Policy & Regulation: Page 31

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    The Commanders and Chiefs

    PharmaVOICE 100 These top-level executives are at the forefront, leading change within the industry and guiding their companies to success. Guided by Values David Mott It has been said that how individuals respond to adversity often defines their character. David Mott, president, CEO, and vice ch...

    By PharmaVoice Team • Jan. 2, 2008
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    PharmaOutlet

    HIPAA’s Impact on Informed Consent The first-ever federal privacy standards — Health Insurance Portability and Accountability Act (HIPAA) — to protect patients’ medical records and other health information provided to health plans, doctors, hospitals, and other healthcare providers took effect Ap...

    By Lynn Meyer and Sandra Young • Jan. 2, 2008
  • rare disease ribbon Explore the Trendline➔
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    Trendline

    Rare diseases

    As drug developers find promise in the rare diseases, deals and treatments are on the rise

    By PharmaVoice staff
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    PharmaTrax

    Sales, Marketing, and R&D Trends from Industry Analysts PharmaTrax Licensing Activity Key Component For Future Business-Development Strategies As competition in the pharmaceutical market continues to grow, effective business-development strategies are expected to become critical to maintain m...

    By PharmaVoice Team • Jan. 2, 2008
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    PharmaCounsel

    The Effects of the HIPAA Privacy Policy Rule on Clinical Research and Registries On April 14, 2003, the privacy rule took effect and most covered entities must now comply with its provisions. The rule establishes minimum federal standards for safeguarding the privacy of individually identifiable ...

    By PharmaVoice Team • Jan. 2, 2008
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    A More Efficient FDA for the Device World

    A More Efficient FDA for the Device World By Denise Myshko Quicker review times are an expected result of user fees, but in the device industry they provide a valuable resource as the sector employs technological advances as part of its submissions. If user fees work for prescription drugs, they ...

    By Denise Myshko • Jan. 2, 2008
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    Accurately Costing a Clinical Trial

    Accurately Costing a Clinical Trial By Denise Myshko Streamlining the budget process not only leads to more accurate resource allocation, it also allows for better predictions and creates more accurate clinical-trial planning. July 2003 Clinical-trial spending has increased considerably over the ...

    By PharmaVoice Team • Jan. 2, 2008
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    Advocacy Relations: Finding Common Ground

    Advocacy Relations: Finding Common Ground Forum By Elisabeth Pena Villarroel Where patient health is concerned, the goals of pharmaceutical companies and advocacy groups intersect. Teri Cox Cox Communications Partners People know about Breast Cancer Awareness Month and Prostate Cancer Awareness M...

    By PharmaVoice Team • Jan. 2, 2008
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    Clinical Data Strategies for Performance Optimization

    Octagon Research Solutions Inc. Data Standards Organizations that hesitate to embrace these standards as opportunities will be at a competitive disadvantage. They will continue to struggle with the tactical “cost” of transforming the ...

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

    New Electronic and Web-based Applications, Sites, and Technologies E-Media June 2005 PharmaVOICE SAS Upgrades Scientific Discovery Solutions In response to the need for modernization in the drug-development process, SAS Institute Inc. has made significant upgrades and additions to its Scientific ...

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

    November 2003E-media MDS Pharma Express is intuitive, user-friendly, and designed to operate with minimal computer requirements and the highest level of Internet security –providing easy access to current study status information in real time, anytime. MDS Electronic Data-Delivery System Allows f...

    By PharmaVoice Team • Jan. 2, 2008
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    The Continuing Evolution of EDC

    Paper may still reign supreme, but the EDC industry is coming of age. There is widespread agreement — at least intuitively — that the use of an electronic device or software application that allows direct data entry into electronic format has the potential to reduce time and money within the drug...

    By PharmaVoice Team • Jan. 2, 2008
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    After They Walk Out the Door

    After They Walk Out the Door By Elisabeth Pena Pharmaceutical companies recognize that direct-to-consumer campaigns have to address compliance with treatment regimens if they are to hold on to patients after they leave the doctor’s office. The messages in direct-to-consumer advertising are shifti...

    By PharmaVoice Team • Jan. 2, 2008
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    Dr. Sidney Pestka -- A Father of Invention

    Dr. Sidney Pestka — A Father of Invention by Kim Ribbink With a wealth of discoveries and other scientific achievements to his name, Sidney Pestka, Ph.D., has positioned his company — PBL Biomedical Laboratories and its subsidiary PBL Therapeutics — to lead the charge in cutting-edge research. Si...

