offers a full range of of launch-support services. RxPedite LLC has been established to provide comprehensive product launch support to emerging pharmaceutical and biotechnology companies. RxPedite is a joint venture between Cardinal Health, a provider of products and services supporting the healthcare industry, and inChord Communications Inc., an independent healthcare marketing company. RxPedite initially was founded as a strategic alliance between Cardinal Health and inChord in May 2002, but growing demand for RxPedite’s services led the two organizations to create a stand-alone company. “Over the past few years, our two companies have identified an unmet need for innovative commercialization solutions and partnership arrangements among pharmaceutical and biotech clients,” says Don Wetherhold, president of RxPedite. “Given the number of new medical innovations that are under development and the ongoing consolidation within the industry, we see tremendous potential for this offering.” The companies worked together on two different projects, and company officials decided to formally establish RxPedite to provide clients with a full range of complementary commercialization services, including product development, manufacturing and packaging, distribution, marketing, medical education, and sales. “As Cardinal Health and inChord worked on typical business-development activities, we increasingly saw that there was an unmet need for not only Cardinal Health’s contract sales services, but for the marketing capabilities that inChord has to offer, such as contract marketing, a full scope of advertising, agency, and marketing communication services, as well as interactive marketing capabilities, and data analytic market research capabilities,” Mr. Wetherhold says. The stand-alone company gives clients the ability to have one point of interaction that reaches across the service offerings of Cardinal Health and inChord. RxPedite also gives clients the ability to create unique or creative deal structures that may not be entertained individually by the two companies. RxPedite’s potential audience includes companies that have products that are in late Phase II or Phase III clinical development, that have not yet partnered with a big pharma company, and are at least partially funded; specialty pharmaceutical companies; and large pharma companies that have mature brands with reduced budgets. As president of RxPedite, Mr. Wetherhold brings more than 16 years of pharmaceutical sales and marketing management experience to the company. For the past five years, he served as president of the contract sales and marketing business unit at Cardinal Health. Industry Experts Form Patient recruiting Firm Integrated Clinical Trial Services (ICTS) has been formed by a team of industry experts to provide a more effective approach for pharmaceutical, biotech, and medical-device companies to enroll patients in clinical trials. The company is capable of managing the entire patient-recruitment process through a menu of a la carte services, including recruitment strategy consulting, market research and protocol review, project management, concept design and production, media placement, community-resource support, compliance and retention, and more. The firm offers a combined 50 years of experience in the patient-recruitment industry. The management team consists of Sheila Hale Ogle, CEO; Tom Sturgis, president; Gregg Sweet, VP of development; Sue Toth, VP of media; and Michele Gallagher, chief legal officer. “More than 80% of clinical trials are delayed because of problems with recruiting and enrolling patients, costing millions in additional development costs and hundreds of millions in lost revenue,” Mr. Sturgis says. “ICTS examines the factors underlying each study and then customizes a plan designed to educate, inform, and create action for the subjects and their caregivers, as well as the sites.” Whether a company is bringing its first drug to market or looking to revitalize a mature brand, RxPedite can offer access to a breadth of outsourced commercialization services, says Don Wetherhold, president of RxPedite. According to ICTS President Tom Sturgis, the new clinical-trial services company examines the factors underlying each study and customizes a plan designed to educate, inform, and create action in the subjects and their caregivers. Choice Media TV Program Allows Marketers to Sponsor Health Show Choice Media has launched a syndicated television newsmagazine, Medical Breakthroughs from HealthCentral. The program is broadcast on network affiliates in more than 50 markets nationwide and provides advertising opportunities for drug marketers seeking a more targeted audience. The show airs on some of the top ABC, CBS, NBC, and FOX stations in the United States and reaches nearly 35 million households with more than 1.2 million health-concerned adult viewers. Each half-hour program presents objective information about a specific condition. The show is backed up by the HealthCentral Website, which provides advertising messages from pharmaceutical sponsors within a medical context. Major pharmaceutical companies are sponsoring segments of the program. Hosted by nationally recognized radio and television expert Dr. Dean Edell, the program covers common medical conditions and provides a fair and balanced overview of cutting-edge treatments. This season’s topics, for example, include new flu treatments, rheumatoid arthritis, genital herpes, heartburn, heart attack, and stroke. On the show, viewers are directed to HealthCentral.com, where they can find content that includes interactive health assessments, videos, 3-D animations, breaking news, and other