EDITORS' DESK

  • A Glimpse Into Thailand’s Ongoing Life Sciences Transformation
    A Glimpse Into Thailand’s Ongoing Life Sciences Transformation

    During my visit to Thailand, I was privy, not only to the particularly innovative research goals being pursued, but also to a number of challenges the country has recognized and hopes to address within the next few years to encourage a stronger, more diverse industry.

What Thailand Revealed About U.S. Pharma R&D

A few weeks ago, I was invited by the Thailand Board of Investment to attend a media trip to learn about the country’s budding life sciences industry. Entering Thailand, a country in which the government is pushing more investment and education in the sciences, was even more striking and meaningful to me given the current scientific climate in the U.S.

Top 5 Biosimilar Developments Of 2016

In the spirit of this list-making season, I compiled what I thought were the five most important biosimilar-related triumphs in the past year. Many of these events were widely covered by the media and will play an influential role in how the biosimilar industry unfolds through 2017 and beyond.

Are You The Future of Pharmaceutical Development?

Pfizer's Bernie Huyghe and ADC Therapeutics' Michael Mulkerrin get bushwhacked with this question in a public forum. Their open replies will help each one of you to your own personal assessment. Be prepared for some soul searching.

The Case For Moving The EMA To Ireland

Relocating an organization as large as the EMA, which employs upwards of 1,000 people in London, will be no easy feat. As such, IDA Ireland, an agency that supports companies in Ireland and promotes foreign direct investments in the country, is working to compile information on why Ireland would be a good location for the EMA.

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GUEST CONTRIBUTORS

  • 7 Steps To Properly Navigate An Event Investigation
    7 Steps To Properly Navigate An Event Investigation

    A recently published article examining recent GMP inspection data from CDER (FDA’s Center for Drug Evaluation and Research) and MHRA (Medicines and Healthcare products Regulatory Agency) notes that “Deficiencies in investigations remains at the top of this list [of the most frequently cited observations] over the past four years. We as an industry cannot seem to get this quite right.” I agree.

  • Practical Application Of Online Water Bioburden Analyzers In Pharmaceutical Manufacturing
    Practical Application Of Online Water Bioburden Analyzers In Pharmaceutical Manufacturing

    Water is the single largest quantity raw material used in pharmaceutical manufacturing. Water is used in all facets of manufacturing, from preparing equipment to manufacturing the final commercial product.

  • An Evaluation Of A Closed Sterile Transfer Process For Aseptic Filling
    An Evaluation Of A Closed Sterile Transfer Process For Aseptic Filling

    Critical control points for conventional aseptic processing are most often related to contamination resulting from human intervention and exposure of critical surfaces before and during fill. Extensive resources are required to install and maintain controls for these typical failure modes which can lead to two critical issues: shortages of essential medicines and inability to meet the timelines critical to control emerging pandemic threats.

     

  • How To Establish An Aseptic Gowning Qualification Program

    Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This four-part article provides a foundational introduction to some of those aspects.

  • Is Blockchain The Solution To Drug Traceability?

    It seems blockchain technology is following the hype path the cloud did a few years ago. The most talked-about example of blockchain is Bitcoin, a digital currency that does not rely on a central authority (such as the Federal Reserve) to clear financial transactions. A few short months ago, the word “blockchain” was seldom mentioned in supply chain circles. Now, it’s not uncommon to be asked what your blockchain strategy is within those same circles. What has changed is its successful use and blockchain platforms adding functionality.

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PHARMA ONLINE WHITE PAPERS

  • The Impact Of Energy Management On Process Automation Systems

    In this paper, we will detail the key functions of an energy-aware process automation system (PAS) and how its links between production and energy result in increased production and energy efficiency.

  • What Is A Mobile Cleanroom?

    The mobile clean room is a self-contained manufacturing space fully constructed off-site. It is shipped to customer facility on a double drop flatbed trailer in one piece and ready to hook up.

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INDUSTRY INSIGHTS

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PHARMA INDUSTRY EVENTS

Logon Williams July 27 - 28, 2017
Chicago, USA, IL
Michael Hayden July 27 - 28, 2017
Rome, NY
7th Digital Marketing for Medical Devices August 1 - 3, 2017
Minneapolis, MN
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TRAINING COURSES

Drug Development 101 – How A Drug Is Made August 3, 2017
1pm-2:30pm EDT, Online Training
ICH E6 Addendum R2 Team Training and Action Planning August 7, 2017
11:00am- 12:00pm EDT, Online Training
Cell Therapy: Process Design Considerations To Support Commercialization August 9, 2017
1pm-2:30pm EDT, Online Training
Effective Batch Record Review - Getting It Right The First Time August 14, 2017
1pm-2:30pm EDT, Online Training
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