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E-Media New electronic and web-based applications, sites, and technologies Model N Introduces Revenue-Management Software Model N Inc. has developed a pharmaceutical-specific suite of applications to manage pricing, contracts, and payment of settlements. The Model N Revenue Management Suite, comprised of an integrated set of modular applications, is built with a Web-based architecture that delivers a breakthrough in linking people, processes, and information across the entire life cycle of revenue. This new integrated approach enables pharmaceutical companies to reduce the risks of noncompliance to government pricing and Sarbanes-Oxley regulations, as well as eliminate the millions of dollars in revenue leakage that is a common problem in pharmaceutical contract sales. “Managing compliance and revenue risk in an increasingly competitive and regulated market is top of mind for many executives in pharmaceutical companies, and the tools that have been at their disposal are woefully inadequate,” says Zack Rinat, founder and CEO of Model N. “Investments in managing the cost side of the business over the last few years have hit a point of marginal returns.” The Model N Pharmaceuticals Suite is the first of its kind suite of modular applications for revenue management in pharmaceuticals. The suite is built upon the Model N Technology Platform, which enables each application in the suite to leverage commonly shared services such as pricing and workflow engines, catalog and community management, document management, reporting, and data management. This approach allows pharmaceutical companies to implement a single application such as charge backs that are “platform ready” to link into other Model N applications or to deploy several applications in the suite that seamlessly work together to eliminate the gaps in pricing, contracts, and settlements processes. Additionally, the Model N solution automates the processes for ensuring regulatory compliance. The Model N Revenue Management Suite provides a comprehensive set of approvals, alerts, and notifications to enable companies to enforce controls on their increasingly complex revenue policies. Underlying the applications are complete systems for tracking and keeping an audit trail for all activities associated with objects such as contracts, price lists, discounts, and incentive payments at the level of individual actions and authorizations. Heartbeat Digital Releases Physician-Relationship Management Suite Heartbeat Digital has released its enterprise strength software suite to assist pharmaceutical and biotechtechnology companies with their physician-relationship management (PRM) needs. The PRM suite consists of three key modules: Heartbeat Profiler, Heartbeat DataMiner, and Heartbeat Communicator. Heartbeat Profiler enables companies to identify, profile, and track the activities of key opinion leaders, thought leaders, investigators, speakers, and medical liaisons. Heartbeat Profiler also includes a robust searching and reporting engine that offers users the ability to identify and sort physicians by a number of user-defined criteria. Heartbeat DataMiner is a real-time data mining crawler that scours the Internet and other data sources to find new content about thought leaders. Heartbeat DataMiner looks for information such as thought leader publication activity and recent clinical-trial involvement and then compiles the findings into an intuitive user interface. Heartbeat Communicator provides ongoing, two-way communications and data-sharing between a pharma company and all its key physicians through a secure, customizable interface. The platform delivers slide and presentation content, a speaking events calendar, live Webcasts, and clinical-trial information, so that physicians are always kept abreast of the latest data. “This is a new category of software that takes business processes that have been managed separately in either stand-alone systems or managed by spreadsheets and links these business processes to allow a pharmaceutical company to manage the entire life cycle of revenue, from planning through negotiating contracts to payments of settlement,” says Steve Zocchi, VP of marketing, Model N. “Today, every pharmaceutical and biotech company is trying to improve the process of thought-leader management,” says Larry Cohen, executive VP of Heartbeat Digital’s software division. Vivisimo’s ClusterMed Organizes PubMed Search Results Vivisimo Inc. has released ClusterMed, a powerful research tool that allows biomedical and life-sciences researchers to search the MedLine database far more productively and efficiently. ClusterMed organizes the long list of results returned by PubMed into hierarchical folders allowing researchers to hone in on the most relevant results quickly. By organizing results into categories, users discover the main themes relating to the subject of the query and can easily reach relevant articles buried deep in the chronological list. In addition, similar articles are grouped together, rather