EDITOR'S DESK

  • Patheon Surfs Outsourcing Waves And Scoops Up Gallus Along The Way
    Patheon Surfs Outsourcing Waves And Scoops Up Gallus Along The Way

    Jim Mullen, CEO of Patheon parent company DPx Holdings B.V., is at it again.

    On the heels of my three-part series with Mullen on the details behind the springtime merger of his company and the pharmaceutical products division of Royal DSM, he has made his next move.

    This time it is a strategic entrée into the U.S.-based market for biologics services via an acquisition of privately held Gallus BioPharmaceuticals. With Gallus, Patheon adds new capabilities at well-established sites with name-brand clientele, in St. Louis, Mo. and Princeton, N.J., to its global locations in Groningen, the Netherlands and Brisbane, Australia.

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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

  • 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. 

More From The Industry Experts

INDUSTRY NEWS

  • Pfizer And Merck Link In Anti-Cancer Combo Trial

    Pfizer and Merck announced that they have signed into an agreement to jointly investigate the effects of combining Pfizer’s Xalkori (crizotinib) and Merck’s candidate anti-PD-1 antibody pembrolizumab in a Phase IB ALK-positive advanced or metastatic non-small cell lung cancer (NSCLC) clinical trial.

     

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FEATURED SERVICES AND PRODUCTS

  • Global Cold Chain Logistics
    Global Cold Chain Logistics As cold chain shipments excursions face increased scrutiny from regulators around the world, it is more important than ever before to get it right the first time.
  • CoSign Connector For SharePoint
    CoSign Connector For SharePoint

    Organizations around the world and across industries have invested in Microsoft® SharePoint® for automating their business processes.

  • PureTemp - Phase Change Materials (PCMs)

    The industry’s only USDA Bio Preferred phase change material. ThermoPhase powered by PureTemp bio-based PCMs are non-hazardous, 100 percent renewable and environmentally-friendly. Even after thousands of thermal cycles, tests show PureTemp experiences no thermal degradation.

  • 21 CFR Part 11 Compliance
    21 CFR Part 11 Compliance

    Many sponsors are concerned with the risks and costs involved in ensuring that their electronic systems comply with the FDA’s ruling on acceptance of Electronic Records and Electronic Signatures in place of their paper equivalents (21 CFR Part 11).

  • Endpoint Adjudication Module For eClinical OS
    Endpoint Adjudication Module For eClinical OS

    Increased pressure from regulatory authorities to conduct endpoint adjudication, as well as business pressures to reduce the overall cost of trials, leaves many companies searching for ways to streamline the adjudication processes and shorten clinical trial timelines.

  • Circulating Tumor Cells
    Circulating Tumor Cells

    Circulating tumor cells (CTC) are cancer cells that have become separated from a solid tumor site and are circulating in the bloodstream. The level of circulating tumor cells can be measured from a blood specimen in patients with metastatic breast, colon, or prostate cancer. Measuring CTC can provide information for assessing disease status as well as a patient’s prognosis, thereby providing recommendations for each patient’s individual care.1-3 The CTC assay is FDA-cleared for metastatic breast, prostate, and colon cancers. CTC measurements may have utility for clinical trials in a number of areas including service as a surrogate marker for clinical outcome and for additional assays on the CTC specimen (e.g., RT-PCR).

  • eClinical Services
    eClinical Services

    BioClinica helps you get the most from your clinical data by combining best-in-class eClinical technology with expert data management and experience in almost 2000 electronic trials to date.

  • High Potency Products
    High Potency Products

    Patheon is the leading publicly listed provider of drug development and manufacturing services to global pharmaceutical, biotechnology and specialty pharmaceutical companies.

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CRO LEADERSHIP AWARD

                                       
Life Science Leader developed the CRO Leadership Awards based on industry leading research conducted by Nice Insight. This award helps pharma and biopharm companies focus on potential partners who can handle their projects and are considered reputable in the industry. Click on the logo above to visit this year’s winners.

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.

Visitors are enriched with valuable information on CRO, Pre-Clinical Contract Research Organization, Bio-Analytical Contract Research Organization, Clinical Contract Research Organization, Pharmacovigilance, Clinical Data Management, Electronic Patient Reported Outcomes (ePRO), Point-of-Care Testing (POCT), Patient Recruitment, Electronic Data Capture (EDC), Clinical Trials Management Systems (CTMS) and more that can improve your business and make it more profitable.

Please take a moment to join our community and discover the benefits of your free membership.

PREMIER SERVICE PROVIDER

CLINICAL LEADER WEBINARS

  • Digital Signatures: Enabling Compliant Collaboration and Streamlined Corporate Governance

    In this webinar, we’ll focus on the middle office where life sciences organizations can achieve tangible operational improvements and cost savings.

  • 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.

  • Will BRIC be the Savior for the Life Sciences and Medical Devices Sector?

    Will BRIC be the Savior for the Life Sciences and Medical Devices Sector?  Discover key lessons from the field and best practices vital to reap rewards from these countries during Frost & Sullivan’s complimentary webinar. The briefing will benefit any senior manager in the corporate strategy or global marketing areas that focuses on emerging markets, as well as any healthcare company looking to explore BRIC countries.

  • New Indications For Existing Medical Entities

    This webinar will take a critical view at the diverse technologies that have been proposed for repositioning. 

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FIND A CRO IN SOUTHERN CALIFORNIA

find a cro in drug development

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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 UPCOMING TRAINING COURSES

Identifying and Closing the Training Gap in Clinical Research

September 4, 2014
1pm-2:30pm EDT, Online Training

Pediatric Clinical Trials: Special Considerations and Requirements

September 8, 2014
1pm-2:30pm EDT, Online Training

CRO Oversight: Risk Assessment & Action Planning

September 16, 2014
1pm-2:30pm EDT, Online Training

Vendor Qualification and Compliance: What Sponsors & CMOs Must Know

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

According to the WHO, over 150m people worldwide, are chronically infected with HCV, with 3 to 4m new infections occurring each year. Together they represent a multibillion dollar market for any successful new drug candidate, with Hepatitis C having the most promising products in development.

 CLINICAL EVENTS

Identifying and Closing the Training Gap in Clinical Research

September 4, 2014
1pm-2:30pm EDT, Online Training
Price:  $299 - Introductory Rate

Pediatric Clinical Trials: Special Considerations and Requirements

September 8, 2014
1pm-2:30pm EDT, Online Training
Price:  $299 - Introductory Rate

Partnerships in Clinical Trials Asia

September 16 - 18, 2014
Shanghai

CRO Oversight: Risk Assessment & Action Planning

September 16, 2014
1pm-2:30pm EDT, Online Training
Price:  $299 - Introductory Rate

Vendor Qualification and Compliance: What Sponsors & CMOs Must Know

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