EDITORS' DESK

  • Top 5 Biosimilar Developments Of 2016
    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.

Thomas Jefferson Hasn’t A Clue About Drug Development

Understanding what went before, and the steadfast resolve to get to the future, are invaluable for reaching success in our industry. An illustrative and teaching example of this – including the past and future of outsourcing – is embodied in the people at a “thirty-year-old biotech.” They have little in common with Thomas Jefferson.

Are CMOs Sufficiently Serving Biotechs?

Louis Demers of Xoma knows what he wants in contract development and manufacturing organizations. For example, they should be networked with other service providers, and in mission-critical alignment. Can he get what he wants? Can any outsourcing leader at a biotech today? CMO consolidation may make it more difficult.

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GUEST CONTRIBUTORS

  • Is Open Collaboration The New Paradigm In Pharmaceutical Manufacturing Innovation?
    Is Open Collaboration The New Paradigm In Pharmaceutical Manufacturing Innovation?

    You’ve heard it before. Change comes slowly to a risk-averse industry like pharmaceuticals. How can we reduce these risks and increase the success in adopting new technologies and better supply chains? Part of the answer is better collaboration between industry, academia, and government. These collaborations “represent the future of pharmaceutical manufacturing and the supply chain R&D,” according to the International Society of Pharmaceutical Engineering (ISPE) Facility of the Year Award judges in their honorable mention award to the Centre for Continuous Manufacturing and Advanced Crystallisation (CMAC) based at the University of Strathclyde in Glasgow, Scotland.

  • Brexit & The Biopharma Industry: What Happens Next?
    Brexit & The Biopharma Industry: What Happens Next?

    Last year, after the fateful June 2016 Brexit referendum that ended in a shocking win for the “Leave” camp, I wrote an article discussing the options going forward and the uncertainty that faced the biopharmaceutical industry. Now, almost a year later and after the official triggering of Article 50 — through a letter delivered by Eurostar, no less — have we actually learned anything new?

  •  Trump’s Deregulatory Agenda:  What It Could Mean For Biopharma & Medtech Companies
    Trump’s Deregulatory Agenda: What It Could Mean For Biopharma & Medtech Companies

    President Trump promised to take action to streamline the federal government. Within just a few days of taking office, he launched his deregulatory agenda, and he has now issued several executive orders that build on each other. How the concept will be implemented and by whom will continue to evolve with the addition of key staff.

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PHARMA ONLINE WHITE PAPERS

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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.

  • 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.

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PHARMA INDUSTRY EVENTS

Pharmaceutical Regulations Summit May 1 - 4, 2017
Dubai
Leeds Conferences May 3 - 4, 2017
Leeds
David Mathews May 3 - 4, 2017
Glasgow
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