Research & Development: Page 52


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    2012 PharmaVOICE 100 - Who's on the List by Company

    360 Vantage Mario Martinez II Agile Therapeutics Marie Foegh, M.D. Alkermes Elliot Ehrich, M.D. Almac Clinical Technologies Graham Nicholls Amgen Martin VanTrieste, R.Ph. Appature Kabir Shahani The Assay Depot Kevin Lustig, Ph.D. Auxilium Pharmaceuticals Adrian Adams Ayogo Games Michael Fergusson...

    By Taren Grom • July 28, 2012
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    Letter from the Editor

    Letter from the Editor Inspiration… Try not to become a man of success but a man of value. — Albert Einstein. Einstein might have been describing this year’s ­Pharma­VOICE 100 honorees. This distinguished group of individuals — men and women — are committed to achieving results that lead to the g...

    By Taren Grom • July 28, 2012
  • 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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    Structuring an eClinical Training Program To Improve Employee Site Performance

    Structuring an eClinical Training Program To Improve Employee Site Performance Clinical trials have the potential to represent the costliest and most time-consuming phase of product development. One study can include hundreds of patients and multiple sites, therefore sponsors, as well as CROs, mu...

    By Ellen Leinfuss • May 29, 2012
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    Solving the Numbers Game - The Three Pillars of Late-Phase Clinical Trials

    Solving the Numbers Game – The Three Pillars of Late-Phase Clinical Trials Each phase of a drug trial presents challenges, but peri-approval and post-approval studies present challenges beyond those experienced by researchers conducting earlier-stage trials. Trial sizes are larger and global in s...

    By Ramita Tandon • May 29, 2012
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    Locating Patients and Investigators for Faster Trials

    Locating Patients and Investigators for Faster Trials Where are the patients? Where are the investigators who have access to them? These are early questions in clinical trials, and it is hard to find the answers. Numerous studies show that half of clinical trials run late. Delay starts with the c...

    By Bill Gwinn • May 29, 2012
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    The Growing Role of Disease Registries in Evidence Generation

    The Growing Role of Disease Registries in Evidence Generation The current policy environment has broadened the scope of evidence that life-sciences companies must provide to healthcare stakeholders. In the United States, the focus is on comparative effectiveness research (CER), and in many other ...

    By William Crown • May 29, 2012
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    Defining the Clinical Cloud

    Defining the Clinical Cloud The term “eClinical" was jargon that the pharmaceutical industry used over the last decade, without ever agreeing on its definition. Similarly, the term “cloud" has become the latest must-have descriptor for all kinds of technologies, across virtually every business se...

    By Glen de Vries • May 29, 2012
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    The Value of Strategic Epidemiology to Inform Product Development and Commercialization

    The Value of Strategic Epidemiology to Inform Product Development and Commercialization Challenges and Changes in the Biopharmaceutical Industry Every year, the industry is confronted with an increasingly constrained environment in which to invest in research and development. Established blockbus...

    By Adrian Levy • May 29, 2012
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    Don't Get Stuck In A Clinical Trial Rut: Study Challenges, Practical Solutions, and Three Reasons Why You Need to Change

    Don’t Get Stuck In A Clinical Trial Rut: Study Challenges, Practical Solutions, and Three Reasons Why You Need to Change The entire biopharmaceutical industry is focused like never before. We are looking critically at mega-spending of global development operations and doing more with less. In an ...

    By Laurie Halloran • May 29, 2012
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    Making the Leap Toward Strategic Outsourcing

    Making the Leap Toward Strategic Outsourcing As a result of the increasing pressure placed upon pharmaceutical companies to move drugs through the pipeline efficiently and cost-effectively, companies are looking at ways to improve productivity. Faced with ever-demanding regulatory hurdles when mo...

    By Tom Avery • May 29, 2012
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    Successful Technology Integration Partnerships: A Coalition of the Willing

    Successful Technology Integration Partnerships: A Coalition of the Willing Most eClinical technology users aren’t looking for bells and whistles. They want solutions that work as promised, are easy to use, and let them focus on running the trial. Choosing specialized eClinical products over a one...

    By Garry D. Johnson • May 29, 2012
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    Patient-Centric Clinical Trials: Fad, Trend, or Future?

    Patient-Centric Clinical Trials: Fad, Trend, or Future? One of the prominent topics of discussion in biopharmaceutical R&D during the past few years has centered on methods for improving patient management in clinical trials. While clinical trials have always focused on patients, only recentl...

