Six Sigma Performance Program Provides Quality of Service Guarantee

TagSYS and IBM collaborate to support pharmaceutical e-pedigree. TagSys brings Six Sigma quality to the table with guaranteed quality of service. ...

... "TAGSYS will provide customers with the same expertise and architecture used in its Six Sigma Performance Program, a quality-of-service program that guarantees fewer than four failures in one million read opportunities. " ...

Via IBM: IBM and TAGSYS Team on Serialization Pilot Kit for Pharmaceutical Manufacturers

Six Sigma Directed Pharmaceuticals

Eli Lilly exec sees Six Sigma as an enabler to improved pharmaceuticals. ...

... "Six Sigma, she said, is working on ways to tailor drugs to specific patients to maximize the benefits of drugs for all patients. " ...

Via Trading Markets: Eli Lilly Six Sigma

Six Sigma Career Path at Eli Lilly

Six Sigma professional discusses career path at Eli Lilly. ...

... "Something I find very attractive about Lilly is the opportunity to own your career. I have worked in business development, marketing, sales and now Six Sigma since joining Lilly. There is no one set career path for MBA hires at Lilly. " ...

Via The Monroe Street Journal: Eli Lilly

Lilly Six Sigma: Biotechnology Research and Development Prodcutivity

Lilly invests in research and development productivity in biotechnology to replenish its product pipeline and position the company for accelerated growth and profitability. Six Sigma techniques such as QFD, Voice of the Customer support the front-end of pharmaceutical innovation. Design for Six Sigma, Design of Experiments, DOE, enables research and development. Biotech products already comprise a third of Lilly's product pipeline and target a number of diseases, such as Alzheimers, diabetes, inflammation, and kidney disease. Lilly is striving to commericalize one major biotechnology molecule per year. ...

... "Paul summarized Lilly's R&D productivity efforts by stating, We are pursuing three broad strategic approaches to improving R&D productivity, with the goals of increasing the number of compounds in our pipeline while driving down the costs per new molecular entity by about one-third, from $1.2 billion to $800 million. These productivity strategies include fully leveraging our biotech capabilities, accessing more flexible and cost effective R&D capacity globally and aggressively pursuing Six Sigma throughout Lilly Research Labs. " ...

Via Lilly: Lilly Delivers Promising Update to Wall Street on Strategic Priorities, Pipeline Progress and Earnings Guidance

Lean Pharma Evolution ...

Survey shows pharma industry implementation of lean six sigma is evolving slowly. ...

... "Despite its huge popularity in the automotive and high-tech industries, Lean Manufacturing hasn't experienced the same high success rate in the pharmaceuticals industry, where complex process manufacturing processes are used. This is according to the results of a recent survey of more than 1,500 pharmaceutical manufacturers conducted by Invistics, a developer of manufacturing performance optimization solutions for complex, asset-intensive industries.


The recently conducted 2006 survey showed that while more than half of the respondents said their companies have implemented Lean, Six Sigma or Operational Excellence, less than half of those Lean initiatives have produced satisfactory results. This is due to the fundamental complexities of the pharmaceutical manufacturing process, which produce challenges not found in simple high-volume manufacturing plants that can dedicate production equipment to specific product lines, such as automobiles and computers. " ...

Via Invistics: Traditional Lean Manufacturing May Not Be Rx for Pharmaceutical Companies ...

Lean Six Sigma: Uniform Initiatives, Common Processes ...

Cardinal Health announces organizational changes to align its manufacturing businesses and focus on market expansion outside of the United States. ...

... "David L. Schlotterbeck, 59, has assumed additional responsibility for Cardinal Health's Pharmaceutical Technologies and Services (PTS) and Medical Products Manufacturing (MPM) segments, in addition to his current responsibility for the Clinical Technologies and Services (CTS) segment. As chief executive officer of Pharmaceutical and Medical Products, Schlotterbeck will lead an organization of approximately 23,000 employees and $6 billion in revenues. The company said PTS, MPM and CTS will remain separate financial reporting segments and separate internal organizations, however the new structure will foster a uniform approach to lean manufacturing and Six Sigma initiatives, and common processes for innovation, research and development, and sourcing. " ...

Lean Six Sigma: Uniform Initiatives, Common Processes: Via Cardinal Health: Cardinal Health Aligns Manufacturing Businesses, Names International President ...

Lean Strategies in Pharma Manufacturing ...

Archived web seminar provides insights into lean strategies that support pharmaceutical manufacturing. ...

