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.

More From The Editor

OUTSOURCED PHARMA WEST CONFERENCE & EXHIBITION

More From Outsourced Pharma West

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

More Clinical Perspectives

FROM THE INDUSTRY EXPERTS

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.

     

More News

FEATURED SERVICES AND PRODUCTS

  • Engaging Investigators
    Engaging Investigators

    DrugDev’s unique combination of technology and relationships ensures you can rapidly mobilize and maintain engagement with the right sites for your study, avoiding lengthy delays and budget blowouts from startup through closeout.

  • Medical Affairs & Pharmacovigilance
    Medical Affairs & Pharmacovigilance

    Chiltern’s highly experienced global Medical Affairs and Pharmacovigilance teams offer medical monitoring and pharmacovigilance services to assist with monitoring patient safety across all stages of drug development. Our teams are strategically located in Europe, India and USA enabling them to provide 24/7 medical support and pharmacovigilance services. To date, our team has been involved in monitoring more than 50 medicinal products in 40 countries across 1,300 sites.

  • Marketing Intelligence and Strategic Thinking
    Marketing Intelligence and Strategic Thinking

    Nice Insight offers products and services focused on a variety of marketing intelligence needs. Whether you need a macro understanding of the contract manufacturing industry, or a micro understanding of particular providers and capabilities, Nice Insight can help with your market research needs.

  • CoSign Signature API (SAPI®)
    CoSign Signature API (SAPI®)

    Signatures play a crucial role in our day-to-day lives. Organizations understand that paper processes are expensive and are looking to migrate from a pen on paper signature (wet signature) to a true paperless environment. CoSign allows organizations to easily meet this goal.

  • eClinical OS Trial Connect Mobile App
    eClinical OS Trial Connect Mobile App

    Access your trials virtually anywhere, at any time. Critical study data – now at your fingertips.

  • Oncology Clinical Trials
    Oncology Clinical Trials

    The unique patient populations, study design challenges, and special endpoints associated with oncology trials demand specialized knowledge.  inVentiv Health Clinical's Oncology team is uniquely qualified to manage that complexity.

  • TrialMax Slate™ eCOA (electronic Clinical Outcome Assessment)
    TrialMax Slate™ eCOA (electronic Clinical Outcome Assessment)

    TrialMax Slate is a software platform that provides a single solution for eCOA (electronic Clinical Outcome Assessments) and is designed for clinicians and caregivers on the study sites.

  • Immediate-Release Tablets
    Immediate-Release Tablets

    Patheon has transformed an exceptional number of complex new chemical entities into immediate-release tablet products, helping customers to accomplish stabilization and take advantage of the most popular and low-cost dose form.

More Featured Services & Products

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. 

More From Clinical Leader Webinar

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.

Get more info...

 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
More Upcoming Courses

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
More Events....