    By Todd Kole • May 29, 2012
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    Top 10 Patient Enrollment and Retention Myths

    Top 10 Patient Enrollment and Retention Myths Myths can Lead to Misses Today’s trial climate frustrates many clinical study teams. Operations must deliver quality trial data under intense pressures. Larger, longer, and more esoterically designed trials place a strain on patient enrollment and ret...

    By Scott H. Connor • May 29, 2012
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    Safety Panels: Combining the Conventional and Novel Toxicity Biomarkers

    Safety Panels: Combining the Conventional and Novel Toxicity Biomarkers The notion of biomarker is not new. The FDA defines a biomarker as the measurable endpoint that can be used as an indicator of a physiological or pathological process. In particular, toxicity biomarkers are those capable of d...

    By Maria-Magdalena Patru • May 29, 2012
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    2012 DIA Preview

    2012 DIA Preview New tools, services, and products to improve drug development from DIA exhibitors. This special Drug Information Association section highlights news as well as new and innovative products being offered by companies exhibiting at the upcoming 2012 DIA, the 48th Annual Meeting, in ...

    By Taren Grom • May 29, 2012
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    UpFront

    UpFront Awards… Octagon receives PACT award Octagon Research Solutions has been named Emerging Life Sciences Company of the Year by the Greater Philadelphia Alliance for Capital and Technologies (PACT). The award honors growing companies in the region’s life-sciences industry that demonstrated cl...

    By Taren Grom • May 28, 2012
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    HBA's 2012 Rising Stars

    Meet the 105 Healthcare Businesswomen’s Association’s Rising Stars… By Taren Grom, Editor HBA’s 2012 Rising Stars These high-potential women, who ­represent all facets and ­disciplines of the ­life-sciences industry, are being ­recognized by their companies for: H Significantly contributing to th...

    By PharmaVoice Team • April 27, 2012
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    The Sun Keeps Rising on Japan's Pharma Industry

    Kim Ribbink Japan’s numerous universities and research institutions, cutting-edge research, ­­ state-of-the-art technology, and high-quality manufacturing facilities are the hallmarks of a leading market for the pharmaceutical industry. Japan is one of the world’s lead developers of pharmaceutica...

    By Kim Ribbink • April 27, 2012
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    Addressing Reimbursement During Development

    Denise Myshko Pharma companies are experiencing greater scrutiny from government, private payers, and consumers. Creating a comprehensive reimbursement plan that begins at early phases of product development is essential in successfully obtaining coverage. Increasingly in the United States and in...

    By Denise Myshko • April 27, 2012
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    New Course for Biotherapeutics

    Denise Myshko Companies developing biotherapeutics are beginning to study indications beyond cancer and autoimmune and infectious diseases and are researching how antibodies and proteins can be used to treat other conditions, such as pain and cardiovascular conditions, that have traditionally bee...

    By Denise Myshko • April 27, 2012
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    Last Word

    Word Building Strong Partnerships John Gargiulo, President and CEO of Daiichi Sankyo Inc., talks about how a philanthropic gift 100 years ago led to a global collaboration for drug development. PV: What is Daiichi Sankyo’s connection to ­Washington, D.C.’s cherry trees? Gargiulo: One hundred year...

    By Carolyn Gretton • April 27, 2012
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    Talent Pool

    Talent Pool executive appointments and promotions in the healthcare industry By Carolyn Gretton Pharmaceutical POOL Dr. Charlotte KREMER Astellas Names Global Medical ­Affairs Head Charlotte Kremer, M.D., has joined Astellas Pharma as head of the global medical affairs organization. Dr. Kremer wa...

    By Carolyn Gretton • April 27, 2012
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    Tools of the Trade

    Tools of the Trade New electronic and web-based applications, sites, and technologies By Carolyn Gretton New Tool from HealthSTAR Provides Virtual Bridge ­Between KOLs, HCPs Trend: New advances in digital platforms are allowing for the capture of peer-to-peer programs via a digital platform that ...

    By Carolyn Gretton • April 27, 2012
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    PharmaTrax

    Pharma Trax Sales, marketing, And R&D?Trends affecting the healthcare industry By Carolyn Gretton GSMA Forecasts Robust Mobile Health Market Growth Areport conducted by PwC for the GSMA predicts the growth of the mobile health (mHealth) market will result in $23 billion worth of revenue oppor...

    By Carolyn Gretton • April 27, 2012
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    SHOWCASE FEATURE: IRBs: Remaking the Rules

    By Carolyn Gretton Institutional review boards (IRBs) and research compliance offices remain at the forefront of providing responsible protection of human subjects within the research environment, but the differences in how each group interprets and implements these responsibilities can directly ...

    By Carolyn Gretton • March 26, 2012