... "The implementation of lean technologies in the pharmaceutical industry can have its greatest impact on the plant floor. Traditionally, inefficiencies in pharmaceutical manufacturing operations have been overlooked. However, today's highly competitive market combined with recent regulatory initiatives have created an environment that forces manufacturers to take a closer look at their production facilities. " ...

Lean Strategies in Pharma Manufacturing: Via Pharmaceutical Processing: Lean Pharmaceutical Manufacturing

Lean Pharma Practitioner Recognized ...

Lean Pharma exec recognized as ASQ chapter president. ...

... "Mr. Chatterjee is Chief Operations Officer of Pharmatech Associates, a full service consultancy serving the regulated life-sciences industry, providing validation services and quality process project management. Pharmatech Associates has managed and successfully deployed Lean and Six Sigma projects for pharmaceutical, biotech, and medical devices/diagnostic customers. The pharmaceutical industry must show continued growth and sustain profits as it faces public pressure to control the skyrocketing costs of therapeutics, Mr. Chatterjee said. Our industry has to seek new ways to increase production and decrease time to market. The application of Lean Manufacturing and Six Sigma methodology, specifically adapted to the pharmaceutical industry, constitutes a unique way to improve business, drive down costs and speed time-to-market. Mr. Chatterjee is a certified ISO 9000 Lead Assessor and Six-Sigma Master Black Belt with extensive experience in the design and implementation of quality systems. Mr. Chatterjee holds a B.A. in Biochemistry and a B.S. in Chemical Engineering from the University of California at San Diego. " ...

Lean Pharma Practitioner Recognized: Via PharmaTech Associates: Bikash Chatterjee Elected President of ASQ Golden Gate Chapter 2006-2007; Seminar: Applying Optimization Methodologies to the Process Industry ...

SixSigma Pharmaceutical Sales Program ...

Lilly implements progressive program in Six Sigma to enable its sales force ...

... "Lilly opened an $18 million sales training center at its Kentucky Avenue campus in 2000, has focused Six Sigma quality enhancement programs on sales efforts, and is reorganizing its sales force under a program called sales force of the future. " ...

SixSigma Pharmaceutical Sales Program: Via IndyStar: Lilly gets kudos for its sales prowess ...

Six Sigma Contract Research Services ...

Maximax launches contract research services that leverage Six Sigma quality processes. ...

... "Maximax International, Incorporated in the State of Michigan, USA, announces launch of its services as a global Contract Research Organization. Maximax International was founded to support the Bio-Pharmaceutical Industry by leveraging a global presence and utilizing advanced processes to stream line the conduct of health product development in a timely, cost-effective, ethical manner. With operations in more than 25 countries across 5 continents and strong teams to support customers, Maximax International intends to become one of the leading players in this Industry. Not only is Maximax International positioned to support customers in global studies, we also have the capability to support regional and local studies. Maximax International utilizes the tools of Six Sigma processes, to offer its customers high quality services, supporting data management both locally and centrally in three major data centers across the globe. " ...

Six Sigma Contract Research Services: Via PharmaLive: Maximax International Launches as CRO

Six Sigma Outstanding Management Exec ...

GE exec leverages Six Sigma experience to outstanding management career. ...

... "Dr. Britell is the Chairman and CEO of Structured Ventures, Inc., advisors to private equity and venture capital firms, and has an extensive financial background, including serving as the former Executive Vice President of Global Consumer Finance and President of Global Commercial and Mortgage Banking at GE Capital. Her tenure at GE Capital also included responsibilities for GE Capital businesses in Austria, Switzerland and Germany. At GE Capital, Dr. Britell was recognized for her outstanding management of Six Sigma and compliance programs. " ...

Via West Pharmaceutical: West Pharmaceutical Services, Inc. Elects Jenne K. Britell, Ph.D., to Board of Directors ...

Six Sigma Producitivty Increasing Value Proposition ...

Lilly drives productivity through Six Sigma, outsourcing, and hiring limits to increase its value proposition to shareholders and the Wall Street. ...

... "Lilly is utilizing several tools to increase productivity and lower its cost structure, including applying Six Sigma across its global operations, which is expected to free up resources, accelerate R&D output, enhance customer satisfaction, and improve earnings with a portion of the overall benefit; expanding the use of biomarkers to more than 90 percent of the company's clinical candidates to facilitate earlier development decisions; maintaining the July 2004 hiring limits that have already reduced headcount by 3,100 or nearly 7 percent, without using disruptive layoffs; and leveraging outsourcing when the work represents non-core business or can be done at a lower cost and similar quality. Lilly's initial efforts have resulted in productivity increasing about 15 percent in 2005 compared with 2004 as measured by adjusted operating income per Lilly employee. " ...