than scattered throughout the results. Using ClusterMed, drug-discovery researchers save mission-critical research time and discover insights that previously required long hours of browsing through results. Results can be organized by author or source allowing researchers to customize their queries based on their research needs. This feature also can profile the research specialties of an author or institution. For additional flexibility, results can be clustered by date of publication or Medical Subject Headingss (MeSH), the National Library of Medicine’s controlled vocabulary thesaurus. “The enormous amount of information being produced today by the life-sciences industry requires new, sophisticated tools to help users synthesize that information into timely, actionable knowledge,” says Don Taylor, senior director, life-sciences solutions, at Vivisimo. “For example, searching PubMed for ‘apoptosis and breast cancer’ returns 2,536 articles in a chronological, one dimensional list. ClusterMed enlivens this unwieldy list into meaningful, hierarchical folders in which PubMed article number 1,432 may appear within a ClusterMed folder just two clicks away.” ClusterMed builds upon Vivisimo’s extensive experience with several of the largest pharmaceutical companies, journals, and and societies. “The enormous amount of information being produced today by the life-sciences industry requires new, sophisticated tools to help users synthesize that information into timely, actionable knowledge,” says Don Taylor, senior director, life-sciences solutions, at Vivisimo. Online Evidence-Based Medicine Data Warehouse Launched by MetaWorks MetaWorks Inc.’s evidencehub.com is an online application that provides quick, organized, and reliable access to vast quantities of pregathered clinical and scientific data, helping to shape clinical-development decisions and improve the efficiency and accuracy of regulatory, formulary, and marketing efforts. The online solution leverages pertinent, up-to-date medical evidence to develop meaningful research, regulatory, safety, and commercialization strategies. From the early stages of clinical trials through marketing and commercialization, internal drug development and commercialization teams, thought leaders, outsourced contract researchers, and regulatory bodies can use the application to benchmark ongoing clinical-trial results to facilitate early decisions regarding a product’s strengths. The application also can be used to identify product differentiators versus those of a competitor on the basis of safety, efficacy, regimen, or use. According to Susan Ross, M.D., MetaWorks’ cofounder, evidencehub.com displays study, data, and treatment matrices that can be used to enhance trial design by querying similar trials and analyzing specific data elements, including study and patient characteristics, efficacy and safety outcomes, and treatment options across various trials to discover patterns that may be missed by manual study reviews. “Evidencehub.com contains database content predominantly formulated through customized systematic reviews that are tailored to address specific research needs,” Dr. Ross says. Licensees can access evidencehub.com’s online applications to search, filter, and sort data by geographic region, treatment, population, and outcome to produce a balanced perspective of a disease and a thorough assessment of all its current treatment options. Queried data can be exported to analytical software to perform customized analyses or integrate data with existing systems. MetaWorks offers flexible licensing options for access to evidencehub.com, enabling clients to independently and cost-effectively conduct research, as well as continuously inform their entire organizations and affiliated healthcare or drug-development communities. “To effectively compete in this era of accelerated, data-driven innovation, life-sciences companies require expert resources to satisfy the information demands of their internal organizations and affiliated healthcare stakeholders,” says Shubh L. Sethi, president and CEO of MetaWorks. FCG Launches FirstDoc Clinical Trials ECM Solution Suite First Consulting Group has launched FirstDoc Clinical Trials, the fifth module in the company’s enterprise content management (ECM) solution suite. FirstDoc offers life-sciences enterprises a flexible single foundation from which to manage clinical information, documentation, and workflow. FCG developed its most recent ECM module to respond to a functional need. According to FCG, R&D remains the area of major IT spend within the pharmaceutical industry – estimated at $13.2 billion in 2002 – yet very little of the investment has addressed companies’ clinical documentation and data challenges. FirstDoc Clinical Trials is one of the few solutions tailored to manage clinical documentation throughout the trials’ process and help companies overcome some of these issues. “FirstDoc Clinical Trials is the cornerstone of FCG’s eClinical roadmap, which aims to reduce clinical-trials time by as much as two-thirds – consistent with estimates the analysts have projected for those companies that leverage clinical-automation tools,” says Mark Vermette, director of clinical solutions for FCG’s life sciences practice. “Currently, 95% of clinical-trial information is paper-based, which results in clinical-trial managers making slow and sometimes inaccurate decisions based on old data. FirstDoc Clinical Trials solution sets the foundation for clinical documentation and data set storage and management.” FirstDoc Clinical Trials allows clinical managers to make real-time decisions about trials, thereby enabling clinical departments to contribute to regulatory submissions in a fraction of the time previously required. With FirstDoc’s foundational information infrastructure, pharmaceutical companies can now gain a competitive advantage through the knowledge collected and shared throughout the trial, improving their ability to launch products faster and more cost effectively. Both Web and client/server enabled, FirstDoc Clinical Trials streamlines trials by managing and organizing all documentation – trial master file documents, and case report forms – created and collected during the planning and execution of clinical trials. “Currently, 95% of clinical-trial information is paper-based, which results in clinical-trial managers making slow and sometimes inaccurate decisions based on old data,” says Mark Vermette, director of clinical solutions for FCG’s life- sciences practice. “Our solution delivers real-time management and status reporting of received clinical documents to researchers, prompting fewer errors and faster drug discovery and development.” Silicon Genetics Introduces a Software Workbench for High-Throughput Genetic Variation Analysis Silicon Genetics has released Varia, a new generation of genetic analysis software designed to meet the requirements of life-science researchers involved in high-volume genetic variation analysis. Designed as a stand-alone workbench incorporating a wealth of integrated analysis algorithms, Varia can smoothly handle the millions of SNP measurements generated by whole genome genotyping measurement platforms. “From day one, our design goal has been to build a tool capable of handling the large volumes of genetic information generated by major research facilities that are taking advantage of recent developments in high throughput SNP measurement platforms,” says Kevin Wandryk, VP of marketing and business development for Silicon Genetics. Varia includes a range of tools to assist all applications of genotyping analysis. Major product features include: navigable displays of the complete human genome at the nucleotide scale, including more than 7 million variations; validated algorithms for the association of variation-to-variation or of variation-to-disease, including linkage disequilibrium and transmission disequilibrium tests, genetic linkage scores, and case control calculations; automated tools for building haplotype maps and constructing pedigrees from user-supplied genotype data; pedigree diagrams, GOLD plots, haplotype maps, and plots of linkage statistics, useful for data exploration and for producing publication quality images; patent-pending algorithms for identifying regions of autozygosity likely to represent transmissible markers of recessive diseases. The software solution also includes dedicated interfaces for managing and analyzing data from large families, including tools for pedigree import and quality control filters to identify incorrect pedigree assignments and unlikely allele calls. It has a simple file format for importing variation measurements from virtually any genotyping technology, including Affymetrix, Illumina, Sequenom, and Parallele. Drag and drop data loading from numerous genotyping technologies and efficient tools for recording the associated clinical metadata are available. Varia includes a range of tools designed to assist all applications of genotyping analysis. MedicalImaging.org Website Offers Resource on the Value of Medical Imaging Medical imaging is offering new savings to healthcare providers. A new Website, medicalimaging.org, provides an evidence-based view of the clinical and economic benefits of medical imaging. The site draws upon peer-reviewed literature and other documentation to highlight the ability of medical diagnostic and therapeutic imaging technologies in detecting disease early, enabling minimally invasive therapies, ensuring quality and patient safety, and fostering efficiencies in the healthcare system. While medical imaging often is criticized as a driver of healthcare costs, its economic value in keeping workers productive and adding new efficiencies to the delivery of health services is often overlooked. “Medical imaging is introducing new savings to healthcare providers through the productivity enhancing power of digital and information technology systems,” says Robert Britain, VP of medical product for the National Electrical Manufacturers Association, which sponsors the site. The site documents, for example, that medical