information of interest to health-minded consumers. The Website also includes excerpts from the TV program. Takeda Establishes Global Research and Development Center Takeda Pharmaceuticals North America, Inc. (TPNA) has established Takeda Global Research & Development Center Inc. (TGRD), a wholly owned subsidiary. The new organization, located on TPNA’s campus in Lincolnshire, Ill., integrates the clinical-development activity of TPNA’s R&D group and Takeda’s European R&D operation, Takeda Europe Research & Development Centre Ltd. The new center is led by John Yates, M.D., who most recently was VP for medical and scientific affairs at Merck. “This new organization was created to enhance the ability of the Takeda global R&D network and to more quickly bring superior pharmaceutical products to patients, both in the United States and other key markets worldwide,” says Yasuchika Hasegawa, president and chief operating officer of Takeda Chemical Industries Ltd. (TCI), parent company of TPNA. “We believe that TGRD, supported by Dr. Yates’ wide range of experience, will realize its full potential in the years ahead to execute a truly global development strategy.” TGRD’s focus will be on developing new product candidates, conducting postmarketing clinical studies, and identifying and developing innovative life-cycle management approaches for marketed drugs. Dr. John Yates is the head of Takeda’s new global R&D subsidiary. What’s New on the Shelves The Pharmaceutical cGMP Desk Reference – a resource for improving manufacturing practices. Published by FDA News, the Pharmaceutical CGMP Desk Reference provides information on how to improve quality control, reduce overall development time and costs from concept to market; how to meet the rigorous risk-based regulation requirements; how to incorporate new scientific and technological advancements; and how to assure the safety, identity, strength, quality, and purity of drug products. For more information, or to place an order, visit fdanews.com/wbi/bookstore. Financing Technology’s Frontier: Decision-Making Models for Investors and Advisors, Second Edition – an investment banker, VC, point-of-view. Published by John Wiley & Sons and written by Richard P. Shanley, a partner with Deloitte & Touche LLP, the 257-page book equips investors and senior executives of technology-based companies, as well as financial and business advisors, with decision-making tools. The book features case studies and financing information from various industry and professional sources and looks at the prospects of biotech beyond the U.S. borders, as well as what bioparks and academic medical centers are doing to encourage innovation. For more information, visit wiley.com. Navigating Good Clinical Practices – a FDA guideline for clinical trials. Published by the FDA News, the book provides guidances and guidelines to better manage clinical trials and avoid costly delays. Navigating Good Clinical Practices helps readers ensure adequate monitoring of clinical investigations; handle clinical holds and combination products; evaluate the influence of gender, ethnic and age factors on clinical data. For more information, visit fdanews.com/wbi/bookstore. Biotechnology: From Bench To Bedside – A primer – a resource handbook for information on biotechnology. Published by Merit Publishing International, the resource handbook is intended as reference for physicians, scientists, stock brokerage firms and their clients, venture capitalists, attorneys, pharmaceutical and biotechnology companies, regulators/legislators, health insurers, medical suppliers, market researchers, academics, the armed services, libraries, and bookstores. The 128-page book includes chapters on: the Human Genome Project; treatment modalities and pharmaceutical companies; the dogma of genetics; emerging treatments and biotechnology companies; a select sample of biological agents in clinical trials targeting cardiovascular disease, diabetes, cancer, rheumatoid arthritis, and psoriasis; pharmacogenomics; and future evolution of biotechnology medicine. For more information, visit meritpublishing.com. Accelera Acquires Kenexa’s learning Solutions Group Accelera Corp., a provider of blended learning solutions for the life-sciences industry, has acquired the Learning Solutions Group of Kenexa. The Learning Solutions Group creates custom and off-the-shelf print and multimedia programs for pharmaceutical, medical-device, and biotechnology companies. The combined operations operate under the Accelera name. The Learning Solutions Group has a number of proprietary disease-state and therapeutic-care products and economical off-the-shelf products that complement Accelera products. The Learning Solutions Group’s New Jersey office strengthens Accelera’s rapid response capability for clients in the Northeast region. The company is retaining all existing staff and plans to build up the Baltimore and Lawrenceville, N.J., operations. New Continuing-Education Company After spending more than 20 years in the field of continuing professional education and achieving two back-to-back six-year accreditation with commendation awards for a communication company, Dr. Jacqueline Parochka, a nationally known leader, has launched a continuing-education consulting business, Excellence in Continuing Education Ltd. The business is designed to assist providers in attaining and retaining best practices in accreditation. Services include guiding potential providers through the initial accreditation process and partnering with already accredited providers to excel in achieving commendations and to explore creative and innovative mechanisms to highlight the strengths of their overall program. site