Six Sigma Producitivty Increasing Value Proposition: Via Eli Lilly: Lilly Tells Wall Street It's Uniquely Positioned To Deliver Sustained Growth ...

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs.

Merck Transformation: Lean Manufacturing Drives Operational Efficiency ...

Merck is in the midst of a major restructuring and lean manufacturing transformation to drive operational efficiencies. Jacob Fenton explores Merck's sale of manufacturing assets, headcount reduction, and impact on the surrounding community. ...

Merck Transformation: Lean Manufacturing: Via North Penn Life: Merck won't close West Point facility ...

... "Manufacturing jobs are being trimmed throughout the company. And while lean manufacturing is at the heart of the company's restructuring plans, Merck also plans to close one basic research site and two preclinical development sites by 2008. " ...

Major restructuring announced by Merck. ...

Via Merck: Merck Announces Initial Steps In Global Restructuring Program: Initial Phase of Cost Reduction Program Expected to Yield Cumulative Pretax Savings of $3.5 Billion to $4.0 Billion in 2006-2010 ...

... "Merck & Co., Inc. (NYSE: MRK) announced the first phase of a global restructuring program designed to reduce the Company's cost structure, increase efficiency, and enhance competitiveness. The initial steps will include the implementation of a new supply strategy by the Merck Manufacturing Division (MMD), which is intended to create a leaner, more cost-effective and customer-focused manufacturing model over the next three years. The actions we are announcing today are an important first step in positioning Merck to meet the challenges the Company faces now and in the future, said Richard T. Clark, chief executive officer and president of Merck & Co., Inc. We are engaged in an ongoing effort to enhance efficiencies throughout the Company and improve the way we discover, develop, manufacture and market our medicines and vaccines and ensure that we get them to patients who need them as quickly, safely and efficiently as possible. Going forward, we also plan to pursue improved approaches to R&D, and marketing and sales. " ...

Emphasis on streamlined business processes and operational efficiency when announcing new CEO of Merck. ...

Richard T. Clark Named Chief Executive Officer and President of Merck; Company Veteran with Managed Care and Manufacturing Experience to Lead Merck ...

... "Here at Merck, Dick Clark has been the architect of some of this Company’s most important strategic initiatives. He has been a force within Merck to maximize the potential of the pipeline, accelerate the introduction of new medicines, streamline business processes, and focus resources in ways that maximize competitive advantage. Dick is uniquely experienced and exceptionally well qualified to lead the Company in turning Merck’s excellent science into innovative products that benefit patients and build shareholder value. " ...

Merck & Co., Inc. is a global research-driven pharmaceutical company dedicated to putting patients first. Established in 1891, Merck discovers, develops, manufactures and markets vaccines and medicines in more than 20 therapeutic categories. The Company devotes extensive efforts to increase access to medicines through far-reaching programs that not only donate Merck medicines but help deliver them to the people who need them. Merck also publishes unbiased health information as a not-for-profit service.

Lean Manufacturing Position: Tech Manager ...

Lean Manufacturing Position: Via Telegraph: Technical Support Manager ...

... "It also involves supporting the production areas in technical problem solving, development of the writing of manuals and training of operators in SOPs etc as well as involvement with continuous improvement and lean strategies. Candidates will be experienced manufacturing, chemical or engineering professionals with a background in the FMCG, food, drink, cosmetics, toiletries, pharmaceutical or medical device industries where products are manufactured to regulatory requirements such as FDA standards and have a background in lean manufacturing and continuous improvement. " ...

Six Sigma RFID Read Rates: Pharma Healthcare Performance ....

TagSys is achieving Six Sigma performance levels with its RFID tag read rates in the pharmaceutical and healthcare environments. ...

Six Sigma RFID Read Rates: Pharma Healthcare Performance: Via TAGSYS RFID: TAGSYS Receives Product Quality Innovation Award for its Complete Turnkey RFID Solutions in the Pharmaceuticals Market ...

... "TAGSYS is involved in the development of RFID standards with various regulatory organizations such as the International Standards Organization (ISO) and EPCglobal, remarks Gouthaman. The company's product range conforms to the ISO 18000 standard specifications and it has also successfully achieved Six Sigma levels of performance on its read rates for various pharmaceutical and healthcare applications. " ...

Six Sigma Project Operational Excellence: Arrow International ...

Arrow International appoints executive to lead their compliance activities in an operational excellence project, using Six Sigma methodology. ...