imaging eliminates about half the unnecessary surgeries for lung cancer; image-guided breast biopsies cost one-third of what surgical biopsies do and take half the amount of time; the primary drug therapy for stroke victims would not be possible without medical imaging; and that employers often judge the value of physician groups and HMOs based, in part, on their performance in medical imaging testing. The content of medicalimaging.org is based on the findings of studies in leading medical journals, as well as on reports from private industry, think-tanks, and government agencies both in the United States and abroad. Intended to provide visitors with an easy reference to the original studies, all sources are documented and in many cases are hyperlinked so that readers can quickly access the original documents. The site’s “Latest News” section highlights current findings relating to health-policy topics. BioInformatics Introduces Online Market-Research Tool BioInformatics LLC’s Results-On-Demand service allows executives to conduct an online survey of hundreds of life scientists on a range of topics, from their opinions on a cutting-edge research tool to how they react to an ad. “There’s a need for market research that falls between low-cost off-the-shelf reports and a high-end custom study,” says Bill Kelly, president of BioInformatics. “Results-On-Demand meets this need by letting companies develop their own questionnaires with the advice of our staff, determine which scientists represent their target market, select the number of responses they need, and then sit back while we do the rest.” For a flat fee, BioInformatics will program the survey, guarantee the required number of responses from qualified participants, as well as deliver statistical analysis and presentation-quality graphics within 10 business days or less. To ensure predictability and quality, BioInformatics turns to The Science Advisory Board, which it sponsors. The Science Advisory Board is a global online community of about 20,000 scientists, physicians, and other life-sciences and medical professionals from 62 countries who participate in surveys that address emerging technologies, test customer reactions to new product concepts, measure brand awareness, and assess advertising effectiveness. The Science Advisory Board does not accept advertising because of the potential to bias responses to a survey. “We maintain strict control over who can respond to the survey; additionally Bioinformatics has strict quality control procedures to make sure that the company fulfills its client’s quota with only qualified scientific customers,” Mr. Kelly says. “Follow-up questions can be posed to specific individuals or additional surveys can be fielded to the same group of respondents. This allows clients to track changing perceptions, purchasing patterns, etc., over time.” “Predictability means knowing that there will be a statistically significant sample, and quality means ensuring that the questions are being answered by precisely the right scientists with the right experience,” says Bill Kelly, president of BioInformatics. Follow up BioInformatics LLC, Arlington, Va., is a market-research company that supports marketing, sales, and R&D executives in the life-sciences, medical-device, and pharmaceutical industries through published research reports, custom research, and consulting. For more information, visit gene2drug.com. First Consulting Group, Long Beach, Calif., is a provider of outsourcing, consulting, systems implementation, and integration services. For more information, visit fcg.com. Heartbeat Digital, New York, is a software development and professional services company specializing in marketing relationship management solutions for the pharmaceutical and financial-services industries. For more information, contact Larry Cohen at 212-941-9041. MetaWorks Inc., Medford Mass., is a consulting company focused on clinical drug development and commercialization within the pharmaceutical, biotechnology, and healthcare industries. For more information, visit metaworksinc.com. Model N Inc., South San Francisco, Calif., offers an integrated suite of applications for pricing, contracts, compliance, rebates, fees, and charge backs optimized for life-sciences companies. For more information, visit modeln.com. National Electrical Manufacturers Association (NEMA), Rosslyn, Va., sponsor of medicalimaging.org, is the leading trade association in the United States representing the interests of its 400 member companies that manufacture products used in the generation, transmission and distribution, control, and end-use of electricity. For more information, visit nema.org. Silicon Genetics, Redwood City, Calif., is a provider of software solutions for life-sciences discovery. For more information, visit silicongenetics.com. Vivisimo Inc., Pittsburgh, provides intelligent software that helps enterprises to organize information from anywhere, anytime, in any language. For more information, visit vivisimo.com.

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