Barnett Educational Services has announced the release of updated editions of three of its market intelligence and clinical practices guides. PAREXEL’S BIOPHARMACEUTICAL R&D STATISTICAL SOURCEBOOK 2010/2011 includes statistics, trends, and proprietary market intelligence and analysis on the biopharmaceutical industry. New additions to the 2010/2011 edition include analyses on the likely impact of theranostics and personalized medicine and their impact on the biopharma market, as well as forecasting models on biopharma sales, R&D spending, and other meaningful industry metrics. GOOD CLINICAL PRACTICE: A QUESTION & ANSWER REFERENCE GUIDE 2010 includes more than 60 pages of all-new Q&As, including questions addressing emerging topics such as the use of social media in clinical trials and the implications of IRB reviews of social media content used for patient recruitment. The 2010 edition also features a new chapter on the priorities and direction of the FDA’s GCP enforcement programs, as well as an updated section with the latest data and trends on the FDA’s clinical trial compliance inspections, inspectional findings, and common areas of GCP noncompliance. 2010 CFR/ICH GCP REFERENCE GUIDE is a pocket-sized reference book providing information on the latest bio/pharma industry codes and regulations from around the world. The 2010 edition also includes a new section on expanded access to investigational drugs for treatment use. For more information, visit barnettinternational.com. New Healthcare-related Products, Services, and Companies Featured Briefs: TGaS Advisors Launch Benchmarking Options New Company Uses Technology to Tackle Growing Nonadherence Problem Blue Chip Adds Patient Recruitment Division FDA Safety Analyses Summaries Available Online Life Technologies Establishes Cell Therapy Systems Arm Sidebar: Around The Globe Merck Forms Global Oncology Research Network Adis Research Journal Now Available Free Online QPharma Adds Engineering Services to Product Suite Sidebar: On The Shelves New Company Focuses on Caspases Research Follow up BLUE CHIP PATIENT RECRUITMENT is a global, full-service strategic marketing division of Blue Chip specializing in patient acquisition and retention. For more information, visit bcpatientrecruitment.com. HEALTHPRIZE TECHNOLOGIES LLC is a provider of Web-based software designed to motivate people to fill and stay on their prescription medications. For more information, visit healthprize.com. TGAS ADVISORS provides benchmarking and advisory services to the biopharmaceutical industry. For more information, visit tgas.com. Wolters Kluwer Pharma Solutions has converted its Adis journal, Drugs in R, to open access, marking the first of its publications to make its online content available for free. “We reinvented Drugs in R as an open access journal to give researchers unrestricted access to all of its peer-reviewed content," explains Anton van Rensburg, editor, Drugs in R. “With increased pressure today for more speed and transparency in drug research and development, Drugs in R is an ideal outlet to further the cause by making its content publically accessible and free for all," he continues. First launched in 1999 on a subscription and pay-per-view basis, Drugs in R includes original research and reviews from all phases of clinical development. The journal is Medline-indexed and available on both Ovid and AdisOnline, which provides high global visibility. “Unlike many new-to-market OA publications Drugs in R is already a well-regarded and trusted source of clinical information by scientific and medical researchers," says Iain Spray, product manager, Adis. “This makes it a high-value platform for researchers looking to make their findings available to the global research community," he continues. For more information, visits wolterskluwer.com. QPharma’s recently established engineering services group provides life-sciences and associated industries with the resources necessary to implement and maintain systems, processes, and facilities from start to finish. The engineering services group further enhances the suite of services already provided by QPharma, including regulatory compliance and validation services. The group is led by Douglas Knight, engineering and regional manager. For more information, visit qpharmacorp.com. Calithera Biosciences is a newly established company focused on the development of activators of caspases, the proteases that promote apoptotic cell death, for the treatment of cancer and other proliferative diseases. “Promoting apoptosis in cancer cells is a validated approach to the treatment of cancer, as many oncology drugs on the market today are known to kill tumor cells by activating apoptotic pathways, albeit through indirect means," says Susan Molineaux, Ph.D., co-founder and CEO of Calithera. “By targeting caspases directly, we hope to develop agents that have broad utility across many types of cancer, with greater specificity than current treatments and the potential to overcome chemoresistance." Calithera’s technology was developed by and licensed from the laboratory of co-founder James Wells, Ph.D., chair of the Department of Pharmaceutical Chemistry in the University of California, San Francisco School of Pharmacy. “Most drug discovery efforts are focused on identifying drugs that inhibit enzyme function," Dr. Wells explains. “But, interestingly, many cellular enzymes remain dormant until activated. In the case of caspases, they can be activated on demand by mimicking the natural process with small molecules." In addition to Dr. Molineaux, Calithera’s management team includes Mark Bennett, Ph.D., senior VP of research, and Eric Sjogren, Ph.D., senior VP of drug discovery. For more information, visit calithera.com. The recently established Merck Oncology Collaborative Trials Network is comprised of leading global cancer research centers that are partnering with Merck to speed the development of innovative treatments for a range of cancers. The Merck trials network currently consists of 15 sites across North America, South America, Europe, and Asia. Its focus is on improving collaborative oncology research approaches by reducing the number of sites, properly funding research efforts, setting strict deadlines, and prioritizing studies based on potential. Through a rigorous proposal and feedback process, the research sites are leading the design and conduct of Phase 0 to Phase IIa clinical studies of Merck’s investigational oncology candidates. The network also is developing the infrastructure to consolidate data, specimen testing results, imaging testing results, and patient outcomes. “Merck has strengthened its commitment to accelerating drug and vaccine development for people with cancer," says Gary Gilliland, M.D., senior VP of Merck Research Laboratories and oncology franchise head. He adds that the network is a cornerstone of the company’s oncology strategy. For more information, visit merck.com. U.K.