Research & Development: Page 56


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    Talent Pool

    Executive appointments and promotions in the healthcare industry By Carolyn Gretton Pharmaceutical POOL Damian BRAGA Sanofi Pasteur Consolidates ­Commercial Operations Leadership Sanofi Pasteur, the vaccines division of global healthcare company Sanofi, has tapped U.S. President Damian Braga as s...

    By Carolyn Gretton • July 26, 2011
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    2011 PharmaVOICE 100 - Who's on the List by Company

    Acorda Therapeutics Andrew Blight, Ph.D. ACT Biotech Inc. Ali Fattaey, Ph.D. Acucela Inc. Ryo Kubota, M.D., Ph.D. Alliance Healthcare Information LLC Mary Anne Greenberg Almac Group Sir Allen McClay The Avoca Group Inc. Patricia Leuchten AXON US Mario Nacinovich Beardsworth Group Donna Beardswort...

    By PharmaVoice Team • July 26, 2011
  • clinical trial diversity Explore the Trendline
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    Trendline

    Clinical trial diversity

    As pharma wises up to the fact that the current playbook for improving clinical trial diversity has yet to make a meaningful impact, the quest is on to refine that approach.

    By PharmaVoice staff
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    Letter from the Editor

    Taking Inspiration to the Next Level This is our favorite issue of the year, and we hope it’s yours too. It has been a joy and a privilege to have had a chance to get to know this year’s PharmaVOICE 100. They certainly illustrate what it means to think bigger, do more, and lead with passion and i...

    By Taren Grom • July 26, 2011
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    Managing Outsourced Development: Designing a Performing Process

    Ronald S. Waife, MPH, President With the rise of mega-CROs, and the widespread willingness of large pharma to outsource clinical development to them, is there anything left for a sponsor’s clinical development group to do? Indeed yes. More than ever, there are hyper-critical functions that sponso...

    By Ronald S. Waife • May 25, 2011
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    Industry Experts Challenge the Status Quo on Content Management

    For more than two decades, life sciences organizations have purchased, customized, configured, deployed, and maintained a series of ever-expanding and complex content management tools to help them efficiently manage content. The creation of industry-specific applications added to these technologi...

    By Ian Talmage • May 25, 2011
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    Clinical Data Gap Analysis ­Uncovering Hidden Opportunities

    David Fishman, MBA President Snowfish LLC The practice of medicine relies on clinical evidence. From a product’s conception through approval, launch, and post-launch activities, clinical evidence is the rationale for a product’s overall existence. Clinical data is critical for differentiation and...

    By David Fishman • May 25, 2011
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    Metrics for Faster Clinical Trials

    Almost half of clinical trials run late, year after year. Why does this happen? The biggest delaying factor is finding enough patients, and the delay starts with the clinical trial protocol. The protocol includes the inclusion and exclusion criteria that define the patients who are eligible for t...

    By Bill Gwinn • May 25, 2011
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    Bringing Process Efficiency to ­Clinical Trial Randomization

    Modern business has fully embraced the benefits of process efficiency. From the widespread adoption of process improvement as driven by Michael Hammer, author of “Reengineering the Corporation," its evolution to the Six Sigma movement, to the more recent “lean sigma" approach, process efficiency ...

    By PharmaVoice Team • May 25, 2011
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    Partnering with CROs: Achieving Operational Excellence

    Our industry is facing a challenge. In 2010, the FDA approved only 21 new drugs, down from 26 in 2009 and 24 in 2008. To counteract this decrease, biopharmaceutical companies are increasingly anxious to launch their products as quickly as possible to benefit from related revenue sooner. One way t...

    By PharmaVoice Team • May 25, 2011
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    Effective Use of Health Technology ­Assessment to Maximize Market Access: Start Early and Update Often

    We all know that the face of drug discovery and the market for new pharmaceutical products (and medical devices/diagnostic technologies) is changing. The era of the blockbuster appears to be over, the cost of bringing a new product to market has skyrocketed and when a new product is eventually li...

    By Andrew Briggs • May 25, 2011
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    Understanding the Finer Points of the Electronic Source Documentation Draft Guidance

    For those involved with collecting data generated by clinical trials, the recent draft guidance on electronic source documentation released by the FDA deserves your scrutiny. The impact of this guidance for sites is significant and the implications for CRAs, data managers, and technology vendors ...

    By Jonathan Andrus VP • May 25, 2011
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    Merhaba, Turkey: Opportunity Knocks

    As the largest pharmaceutical market in the Middle East and the fastest growing in the Mediterranean region, Turkey presents some exciting opportunities for the pharmaceutical market. Consumption of pharmaceuticals in Turkey totals around $8 billion, with 50% of these drugs being manufactured dom...

