Research & Development: Page 86


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    Overcoming Poor Quality Data for ECG Collection

    Overcoming Poor Quality Data for ECG Collection Timothy Callahan, Ph.D., Chief Scientific Officer The ICH E14 has become the touchstone guideline when designing and implementing Thorough QT (TQT) trials. Even protocols that are not designed primarily as a QT trial often use recommendations fr...

    By PharmaVoice Team • Jan. 2, 2008
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    Using Advanced Simulation in Clinical Operations

    Using Advanced Simulation in Clinical Operations Jack Porter, President and CEO, ePharmamindshare The introduction of supercomputers and sophisticated simulation software for planning and optimizing clinical trials is rapidly becoming established in the pharmaceutical industry. These simulati...

    By PharmaVoice Team • Jan. 2, 2008
  • exploding pills Explore the Trendline
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    Trendline

    Big Pharma Business Strategies

    Large pharmas are consistently tasked with the goal of growth. But in recent years, the upward trajectory has been littered with new hurdles. 

    By PharmaVoice staff
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    Benefits of Using an EDC System to Collect and Reconcile Serious Adverse Events

    Benefits of Using an EDC System to Collect and Reconcile Serious Adverse Events Gary Tyson, Senior VP, Clinical Development Practice Marybeth Lynch, Associate Practice Executive, Clinical Development Practice Collecting and reconciling adverse events (AEs) and serious adverse events (SAEs)...

    By PharmaVoice Team • Jan. 2, 2008
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    Pediatric Patient Retention: It's not Child's Play

    Pediatric Patient Retention: It’s not Child’s Play Elizabeth Moench President and CEO Samantha Cook Pediatric Account Manager John Hartigan VP, Creative and Editorial Services The Ever-Changing Population A universal challenge of conducting long-term pediatric studies is the constant ...

    By PharmaVoice Team • Jan. 2, 2008
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    The ROI of ePRO

    The ROI of ePRO Phil Lee, President and CEO The power of listening to the patient voice by using e-diary systems to collect the best PRO data possible and manage subject enrollment, compliance, and safety in real time may still be overlooked by some sponsors, who are hesitant to switch to eP...

    By PharmaVoice Team • Jan. 2, 2008
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    Letter from the Editor

    rug development is a lengthy, complex, and expensive process, requiring hundreds of moving parts to act in concert to bring a therapeutic agent safely to market. According to the Association of Clinical Research Organizations, bringing a new drug or medical device to market can take 20 years an...

    By PharmaVoice Team • Jan. 2, 2008
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    Pharma Solutions and Services: The Wider Landscape

    Pharma Solutions and Services: The Wider Landscape by Jeffrey Smith, Managing Director Given the central role of pharmaceuticals in the single largest U.S. economic sector, and the extent to which the pharma industry is information-driven, the already very act...

    By PharmaVoice Team • Jan. 2, 2008
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    Clinical Resource Management: New Strategy Minimizes Co-Employment Risk

    Clinical Resource Management: New Strategy Minimizes Co-Employment Risk inVentiv Clinical Solutions LLC The approval of a new drug candidate is typically impacted by hundreds, if not thousands, of people during the development cycle. Without talented people, the clinical development plan is...

    By PharmaVoice Team • Jan. 2, 2008
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    An Emissary for Patients -- Kathy Giusti

    An Emissary for Patients — Kathy Giusti Nonprofit and successful business are terms seldom spoken together, yet demonstrably this is the way to achieve results. Make no mistake, uniting these two concepts takes a truly special individual. Kathy Giusti, founder and CEO of the Multiple Myeloma Rese...

    By Kim Ribbink • Jan. 2, 2008
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    Last Word

    ACRO’s Chair Jeffrey McMullen In December 2006, Jeffrey McMullen, president and CEO of PharmaNet Development Group, was elected chair of the Association of Clinical Research Organizations (ACRO), Washington, D.C. (For more information about ACRO, visit acrohealth.org.) He is joined on the board b...

    By PharmaVoice Team • Jan. 2, 2008
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    UpFront

    ACRP conference Record Attendance The 2007 ACRP Global Conference and Exposition in Seattle drew more than 2,700 attendees, making this year’s event one of the most successful for the organization. The association is positioned as the primary resource for clinical research professionals in the ph...

    By PharmaVoice Team • Jan. 2, 2008
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    Managed Markets: Pharmacists

    Playing a Pivotal Role Experts believe that pharmacists are ideally positioned to help patients better manage their drug therapies, as such they play a pivotal role helping seniors navigate the new Medicare Part D prescription drug plan. By Denise Myshko Pharmacists across the United States conti...