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

    Society of Hospital Medicine Launches New Medical Journal The Society of Hospital Medicine plans to launch a new peer-reviewed medical journal, The Journal of Hospital Medicine, in 2006. The journal will promote the science and practice of hospital medicine and the enhancement of in-patient care....

    By PharmaVoice Team • Jan. 2, 2008
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    Talent Pool

    Pharma POOL Kevin Guthrie Thom Rowland Solvay Promotes VPs Solvay Pharmaceuticals, Marietta, Ga., a pharmaceutical company focused on cardiology, gastroenterology, mental health, women’s health, and select specialized markets, has promoted Kevin Guthrie to VP of commercial operations, neuroscienc...

    By PharmaVoice Team • Jan. 2, 2008
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    Shifting the Compliance Paradigm

    VIEW on regulatory compliance Michael Kuehne is President of ACSYS Inc., Hillsborough, N.J., which specializes in developing quality and compliance solutions that combine R&D and manufacturing capabilities to deliver sustained improvement in R&D, Quality, Operations, Clinical, and Regulat...

    By PharmaVoice Team • Jan. 2, 2008
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    Medicare

    Medicare Campbell. Executives will continue to prepare for the new regulations approved under the Medicare Prescription Drug, Improvement and Modernization Act (MMA). These regulations will take effect as scheduled on Jan. 1, 2006. Before the full benefit’s official start, however, the industry f...

    By PharmaVoice Team • Jan. 2, 2008
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    Regulatory

    FDA Acts to Strengthen the Safety Program for Marketed Drugs On Nov. 5, 2004, Acting FDA Commissioner Dr. Lester M. Crawford issued the following statement: Modern drugs provide unmistakable and significant health benefits, but experience has shown that the full magnitude of some potential risks ...

    By PharmaVoice Team • Jan. 2, 2008
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    Culture of Compliance: Cutting Through the Confusion

    Culture of Compliance: Cutting Through the Confusion A few years after the Pharmaceutical Research and Manufacturers of America (PhRMA) code and the Office of the Inspector General (OIG) guidance, and the more recent implications of the Accreditation Council for Continuing Medical Education (ACCM...

    By PharmaVoice Team • Jan. 2, 2008
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    What's on Your Mind -- Opinions

    What’s on your Mind Opinions Monitoring Drug Safety The industry and the U.S. Food and Drug Administration have come under significant scrutiny since Merck’s withdrawal of Vioxx. Six papers on the issue were published on the subject in the Dec. 1, 2004, issue of the Journal of the American Medica...

    By PharmaVoice Team • Jan. 2, 2008
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    Cautious Capital

    The funding environment for biotech and start-up companies has improved considerably during the past few years. But venture capital investors are more cautious and more demanding than ever before. Karen Boezi Venture capital investors will increasingly be focused on capital efficiency and reducin...

    By Lisa Dress • Jan. 2, 2008
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    PharmaTrax

    Pharma Trax Sales, Marketing, And R&D Trends Affecting the Healthcare Industry Doctors Prefer Details by Specialty Reps In the past three years, specialty sales representatives have become an increasingly important promotional investment for pharmaceutical companies, according to Verispanís l...

    By PharmaVoice Team • Jan. 2, 2008
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    Pharmacogenomics: The Next Step Forward

    Pharmacogenomics The Next Step Forward The first NDA based on pharmacogenomic data may still be a long time coming, but in anticipation of such filings, the FDA has issued a draft guidance that encourages companies to conduct pharmacogenomic tests during the drug-development process. Pharmacogeno...

    By Denise Myshko • Jan. 2, 2008
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    Sea Change

    Sea Change Turning the tide The Product Life-Cycle Management Wave Commonly thought of as a strategy for the end-phase of a drug, life-cycle management increasingly is being deployed by life-sciences executives earlier in the development phases to maximize product value, provide greater benefits ...

    By PharmaVoice Team • Jan. 2, 2008
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    PharmaOutlet

    Contributed by Harry Sweeney Back to the Future Credit the Food and Drug Administration with showing up in force and spelling out its intentions clearly at Parade Magazine’s Direct-to-Consumer Advertising Draft Guidance Symposium in New York City in one of the most collegial sessions I’ve attende...

    By PharmaVoice Team • Jan. 2, 2008