Research & Development: Page 80


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    EDC: Crossing the Chasm

    In the figurative but practical language of Silicon Valley marketing guru Geoffrey Moore, the leading EDC companies have “crossed the chasm” from the fluidity of the early adopter market to the more established needs of the mainstream market. This may be the dream of many an EDC company CEO, but ...

    By PharmaVoice Team • Jan. 2, 2008
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    PharmaOutlet

    Overcoming Challenges to the Path to Combination Product Development Combination products have the potential to vastly improve medical care, making treatment more effective and safe, as well as improving compliance for patients. But because of the novelty and complexity of such products, companie...

    By Christine Ford • Jan. 2, 2008
  • clinical trial diversity Explore the Trendline
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    Trendline

    Clinical trial diversity

    As pharma wises up to the fact that the current playbook for improving clinical trial diversity has yet to make a meaningful impact, the quest is on to refine that approach.

    By PharmaVoice staff
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    Table of Contents

    Table of Contents March 2007 On the Cover Leadership Development: The Next Generation Industry leaders have to manage a complex and evolving environment. A company’s success will depend on its ability to identify and develop these executives. Features The Making of a Successful Publication Strate...

    By PharmaVoice Team • Jan. 2, 2008
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    Looking Ahead: The Deficit Reduction Act

    A prescription to adopt forward-looking strategies and ensure corporate and regulatory compliance excellence As government healthcare spending increases, Congress, states, and agencies will continue to put cost management and containment on their agendas. Given this reality, it is important to bu...

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

    On the Calendar February 2007 Industry Events 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 dis...

    By PharmaVoice Team • Jan. 2, 2008
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    Talent Pool

    Talent Pool Executive Appointments and Promotions Pharma POOL Mark Acosta Diana Bodden Anne Carlson Robert Corrie Cynthia Devereux Barry Gorewit Patrick Gose Darbi James Lawrence Kristoff Richard Laurie Randy Lawson Dr. David Levin Rita Myers June Nguyen Lynda Parker Bradley Pierson John Schillo ...

    By PharmaVoice Team • Jan. 2, 2008
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    PharmaOutlet

    Medicare Part D: It’s Crunch Time … Again Manufacturers are facing déjà vu with Part D. While the 2006 Part D year recently came to a close and the 2007 Part D year is nascent, crucial decisions related to 2008 Part D are right around the corner. The Centers for Medicare and Medicaid Services (CM...

    By Kevin Barnett • Jan. 2, 2008
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    UpFront

    PDUFA Update FDA Requests $87.4 million increase The FDA has put before Congress its recommendations for reauthorizing the Prescription Drug User Fee program (PDUFA). If adopted, PDUFA IV — the fourth reauthorization since the program began almost 15 years ago — would significantly broaden and up...

    By PharmaVoice Team • Jan. 2, 2008
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    PharmaOutlet

    Greg Sarian discusses executive trading rules. Contributed by Greg Sarian In an age when corporate scandals are top of mind and full financial disclosure is a must, executives may find it difficult to trade their company’s stock without raising eyebrows about how their insider knowledge may have ...

    By Greg Sarian • Jan. 2, 2008
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    PharmaTrax

    Life-Sciences Marketers Capitalize on Media Engagement Level A recent survey — Marketing to Life Scientists 2006: Capitalizing on Media Engagement — from BioInformatics LLC found that life scientists who are highly engaged differ significantly from less engaged scientists in their media preferenc...

    By PharmaVoice Team • Jan. 2, 2008
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    Stroke: Bats and Snakes May Hold the Answer

    By Cynthia Borda A decade ago, the introduction of tPA was a major step forward in stroke treatment, and the hope was that other approaches and additional therapies would soon be available. Unfortunately, the next generation of products has yet to materialize. Every 45 seconds, someone in the Uni...

    By Cynthia Borda • Jan. 2, 2008
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    Flying Sky High -- Rajesh C. Shrotriya

    With enormous enthusiasm and a joie de vive, Dr. Rajesh Shrotriya, chairman and CEO of Spectrum Pharmaceuticals, is instilling his employees with the same gusto for development of new drugs. Propelled by a joy of work and a commitment to remaining focused on a task until it is accomplished, Rajes...

