Policy & Regulation: Page 23

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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
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    Letter from the Editor

    If you are feeling downtrodden by the continuing barrage of negative news about our industry, then this issue is the cure for what ails you. This issue showcases dozens of individuals who exemplify the best of the best in terms of their commitment, passion, and conviction to improving the health ...

    By Taren Grom • Jan. 2, 2008
  • biotech market Explore the Trendline➔
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    Trendline

    Emerging biotech

    After years of financial turmoil, the biotech market is turning the page. Strong fundamentals, including solid clinical data, are key for biotechs hoping to capitalize on the improving conditions.  

    By PharmaVoice staff
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    UpFront

    Consumer-Driven Healthcare Retail Primary Care One in 10 retail clinic users is replacing his or her primary-care physician with a retail clinic for the treatment of common ailments, according to a recent study by Market Strategies Inc. The study indicates substantial interest by consumers to rec...

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

    Connecting the Dots: The Big Picture in Connected Health While the adoption of electronic medical records (EMR) is enormously important — and a robust connected health vision depends on EMR — it is only one aspect of connected health as it exists today and as we envision it for tomorrow. — Joseph...

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

    Letter from the Editor The Forum Biotech: The States of the Industry — To harness talent and leverage the niche characteristics to grow business, the biosciences require the specific capabilities certain regions have to offer. In this special Forum, Governors from five biotech-centered states rep...

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

    By Denise Myshko An Opportunity and a Challenge Placement on hospital formularies has become more competitive. Pharmaceutical companies that can demonstrate that their products positively impact the total cost of patient care will have the advantage. While small, the hospital market offers a uniq...

    By Denise Myshko • Jan. 2, 2008
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    UpFront

    Drug Sales U.S. Prescription Update Sales Jumped 8.3% to $274.9 Billion IMS Health reports that U.S. prescription drug sales grew 8.3% to $274.9 billion in 2006, the third straight year of growth. The increase was fueled by the Medicare Part D prescription benefit, the increased use of generics w...

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

    etrials Unveils New Version of EDC Solution etrials Worldwide has unveiled EDC 2.0 solution. Combining more than 10 years of market validation and customer deployments, the newest solution builds upon existing Web-based software as a service (SaaS) solution for collecting, managing, and analyzing...

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

    Making Personalized Medicine Understandable Education is Key As William D. Young, CEO of Monogram Bioscience, states in The Age of Personalized Medicine, (PharmaVOICE February 2007), honestly and clearly addressing the concerns of the stakeholders (drug makers, insurance companies, doctors, and p...

    By PharmaVoice Team • Jan. 2, 2008
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    DNA-Based Diagnostics: Testing for Personalized Medicine

    By Cynthia Borda Theranostic testing There will come a time when genetic testing will be as common in the physician’s office as a blood pressure reading or the use of an MRI. The pharmaceutical industry is making headway in the personalized medicine arena, and diagnostic companies are actively de...

    By Cynthia Borda • Jan. 2, 2008
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    Connected Health: The Push for Electronic Medical Records

    Connected Health: The Push for Electronic Medical Records By Kim Ribbink While the medical profession has lagged on the use of technology to manage and communicate patient information, increased focus on the use of electronic medical records — from the federal government, doctors’ groups, and pat...

    By Kim Ribbink • Jan. 2, 2008
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    What's New

    Roche Introduces New Operating Model for its Global R&D Activities The focus is on disease biology areas to enhance alignment of R&D. Roche has introduced a new operating model for its global R&D activities, organized around disease biology areas (DBA). Each DBA covers a range of acti...

    By PharmaVoice Team • Jan. 2, 2008
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    PharmaOutlet

    Contributed by Nancy Smerkanich The U.S. Food and Drug Administration (FDA) called a Part 15 (21 CFR Part 15) hearing on Dec. 18, 2006, primarily as “a listening exercise” to gather information so that the agency could move forward to “an all electronic submission environment and electronic data ...

    By Nancy Smerkanich • Jan. 2, 2008
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    Table of Contents

    Table of Contents April 2007 On the Cover The Evolving Role of the Clinical Project Manager Clinical studies have become more complicated, are multinational, and must adhere to a variety of laws and regulations. As a result, the project manager role has become a core capability needed for drug de...

    By PharmaVoice Team • Jan. 2, 2008
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    Going Public: Pharma's Commitment to Public Health

    By Elisabeth Pena Villarroel Forum The pharmaceutical industry’s commitment to public health is at the core of its very existence; the mission and work of the industry’s companies are to create, develop, and bring to market lifesaving and life-enhancing medicines. A natural extension of this miss...

    By PharmaVoice Team • Jan. 2, 2008
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    The Evolving Role of the Clinical Project Manager

    The Evolving Role of the Clinical Project Manager By Denise Myshko Forum Clinical studies have become more complicated. More studies are multinational, which means that projects must adhere to a variety of regulations and laws. Today’s studies also require project managers to work across teams to...

    By PharmaVoice Team • Jan. 2, 2008
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    Talent Pool

    Pharma POOL Dr. Eric G. Carter King Appoints Chief Science Officer King Pharmaceuticals, Bristol, Tenn., an integrated branded pharmaceutical company, has appointed Eric G. Carter, M.D., Ph.D., as chief science officer. Dr. Carter oversees King’s R&D, regulatory, and medical-affairs activitie...

    By PharmaVoice Team • Jan. 2, 2008
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    Meet the Creative Directors

    By Taren Grom, Editor Special Feature PharmaVOICE is pleased to publish this special feature showcasing the individuals who influence the look and feel of the industry through their creative executions and insights, strategic thinking, and mentorship of up-and-coming talent. GETTING PERSONAL ABOU...

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

    Thomson Scientific Expands Pharmaceutical Regulatory Intelligence Coverage Thomson Scientific announces that three new country modules, India, Israel, and Turkey, are now available in IDRAC, the global pharmaceutical regulatory intelligence database. IDRAC is recognized by regulatory professional...

    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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    Raise Your Voice -- Letters

    Changes in Washington: Will it Affect the Pharmaceutical Industry? One way that the U.S. government is making good on its promise to reduce the cost of healthcare is by approving Medicare Part D. — Patricia Santos-Serrao, RAC, Regulatory Advisory, Qumas A shift in command Healthcare has always be...

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

    By Denise Myshko MCOs and PBMs are now applying their cost-management strategies to biotech and specialty drugs. Biologics and injectable medications are coming under increased scrutiny by managed care organizations (MCOs). MCOs, pharmacy benefit management companies (PBMs), and other payers are ...

    By PharmaVoice Team • Jan. 2, 2008
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    FDA: An Agency in Transition

    In the past year, the Food and Drug Administration has built some momentum in speeding drug development and addressing product safety. Despite the progress made in improving its internal structure, the agency in the coming year will continue to face obstacles. Robert DeLuccia MacroChem A shifting...

    By Denise Myshko • Jan. 2, 2008
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    UpFront

    Top 7 Healthcare Issues This year is expected to be a watershed period for the health industries, according to PricewaterhouseCoopers LLP, as health savings accounts reach a tipping point, states act where the federal government hasn’t, and pressure on pricing amid demand for transparency forces ...

    By PharmaVoice Team • Jan. 2, 2008
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    Counter Measures: Switching from Rx to OTC

    Switching products from Rx to OTC status can be a viable life-cycle management strategy, one that is expected to be used more frequently. By Cynthia Borda Consumers are increasingly comfortable managing their own healthcare. They want easy access to low-cost, effective, safe, and easy-to-get prod...

    By Cynthia Borda • Jan. 2, 2008