-based ALPHA-PLUS MEDICAL COMMUNICATIONS has become part of The Fishawack Group of Companies, an independent medical communications agency with offices in the United States and United Kingdom. For more information, visit alpha-plus.co.uk. ICON CENTRAL LABORATORIES, a global provider of outsourced development services to the pharmaceutical, biotechnology, and medical device industries, has opened a laboratory facility in Tianjin, China, in partnership with Fountain Medical Development (FMD). It is the third Icon laboratory in the Asia Pacific region. Icon Central Laboratories China delivers site support services to clinical investigators throughout China. The Tianjin facility is the third such laboratory in the Asia Pacific region. For more information, visit iconplc.com. Global clinical research organization KENDLE INTERNATIONAL has opened a new operations center in the special economic zone (SEZ) of the Ahmedabad-Gandhinagar Knowledge Corridor in Guajarat, India. The SEZ center strengthens the company’s commitment to further investment in the Asia Pacific region. For more information, visit kendle.com. THE PLANNING SHOP INTERNATIONAL (TPSi), a market research company with offices in London, Brussels, and Philadelphia, has launched a fully dedicated oncology business unit. The new unit is led by Kelly Price, who has spent eight years working in both syndicated and customized oncology research throughout Asia-Pacific and, most recently, in the United States. For more information, visit planningshopintl.com. Global clinical research organization PRA INTERNATIONAL has opened a Phase I facility in Budapest, Hungary, that provides unit-on-demand service and further enhances PRA’s capabilities for conducting early-development trials in patients. For more information, visit prainternational.com. THOMSON REUTERS has donated two ScholarOne Manuscripts sites to the newest members of the African Journal Partnership Project: the Medical Journal of Zambia and the Ethiopian Journal of Health Services. ScholarOne Manuscripts is a Web-based peer review and submission application for scholarly publishers that enables the automation of the manuscript submission process, allowing for easy administrative, editing, and reviewing capabilities. For more information, visit scholarone.com. TKL Research, a full-service, U.S.-based clinical research organization (CRO) focused on enrollment-driven Phase I through Phase IV clinical trials, has expanded its presence and capabilities in Europe by taking an equity position in proinnovera GmbH, a full-service CRO based in Munster, Germany. For more information, visit tklresearch.com. UNITED BIOSOURCE CORPORATION (UBC) has launched a new office in Lörrach, Germany, further expanding the company’s clinical research and medical affairs capabilities in Europe. The Lörrach office is the 10th UBC office to open in Europe. It is being led by Hazel Wohlfahrt, executive director of clinical services, Europe. For more information, visit unitedbiosource.com. The U.S. Food and Drug Administration is providing periodic summaries of safety analyses of recently approved drugs and biologics on its website, fda.gov, along with a brief discussion of the steps FDA is taking to address any identified safety issues. The new summaries provide a comprehensive look at safety data early in the product’s post-approval life cycle and are based in part on reports by manufacturers, providers, consumers, and others to the FDA’s Adverse Event Reporting System (AERS), the Vaccine Adverse Event Reporting System maintained by the FDA, and the Center for Disease Control and Prevention. Other sources include periodic safety information submitted by manufacturers, information contained in the medical literature, and data from ongoing drug and biologic studies. “Conducting systematic, comprehensive, safety reviews of recently approved drugs and biologics provides an early detection mechanism for potentially serious risks and complements the FDA’s analysis of safety data during drug development and the agency’s routine monitoring of safety information after product approval," says Gerald Dal Pan, M.D., director of the Office of Surveillance and Epidemiology in the FDA’s Center for Drug Evaluation and Research. For more information, visit fda.gov. The U.S. Food and Drug Administration is providing periodic summaries of safety analyses of recently approved drugs and biologics on its website, fda.gov, along with a brief discussion of the steps FDA is taking to address any identified safety issues. The new summaries provide a comprehensive look at safety data early in the product’s post-approval life cycle and are based in part on reports by manufacturers, providers, consumers, and others to the FDA’s Adverse Event Reporting System (AERS), the Vaccine Adverse Event Reporting System maintained by the FDA, and the Center for Disease Control and Prevention. Other sources include periodic safety information submitted by manufacturers, information contained in the medical literature, and data from ongoing drug and biologic studies. “Conducting systematic, comprehensive, safety reviews of recently approved drugs and biologics provides an early detection mechanism for potentially