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.

More From Our Editors

GUEST CONTRIBUTORS

  • An ADE-Derived Scale For Assessing Product Cross-Contamination Risk In Shared Facilities

    Beginning in 2004, a global team of pharmaceutical toxicologists, industrial hygienists, quality assurance professionals, a cleaning validation professional, and a representative from the US FDA participated in the development of the International Society for Pharmaceutical Engineering's (ISPE) Risk-Based Manufacturing of Pharmaceutical Products (Risk-MaPP) Baseline Guide.

  • Beyond The FDA Guidance: Practical Considerations For Quality Agreements

    Much has been written in recent months about the FDA’s final guidance for industry, Contract Manufacturing Arrangement for Drugs:  Quality Agreements, issued in November 2016.  Recently, a thorough assessment of the guidance requirements and gaps was published on this website. (See FDA's New Quality Agreement Guidance — What It Says (And What It Fails To Say) and Examining FDA's New Quality Agreement Guidance.)

More From Guest Contributors

PHARMA ONLINE WHITE PAPERS

More Pharma Onine White Papers

INDUSTRY INSIGHTS

  • New Guidelines Offer Menu Of Standard Sterile Packaging Tests
    New Guidelines Offer Menu Of Standard Sterile Packaging Tests

    High-risk packaging applications, such as pharmaceutical and class III medical devices, are coming under increasing scrutiny. A package protects the product throughout the product life cycle, and package integrity is a significant pocket of risk that can be mitigated. 

  • Paving The Road To Compliance: Serialization Standardization Through Open-SCS
    Paving The Road To Compliance: Serialization Standardization Through Open-SCS

    As companies around the world implement the necessary changes to become compliant, it will add an increased level of cost, risk, and especially complexity to today’s operations. Specifically, part of these mandates requires that production floor and warehouse equipment are able to exchange information with a customers’ business system throughout the drug’s packaging lifecycle.

  • The Multivariate World Is Expanding For Research And Industrial Data Analysis
    The Multivariate World Is Expanding For Research And Industrial Data Analysis

    The field of chemometrics has been around for quite some time now and has played its role in both research and industrial environments. While the multivariate research toolbox is well established and ever increasing, its industrial counterpart is only beginning to see widespread use in the last decade.

  • How Big Data Is Transforming Pharmaceutical Manufacturing
    How Big Data Is Transforming Pharmaceutical Manufacturing

    Pharmaceutical manufacturers now have the ability to analyze massive amounts of quality, environmental, and IoT-generated factory data, which enables them to build end-to-end process controls — resulting in higher-quality products, more predictability, more efficient manufacturing, and faster time to market.

  • Biosimilars Producer, Alvotech, Finds Opportunities In Iceland
    Biosimilars Producer, Alvotech, Finds Opportunities In Iceland

    In June 2016, Alvotech opened their new biosimilar manufacturing facility in Reykjavik, Iceland, using best of breed solutions from leading Life Science vendors.  The key directive for Alvotech was to create a flexible, agile process which could adapt and be used for any conceivable process.  The result:  A high yield disposable fermentation and downstream process, with a fill-and-finish line for vials and prefilled syringes, tied together with a complete, end-to-end upstream/downstream automation and Manufacturing Execution System. 

More Industry Insights

PHARMA INDUSTRY EVENTS

euroPLX 64 Vienna Pharma Partnering May 29 - 30, 2017
Vienna
Pre-Filled Syringes West Coast June 5 - 6, 2017
San Diego, CA
2nd Global Pediatric Ophthalmology Congress June 5 - 6, 2017
Milano, IN
Patient Experience 2017 June 5 - 6, 2017
Jersey City, NJ
More Industry Events