Policy & Regulation: Page 26

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    IRBs The Safety Gatekeepers

    By Denise Myshko Current pressures to speed drugs to market have resulted in the increased use of independent, centralized institutional review boards as an alternative to academic IRBs, because they can offer faster and more efficient protocol reviews. Institutional review boards, or IRBs, are a...

    By Denise Myshko • Jan. 2, 2008
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    PharmaTrax

    Nanotech Sector Continues Strong Growth Sales, Marketing, and R&D Trends from Industry Analysts The commercialization of nanotechnology continues to gain momentum worldwide, according to The Nanotech Report, 4th Edition, a comprehensive and up-to-date reference study on nanotechnology, releas...

    By PharmaVoice Team • Jan. 2, 2008
  • drug shopping cart Explore the Trendline➔
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    Trendline

    Commercialization, marketing and social media

    As the pharma industry stares down a historic patent cliff, macroeconomic headwinds and challenging R&D costs for increasingly complex medicines, nailing the launch of new medicines has become increasingly critical. 

    By PharmaVoice staff
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    DIA 2006 -- Annual Conference

    DIA 2006 — Breaks Attendance Records September 2006 Sanjay Gupta, M.D., senior medical correspondent for the health and medical unit at CNN, practicing neurosurgeon, and an assistant professor of neurosurgery gave the keynote speech at the 42nd Annual DIA Meeting. The conference drew record numbe...

    By PharmaVoice Team • Jan. 2, 2008
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    Name That Brand

    Choosing a brand name is the most defining moment in a pharmaceutical product’s life. Name That Brand September 2006 Apharmaceutical product’s brand name is more than a series of letters that identify a chemical compound or biological agent used to treat a specific condition. The brand name evoke...

    By PharmaVoice Team • Jan. 2, 2008
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    UpFront

    Consumers Talk Back Countering DTC Criticism Challenging many of the assumptions of both academic and public-policy critics of DTC, CommonHealth filed a research report with the FDA based on analysis of 440 transcripts of actual provider-patient interactions in community-practice settings recorde...

    By PharmaVoice Team • Jan. 2, 2008
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    Cover

    A Team Approach Breaking Down the Silos Debugging the Pipeline with Graham Allaway, Ph.D. Name that Brand Clinical Gatekeepers: Institutional Review Boards The Forum for the Industry Executive September 2006 Volume 6 Number 8 Download PDF

    By PharmaVoice Team • Jan. 2, 2008
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    Adapting to Meet the New Guidelines and Clients' Needs

    Adapting to Meet the New Guidelines and Clients’ Needs Compliance Heidi L. Liston, Pharm.D. Senior VP and General Manager DiMedix To ensure success in today’s environment, MECs will need to invest to meet the requirements of set guidelines and stan...

    By PharmaVoice Team • Jan. 2, 2008
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    Accredited MECCs Embrace the Rules and Spirit of CME and Adapt to Achieve Success

    Accredited MECCs Embrace the Rules and Spirit of CME and Adapt to Achieve Success Compliance Sherri Foster, Senior VP, Director of Medical Education With the spotlight of government and public scrutiny shining brightly on CME in search of undue influence by pharmaceutical companies, accred...

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

    Steering a company in the right direction is no easy task in today’s highly regulated and competitive environment. These individuals wear the mantle of responsibility well and are the guiding forces of ethics, good corporate citizenship, and strategic vision for their companies. Mark Booth Constr...

    By PharmaVoice Team • Jan. 2, 2008
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    The Change Agents

    The Change Agents Not content with the status quo, these individuals have decided to shift the paradigm in their fields and are impacting business processes, technologies, and strategies across the life-sciences industry. Mark Bard Keeping the Focus on Results Education B.S. in health administrat...

    By PharmaVoice Team • Jan. 2, 2008
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    PharmaOutlet

    FDA Draft Guidance Impact on the E-PRO Industry Contributed by Dr. Richard Piazza As some treatment effects are only known to the subject enrolled in a study, patient-reported outcome (PRO) measures have become a common metric in determining treatment efficacy and safety in clinical trials. Advan...

    By Dr. Richard Piazza • Jan. 2, 2008
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    Stepping Up to Challenges Across the Board -- Theresa Kane Musser

    Stepping Up to Challenges Across the Board For every idea and opinion, there are contrary points of view; this give and take is what feeds innovation, propels scientific thinking and discovery, and creates rounded, well-adjusted teams and companies. It’s a perspective that Theresa Kane Musser emb...