Six Sigma Project Operational Excellence: Arrow International: Via Arrow International: ARROW INTERNATIONAL, INC. NAMES KENNETH E. IMLER SENIOR VICE PRESIDENT OF REGULATORY AFFAIRS AND QUALITY ASSURANCE ...

... "Mr. Imler has been the lead consultant from Quintiles Consulting, a provider of global consulting services to the medical device, pharmaceutical and biologics industry, working on-site at Arrow for the past nine months. He will be the Company's main point of contact with the United States Food and Drug Administration (FDA), helping to ensure that Arrow continues to meet, and in many respects even exceeds, FDA and international regulatory requirements in its products, manufacturing processes, procedures, and systems. He also will guide Arrow in its efforts to implement rigorous compliance procedures designed to achieve the highest practical levels of quality assurance as part of its Project Operational Excellence and attain Six Sigma quality over the longer term. " ...

Arrow International, Inc. develops, manufactures and markets a broad range of clinically advanced, disposable catheters and related products for critical and cardiac care. The Company’s products are used primarily by anesthesiologists, critical care specialists, surgeons, emergency and trauma physicians, cardiologists, interventional radiologists, electrophysiologists, and other health care providers.

Coldstream Lean Manufacturing Industry ...

Karla Ward reports on $50 million investment in new construction for offices and labs at the University of Kentucky's Coldstream Research Campus, which is aimed at creating a base for lean manufacturing industry, etc. ..

Coldstream Lean Manufacturing Industry: via Herald-Leader: Coldstream to get new $50 million facility ...

... "Now, Parks said, the activity at Coldstream represents a good start to making the property a mecca for high-tech industries such as lean manufacturing, pharmaceutical research and equine pharmaceuticals and diagnostics. " ...

EliLilly SixSigma Operational Efficiency Program

Lilly unleashes a portfolio of Six Sigma improvement projects, staffed by Black Belts, to identify and root out inefficiencies in its quest for operational excellence. Jeff Swiatek explores the Six Sigma program at pharmaceutical manufacturer, Eli Lilly, in the article below ....

Via IndyStar.com: Lilly breaks out the black belts ...

... "Since March, Lilly has let loose 200 trained employees, armed with the principles of Six Sigma and dubbed black belts, to tackle some of the stickier operational challenges the Indianapolis drug maker faces. " ...

SixSigma PAT Process Analytic Technology

SixSigma PAT Process Analytic Technology: Via Irish Developer Network: Factory efficiency,pharmaceutical opportunity ...

Joanne Kelly explores the opportunity for operational efficiency in the pharmaceutical industry and how Lean Six Sigma and process analytic technology PAT is being leveraged for success in pharma manufacturing processes ...

... "leading pharmaceutical manufacturers are beginning to adopt proven best practice methodologies such as Lean Manufacturing and Six Sigma. These quality management techniques are being combined with new Process Analytic Technologies (PAT) to improve quality on the factory floor. " ...

Additional references on PAT process analytic technologies:

Process Analytical Technology tools, via the FDA:

There are many current and new tools available that enable scientific, risk-managed pharmaceutical development, manufacture, and quality assurance. These tools, when used within a system can provide effective and efficient means for acquiring information to facilitate process understanding, develop risk-mitigation strategies, achieve continuous improvement, and share information and knowledge.

Process Analytical Software PAT, via Symbion:

On-Line Process Analysis: The Symbion-DX and RX software suites were designed from the start to meet all of the established requirements of on-line process analysis. These include sample system design and control, operation of diverse instruments, extraction of process variable information from raw data, real time trending of multiple streams, system diagnostics, alarming, remote communications, historical data analysis, and archiving of data in a local or remote SQL database.

PAT Process Analytical Technology and Automated Chemistry, via Mettler Toledo:

Process Analytical Technology (PAT) is playing an increasingly important role in manufacturing processes, where it affects applications from raw material identification through packaging. PAT is also affecting techniques from traditional light spectroscopy to particle characterization techniques.

cGMP LeanSixSigma Accelerates Pharma Commercialization ...

cGMP LeanSixSigma Accelerates Pharma Commercialization: Via Cambrex: Innovative Biosensors, Inc. and Cambrex Establish Manufacturing Relationship ...

Manufacturing partnership will build upon a Lean Six Sigma and cGMP foundation to accelerate pharmaceutical commercialization ...

... "Cambrex's state-of-the-art facilities and scale-up expertise are among the many advantages of this manufacturing relationship, said Joe Hernandez, IBI's President and CEO. Cambrex's commitment to quality through cGMP and Lean Six Sigma will quicken the commercialization of our human clinical diagnostic products. " ...