potential Program Helps Clinical Researchers Recruit, Retain Patients nTEGRA has introduced Site Potential, a proprietary training program that helps clinical researchers improve their patient-service techniques and site-management skills. A focus of Site Potential is teaching clinical staff how to treat a patient as a valued partner in the clinical-development process. By using Site Potential, clinical-research sponsors and investigators can improve adherence to a study’s protocol and can reduce study dropout rates by teaching recruitment and retention techniques. The program provides information on how to create service excellence by establishing patient-centered performance standards and quality service goals at each site; how to get the most from recruitment and retention techniques and tools; how proper office etiquette leads to better recruitment and retention, while limiting legal liability; and how to ensure prompt payment from sponsors. thomson Purchases Biosis’ Publishing Assets The Thomson Corp. has acquired the publishing assets of Biological Abstracts Inc. and Biosis, including one of the world’s largest life-sciences abstracting and indexing services. Biosis’ information services have become part of Thomson ISI, a business unit of Thomson Scientific and Healthcare. The Biosis product line is to be integrated within ISI Web of Knowledge, the multidisciplinary information solution that facilitates discovery by offering seamless navigation to the highest quality content, evaluation tools, and bibliographic management products. Founded in 1926, Biosis is a nonprofit organization that produces vital databases and services for life-sciences research, including Biological Abstracts, Biosis Previews, and Zoological Records. These databases are made available globally on a wide variety of platforms. Biosis offers both custom and standard information resources designed to fit the information needs of researchers, students, and information professionals worldwide. The board of Biosis continues to support their new mission under the interim name of The J.R.S. Foundation. AXIOM Professional Health Learning to Provide Training and Education to Pharmaceutical Professionals, Physicians, Patients The recently launched AXIOM Professional Health Learning LLC offers innovative and technology-leveraged training and education for pharmaceutical professionals, physicians, and patients. A unit of AXIS Healthcare Communications LLC, the division is led by Kevin Kruse, president. AXIOM focuses on three areas that are critical to the success of innovative medical education and training: the science of medicine, the science of instruction and adult learning, and the science of digital technologies. “The addition of AXIOM to our family of companies takes us another step closer to being able to offer our clients a full set of services under the management of a common client-services director,” says Neil Matheson, CEO of AXIS Healthcare Communications. “Our vision is to be the life-cycle services company, and we are now very close to realizing that vision.” For the last 12 years, Mr. Kruse led a pharmaceutical sales-training company that he founded. He also is the e-learning columnist for Chief Learning Officer magazine, the author of “Technology-based Training,” and a writer for numerous other publications. Kevin Kruse leads AXIS Healthcare’s new education division, AXIOM Professional Health Learning. Institute For Advanced Health Education Awarded CME Accreditation The Institute for Advanced Health Education has received accreditation from the Accreditation Council for Continuing Medical Education (ACCME). The Institute is now a recognized facility for continuing medical education (CME) courses and credits. The initial accreditation for the Institute is for two years, with the opportunity to receive a longer accreditation term after the two-year period has ended. Since its founding a year ago, the Institute has been offering CME programs in partnership with the University of Medicine and Dentistry of New Jersey (UMDNJ) and has established an informal partnership with the Harvard School of Public Health. The Institute delivers high-impact CME programs across a diverse range of therapeutic areas and has partnerships with recognized medical institutions and organizations. MedPharm Communications Launches Medical-Education Division MedPharm Communications LLC, a healthcare communications company, has launched EthicalDrug CME LLC, a medical-education division dedicated solely to offering a full range of continuing medical education (CME) services from symposia and roundtables to cutting-edge “webinars” and postconference publications. EthicalDrug conforms to all current and pending guidelines for CME issued by the Accreditation Council for Continuing Medical Education, the Office of Inspector General, and the Pharmaceutical Research and Manufacturers of America. Adhering to the standards has meant that MedPharm has had to hire a separate staff of writers and project managers, maintain separate physical offices, and install a distinct IT system to guard against inadvertent sharing of data between companies. Similar to its parent company, EthicalDrug has its own internal advisory board, a group of academic and community-based opinion leaders. Members include some of the country’s top researchers and clinicians across a wide variety of disciplines, including cardiology, oncology, infectious disease, neurology and neuropsychology, CNS, ENT, pharmacology, statistics, endocrinology, pediatrics, allergy, immunology, and pulmonary disease. “We believe this is EthicalDrug’s most unique asset,” says Norma-Jeanne Hennis, president. “The advisory