FROM THE EDITOR

  • Supply Chain Management Of Temperature-Sensitive Products At Novartis: Advice From An Expert
    Supply Chain Management Of Temperature-Sensitive Products At Novartis: Advice From An Expert

    Gone are the days when pharma can depend on blockbuster drugs to carry them to financial heights; instead, successful pharmaceutical companies are taking a different approach and looking to demand to determine their next step in drug development and supply chain management. For Novartis’ Michael Trocchia, this demand has resulted in a new role as the Global Supply Chain Lead for Cell Therapy Products. In this article, he discusses the challenges associated with managing the supply chain for a temperature-sensitive product and what best practices he applies in order to contribute to Novartis’ ability to maintain a top spot in big pharma.

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OUTSOURCED PHARMA WEST CONFERENCE & EXHIBITION

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PHARMA MANUFACTURING INSIGHTS

  • Marken Delivers Medicine To Help Save A Child’s Life
    Marken Delivers Medicine To Help Save A Child’s Life

    It is 11 p.m. on a Wednesday in early September 2014, and a child at Mater Children’s Hospital in Brisbane, Australia is critically ill and in immediate need of a drug available only in the United Kingdom. The drug needed to save this child must consistently remain at 2-8oC in order to maintain efficacy. To further complicate the situation, quick routes with direct flights from the U.K. to Brisbane are very limited, and the pharmacy originally designated for delivery of the shipment is unable to accept weekend deliveries.

  • New Technologies Drive Efficiencies In Drug Processing And Packaging
    New Technologies Drive Efficiencies In Drug Processing And Packaging

    By Julie Ackerman, senior director PR and communications, PMMI, The Association for Packaging and Processing Technologies

    Pharmaceutical manufacturers continually seek solutions to speed products to market, ramp up production in times of outbreaks or increased demand, protect their brand integrity throughout the supply chain and streamline efficiencies to remain highly cost-effective. Of course, the critical need to ensure patient safety makes rigorous quality control and precision in pharmaceutical manufacturing incredibly important.

  • A Global Forum For Outsourcing (With Simple Objectives)
    A Global Forum For Outsourcing (With Simple Objectives)

    Perhaps the best advice I’ve heard regarding industry conferences is twofold: first, make sure you attend, and second, keep your objectives for attending simple.

  • A Trait For Quailty In John McKay's DNA
    A Trait For Quailty In John McKay's DNA

    If you string together some of John McKay’s qualifications, they form what looks something like a strand of DNA from a new life form: CMQCQAQMS. And this particular gene would express a single trait: McKay knows quality like few others.

  • Serial Entrepreneur Points To Initial Funding Sources For Biotechs
    Serial Entrepreneur Points To Initial Funding Sources For Biotechs

    Kevin Judice lists himself on LinkedIn as “Entrepreneur.” Perhaps he has to; there just isn’t enough space to include the three companies he recently started and at which he concurrently is employed as CEO or CSO.

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PHARMA CONTRIBUTING EDITORS

  • Pfizer Issues A Challenge – Cook Pharmica Delivers

    When Pfizer approached Cook Pharmica about producing a monoclonal antibody, Cook saw it as an opportunity to demonstrate its ability to deliver a product to the specifications the sponsor desired. Cook was fairly new at the time, and had been working with clients for just over four years. The company looked good on paper, and was one of a few facilities that could produce ingredients as well as final drug products in the same facility. Still, Cook executives knew they needed to prove they could measure up to the six driving principles (quality, cost, timeliness, adaptability, timeliness, and risk) that were crucial to Pfizer.

  • Are Regulators Providing The Right Quality Incentives?

    If you want to get a horse to move, there are two schools of thought on how to get it done. One says stand behind the animal with a stick and hit it until it does what you want. This method is not the most humane, and would not do much to endear you to the horse. The other approach says hold a carrot in front of the horse, and get it to move of its own volition. The carrot would be a reward to the animal for doing the right thing.

    Looking at this situation in a different context, we all want quality outcomes in pharmaceutical manufacturing facilities. Good manufacturing practices will provide safe products to patients, prevent injury to workers, and minimize or eliminate plant shutdowns, which can ultimately lead to drug shortages. Guy Villax, CEO of CMO Hovione, believes the FDA and other regulatory agencies have many tools at their disposal that can be used to hit manufacturers for poor quality practices. In the future, he would like to see the oversight agencies make more use of carrots to get manufacturers producing to the standards that would benefit the entire industry.

  • 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.

  • 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.

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PHARMACEUTICAL ONLINE VIDEOS

  • Introduction to Multivariate Data Analysis
    Introduction to Multivariate Data Analysis

    Brad Swarbrick, Vice President of Business Development at CAMO Software, gives a short introduction to multivariate data analysis, discusses some of its applications and how these powerful analytical tools are being used to improve products and manufacturing processes in a wide range of industries.

  • 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.

  • Real-Time Information On Microbial Contamination In Pharma Cleanrooms
    Real-Time Information On Microbial Contamination In Pharma Cleanrooms

    The BIOTRAK® Real-Time Viable Pharmaceutical Particle Counter from TSI provides real-time information on microbiological contamination in pharmaceutical cleanrooms.

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INDUSTRY NEWS

  • Weekly Pharma Manufacturing News Roundup — September 30, 2014

    A Pharmaceutical Processing article discusses the factors that are driving the future of high toxic pharmaceutical manufacturing. In particular, the article highlights a risk-based approach for manufacturing pharmaceutical products for pharma and CMOs planning to expand or add high-potency API manufacturing capacity to their offerings. The article breaks down the risk-based approach into three categories: Hazard characterization, OEL Setting, ADE setting, and Hazard Bands.

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FEATURED SUPPLIERS

  • World Courier Management
    World Courier Management

    World Courier is the largest, most successful specialty courier company in the world. World Courier pioneered the offering of specialty logistics services for the medical and bio-pharmaceutical communities, transporting the first human heart tissue for transplant in 1984.

  • Beckman Coulter Life Sciences
    Beckman Coulter Life Sciences

    The integrated resources of Hach help you monitor compliance to pharmaceutical water and cleanroom facility standards. Our world-renowned instrumentation combined with our associates' expertise gives you the confidence to move towards parametric release and process peace of mind.

  • Lighthouse Worldwide Solutions
    Lighthouse Worldwide Solutions

    Lighthouse has the most complete line of particle counting and contamination monitoring solutions available. Including airborne particle counters, liquid particle counters, microbial samplers, facility monitoring systems

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PHARMA EXPO 2014

As the highly anticipated November debut of Pharma EXPO approaches, we’ve developed this resource center for our readers to access the most relevant information about the event. 

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 UPCOMING TRAINING COURSES

Surviving a FDA GCP Inspection – Preparation Techniques for Success

October 2, 2014
1pm-2:30pm EDT, Online Training

Protocol Deviations: Calculated Risk or Risk to be Managed?

October 6, 2014
1pm-2:30pm EDT, Online Training

FDA Guidance on Social Media: Questions Answered and Unanswered

October 8, 2014
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The Pharma Licensing Negotiation Master Class

September 30, 2014 - October 1, 2014
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September 30, 2014 - October 1, 2014
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September 30, 2014 - October 3, 2014
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September 30, 2014
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