serious risks and complements the FDA’s analysis of safety data during drug development and the agency’s routine monitoring of safety information after product approval," says Gerald Dal Pan, M.D., director of the Office of Surveillance and Epidemiology in the FDA’s Center for Drug Evaluation and Research. For more information, visit fda.gov. Life Technologies’ Gibco Cell Therapy Systems (CTS) group offers a wide array of products to the life-sciences industry to support cell therapy applications such as regenerative medicine. Specifically designed to help cell therapy practitioners accelerate the transition from research to clinical applications, the CTS product portfolio includes a broad and deep offering of Invitrogen devices and reagents, as well as media and other components of integrated workflow solutions. The high-quality materials come with easily accessible documentation, such as certificates of analysis and certificates of origin, and are backed up with the highest level of technical, regulatory, and Web-based support. “We’ve leveraged our expertise, as well as our broad and deep product portfolio to create workflow solutions for cell therapy that help investigators move their research applications into the clinic more quickly and efficiently, while enhancing patient safety," says Paul Pickering, general manager of Cell Therapy Systems at Life Technologies. For more information, visit lifetechnologies.com. TGaS Advisors has added three options to its Pharmastance series of peer-to-peer benchmark advisory services designed to help companies or departments take their commercial operations to the next level. “We want to ensure our operations clients thrive in this challenging environment by helping them become more effective strategic business partners," says Stephen Gerard, TGaS Advisors founder and managing partner. The new options included are: • Best of Benchmark covers what it would take to be best in every area for a commercial organization or department. • Efficiency Benchmark covers what it would take to be the most efficient in every area, supporting capabilities comparable to their peers but with the fewest possible resources. • Strategic Priorities Benchmark covers how to model a commercial operations organization or department against the best in some areas and the most efficient in others, customized to the organization’s own unique needs and priorities. For all three benchmarks, TGaS Advisors evaluates strategy, tactics, resources, metrics, and trends for an operations group, department, or function. The firm’s associates then provide specific insights and recommendations compared with the best, the most efficient, or a strategic combination of the two, drawing on data from members of TGaS Advisors’ extensive network of benchmark companies. Every functional area in almost every pharmaceutical company is re-examining the way it does business and making changes to meet the demands of the industry’s new normal, says Stephen Gerard. HealthPrize Technologies is a recently launched Web-based software company that approaches the problem of medication nonadherence by tracking users’ medication-taking and prescription-refilling activities, educating consumers on the importance of taking medication properly and rewarding them for doing so. HealthPrize’s combination of medication tracking and refill verification, coupled with the company’s Engagement Engine interactive online program, rewards and educates consumers, increasing both extrinsic and intrinsic motivations to drive greater medication adherence and increase medical literacy. “Patients can and should play a larger role in their own healthcare, but for many people, the promise of improved health and welln ss is simply not enough," says HealthPrize CEO Tom Kottler. “By providing financial incentives, education, games, and opportunities for interaction with other users, we’re giving them the motivation they need to take their medications as prescribed and, ultimately, to lead healthier lives." HealthPrize has developed its system to provide users with tangible benefits that accrue as users engage the system and take their medications more frequently. Benefits include awards points similar to a credit card or airline mileage loyalty program, as well as chances to win sweepstakes and monthly competitions. “We’ve studied and applied knowledge from behavioral economics and consumer research, and we’ve found ways to combine these insights with the most advanced and most cost-effective technologies," says Katrina Firlik, chief medical officer of HealthPrize. “As a result, we’re uniquely positioned to have a greater impact on the nonadherence problem over the long term than companies that have come before us," she continues. HealthPrize currently holds 10 patents licensed from Walker Digital/Science House that cover various systems and methods for providing financial and other incentives to increase medication adherence. Blue Chip Patient Recruitment (BCPR) is a recently launched division of global marketing agency Blue Chip dedicated to serving pharmaceutical and biotech clients with clinical trial recruitment marketing. BCPR reflects Blue Chip’s 15 years of continued growth in patient recruitment and leverages the resources of a full-service agency with deep expertise in direct response media, retail brand marketing, and clinical site recruitment management. The division uses a scientific and tested approach to clinical trial marketing that combines proprietary predictive modeling tools with original patient acquisition strategies and continuous evaluation. “Our track record to date has included conducting nearly 600 clinical trials with a 90% success rate, making the launch of Blue Chip Patient Recruitment a natural evolution of our business," observes Blue Chip Chairman and CEO Stanton Kawer. In the treatment of chronic medical conditions, only long-term behavior change makes a significant difference in reducing medical cost, says Katrina Firlik. For many people, the promise of improved health and wellness is simply not enough, says Tom Kottler.
