EDITOR'S DESK

  • “Everyone’s Risk, Everyone’s Benefit”: The Keys To Effective Strategic Partnerships
    “Everyone’s Risk, Everyone’s Benefit”: The Keys To Effective Strategic Partnerships

    Whether it be a collaboration between Big Pharma companies, a sponsor and CRO, or a pharma company and a research foundation, partnerships are dependent on the proper alignment of goals, trust, and risk management. As the industry is faced with increasing demand for timely drug research and development, partnerships need to be a balance of equals, and both parties need to be ready to tackle whatever challenges might arise.

    Clinical Leader spoke with Mark Scullion, Senior VP, Strategic Resources, from inVentiv Health Clinical to learn more about the changes in the industry that are influencing partnership strategies, collaborative drug development, and innovation. 

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OUTSOURCED PHARMA WEST CONFERENCE & EXHIBITION

  • A Witness To The History of Outsourcing
    A Witness To The History of Outsourcing

    Joe Guiles seems too young and mild-mannered to have been at the outbreak of a revolution that began many years ago. But he witnessed firsthand the inception of what would become the complete penetrability of outsourcing throughout the drug industry. 

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CLINICAL PERSPECTIVES

  • BRIC Nations: Divergent Patterns in the Clinical Trials Landscape
    BRIC Nations: Divergent Patterns in the Clinical Trials Landscape

    The clinical trial landscape in BRIC countries is changing. Long heralded as a low-cost alternative to Western markets, Brazil, Russia, India and China are experiencing a shift in trial initiation by global sponsors.

  • FDA Safety Labeling Requirements
    FDA Safety Labeling Requirements

    Prior to 2007, the U.S. Food and Drug Administration’s labeling authority was limited; the agency could only request changes to the labeling of approved drug products. That changed, however, with the enactment of the Food and Drug Administration Amendments Act of 2007, in particular, section 505(o)(4). In that section, the FDA was given new authority to require safety labeling changes for approved drugs.

    This means the FDA can now order labeling changes if it becomes aware of new safety information that it believes should be included in the labeling of a drug. This article summarizes the FDA’s thinking in this regard, as indicated by its guidance released in recent weeks.

  • ‘Middle-Out’–Joined-Up Thinking For Pharmacokinetic–Pharmacodynamic Model-Based Learning And Confirming In Drug Development
    ‘Middle-Out’–Joined-Up Thinking For Pharmacokinetic–Pharmacodynamic Model-Based Learning And Confirming In Drug Development

    Emeritus Professor of Clinical Pharmacology, University of Sheffield, UK; Vice President of Translational Sciences (Certara); Head of Consultancy (Simcyp (Certara)); and Chair of the Board of Pharmaceutical Sciences, International Pharmaceutical Federation. By Geoff Tucker

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FROM THE INDUSTRY EXPERTS

  • Clinical Endpoints:  What Do Payers And Regulators Want?
    Clinical Endpoints: What Do Payers And Regulators Want?

    In 1962, the Federal Food, Drug, and Cosmetic Act added an amendment that requires new drugs to show substantial evidence of effectiveness and specifies that this evidence must be derived from adequate and well-controlled clinical investigations.  Clinical benefits that have supported drug approval in the past include important clinical outcomes – for example, increased survival or symptomatic improvement, as well as effects on established surrogate endpoints – e.g., blood pressure, tumor markers, and serum cholesterol. 

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WHITE PAPERS AND CASE STUDIES

  • Electronic Drug Accountability Systems: Ensuring Compliance, Safety, And Data Integrity In Clinical Trials

    By Stefan Duerr, Associate Director Of Project Management, Cenduit

    Clinical trial sites, both foreign and domestic, have been subjected to an increasing number of FDA audits in recent years. Federal investigators cite non-compliance with federal drug accountability regulations as one of the most common problems found in site audits.1,2 A failed site audit is a serious problem for a clinical trial, leading to costly delays, non-approval of the investigational drug, or criminal liability.2,3 Ensuring compliance with federal regulations is key to the success of a clinical trial and the entire drug development program.

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INDUSTRY NEWS

  • Merck Posts Positive Phase 3 Data For Osteoporosis Drug

    Merck reported new positive data from the Phase III trial LOFT investigating odanacatib in postmenopausal women with osteoporosis. The company presented its findings at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in Houston.

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ABOUT CLINICAL LEADER

Welcome to Clinical Leader, the premier online community that helps streamline clinical research by connecting trial sponsors and cutting edge service providers. Clinical Leader is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market in an efficient manner. Connect, Collaborate, Contribute.

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  • Adaptive Trials In Oncology Research Webinar

    Adaptive trial design is critical in all phases of oncology drug development and helps overcome many hurdles of traditional study design. In a recent webinar, PPD’s Dirk Reitsma, M.D., vice president, global product development, and Niklas Morton, vice president, global biostatistics, programming and medical writing, analyzed the incorporation of adaptive trial design in oncology trials. They were joined by Scott Berry, Ph.D., president and senior statistical scientist with Berry Consultants, to assess the early decision making benefits that are critical to the decreasing drug development time and providing increased benefit to patients.

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Find a CRO with BIOCOM’s drug development guide which provides a description of each phase along with a list of companies that can accommodate your needs in the drug development cycle.

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Vendor Qualification and Compliance: What Sponsors & CMOs Must Know

September 17, 2014
1pm-2:30pm EST, Online Training

CRA Oversight - A Risk-based Approach

September 23, 2014
1pm-2:30pm EDT, Online Training

It's Ten O'Clock. Do You Know Where Your Trial Master File Is?

September 24, 2014
1pm-2:30pm EDT, Online Training
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CLINICAL BULLETIN BOARD

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Vendor Qualification and Compliance: What Sponsors & CMOs Must Know

September 17, 2014
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DIA Biosimilars 2014, September 18-19, Washington, DC

September 18 - 19, 2014
Washington, DC

Medical Device Regulatory Affairs 101: Regulatory Affairs For Non-Regulatory Personnel

September 18, 2014
1pm-2:30pm EDT, Online Training
Price:  $299 - Introductory Rate

EDM and ERS 2014

September 22 - 24, 2014
Washington, DC
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