Cambrex Corporation (NYSE: CBM) is a global, diversified life science company dedicated to providing products and services to accelerate the discovery and commercialization of human therapeutics. The company employs approximately 1,900 people worldwide.

GE Six Sigma Management Experience ...

GE Six Sigma Management Experience: Via AMRI News: Albany Molecular Research, Inc. Adds Three Key Hires to Management Team ...

... "Mary M. Cullinan has been named manager of financial planning and analysis. She will be responsible for budgeting, forecasting, analyzing and financial modeling. Mary brings over twenty years of experience with General Electric Company, where she worked at a senior level across multiple businesses in finance, strategic planning, six sigma and global product management. Most recently, she was the senior financial analyst at GE's Silicone Products Division in Waterford, New York. " ...

Albany Molecular Research, Inc. is a chemistry-based drug discovery, development and manufacturing company. The company provides contract chemistry services to pharmaceutical and biotechnology companies and conducts its own proprietary R&D.

Quality Improvement: Healthcare Industry ...

Technology and Innovation: Their Effects on Cost Growth of Healthcare

... "Meanwhile, best practices in manufacturing technologies and methods have undergone significant progress over that time, particularly in other high-tech industries. For example, the semiconductor industry also has a very low tolerance for impurities and inaccuracies in production. When its production processes were lagging because of high costs and too many errors that industry helped invent the 'six sigma' production methods. Through continuous quality improvement, those methods achieved enormous improvements in production cost and quality, and they have since been widely adopted in manufacturing industries. But continuous quality improvement in manufacturing hasn't been the subject of as much attention in the pharmaceutical industry, even though many experts on manufacturing processes believe that large savings in production costs could be realized while maintaining very high standards for purity and accuracy. " ...

Six Sigma Career Path: GE 6S Experience Pays Off ...

Invitrogen Promotes Mark Gardner to Chief Marketing Officer; Process Excellence and Marketing Expert to Expand Reach to Customers Through Broad Range of Channels ...

... "Gardner has served Invitrogen in several roles since 2003, including Vice President of Process Improvement, where he introduced concepts such as Six Sigma and LEAN to the company. Most recently, he served as Vice President of Commercial Marketing, where he established a global council to leverage opportunities across the spectrum of marketing channels for the company's product portfolio. He first came to Invitrogen after a series of highly successful six sigma and acquisition integration projects at General Electric Medical Systems, Information Technologies division. " ...

Invitrogen Corporation (Nasdaq:IVGN) provides products and services that support academic and government research institutions and pharmaceutical and biotech companies worldwide in their efforts to improve the human condition. The company provides essential life science technologies for disease research, drug discovery, and commercial bioproduction. Invitrogen's own research and development efforts are focused on breakthrough innovation in all major areas of biological discovery including functional genomics, proteomics, bioinformatics and cell biology -- placing Invitrogen's products in nearly every major laboratory in the world. Founded in 1987, Invitrogen is headquartered in Carlsbad, California and conducts business in more than 70 countries around the world. The company globally employs approximately 4,500 scientists and other professionals and had revenues of more than $1 billion in 2004.

Lean Manufacturing Intelligence Solution ...

ICONICS' New Manufacturing Intelligence Solutions for Regulated Industries

... "ICONICS, a leader in Web-enabled, OPC-based HMI/SCADA and Manufacturing Intelligence Visualization software for Microsoft Windows operating systems, today announced its new Manufacturing Intelligence Software Suite for Regulated Industries. BizViz, ICONICS' real-time manufacturing intelligence solution, enables pharmaceutical and other regulated industries to overcome today's business challenges regarding collection, management, analysis, and sharing of real-time information. ... Configurable Key Performance Indicators (KPIs) enable real-time performance tracking against set targets. BizViz supports Lean Manufacturing, Six Sigma, and Demand Pull process-improvement initiatives with many KPIs used in the pharmaceutical industry, such as OEE, Cycle Time, and Productivity. BizViz embraces the framework of Collaborative Manufacturing, and extends it via a reliable and OPC-based interoperable platform that can be easily customized to meet one's specific needs. " ...

