Policy & Regulation: Page 20


  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    E-Media

    E-MEDIA NEW ELECTRONIC AND WEBBASED APPLICATIONS, SITES, AND TECHNOLOGIES FDAnews has launched Drug Industry Daily, an electronic daily publication that provides news coverage of what’s happening on Capitol Hill, in the courts, and at the Food and Drug Administration, the Federal Trade Commission...

    By PharmaVoice Team • Jan. 14, 2010
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    What's New

    NEW HEALTHCARERELATED PRODUCTS, SERVICES, AND COMPANIES Doctors+Designers has changed its company name to HealthEd to reflect a change in business strategy focusing on developing patient-centered health education programs. “With noncompliance costing the pharmaceuti cal industry $15 billion to $2...

    By PharmaVoice Team • Jan. 14, 2010
  • drug shopping cart Explore the Trendline
    Image attribution tooltip
    Stock via Getty Images
    Image attribution tooltip
    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
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    The IRS vs. Independent Contractors

    Many pharmaceutical companies are now using independent contractors in increasing numbers; in many cases, these contractors are former employees. What started off as a trickle a few years ago has become a torrent. Quite often, former employees — whether they left voluntarily or not — end up back ...

    By Andrew E. Schultz • Jan. 11, 2010
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Contents

    In Every Issue 3 Letter from the Editor 8 Upfront A brief review of industry news at press time 36 Pharma Trax Sales, marketing, and R&D trends from industry analysts 40 What’s New New healthcare-related products, services, and companies 42 E-Media New electronic and Web-based applications, s...

    By PharmaVoice Team • Dec. 28, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Name That Brand: A Pilot Program

    The eventual outcome of the FDA’s two-year Proprietary Name Review pilot project may have positive implications for the industry in the long run, but in the short term, it means more money spent and more time pressure for marketers. Our experts say the burden on pharma companies to conduct their ...

    By Robin Robinson • Dec. 28, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    The Salesforce of the Future

    Our experts agree: the salesforce of the future will be more specialized, more technically advanced, and more clinically savvy; oh, and there will be fewer feet on the street, finally. If the past year is any indication, the salesforce of the future is going to experience an extreme makeover. For...

    By PharmaVoice Team • Nov. 10, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    The Innovation Challenge

    There has been a great deal of discussion related to the challenges­ ­hampering innovation to create differentiated medicines. Never before have research and cutting-edge science been more important to ensure a steady flow of innovation. Much has been made of the industry’s decline in R&D pro...

    By PharmaVoice Team • Nov. 10, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Supply Chain Strategies

    Companies need to evaluate their business through their value streams rather than by individual processes or components. ccording to Bob Silvers, managing director, at SSA & Co., by applying the rigors of Lean Six Sigma to underperforming areas, pharmaceutical companies can completely transfo...

    By Denise Myshko • Nov. 10, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Talent Pool

    Pharmaceutical POOL Stanley BARSHAY Dr. Richard BOWLES Richard CLARK Willie DEESE Kenneth FRAZIER Dr. Peter KIM Raul KOHAN Merck Unveils Post-Merger Organizational Structure Merck has announced its new organizational structure following the completion of its merger with Schering-Plough. The new M...

    By PharmaVoice Team • Nov. 10, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    On the Calendar

    November 16-17 Pharmaceutical Coverage & Reimbursement Conference Washington, D.C. Q1 Productions, q1productions.com November 16-17 The 3rd Pediatric Clinical Trials Grand Hyatt Washington, Washington, D.C. ExL Pharma, exlpharma.com November 17-18, 2009 13th Advanced Forum on Structuring, Neg...

    By PharmaVoice Team • Nov. 9, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    CRM: Connecting the Dots...

    CUSTOMER RELATIONSHIP MANAGEMENT BY TAREN GROM CRM requires a multilevel, enterprisewide view of customers — thereby demanding a strong customer data management business practice . A 5% increase in customer retention can lead to a 25% to 85% profit increase,depending on the industry. — HarvardBus...

    By PharmaVoice Team • Nov. 4, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Talent Pool

    Pharmaceutical POOL Dr. Per FALK Novo Nordisk Names Clinical Research Head for North America Novo Nordisk, a global healthcare company focusing on diabetes care, has appointed Per Falk, M.D., Ph.D., as VP for clinical, medical, and regulatory affairs for North America. Dr. Falk leads clinical res...

    By PharmaVoice Team • Sept. 28, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    E-Media

    New Electronic and Web-based Applications, Sites, and Technologies Featured Briefs: Inclinical, Terrosa Offer Collaborative CTMS Subscription Services Pharsight Offers PK Data Management Solution Compass Healthcare Leverages Social Media in Community Website IMS Health Speeds Access to Promotiona...

