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

  • A Framework For Measuring Training ROI Using Quality Metrics
    A Framework For Measuring Training ROI Using Quality Metrics

    This article proposes an approach using data-driven insights from standard quality culture and performance metrics, with CoPQ calculations, to measure training return on investment (ROI). Calculation of ROI answers the question, “Is this investment worth the expense?” It measures how much money is earned or lost from investment in training and the impact of training on the bottom line.

  • An MSSR-Derived Scale For Assessing Detectability Of Visual Inspection
    An MSSR-Derived Scale For Assessing Detectability Of Visual Inspection

    This article discusses how the maximum safe surface residue (MSSR) can be combined with the visual residue limit (VRL) to assess the acceptability of visual inspection for detecting the possibility of compound carryover in shared facilities.

  • The FDA/EU Mutual Recognition Agreement — What You Need To Know
    The FDA/EU Mutual Recognition Agreement — What You Need To Know

    The revised version of the Agreement on Mutual Recognition (MRA), once fully implemented, will allow the FDA and the EU inspectorates to use inspection reports and other related information obtained during GMP inspections, whether conducted by an EU inspectorate or by the FDA, to help determine whether statutory and regulatory requirements of the respective authorities have been met.

  • Best Practices For Data Integrity Oversight At Your Contract Manufacturer

    Part 1 of this two-part article addressed FDA warning letter enforcement actions and discussed things that can go awry in these relationships related to data governance and data integrity. In Part 2, we turn our attention to health authority GMP guidance on contractual relationships and best practices that should be considered in this area.

  • Process Analytical Technology: Benefits Of Spectroscopic Tool Use

    To increase familiarity with process analytical technology (PAT), this article provides examples that illustrate where traditional analytical tests could be supplemented, improved, or replaced with these new tools, such as identity testing, concentration verification, and concentration monitoring (in real time).

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PHARMA ONLINE WHITE PAPERS

  • In Vivo Study And The Impact Of The Dissolution Rate On Bioequivalence

    Comparative human in-vivo study of an immediate release tablet over-encapsulated by gelatin and hydroxypropyl methyl cellulose capsules – impact of dissolution rate on bioequivalence.

  • Wireless Dose-Compliance Monitoring In Drug-Delivery Devices

    Incorporating wireless technology into medical devices is about more than just keeping up with the hottest technology trends; the benefits are real and significant, especially with regard to monitoring and encouraging dose compliance in the pharmaceutical and medical realm. Prior to embarking on the development of a wireless-enabled drug-delivery device, however, it is crucial to know what, specifically, the benefits are, and exactly what kinds of challenges and design considerations must be taken into account.

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INDUSTRY INSIGHTS

  • What’s Next For Single-Use Technology In Bioprocessing
    What’s Next For Single-Use Technology In Bioprocessing

    The advantages of single-use are amplified as patent expiration and increasingly globalized manufacturing continues to change the dynamics of biomanufacturing.

  • 3 Regulatory Guidelines For Navigating China’s Drug Delivery And Medical Device Markets
    3 Regulatory Guidelines For Navigating China’s Drug Delivery And Medical Device Markets

    Global spending on healthcare medicines is expected to reach $1.3 trillion by end of year 2018. While many of these medicines may be developed in the traditional dosage forms, companies are increasingly developing more and more drug delivery devices, in order to deliver patient convenience, more effective routes of administration through targeted therapies, and value to the global payors. As the world’s second largest medical device market, China offers a significant opportunity for drug delivery companies to expand their global footprint in Asia.

  • The Building Blocks Of A Successful Drug Delivery Device
    The Building Blocks Of A Successful Drug Delivery Device

    Creating a successful drug delivery device requires the seamless integration of the biological or pharmaceutical regulatory requirements with the device regulatory requirements. There are several factors that need to be considered in order to do this, all while ensuring the patient is kept at the center of the design.

  • Chambers Versus Room Monitoring: What Sensors Are Best For Your Application?
    Chambers Versus Room Monitoring: What Sensors Are Best For Your Application?

    Many chamber applications are cold temperature applications and usually temperature is the only parameter monitored. Cold air cannot hold much moisture so it is uncommon to use a humidity sensor in a cold temperature situation (specifically closed chamber situations wherein the air is cycled over the cooler to remove the condensation. But initial cooling will result in 100% RH. But for the purposes of continuous monitoring we can go with the lower RH accompanying colder temperatures). Low temperature presumes low humidity.

  • Classification And FDA Regulations: Medical Device, Pharma, Combo Products
    Classification And FDA Regulations: Medical Device, Pharma, Combo Products

    How the FDA regulates various product classes and the guidance documents driving regulatory enforcement varies from product to product.

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