Founded in 1986, ICONICS is a leader in the development of Web-enabled industrial automation and manufacturing intelligence software for Microsoft® Windows® operating systems. Offering the industry's only suite of fully-integrated OPC-based components and products, GENESIS32™ Enterprise Edition is available for Windows XP, 95, 98, Millennium, and 2000, and Windows NT®. Pocket GENESIS™ for Windows CE and Pocket PC was built from the ground up based on ICONICS' OPC-To-The-Core™ framework. BizViz™ is a suite of manufacturing and business intelligence products, which bridge the gap between manufacturing and corporate business information systems. BizViz is designed around Microsoft .NET technology, Microsoft SharePoint™ and runs on Microsoft server 2003. ICONICS also offers a complete set of Plug and Play automation components, including best-in-class OPC ActiveX® Controls, OPC Toolkit, Human Machine Interface (HMI), Microsoft SQL Server®–based data logging, Multimedia Alarming, and Supervisory Control and Data Acquisition (SCADA) products. ICONICS is a Microsoft Gold Certified partner, represented in over 50 countries and has in excess of 150,000 products installations worldwide.

Lean Accounting: Summit in the Fall ...

Lean Accounting Summit

... "Flexware Innovation announces the first annual Lean Accounting Summit to take place in Dearborn, Michigan September 22-23, 2005. The event is being sponsored by Flexware, the Association for Manufacturing Excellence (AME), and the Society for Manufacturing Engineers (SME) and will feature more than 20 lean accounting thought-leaders. Notable presenters will include, among others, Tom Johnson, Professor of Business Administration at Portland State University, Brian Maskell, President of BMA Inc., and Orry Fiume, 2004 Shingo Prize winning author of Real Numbers: Management Accounting in a Lean Organization." ...

Flexware was founded in 1996 by Scott Whitlock as a manufacturing IT and automation services company. The company quickly formed a niche in Manufacturing Execution Systems (MES), helping companies strategize, select, and implement custom and commercial-off-the-shelf systems. Flexware employs more than 30 manufacturing systems professionals and support staff, serving clients in the pharmaceutical, medical device, assembly, and automotive industries. In 2002 Flexware defined a unique continuous improvement process called highlandpath to guide clients through operational and enterprise excellence transformations. This group utilizes this proprietary process to find high leverage, high meaning opportunities and seizes those opportunities with the best of Lean, Six Sigma, and other continuous improvement methodologies.

Partnership for Merger Acquisition Acceleration ...

Partnership for Merger Acquisition Acceleration: IntraLinks and PowerSteering Software Form Strategic Partnership ...

Mergers and acquisitions can be accelerated through the use of tools integrated through this strategic partnership ...

From Business Wire (press release), CA ... responsible for delivering results from corporate initiatives such as mergers and acquisitions, strategic sourcing, Sarbanes-Oxley and Six Sigma are able to ...

... PowerSteering, the only provider of solutions for measuring and managing strategic enterprise programs, and IntraLinks, the leading provider of virtual data rooms to the global merger and acquisition industry, today announced that they have formed a strategic partnership. Under the terms of the agreement, PowerSteering and IntraLinks will cross-sell each other's services, providing a seamless M&A process from due diligence to post-merger integration. IntraLinks Virtual Data Rooms enable dealmakers to take the M&A process online, cutting an average of 30 days off dealtime. ...

PowerSteering Software, Inc. has dramatically improved the way businesses drive, manage, and track critical corporate innovation and growth initiatives. Using PowerSteering, corporate executives responsible for delivering results from corporate initiatives such as mergers and acquisitions, strategic sourcing, Sarbanes-Oxley and Six Sigma are able to easily review all projects in real-time and act on project status to ensure timely completion. PowerSteering is the only software that enables executives to tie financial savings directly to project outcomes and drive improvement in key performance metrics quickly, effectively and in real-time. The company leverages its deep experience in enterprise class quality and process improvement software to bring the speed, focus, and discipline of Six Sigma to enterprise program management. The PowerSteering suite is currently being used to manage more than $15 billion in target savings, supporting over 35,000 active users and nearly 100,000 projects. Global clients include Alpharma, Diageo, EMC, General Electric, Pitney Bowes, Raytheon, Textron and Tyco.

IntraLinks (www.intralinks.com), the leading provider of digital workspaces, connects business communities and accelerates the intelligent flow of information and documents among participants. Through IntraLinks' secure, neutral, online environments, companies are better able to compete globally by accelerating essential business processes, simplifying communication and fostering rapid workflow. IntraLinks is easily accessible anywhere, anytime using a web browser. Since April 1997, more than 200,000 participants representing over 13,000 companies worldwide have used IntraLinks digital workspaces to communicate and collaborate on more than 20,000 projects and transactions. IntraLinks has been rapidly adopted by the financial services and pharmaceutical markets. Over 250 global companies are IntraLinks clients, including AstraZeneca Pharmaceuticals LP, Bank of America, Bear Stearns, Deutsche Bank, Dresdner Kleinwort Wasserstein, Ernst & Young, FDIC, JPMorgan Chase, TD Securities, Thomas Weisel Partners and WestLB. Founded in June 1996, IntraLinks is headquartered in New York with offices in Boston and London.