    By Kim Ribbink • Jan. 2, 2008
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    Targeted Media Messaging: Patient Recruitment Marketing

    By Kim Ribbink Patient recruitment is widely considered to be the most costly and time-consuming aspect of clinical trials, and the need to improve the process is pressing. One key aspect to achieving this goal is the use of appropriate media as part of a marketing campaign to improve patient enr...

    By Kim Ribbink • Jan. 2, 2008
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    E-Media

    Blue Spoon Releases Ecosystem Solution For Pharma Sales Effectiveness Blue Spoon Consulting has released a marketing ecosystem-based solution for pharmaceutical sales effectiveness. The new design links the context, content, and process of the virtual and physical domains of pharmaceutical sales ...

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

    The Future of eClinical Recently, I had the opportunity to participate in an eClinical conference sponsored by etrials Inc. Clearly, among the participants at the event — both sponsors and trial partners –there was an underlying consensus that we understand the benefits of real-time data, know th...

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

    On the Cover The age of personalized medicine The study of genomics holds promise for helping to identify better drug targets and guiding companies in designing trials. The hope is that pharmacogenomics will lead to more targeted therapies. Features Patient recruitment marketing Patient recruitme...

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

    Is there anything more personal than healthcare? Whether we are talking about medical records or medicine — personalization is coming into vogue, albeit with a caveat on privacy protection. According to a recent Wall Street Journal Online/Harris Interactive Health-Care poll, when it comes to the ...

    By PharmaVoice Team • Jan. 2, 2008
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    PharmaTrax

    PharmaTrax Sales, Marketing, and R&D Trends from Industry Analysts Scientific Expertise and Good Value Are Important When Choosing a CRO The primary factors pharmaceutical and biotechnology companies consider when selecting a CRO are the strength of its scientific expertise and the cost/value...

    By PharmaVoice Team • Jan. 2, 2008
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    PharmaOutlet

    Contributed by James Rogers Merging Clinical-Trials Safety and Pharmacovigilance The Winds of change in safety monitoring In November 2003, Mark B. McClellan, M.D., Ph.D., a former commissioner with the Food and Drug Administration, made the comment: “…there is no such thing as a completely safe ...

    By James Rogers • Jan. 2, 2008
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    Registering Safety

    By Kim Ribbink As the emphasis on drug development shifts toward improving risk management, new tools have emerged to evaluate safety both pre- and postapproval. Increasingly, companies are looking at patient registries as an integral part of their safety arsenal. Drug safety has become the focal...

    By Kim Ribbink • Jan. 2, 2008
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    Letter from the Editor

    Already 2007 is shaping up to be an interesting time. A new Congress, shifting demographics, regulatory restrictions, and other factors are sure to keep industry leaders on their toes. In early December, Pfizer’s two big announcements made headlines: first, a major reduction in its salesforce, th...

    By Taren Grom • Jan. 2, 2008
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    E-Media

    New Electronic and Web-based Applications, Sites, and Technologies Phase Forward Expands Clinical-Trials Signal Detection System Phase Forward has unveiled a new version (2.0) of its clinical trials signal detection system — CTSD. The CTSD system enables clinical safety and medical monitoring sta...

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

    January 16-17 Pharma Pricing Strategies Radisson SAS, Rome For more information, contact Martin Manik, Jacob Fleming Group, at 42-12-5825-2729, e-mail [email protected], or visit jacobfleming.com. January 16-18 Pharmaceutical Leaders’ Summit Delray Beach Marriott, Delray Beach, Fla. F...

    By PharmaVoice Team • Jan. 2, 2008
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    Is EDC the next CDMS?

    VIEW on Data Management Is EDC the next CDMS? The lines between EDC and CDMS continue to blur as technology catches up with practicality and the need for cleaner data faster. Glen de Vries Glen de Vries, Cofounder and Chief Technology Officer of Medidata Solutions Worldwide, discusses why EDC is ...

    By PharmaVoice Team • Jan. 2, 2008
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    EDC VS. CDM -- Choosing A Data-Collection Model

    Conducting clinical trials is a highly specialized business that requires highly specific supporting software. The combination of complex functional and technical requirements, along with stringent regulatory requirements, means that standard cross-industry applications are rarely adequate. data ...

    By PharmaVoice Team • Jan. 2, 2008