Policy & Regulation: Page 19

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    R&D Innovation: The Key to Long-Term Success

    When the scientific discoveries and pipeline-building process of many successful biotechs are layered together, the results are likely to be dramatic. Experts predict there will be a number of game-changing product candidates in development in the next decade. “We view ourselves as part of the ‘m...

    By PharmaVoice Team • March 7, 2011
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    Agility: Key to Agency Success in the Future

    For anybody involved in healthcare advertising, on the agency as well as the client side, the last decade has been marked by myriad changes and market factors that have impacted all aspects of the business. Client mergers and acquisitions, heightened regulatory scrutiny of messaging, more messagi...

    By PharmaVoice Team • March 7, 2011
  • 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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    Talent Pool

    Pharmaceutical POOL Dr. Robert CUDDIHY Sanofi-Aventis Adds to Diabetes Team Sanofi-Aventis U.S. has appointed Robert Cuddihy, M.D., VP, medical diabetes head in the U.S. Dr. Cuddihy is responsible for developing and executing the U.S. medical affairs strategy for Sanofi-Aventis’s diabetes divisio...

    By PharmaVoice Team • March 3, 2011
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    On the Calendar

    March 21-22 BioConference Live: Life Sciences PharmaVOICE is exhibiting at this event. BioConference Live, bioconferencelive.com March 21-23 Digital Marketing & ­Communications for Canadian Pharma Toronto PharmaVOICE subscribers receive a $200 discount; register using keycode PharmaVOICE Adva...

    By PharmaVoice Team • March 3, 2011
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    The Era of Proactive Safety

    Process, people, and technology have to align to ­enable a truly proactive risk-management and ­pharmacovigilance program that protects patients. First, do no harm. This is medicine’s highest ethical standard, an oath physicians take when they begin to practice. In the last few years, dangerous s...

    By Denise Myshko • Jan. 26, 2011
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    Talent Pool

    Pharmaceutical POOL Robert DAVIS Dr. Ludwig HANTSON Baxter International Forms Medical Products Business Baxter International has appointed Robert Davis corporate VP and president of its newly created medical products business, which combines the company’s renal and medication delivery businesses...

    By PharmaVoice Team • Jan. 26, 2011
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    Healthcare Reform and Comparative Effectiveness

    We all know that R&D focus, pharmaceutical promotion, pricing, and reimbursement are all, or will be, critically affected by the biggest U.S. healthcare reform to occur in 40 years. The impact is going to be disruptive, but overall, experts says it will be a positive gain for the pharmaceutic...

    By PharmaVoice Team • Nov. 10, 2010
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    On the Calendar

    November 18-19 2nd Annual VA * DoD * PHS Federal Pricing and ­Contracts for Bio/Pharmaceutical Companies Courtyard Philadelphia Downtown, Philadelphia PharmaVOICE subscribers receive $400 discount; register using keycode RGR396. Center for Business Intelligence, cbinet.com November 18-19 West Coa...

    By PharmaVoice Team • Nov. 9, 2010
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    Effective Global Teams Are Aligned, Not Built

    Trust, understanding, common goals and perceptions, speaking the same language —­literally and figuratively — all sound like the ingredients for a ­successful marriage. The same factors that are inherent in any successful ­relationship must be present among the ­members of global ­cross-functiona...

    By PharmaVoice Team • Sept. 29, 2010
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    Talent Pool

    Pharmaceutical POOL Timothy HAYES Bayer Adds Global Business Development Oversight Timothy Hayes, currently senior VP and region head for Bayer HealthCare’s Consumer Care division in North America, has assumed the additional responsibility of leading the business unit’s global business developmen...

    By PharmaVoice Team • Sept. 28, 2010
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    The REGULATORS

    The fight against counterfeit drugs has an eminent champion in Paul Orhii, M.D., Ph.D., J.D. As director-general of Nigeria’s regulatory body, the National Agency for Food and Drug Administration and Control (NAFDAC), and in his role as vice chairman of the World Health Organization’s Internation...

    By PharmaVoice Team • July 28, 2010
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    What's New

    New Healthcare-related Products, Services, and Companies Featured Briefs: Augme Expands Mobile Health ­Division Service Combines Wolters Kluwer’s Scientific Writing, Publishing Expertise Compass Healthcare Marketers Focuses on Full Marketing Package FDA Task Force Seeks Public Input on Proposed D...

