Policy & Regulation: Page 24

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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
  • 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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    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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    E-Media

    BBK Launches E-Business Suite of Tools for Patient Recruitment Pharmaceutical, medical-device, and biotechnology companies can now take advantage of BBK Worldwide’s TCN e-Systems, a licensable e-business patient-recruitment solutions offering. With TCN e-Systems, study sponsors have greater contr...

    By PharmaVoice Team • Jan. 2, 2008
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    Sales & Marketing Compliance: Keeping up with Global and Local Challenges

    As pharmaceutical manufacturers continue to refine and adjust their compliance policies to meet a slew of regulations enacted over the past five years, they also are looking ahead and preparing for regulatory changes that could create many challenges. Six states have legislation that require phar...

    By PharmaVoice Team • Jan. 2, 2008
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    Then & Now

    Year in Preview Prognostications for the future PharmaVOICE asked several experts who participated in the December 2005 issue to review what they predicted for 2006. We wanted to know if indeed their prognostications for the future came true. In some cases, they were right on, and in other instan...

    By PharmaVoice Team • Jan. 2, 2008
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    UpFront

    Year in Preview FAST FACTS The Industry at a Glance In 2007, the market will be absorbing changes that have defined a new economic reality, one in which growth is shifting from mature markets to emerging ones; new product adoption is not keeping pace with the loss of patent protection by establis...

    By PharmaVoice Team • Jan. 2, 2008
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    Partnerships For Success

    Year in Preview Strategic Alliances Strategic alliances — between pharmaceutical companies, contract research organizations, and other outsourcing providers — are expected to impact the future of drug development. Pharmaceutical companies are under pressure from the public, analysts, Wall Street,...

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

    GSW Launches Pink Tank Specialty marketing group offers expertise in understanding and speaking to women. Remarkably, many marketers don’t realize that women connect with brands differently from men. We established Pink Tank to help companies understand those differences and to counsel them on ho...

    By PharmaVoice Team • Jan. 2, 2008
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    PharmaTrax

    Sales, Marketing, and R&D Trends from Industry Analysts Technology Use Among Regulatory Affairs Professionals Rising Many regulatory affairs professionals rely on both paper and electronic submissions, and 70% of these professionals expect this trend to continue into the future, according to ...

    By PharmaVoice Team • Jan. 2, 2008
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    Talent Pool

    Executive Appointments and Promotions Pharma POOL Manoj Aggarwal James Bongi Jeffrey Chodos Colette Curran Brian Doyle Dr. Sean Fenton Patrick Grenyo Lloyd Hilton Taewon Kim Paul Korathu Michelle LaBonte Marcia Leishman Carter McBride Dr. Eran Nadav Bud Powell Kenny Rankin Peter Rossmann Kelly St...

    By PharmaVoice Team • Jan. 2, 2008
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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
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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