September 2010

Comparative Effectiveness: Real-World Evidence of Outcomes

August 27, 2010

Comparative effectiveness research is going to have a huge impact on every stakeholder in healthcare delivery. It requires a much broader view of the healthcare system so that information will exist about a patient’s outcome as he or she moves from diagnosis to treatment in the healthcare system. Comparative effectiveness data are geared broadly to […]

Comparative Effectiveness Research — Watch and Worry or Weigh In and Leverage?

August 27, 2010

A little-publicized provision of the American Recovery and Reinvestment Act of 2009 is likely to have at least as big, if not a bigger, long-term impact on the pharmaceutical and medical device business as the recently passed Affordable Care Act. This provision allocated $1.1 billion for comparative effectiveness research (CER) — a mode of research […]

View on Med Ed: Refining the Formula

August 26, 2010

Amid public protests from high-profile figures such as former AHA President Clyde Yancy, M.D., and National Institutes of Health Director Francis Collins, M.D., Ph.D., in June the Accreditation Council for Continuing Medical Education (ACCME) provided additional guidance to its 2004 Standards for Commercial Support related to the role of ACCME-defined commercial interest employees in ACCME-accredited […]

SHOWCASE FEATURE: No Longer Lost in Translation

August 26, 2010

As drug development continues to become more of a global endeavor, it’s more important than ever to ensure that documents, especially informed consent and other patient materials, are correctly translated into local languages to ensure the success of the trial. The increasing number of trials, as well as the need for treatment-naïve patients, is forcing […]

DIA Recap

August 26, 2010

DIA editor’s Choice Videos BBK Joan F. Bachenheimer and Matthew Stum Bioclinica Peter Benton Cognizant Nagaraja Srivatsan Cytel Irving Dark i3 Research Dr. Tracy Tsuetaki INC Research Alistair Macdonald Integrated Clinical Solutions Inc. J. Peter Armerding Kendle Ken Hintze, Ph.D. Kendle Drew Kilpatrick, Ph.D. Kforce Mark Lanfear MediciGlobal Elizabeth Moench Medidata Solutions ­Worldwide Glen de […]

Dr. Leon Smith — Age of Excellence

August 26, 2010

Imagine an active and comfortable ­retirement, pursuing your hobbies at will and taking time to enjoy the golden years. Sound like fun? Not to Leon Smith, M.D., it ­doesn’t. After almost 55 years as a practicing physician, Dr. Smith is every bit as enthralled and impassioned about being a doctor as he was as a […]

Nichebusters vs.Blockbusters

August 26, 2010

Transformation in the industry is everywhere, driven by healthcare reform, increased regulatory scrutiny, patent expiry cliffs, and thinning pipelines. The old ways of doing anything — drug development, drug research, sales, marketing, launch activities, market research — are no longer effective and need serious revamping. Enter the nichebuster model — a business paradigm that involves […]

Midlevel Healthcare Providers: An Untapped Prescribing Force

August 26, 2010

Billions of prescriptions — and millions of dollars — are being influenced by a group of individuals who go largely untapped when it comes to communications, outreach, and education. Nurse practitioners (NPs) and physician assistants (PAs) wrote 7.8% of U.S. prescriptions — 308 million from June 2009 through June 2010 — up 20.24% from the […]

Last Word

August 26, 2010

USING MONOCLONAL ANTIBODIES What are the opportunities for using monoclonal antibodies to treat Alzheimer’s disease? CHAIN: It took a long time to understand the hallmarks of Alzheimer’s disease. The beta amyloid plaques that appear in the brains of patients with Alzheimer’s are just a sign of what has happened. The soluble, floating toxins, amyloid precursors, […]

Talent Pool

August 26, 2010

Pharmaceutical POOL Lonnel COATS Eisai Names CEO for U.S. Subsidiary Eisai Inc., a U.S. subsidiary of Japan’s Eisai Co., has promoted Lonnel Coats to president and CEO, from president and chief operating officer. In addition, Mr. Coats has been appointed senior VP of Eisai Co.’s pharmaceuticals business in the United States, responsible for leading Eisai’s […]

E-Media

August 26, 2010

New Electronic and Web-based Applications, Sites, and Technologies Featured Briefs: Tibco Unveils Solution for Accelerating Drug Development C3i Offers Subscription-Based Data Management Hosting Medidata Adds Supply Management, Source Document Verification Solutions Chiltern Solution Consolidates Study Data Perceptive’s Web-Based Tool Provides Easy ­­Study-Design Access PharmaPros Service Aimed at Smaller ­Companies’ Data ­Management Needs ICON Application Enables […]

PharmaTrax

August 26, 2010

Sales, Marketing, and R&D Trends from Industry Analysts Featured Briefs: Pharma Could Benefit from Earlier Planning of Counter-Generics Strategies Sidebars: Counter-Generics Strategies Used by All Companies in Past 3 Years (2008-2010) Changes in Medical Treatment in Past Year Due to Economic Conditions More Women Seek Health Information Biotech Executives Show Strong Interest in HCRA Tax […]

What’s New

August 26, 2010

Barnett Educational Services has announced the release of updated editions of three of its market intelligence and clinical practices guides. PAREXEL’S BIOPHARMACEUTICAL R&D STATISTICAL SOURCEBOOK 2010/2011 includes statistics, trends, and proprietary market intelligence and analysis on the biopharmaceutical industry. New additions to the 2010/2011 edition include analyses on the likely impact of theranostics and personalized […]

UpFront

August 26, 2010

Chandler Chicco Co-Founder Receives SABRE Award Bob Chandler, principal and co-founder of the Chandler Chicco ­Companies, part of ­inVentiv Health, received a SABRE Award for ­Individual Achievement. Mr. Chandler received the award, which honors the exceptional work of public relations professionals, in recognition of his vision and his leadership. He is one of three award […]

Letter from the Editor

August 26, 2010

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 Copyright 2010 by PharmaLinx LLC, Titusville, NJ Printed in the U.S.A. Volume Ten, Number Eight PharmaVoice […]

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