    By PharmaVoice Team • July 28, 2010
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    Who's on the List by Company

    Anavex Life Sciences Cameron Durrant, M.D. 18 ApotheCom David Dunn 16 Astellas Pharma US Margaret Long 73 AstraZeneca David Brennan 46 bioCapture Johanna Allston, Ph.D. 12 C3i Robert Piwko 112 Cegedim Dendrite Angela Miccoli 74 Cipla Ltd. Yusuf Hamied, Ph.D. 19 ClearTrial Mike Soenen 29 closerloo...

    By PharmaVoice Team • July 28, 2010
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    Letter from the Editor

    The PharmaVOICE 100: 2010 Every year, I think this is it, we’ve reached the pinnacle. And yet, every year, I ­continue to be amazed by the ­individuals whom our readers have identified as the most inspiring, ­motivating, and outstanding leaders in the life-sciences industry. This special issue, n...

    By Taren Grom • July 28, 2010
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    ACRP 2010 Global Conference & Exhibition Wrap Up

    The Association of Clinical Research Professionals (ACRP) remains steadfast in its mission to provide value and excellence to conference participants against a backdrop of continued economic and regulatory challenges to individuals and businesses. This year’s conference featured 55 sessions and 2...

    By PharmaVoice Team • May 27, 2010
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    PharmaOutlet

    Reputation malaise has made the U.S.-based pharmaceutical industry vulnerable to “Beltway advocacy." Science has lost its life-enhancing societal mystique and at risk is its intellectual property. Drug-discovery successes and the stellar reputation of the 1980s and 1990s — driving breakthrough tr...

    By Gil Bashe • May 24, 2010
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    Last Word

    The Impact What will be the impact of the federal legislation requiring companies to disclose financial transactions with providers? Fisher. The federal legislation is not going to hugely impact pharmaceutical companies. The PhRMA guidelines cover a lot of this already. The biggest change is how ...

    By PharmaVoice Team • April 29, 2010
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    Letter from the Editor

    Forms, forms, and more forms… We’ve probably all been hospitalized at one time in our lives, and during whatever span of time we had to spend there, we probably experienced one or two moments of concern when we were repeatedly asked the same questions by a variety of well-meaning practitioners. S...

    By Taren Grom • April 28, 2010
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    Software as a Service: Gaining Traction

    Many research firms have predicted that the worldwide economic recession is responsible for the global increase in the software-as-a-service (SaaS) market revenue. According to a recent Gartner report, SaaS is forecast to have a 17.7% compound annual growth rate through 2013 for the aggregate ent...

    By PharmaVoice Team • March 23, 2010
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    Talent Pool

    Pharmaceutical POOL Dr. Jay FEINGOLD DSI Strengthens Expertise in Oncology Daiichi Sankyo Inc. (DSI) has appointed Jay Feingold, M.D., Ph.D., to manage the strategic direction of its medical affairs department as VP of medical affairs. DSI is the U.S. subsidiary of Tokyo-based Daiichi Sankyo Co.,...

    By PharmaVoice Team • March 22, 2010
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    Launch: Safety Counts

    Approval is no longer the final step," says Anne Tomalin, president of i3 CanReg. “Companies need to consider the possibility that their product may have to be removed from the market one to two years down the road because a safety signal develops." In addition to collecting data and managing a d...

    By Robin Robinson • March 4, 2010
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    The New Washington Office

    The legislative push for healthcare reform came with a speed and scope that surprised many in the pharmaceutical industry, drawing new attention to the Washington, D.C., offices of many drug companies. With this new attention comes the potential for new roles and responsibilities for Washington-b...

    By Dennis R. Cryer • Jan. 26, 2010
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    Reducing Regulatory Risk for the Development of Drugs, Biologics, and Devices

    Thorough review of all FDA activity in the area of clinical development provides insights into regulatory risks. This information can be used to: n Evaluate and review clinical investigators and CROs. n Develop effective strategies for managing clinical initiatives. n Establish improved monitorin...

    By Michael Kuehne • Jan. 26, 2010
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    A 360-Degree View of E-Patient Connections

    Healthcare information technology has created the platform for the exchange, collection, and documentation of health data and information, but it is up to the crucial players — patients, physicians, pharma companies, and service providers — to make e-connections work. The patient, the physician, ...

    By PharmaVoice Team • Jan. 26, 2010
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    Talent Pool

    Biotechnology POOL Dr. Paul LAMMERS Mirna Appoints Chief Executive Mirna Therapeutics has named Paul Lammers, M.D., president and CEO. As head of Mirna, Dr. Lammers is responsible for driving the company’s discoveries in the field of microRNA (miRNA) into the clinic. Dr. Lammers was previously pr...

    By PharmaVoice Team • Jan. 26, 2010