New Product Innovation in Pharma Industry ...

Improving the PPI samples for prescription pharmaceuticals (EXCERPT), Monthly Labor Review Online ...

From Monthly Labor Review Online, Gregory G. Kelly writes ...

... "The pharmaceutical industry is characterized by frequent product innovation, with manufacturers continually developing and marketing new products. Some of these newly-developed products compete with existing products; others are completely new. The development of prescription pharmaceuticals requires costly and time-consuming research. After a product has been developed, it must undergo the rigorous approval process of the Food and Drug Administration (FDA). This process, which currently takes about 18 months, tests the product for safety as well as its efficacy in treating specific conditions. " ...

BioInformatics Software Integration Supports Data Analysis ...

BioInformatics Software Integration Supports Data Analysis: Rosetta Biosoftware Integrates Affymetrix GeneChip Operating ...

From Business Wire (press release), CA ... rosettabio.com. Rosetta Biosoftware is a leading provider of enterprise bioinformatics solutions for life science research. Its ...

... Rosetta Biosoftware today announced the integration of the Affymetrix GeneChip(R) Operating Software (GCOS) with version 5.0 of the Rosetta Resolver(R) gene expression data analysis system. The integration between the two systems will ease collaboration efforts between scientists, improve productivity in high-throughput gene expression laboratories, and seamlessly allow advanced data interpretation and data mining of results from Affymetrix GeneChip brand microarrays. ...

Rosetta Biosoftware is a leading provider of enterprise bioinformatics solutions for life science research. Its enterprise software solutions, including the Rosetta Resolver and Rosetta Luminator gene-expression data analysis systems, empower life scientists with advanced, scalable, and easy-to-use analysis platforms that accelerate discovery research. Rosetta Biosoftware is a business unit of Rosetta Inpharmatics LLC, a wholly owned subsidiary of Merck & Co., Inc. (NYSE:MRK). The Rosetta Resolver system is a high-capacity data storage, retrieval and analysis solution for gene expression data. The system is ideal for life science research organizations that need to assess compound specificity or toxicity, identify new genes or therapeutic targets or compare and analyze large databases of expression profiles. The Rosetta Resolver system combines flexibility and ease of use with high-performance algorithms to produce an enterprise solution for rapid analysis of gene expression data. The Rosetta Resolver system can accept and analyze data from a wide variety of expression profiling formats, including Affymetrix GeneChip, Agilent DNA and GE Healthcare Biosciences CodeLink microarrays, and applies Rosetta Biosoftware's proprietary error models to yield quality statistics for every gene expression measurement within the system. These statistics are automatically leveraged by Rosetta Resolver system analysis tools for optimal results. The system is also highly customizable, and includes a Software Development Kit (SDK) for extension and customization. Life science research organizations that have licensed the Rosetta Resolver system include many of the top pharmaceutical companies in the world, such as Aventis Pharmaceuticals, Bristol-Myers Squibb, GlaxoSmithKline and Merck & Co., Inc., as well as premier academic institutions such as the Harvard University Center for Genomics Research. The Rosetta Resolver system is distributed exclusively by Agilent Technologies.

Six Sigma Clinical Trials Supports EU Regulations While Enabling Innovation ...

Six Sigma Clinical Trials Supports EU Regulations: Atrium Medical Center Selects Sopheon's Accolade Solution to ...

From Business Wire (press release), CA ... closely with the Atrium team to configure Accolade to fit a new, jointly-developed process incorporating elements of the Six Sigma manufacturing methodology ...

... Sopheon, the international software and services company, announced today that Atrium Medical Center, one of the largest general hospitals in the Netherlands, is deploying Sopheon's Accolade solution to support implementation of a structured process for comprehensive management of clinical trials. Use of the software is expected to help Atrium enhance management of trials activity and ensure compliance with the latest European Union (EU) clinical research regulations. Accolade will also be used by the hospital to manage innovation projects, including major capital investment initiatives. In May 2004, new regulations went into effect across the EU aimed at establishing common guidelines for clinical-trial procedures. Atrium is using these compliance directives as an opportunity to strengthen the organization and management of its clinical-trials operations. ...

