FROM THE EDITOR

  • Analytical QbD at Teva: Knowledge Is Power Only When You Share It
    Analytical QbD at Teva: Knowledge Is Power Only When You Share It

    Rosario LoBrutto, is currently Senior Director, Head of Development Parenterals at Teva. Throughout his career he has designed, coordinated, and implemented QbD programs and provided risk management trainings to product development units (quality, analytical, formulation, process chemists), and quality control, regulatory, and operations units. He understands the value of risk assessment and strategy for proactive failure reduction as opposed to reactive trouble shooting. In his interpretation of the ICH Harmonised Tripartite Guideline for Pharmaceutical Development Q9, a guidance document for QbD, LoBrutto breaks the QbD process down into three phases of risk facilitation as it relates to analytics.

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OUTSOURCED PHARMA WEST CONFERENCE & EXHIBITION

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PHARMA MANUFACTURING INSIGHTS

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PHARMA CONTRIBUTING EDITORS

  • When To Invest In Protein Production: The Risk-Reward Calculation

    A message to biotech start-ups, scientist-entrepreneurs and life sciences organizations banking on your exciting protein-based drug-discovery programs and technologies: When it comes to the timing of your investment, if you don’t pay now, you might pay (much) more later. 

  • Industry Insights From The Executive Director Of Compliance At Seattle Genetics

    Kristin Rand always had a fascination with questions science had not yet answered, and she developed an interest in genetics while still in high school. She obtained an undergraduate degree in the Diagnostic Genetic Sciences program at UCONN. FDA law and bioethics were the focus of her graduate degree in law, and she later earned a master degree in industrial-organizational psychology.

    After serving in various positions at Wyeth and Genentech, she landed at Seattle Genetics, where she currently serves as executive director of compliance. In this piece she discusses trends in pharma compliance, and challenges companies can expect to face in 2014 and beyond.

  • WIB Profile - bluebird bio Scientist On 10 Years Of Performing Tech Transfers

    Kelly Kral has worked in the pharmaceutical industry for more than 10 years. She started her career at Genzyme, working as a process engineer developing a fed batch process for the production of adenovirus in HEK293 suspension cells. Her responsibilities included media screening, cell growth characterization, and virus production in shake flasks, spinners, and bioreactors. She assisted in process transfer to a CMO and authored process documentation, skills she used extensively in her work as group leader for upstream process development at Percivia and in her current role of scientist I at bluebird bio.

  • Pharmaceutical Customers In An Outsourcing Provider Merger -- Part 3 Of Interview With CEO of Newly Formed DPx Holdings B.V.

    This final article in our series featuring Jim Mullen, CEO of newly formed DPx Holdings B. V., discusses how to keep the focus on customers during M&A activity, and the broader transformation of sponsor–provider relationships in the pharmaceutical outsourcing industry.

  • eTMF Survey: Lagging Technology Adoption Will Impact Clinical Trials

    When you think of the pharmaceutical industry, you probably do not picture firms that are anxious to jump on new technologies, or willing to adopt new tools that have not been proven successful. New technologies are now available to facilitate the collection of data in clinical trials, yet Big Pharma and CROs are not climbing over one another to be the early adopters. So is it really surprising that with electronic trial master files (eTMF) now available to clinics, and bearing the blessing of the FDA, that many sites continue to amass large volumes of paper?

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PHARMACEUTICAL ONLINE VIDEOS

  • Introduction to Pharmaceutical Bag Filling and Sealing Equipment
    Introduction to Pharmaceutical Bag Filling and Sealing Equipment

    Umbra bag filling and sealing machinery for all sorts of dry products in the food, pharmaceutical, chemical, and agricultural industries. A single Umbra packaging machine can fill bags of any material with varying fill weights and with different closure techniques, providing an extremely versatile solution to customers looking for high flexibility.

  • What Is mHealth? Video
    What Is mHealth? Video

    AT&T mHealth Solutions are on the cutting edge of transformation in healthcare and offer solutions that enable health enterprises to engage patients, improve outcomes and lower costs.

  • AT&T mHealth Platform Video
    AT&T mHealth Platform Video

    The AT&T mHealth Platform enables enterprises and developers to rapidly develop, launch and scale enterprise and patient centric healthcare solutions. By providing a comprehensive infrastructure for the sharing of health information across healthcare enterprises, patients, and clinical professionals in a highly secured environment designed to meet HIPAA and HITECH security and privacy requirements.

  • PTI Inspection Overview Video
    PTI Inspection Overview Video

    Video overview of PTI’s non-destructive inspection solutions for leak detection, seal integrity, package integrity and container closure integrity testing. We manufacture technologies ranging from high voltage leak detection (HVLD), vacuum decay, to airborne ultrasound.

  • Online Continuous Motion Leak Tester For Efficient Container Handling

    The VeriCon 135 is a single station continuous mtion leak tester with feedscrew for efficient container handling and control.

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INDUSTRY NEWS

  • U.K.’s NICE To Re-Review Ferring’s Firmagon Ferring Pharmaceuticals confirmed the U.K.’s National Institute for Health and Care Excellence (NICE) Appeals Panel has upheld Ferring’s appeal regarding Firmagon (degarelix). The panel listened to Ferring’s oral arguments at a hearing in London and agreed that the agency’s Final Appraisal Determination (FAD) was improper. Appeals by the British Uro-Oncology Group (BUG) and Tackle Prostate Cancer were also upheld.
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FEATURED SUPPLIERS

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    Southwest Airlines Cargo

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  • Thermo Scientific Product Inspection
    Thermo Scientific Product Inspection

    Thermo Scientific Product Inspection equipment protects your brands by ensuring the quality and safety of your products. With more than 50 years of making sure little things don't turn into big problems, we know that little things can make a big difference in your bottom line.

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You’ve seen Jay Leno on The Tonight Show, now you can see him in person! After a day on the show floor, unwind with drinks, hors d’oeuvres, friends—and a good laugh—while contributing to K9s For Warriors.

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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
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CRO Oversight: Risk Assessment & Action Planning

September 16, 2014
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Vendor Qualification and Compliance: What Sponsors & CMOs Must Know

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National Conference on Addiction Disorders

August 22 - 26, 2014
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