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 Surefire Ways To Motivate A Life Science Consultant
    7 Surefire Ways To Motivate A Life Science Consultant

    Consultants play a significant role in the pharmaceutical, biopharmaceutical, vaccine, and medical device industries. They are experienced resources in crisis situations; when new facilities are being installed; under circumstances requiring technical expertise; and during regulatory emergencies, remediations, consent decrees, and other planned and unplanned situations. Problems often occur between clients and consultants, and both contribute to them. Motivational enablers/drivers increase the probability that a project will be completed successfully, provided the consultant acquires their own motivational abilities coupled with experience that meets the project requirements.

  • Emerging Best Practices For Contamination Management In Pharmaceutical Manufacturing
    Emerging Best Practices For Contamination Management In Pharmaceutical Manufacturing

    Despite quality audits and third-party oversight, contamination of prescription and over-the-counter (OTC) pharmaceutical products is still prevalent. This is despite the adoption of cGMP practices, SOPs, risk mitigation methods, and metrics such as key performance indicators. We evaluated various emerging practices to overcome contamination issues. Novel batch concentration tests and dedicated capacity utilization have proven to overcome the source of contaminants. For technology adoption in continuous manufacturing, which is unclear in terms of compliance, the FDA Emerging Technology Team could be used for advisory oversight.

  • Big Data Vs. Small Data: What’s The Proper Prescription For You?
    Big Data Vs. Small Data: What’s The Proper Prescription For You?

    This article will explain what Big Data and small data are, build your fluency with the benefits and risks of each, and provide recommendations to improve our data-rich future.

  • When And How To Implement Data Integrity Practices In The Product Development Lifecycle

    Data integrity is frequently discussed in many industries. It is more formally defined within the life sciences industry through regulation (e.g., current good manufacturing practices [cGMPs], good laboratory practices, good clinical practices, the application integrity policy) and in guidance documents from health agencies, including the FDA and WHO. These regulations set the expectations for companies to ensure data integrity and traceability by establishing and monitoring the effectiveness of their quality systems.

  • Tech Transfer Project Management Best Practices

    When I first became a project manager, it did not take long to realize the pain associated with a lack of resource availability and cross-functional cooperation. This includes a lack of direct project support from functional areas and having the project work low on their priority lists. There simply had to be a better way for the teams to succeed.  A few years later, I became a PMP (project management professional) and then grew into the manger of project management role.

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PHARMA ONLINE WHITE PAPERS

  • Beyond Item-Level Serialization: Extending Traceability Schemes To Secondary And Tertiary Packaging

    Falsified and counterfeit medicines are a chronic problem for the pharmaceutical sector, with a third of all shipments in the worst affected parts of the world estimated to contain fake medicines.

  • Graceful Scale-Up Of Mixing Systems: Make It Happen For You

    When acquiring a process that involves one or several mixing steps, foresight for scale-up or expansion remains to be a subtle but important factor for long-term success. As production requirements grow, your ability to shift gears smoothly, quickly and efficiently is critical because it can spell the difference between an economical transition and a financial disaster. Many process engineers have answered the call for greater capacity while avoiding scaleup entirely by simply adding more mixers identical to the ones they already had. Submitted by Charles Ross and Son Company

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INDUSTRY INSIGHTS

  • How Process Simulation Can Benefit The Food Industry
    How Process Simulation Can Benefit The Food Industry

    This article discusses how a properly-validated process model with the right details can be an invaluable tool to compare alternatives and justify cost for manufacturing and its related processes.

  • 10 Sustainable Lab Solutions To Implement Today
    10 Sustainable Lab Solutions To Implement Today

    Explore several low-cost, high-impact strategies that an institution can implement to reduce a building’s carbon footprint and improve operational expenses—even without large-scale upgrades.

  • Missed Opportunities For Adventitious Agents Testing
    Missed Opportunities For Adventitious Agents Testing

    Current adventitious agent test methods feature numerous limitations. Assays based on polymerase chain reaction (PCR) offer the potential to lift these limitations and offer better overall detection of adventitious agents. This is an area that biologics manufacturers are actively exploring, and current research indicates that PCR-based testing is not only scientifically valid but also acceptable to regulators.

  • Biocontainment Strategies: Defining The Boundaries
    Biocontainment Strategies: Defining The Boundaries

    Successful biocontainment strategies are holistic, with a focus on defining boundaries, training, careful logistics and consistent implementation.

  • 4 Factors To Consider When Building Complex Production Systems
    4 Factors To Consider When Building Complex Production Systems

    When machine builders partner with subsystem specialists to simplify and streamline their equipment design, engineering, production, and support, they can save time and boost customer satisfaction.

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PHARMA INDUSTRY EVENTS

International Pharma Conference and Expo November 20 - 22, 2017
Dubai, UAE
2nd World Summit & Expo on Food Technology and Pro November 20 - 22, 2017
Las vegas, NV
Nancy Reeder November 20 - 22, 2017
Novotel Melbourne St Kilda 16 The Esplanade, St Kilda VIC 3182, Australia Melbourne, Australia , FL
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TRAINING COURSES

Implementing the ASTM E2500 Validation Method: 10 Years of Key Learnings November 28, 2017
1pm-2:30pm EST, Online Training
The Top Method Validation Mistakes – And How to Avoid Them November 29, 2017
1pm-2:30pm EST, Online Training
An Introduction to Good Laboratory Practices (GLP) December 5, 2017
1pm-2:30pm EDT, Online Training
Quality by Design (QbD): Making Sense of the ICH Q8, Q9, Q10 Puzzle December 6, 2017
1pm-2:30pm EST, Online Training
More Upcoming Courses