Sopheon (LSE:SPE) is an international provider of software and services. The Sopheon Accolade product development system automates gate- or phase-based product development processes and provides strategic decision support that allows companies to improve innovation, cut product development spending waste and shorten time-to-market. Sopheon's Monitor software operates as a "reading robot" that automatically reviews, filters, analyzes and pushes relevant content to healthcare and engineering professionals to enable effective compliance with protocols, standards and regulations. Sopheon is listed on the AIM Market of the London Stock Exchange and on the Euronext in the Netherlands.

With 3600 employees and 1230 beds, Atrium Medical Center (Atrium) is one of the largest employers in the south of the Netherlands. In 2004 Atrium celebrated its 100-year anniversary. It has a national reputation for hospital innovation, and has recently participated in experimental studies on reducing patient wait-lists, increasing care-delivery production, implementing new budgetary systems and improving patient safety. In 2003, supported by a EUR 187 million budget, Atrium registered 28,000 clinical admissions, 24,000 day admissions and 432,000 patient visits to its policlinics. Atrium's focus on patients, professionalism, and continuity and effectiveness of treatment ensures that the quality of care it provides remains on the highest levels.

Additional resources on Six Sigma clinical trials that support European Union EU regulations ...

Cognizant's Differentiators - Life Sciences Practice: electronic data capture product in over 160 clinical trials. ... Experience in execution of Six Sigma projects. ... and data investments to support sales, marketing ...

Conferences, Workshops, Meetings: goal of addressing reasons for clinical trial failure earlier ... discuss how the deployment of Six Sigma could help ... to application in a clinical setting, allowing ...

Concurrent engineering in a pharmaceutical firm: a case study: File Format: PDF/Adobe Acrobat ... new molecules developed by DRL undergoing clinical trials. ... technical and regulatory support to customers ... product development using six sigma methodology with a ...

BioInformatics Role in Discovery of New and Novel Drug Compounds ...

BioInformatics Role in Discovery of New Compounds: deCODE Submits IND for Novel Anti-atherosclerosis Compound DG041 ...

From PR Newswire (press release) ... drug discovery and development capabilities to offer innovative products and services in DNA-based diagnostics, bioinformatics, genotyping, structural biology ...

... deCODE genetics (Nasdaq: DCGN) has submitted an investigational new drug application (IND) to the U.S. Food and Drug Administration (FDA) for DG041, a novel, first-in-class, orally-administered small molecule for the treatment of peripheral arterial occlusive disease (PAOD). In preclinical studies, DG041 has been shown to be a selective and potent antagonist of the EP3 receptor for prostaglandin E2 (PGE2), inhibiting, in a dose-dependent manner, human platelet aggregation induced in vitro by PGE2. deCODE identified EP3 as a target in PAOD through its population genetics research, which linked variations in the gene encoding EP3 to a significantly increased risk of the disease. Pending clearance by the FDA, deCODE intends to initiate a Phase I clinical trial of DG041 this spring. ...

Through its population genetics research in Iceland, deCODE identified common versions of the gene encoding EP3 (the PTGER3 gene) that confer significantly increased risk of PAOD. These variants are believed to increase susceptibility to the disease through heightened expression of EP3. Functional analysis underscores the important role of EP3 in modulating the biology of the platelet and the vessel wall. Binding of PGE2 to EP3 is known to increase platelet aggregation, and EP3 is expressed in smooth muscle cells found in atherosclerotic plaque. DG-041 is a novel, selective and potent antagonist of the EP3 receptor. In preclinical in vitro studies it has been shown to inhibit human platelet aggregation induced by PGE2, and to do so in a dose-dependent manner. Furthermore, ex-vivo inhibition of rat platelet aggregation can be demonstrated after oral dosing with DG041. In mice, DG041 has been shown to protect against intravascular coagulation in a model based on prostanoid-induced platelet activation. DG041 has been shown to have minimal effect on bleeding time in animal studies, nor does it inhibit the effect of other platelet agonists such as adenosine diphosphate (ADP), collagen, thrombin or epinephrine.

deCODE is a biopharmaceutical company applying its discoveries in human genetics to the development of drugs for common diseases. deCODE is a global leader in gene discovery - our population approach and resources have enabled us to isolate key genes contributing to major public health challenges from cardiovascular disease to cancer, genes that are providing us with drug targets rooted in the basic biology of disease. deCODE is also leveraging its expertise in human genetics and integrated drug discovery and development capabilities to offer innovative products and services in DNA-based diagnostics, bioinformatics, genotyping, structural biology, drug discovery and clinical development. deCODE is delivering on the promise of the new genetics.(SM)

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