    By Denise Myshko • Jan. 2, 2008
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    E-Media

    New Electronic and Web-based Applications, Sites, and Technologies HealthCentral Introduces Online Network The HealthCentral Network (THCN) has relaunched its network of sites to better meet the needs of today’s patients. Each Website offers interactive medical information targeted to a specific ...

    By PharmaVoice Team • Jan. 2, 2008
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    Talent Pool

    Pharma POOL Dr. Zhi Hong GSK Appoints Head, Infectious-Diseases Research Center Healthcare company GlaxoSmithKline, Philadelphia, has appointed Zhi Hong, Ph.D., to lead a newly organized research unit dedicated to discovering therapies for infectious diseases. Dr. Hong heads the Infectious Diseas...

    By PharmaVoice Team • Jan. 2, 2008
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    Raise Your Voice -- Letters

    Project Teams Can Benefit from Better Data The one thing we see more than anything else, regardless of company size, is a lack of trustworthy data. — Karen Briegs, Director, 3C Company Embracing Business Intelligence It was so interesting to read the thoughts of the various project managers on th...

    By PharmaVoice Team • Jan. 2, 2008
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    On the Calendar

    On the Calendar June 2007 June 17-21 DIA 43rd Annual Meeting Georgia World Congress Center, Atlanta PharmaVOICE is exhibiting at this event. For more information, contact Drug Information Association at 215-442-6100, e-mail [email protected], or visit diahome.org. June 18-19 3rd Annual Medical Devi...

    By PharmaVoice Team • Jan. 2, 2008
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    Strategic Patient Adherence Awards

    The SPA Awards cosponsored by CBI and PharmaVOICE were presented at the 6th Annual Forum on Patient Compliance, Adherence and Persistency. 6th annual Forum on patient compliance, adherence and persistency Informative presentations, executive thought leadership, and a prestigious awards ceremony p...

    By PharmaVoice Team • Jan. 2, 2008
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    What's New

    New Healthcare-related Products, Services, and Companies TGaS Advisors Offers Collaborative Benchmarking Services for Pharmaceutical Companies Pharmastance operational resource lets companies learn where they stand. TGaS Advisors has launched the Pharmastance family of benchmarks. These collabora...

    By PharmaVoice Team • Jan. 2, 2008
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    The Commanders & Chiefs

    These champions of industry demonstrate their commitment to their employees, their companies, and their communities by setting high personal and corporate standards. Mehmood Khan, M.D. Mehmood Khan, M.D.’s favorite quote is from Michelangelo: Ancora Imparo, which translates into “I am still learn...

    By PharmaVoice Team • Jan. 2, 2008
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    Nanotech Comes of Age

    By Kim Ribbink The once futuristic science of nanotechnology has come of age and branched into a broad spectrum of applications. Among these is nanomedicine: medicinal intervention at the molecular level for curing disease, repairing damaged tissue, and monitoring biological systems. The National...

    By Kim Ribbink • Jan. 2, 2008
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    Section 199 Deduction for Qualified Production Activity Income

    In October of 2004, the U.S. Congress and President Bush signed into law the American Jobs Creation Act of 2004. The Act is the first major corporate tax act in over a decade. A key provision of the Act is a new domestic manufacturing deduction designed to improve the global competitiveness of U....

    By PharmaVoice Team • Jan. 2, 2008
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    One Step Ahead -- Dr. Mitchell S. Steiner

    Bio An apt descriptor for Mitchell S. Steiner, M.D., F.A.C.S., is a man ahead of his time. This character trait has helped him in his academic background, in helping patients, and in establishing a biopharmaceutical company focused on novel hormonal therapeutics for cancer, muscle wasting, osteop...

    By Kim Ribbink • Jan. 2, 2008
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    On the Calendar

    On the Calendar May 2007 Your Source for Life-Sciences Events and Conference Information Professional education is an ongoing endeavor for most executives. PharmaVOICE has partnerships with every major conference provider serving the life-sciences industry. PharmaVOICE is distributed at more than...

    By PharmaVoice Team • Jan. 2, 2008
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    E-Media

    New Electronic and Web-based Applications, Sites, and Technologies CIS Launches Pharma Compliance Exchange Website Compliance Implementation Services (CIS) recently released the Pharma Compliance Exchange (PCX), a new subscription-based source for government guidance documentation. For the first ...

    By PharmaVoice Team • Jan. 2, 2008
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    Table of Contents

    May 2007 Table of Contents On the Cover Pharma’s Commitment to Public Health A natural extension of the industry’s mission of providing safe, lifesaving medicines is participation and sponsorship of myriad public-health initiatives around the world. Features Nanotech Comes of Age With products al...

    By PharmaVoice Team • Jan. 2, 2008