FROM THE EDITOR

  • How To Prepare A Facility For The Biopharmaceutical Revolution
    How To Prepare A Facility For The Biopharmaceutical Revolution

    Drug discovery is an inherently inefficient process. It takes thousands of failed compounds before one can get approved as safe and efficacious, and this effort does not come at a low cost. Because of this, the industry is constantly looking for ways to bring safe, compliant, and profitable drugs to market faster and cheaper. Patheon facility in Brisbane, Australia, exemplifies the facility needed to survive the future of pharma. But how did they do it?

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PHARMA MANUFACTURING INSIGHTS

  • Why The Pharmaceutical Industry Should Require Sealing Suppliers To Be ISO 9001:2008 Certified

    By George Bovenzi, Director of Quality, and Steve Pitolaj, Principal Engineer, Garlock Sealing TechnologiesQ

    The pharmaceutical industry is global in scope and subject to international standards, such as International Standards Organization (ISO) 9001:2008, which establishes the requirements for quality managements systems. Compliance with this standard is completely voluntary, but increasingly, major global pharmaceutical companies are requiring its suppliers to be registered by an accredited, third-party registrar or certified by self-auditing, the former being preferable. These suppliers include manufacturers of sealing products used in the industry’s production processes.

  • Three Key Performance Indicators For Protecting Your Product
    Three Key Performance Indicators For Protecting Your Product

    From high-demand drugs to life-saving treatments, it seems that none of today’s pharmaceuticals are safe from the threat of counterfeiting.

  • Life Science Partnerships With Patient Foundations: Best Practices
    Life Science Partnerships With Patient Foundations: Best Practices

    Voices of BayBio’s "Successful Public-Private Partnerships" Survey

  • Boehringer Ingelheim Ups The Ante In Treating Lung Disorders
    Boehringer Ingelheim Ups The Ante In Treating Lung Disorders

    Tunde Otulana, M.D., heads Boehringer Ingelheim’s clinical development and medical affairs group. He is a former FDA reviewer who studied, learned, and finally got the chance to apply his knowledge of clinical trials when he stepped over into industry in 1997. As a pulmonologist who previously worked for about seven years in the FDA’s pulmonary division, Otulana subsequently led related R&D efforts at several companies before coming to BI in 2011. He now plays a key role in the U.S. in preserving the company’s position as a pioneer and leader in respiratory therapy, mainly in chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

  • ONO Pharmaceutical Strives For Global Sales
    ONO Pharmaceutical Strives For Global Sales

    Gyo Sagara, president, representative director and CEO, challenges his company to enter the cancer field and gain big-pharma relevance.

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PHARMA CONTRIBUTING EDITORS

  • 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?

  • 7 Essential Steps To Hiring A Pharmaceutical Consultant

    In preparation for the spring 2014 hiring season, The CECON Group has recently developed guidelines for choosing the best consultant for a project. Selecting and managing a technical consultant can be a challenge, especially if the subject matter is well outside of the hiring manager’s field of expertise. In the pharmaceutical industry, consultants can help companies of any size to deal with various aspects of drug development, including the selection of suppliers and outsourcing partners.  

  • Women In Bio Profile: Industry Insights From The Executive Director Of Compliance At Seattle Genetics

    From the time she was young, Kristin Rand’s mother said she would be an actress or a lawyer. Although she thought her mother was probably correct, she didn’t like the prospect of becoming either, merely because she did not want her mother to have predicted her future. While in high school she developed an interest in genetics and the promise it held for the future of personalized medicine. Rand notes she always had an interest in the questions that science had not yet answered.  

    She began her collegiate career at Fordham University as a pre-med student but was not sure she would want to go to medical school after graduation. She opted to pursue a specialized undergraduate degree, eventually transferring to UCONN and landing on their Diagnostic Genetic Sciences Program. When she later decided to go on to graduate work, the choice was between a degree in law or molecular genetics. She chose law and finally succumbed to what her mother always felt she was naturally inclined to do. She made FDA law and bioethics the focus of her training. After working in medical communications, education, and legal for various vendor companies, she moved over to the pharma side of the house. Her first position was with Wyeth, prior to its acquisition by Pfizer. The dynamics of working in such a large and complex global organization again peaked her interest, and was the impetus for her returning to school, this time to secure a masters degree in industrial-organizational psychology.

More From Pharma Contributing Editors

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

  • Novartis’ Vaccinates Over 45K People In Bexsero Campaign Novartis reported high uptake in its first large-scale public Bexsero vaccination program. The campaign was conducted in Quebec’s Saguenay-Lac-Saint-Jean region where the vaccine was offered to everyone aged 2 months through 20 years old.
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FEATURED SUPPLIERS

  • Pall Life Sciences - BioPharmaceuticals
    Pall Life Sciences - BioPharmaceuticals Pall Corporation is a specialty materials and engineering company with the broadest-based filtration and separations capabilities in the world|We serve a diverse, global customer base with products that are used to purify raw materials, keep equipment running efficiently, ensure product quality and clean up and minimize waste
  • Grace
    Grace

    Grace is a global provider of process manufacturing solutions supporting pharmaceutical and biotech industries. Our range of solutions includes peptide building blocks for API synthesis, chromatographic media and packing equipment for process purification, and multifunctional silica excipients for pharmaceutical formulation.

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