    By PharmaVoice Team • Sept. 28, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    What's New

    New Healthcare-related Products, Services, and Companies Featured Briefs: FDA Anticounterfeiting Draft Guidance Focuses on Chemical Identifiers inVentiv Renames Professional Development Business PCE Partners with ACU on Continuing Education for NPs, PAs Gullapalli Launches Patient-Centered CME Of...

    By PharmaVoice Team • Sept. 28, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    UpFront

    Milestones 15th Anniversary CenterWatch, a provider of industry news, data analysis, and proprietary market research for clinical trials professionals and patients, recently celebrated its 15th anniversary. CenterWatch, which was founded in 1994, was acquired by Jobson Medical Information in 2008...

    By PharmaVoice Team • Sept. 28, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Letter from the Editor

    Publisher Lisa Banket Editor Taren Grom Creative Director Marah Walsh Managing EDitor Denise Myshko Senior EDitor Robin Robinson features EDitor Kim Ribbink Contributing Editor Carolyn Gretton design associate Ariel Medel national account manager Cathy Tracy CIRCULATION Assistant Kathy Deiuliis C...

    By Taren Grom • Sept. 28, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Letter from the Editor

    A Cautionary Tale Commissioner of Food and Drugs Margaret A. Hamburg, M.D., who was confirmed May 18, 2009, by a unanimous Senate voice vote, recently outlined her commitment “to prevent harm to the American people" through swift, aggressive, and effective enforcement of FDA laws and regulations....

    By Taren Grom • Aug. 20, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Who's on the List by Section

    The Commanders & Chiefs 12 Ahsan Awan Ross Bjella Laurie Cooke, R.Ph. John Farinacci Tuan Ha-Ngoc Fred Hassan Thomas Hughes, Ph.D. Greg Johnson Rick Keefer Kyle Kennedy William Maichle John Maraganore, Ph.D. Francois Nader, M.D. Nader Naeymi-Rad Angus Russell Laurent Schockmel, DVM Jeffrey St...

    By PharmaVoice Team • July 30, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    The Reading List

    NON-FICTION Memo to the President: How We Can Restore America’s Reputation and Leadership • Madeleine Albright Making it all Work: Winning at the Game of Work and the Business of Life • David Allen Who Goes First?: The Story of Self-Experimentation in Medicine • Lawrence K. Altman It’s Not About ...

    By PharmaVoice Team • July 30, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Manufacturer Windfall Rebates: Change on the Horizon

    The transfer of drug coverage for the dual eligible beneficiaries from Medicaid to Medicare Part D has come under scrutiny by Congress for alleged profit windfalls for manufacturers. The implications of the windfall issue for the pharmaceutical industry are vast. Manufacturers with a large Medica...

    By Matthew Warburton and Carleen Kelly • May 25, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Predicting the Future The Business Case for Forecasting

    By Kim Ribbink Risk is an inherent part of the pharmaceutical business — risk of failure in clinical trials, risk that a product won’t achieve regulatory approval, risk that a product underperforms in the market, and risk of withdrawal after adverse reactions and the costly lawsuits that can foll...

    By PharmaVoice Team • March 25, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    What's New

    New healthcare-related products, services, and companies TGaS Advisors Offers Regulatory Service TGaS Advisors has launched the next generation of its Commercial Compliance Benchmark (CCB) to help companies navigate in a demanding and evolving regulatory environment. The new benchmark expands and...

    By PharmaVoice Team • March 25, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Defining GLOBAL

    BY DENISE MYSHKO AND ROBIN ROBINSON KARLA ANDERSON Managing Director, Life Sciences BearingPoint Global is a perspective of looking at the business in its totality, not just at a given market or a given country or a given set of rules and regulations, but at the business as a whole. It’s always c...

    By Denise Myshko and Robin Robinson • March 1, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    Global Thought leaders

    Karla Anderson, Managing Director, Life Sciences, BearingPoint Inc. — A provider of management and technology consulting services. For more information, visit bearingpoint.com. Leone Atkinson, M.D., Senior Director of Clinical Development, PTC Therapeutics Inc. — A biopharmaceutical company focus...

    By PharmaVoice Team • Feb. 27, 2009
  • Image attribution tooltip
    PharmaVoice Team/PharmaVoice
    Image attribution tooltip

    GLOBAL Safety Issues

    BY DENISE MYSHKO The European Commission has proposed a series of efforts, commonly referred to as the Pharmaceutical Package, which contains three important initiatives: a proposal for a directive on how to modernize pharmacovigilance; a proposal to address counterfeit medicines; and a directive...

    By Denise Myshko • Feb. 27, 2009