board serves as a ready pool of expertise. We can give institutions immediate access to eminent speakers who can round out their own roster of internal experts. This not only helps keep projects on schedule, it also helps attract audiences and makes clinical discussions much more robust because of the wide range of opinions that can be represented.” Phoenix Marketing Solutions Launches DiMedix To Help Drug Industry comply with OIG guidelines Phoenix Marketing Solutions, a medical communications firm that designs promotional programs for the pharmaceutical industry, has launched DiMedix, a scientific subsidiary for continuing medical education (CME) activities. The new division was created in response to the official guidelines of the Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services. The final report, issued in April 2003, requires the complete separation of promotional and CME activities. Spearheading course curricula and monitoring medical content is Michelle Matter, Ph.D., a research scientist, who was previously with the Chatham Institute, a medical-education company. At DiMedix, she will continue working with universities and other nonprofit groups as the company’s scientific director. The new subsidiary offers clients a wide range of services as part of its complete CME solutions approach. These services include content development and management of satellite symposia at national medical conferences, local CME symposia, grand rounds, CME, Webconferences and dinner meetings, along with CD-ROMs. DiMedix clients can also benefit from a new scientific information delivery system called IDeX, a Web-based tool that allows the company to provide scientific information that sales representatives are frequently unable to discuss. Follow up Accelera, Baltimore, a subsidiary of privately held Alpha Genesis LLC and a licensee of The Johns Hopkins University, provides learning solutions that accelerate the global adoption of advanced medical products. For more information, visit accelera.com. AXIOM Professional Health Learning LLC, Yardley Pa., a subsidiary of AXIS Healthcare Communications LLC, provides a full spectrum of healthcare communications services to the pharmaceutical, biotechnology, and medical-device industries through its medical communications, medical education, healthcare advertising, and professional training agencies. For more information, visit axiom-health.com. Choice Media, Somerville, N.J., is a convergence marketing firm for healthcare companies and operates one of the world’s largest Internet health networks. For more information, visit choicemedia.com. DiMedix, Warren, N.J., is a CME subsidiary of Phoenix Marketing Solutions,a medical communications firm that designs promotional programs for the pharmaceutical industry. For more information, e-mail email@example.com. EthicalDrug CME LLC, Randolph, N.J., the medical-education division of MedPharm Communications LLC, is dedicated solely to providing continuing medical education services. For more information, visit medpharmcom.com. Excellence in Continuing education ltd., Gurnee, Illinois, provides continuing-education consulting services for industry, professional associations, academic institutions, healthcare institutions, medical education and communication companies, and other corporate providers. For more information, visit excellencece.com. FDA news, Falls Church, Va., is a provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the U.S. Food and Drug Administration and the European Commission. For more information, visit fdanews.com. The Institute for Advanced Health Education, Union, N.J., offers continuing medical education for healthcare professionals including physicians, pharmacists, and nurses through symposia, grand rounds meetings, and teleconferences, as well as Internet-based programs, CD-ROM, and video. For more information, visit thecmeinstitute.org. Integrated Clinical Trial Services, Cary, N.C., is a full-service patient recruiting and enrolling firm that works with clinical-trial sponsors, CROs, and site networks. For more information, visit integratedtrials.com. John Wiley & Sons Inc., Indianapolis, is a global knowledge company with a diverse portfolio of technology, business, consumer, and how-to brands, computer-based learning tools, Web-based products, and Internet e-services. For more information, visit wiley.com. merit publishing international inc., West Palm Beach, Fla., publishes medical literature for a range of clients in the book trade, pharmaceutical, and library industries. For more information, visit meritpublishing.com. RxPedite LLC, Westerville, Ohio, provides product launch-support services to emerging pharmaceutical and biotechnology companies and is a joint venture between Cardinal Health, a provider of products and services, and inChord Communications Inc., an independent healthcare marketing company. For more information, visit inchord.com. nTEGRA, Richmond, Va., is a therapeutic development company with expertise in stewarding compounds, agents, and devices from clinical studies through post-approval marketing and category leadership. For more information, visit n-tegra.com. Takeda Global Research & Development Center Inc., Lincolnshire, Ill., is a wholly owned subsidiary of Takeda Pharmaceuticals North America Inc. For more information, visit takedapharm.com. The Thomson Corp., Stamford, Conn., provides integrated information solutions to more than 20 million users in the fields of law, tax, accounting, financial services, higher education, reference information, corporate training and assessment, and scientific research and healthcare. For more information, visit thomson.com. March 2004 PharmaVOICE