    By Kim Ribbink • Jan. 2, 2008
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    PharmaOutlet

    Contributed by Donna Lee Yesner Donna Lee Yesner talks about the Medicaid rebate program. On Feb. 8, 2006, President Bush signed the Deficit Reduction Act (DRA) into law. Title VI imposes changes to the formula for state reimbursement of prescription drugs and changes to the Medicaid rebate progr...

    By Donna Lee Yesner • Jan. 2, 2008
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    PharmaTrax

    Genomics Will Drive Drug Development Once clear, unambiguous pathways and procedures are laid out, genomic applications will blaze a path through the clinic, the physicians’ offices, and eventually into the hands of consumers, says Mike Goodman, General Manager of CHA Advances Reports. Mike Goodm...

    By PharmaVoice Team • Jan. 2, 2008
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    Meeting the Needs of Patients with Rare Diseases

    Incentives designed to bring drugs to the market to treat rare diseases have been successful, yielding 280 products, but there are still many patients without adequate treatment. The National Institutes of Health Office of Rare Diseases (ORD) lists more than 6,000 rare diseases affecting an estim...

    By Cynthia Borda • Jan. 2, 2008
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    A Rising Tide for Clinical Services

    A Rising Tide for Clinical Services By Daniel Limbach June 2006 VIEW on Clinical Services Contract drug-development expenditures were $19 billion in 2005 and are expected to increase at an annual rate of 17%, eventually exceeding $42 billio...

    By PharmaVoice Team • Jan. 2, 2008
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    Meet the R&D Leaders

    By Denise Myshko Executives charged with R&D responsibilities within biotech and pharmaceutical organizations, both large and small, face myriad opportunities and challenges. Drug development is a costly and risky business. The pharmaceutical industry is challenged by many factors related to ...

    By PharmaVoice Team • Jan. 2, 2008
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    UpFront

    Office Visits — The Doctor Is In Docs Want More from Rep Calls Pfizer, Novartis, and GlaxoSmithKline have been identified as three companies whose sales reps are doing the best job of meeting the needs of physicians, but a TNS Healthcare study finds that there is room for improvement across the b...

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

    Ventiv Health Changes Name to Reflect Broader Capabilities Rebranding initiative integrates inChord nomenclature to more clearly communicate services. Ventiv Health Inc. has changed its corporate brand name to inVentiv Health as part of a rebranding initiative that began when Ventiv acquired inCh...

    By PharmaVoice Team • Jan. 2, 2008
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    Combination Products: Drugs and Devices

    The possibilities are endless. Emerging drug-delivery technologies and smarter drug-development strategies are providing a one-two punch for researchers and marketers who envision scientific advancements that could span multiple therapeutic categories. By Denise Myshko In the broadest sense, phar...

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

    New Electronic and Web-based Applications, Sites, and Technologies DataLabs Launches Products to Enhance e-CDM DataLabs has released DataLabs Clinical, a single data-management system that unifies the functionality of paper data entry (PDE) with the flexibility of electronic data capture (EDC). D...

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

    On the Cover Drugs in the real world There is an increasing need for more information about prescription drugs once they are approved and available to the larger marketplace. Phase IV studies have become important vehicles for postapproval risk-management and drug-safety assessment. Features The ...

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

    Damn the Torpedoes, Full Speed Ahead Recent calls from academic ivory towers to end pharmaceutical and device company collaboration with doctors and medical centers are stupefying and potentially dangerous. Stupefying because pharmaceutical companies are often a patient’s best ally against pain, ...

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

    Phase IV studies appear to be the hottest thing in clinical research. More and more companies are fulfilling their regulatory commitments, more CROs are benefitting from the outsourced programs, and physicians have additional avenues for bolstering their resumes. But what about the patients — you...

    By Taren Grom • Jan. 2, 2008
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    PharmaTrax

    Sales, Marketing, and R&D Trends from Industry Analysts Market for Biochips in Clinical Research Expected to expand As biochip technology makes the transition from bench to bedside in the clinical-trial process, improved patient therapies will result, according to a recent report from Frost &...

    By PharmaVoice Team • Jan. 2, 2008