    By Kim Ribbink • May 24, 2011
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    Changing Oncology Regulations

    Developing oncology therapies can be complex. These products often have a tough time making it to the market. In fact, a study released in February by the Biotechnology Industry Organization and BioMedTracker shows that oncology products had the lowest Phase III success rate among seven therapeut...

    By Denise Myshko • May 24, 2011
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    Educating the Scientists of the Future

    High-quality science education is critical for the success of pharmaceutical and biotechnology companies, not only to meet the need for scientists in the future but also to foster scientific ­literacy. Education reform is a hot-button issue for the nation in general and the pharmaceutical industr...

    By Denise Myshko • May 24, 2011
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    DIA Preview

    New Tools, Services, and Products Designed to Improve Drug Development This special Drug Information Association section highlights the new and innovative products being offered by ­companies exhibiting at the upcoming 2011 DIA — 47th Annual Meeting in Chicago. (Note: briefs are listed alphabetic...

    By PharmaVoice Team • May 24, 2011
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    R&D's Technology Evolution

    Technology tools are the cornerstones for achieving a drug development process that is faster, cheaper, and easier. Over the last 10 years, there has been increasing use of EDC, ePRO, CTMS, dashboards, and other tools to streamline the drug development process. Now a changing R&D paradigm is ...

    By Denise Myshko • May 24, 2011
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    Pharma 3.0: A Call for Collaboration and Experimentation

    Success or failure in Pharma 3.0 — an ecosystem comprised of established industry members, nontraditional companies, and an increasingly informed data-empowered consumer — will be based on life-sciences companies’ ability to develop innovative, outcomes-focused offerings through structured, syste...

    By Robin Robinson • May 24, 2011
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    Last Word

    Combating Drug Resistance Roger Pomerantz, M.D., Senior VP and Head of Infectious Disease Research at Merck, talks about why antimicrobial resistance is a major global concern. PV: How big of a problem is antimicrobial ­resistance? Pomerantz: For the first time since the antibiotic era started in...

    By PharmaVoice Team • May 24, 2011
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    Talent Pool

    Pharmaceutical POOL Dr. Janet HAMMOND Roche Strengthens Translational Medicine Leadership Roche has appointed Janet Hammond, M.D., Ph.D., VP, translational medicine – virology in pharmaceutical research and early development (pRED). Dr. Hammond joins Roche from Valeant Pharmaceuticals Internation...

    By PharmaVoice Team • May 24, 2011
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    PharmaTrax

    Sales, Marketing, and R&D Trends from Industry Analysts Featured Briefs: Specialists More Likely to Open and Click Through Email Sidebar: Email Campaigns to Physicians by Type, July-December 2010 Branded Pharma Sites Help Drive Prospect, Patient Conversions Personalized Medicine Strategy Coul...

    By PharmaVoice Team • May 24, 2011
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    UpFront

    Awards… GSK Medical Officer Honored Merck Scientists ­Recognized by PhRMA Kendle Recieves ­Achievement Award INDUSTRY at Large Going BIOSimiliar Parents Need Education about Nutrition Quote of the Month… Terry Hisey / Deloitte Podcasts Clinical Supply Optimization: Challenges & Solutions Thou...

    By PharmaVoice Team • May 24, 2011
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    Letter from the Editor

    Ready or Not Here Comes Pharma 3.0 Pharma 2.o was so last decade. Thanks to the good folks at Ernst & Young, who have coined the term Pharma 3.0 to describe a new ecosystem of healthcare, we are indeed entering new territory. As noted back in February, nontraditional pharma companies, such as...

    By Taren Grom • May 24, 2011
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    Navigating the New ­Communications Landscape

    The ways patients seek and share information—both in and out of the doctor’s office—are undergoing radical change. From the rise of the Internet to the explosion of social media to the growing patient demand for active participation in treatment decisions, a multitude of forces are converging to ...

    By Chris DeAngelis • April 25, 2011
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    Creating a Personalized Medicine Strategy

    Considered broadly, healthcare is personal. The goal of medical practitioners has always been to get the right drug to the right person at the right time at the right dose. But now industry experts say personalized medicine is at a tipping point as a multitude of factors converge, including advan...

    By Denise Myshko • April 25, 2011
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    Last Word

    John Gargiulo, Daiichi Sankyo’s new President and CEO, discusses the future opportunities for the company and the industry. Keeping the Patient Front and Center Last Word PV: What are your goals for Daiichi Sanyko? Gargiulo: The healthcare industry is currently experiencing unprecedented challeng...

    By PharmaVoice Team • April 25, 2011