EDITORS' DESK

  • Biosimilar Makers To Congress: Time To Act On REMS Legislation
    Biosimilar Makers To Congress: Time To Act On REMS Legislation

    REMS and voluntary restricted distribution programs have become a significant stumbling block for biosimilar companies. The Subcommittee on Health Care, Benefits, and Administrative Rules recently held a hearing on these controversial practices. If there was one big takeaway from the presenting witnesses, it’s that the biosimilars industry is ready for legislative action against these abuses.

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.

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GUEST CONTRIBUTORS

  • What Outcomes-Based Contracting Means For Drug Development & Drug Pricing

    The mounting public outcry over drug prices — fueled by dramatic increases in cost for a few high-profile, older, life-saving drugs — has put intense pressure on the pharmaceutical industry to lower list prices and curtail price increases or face government controls.

  • Are You Prepared For The Upcoming USP <800> Requirements?

    The United States Pharmacopeial Convention (USP) has developed a chapter on hazardous drug (HD) handling in healthcare, USP <800>, which will become effective on July 1, 2018. For facilities that handle hazardous drugs, there’s no time to waste in working toward compliance, because facility design/redesign and construction may be necessary to achieve it.

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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.

  • Establishing Best Practice Qualification Metrics For Smart Shipping Containers
    Establishing Best Practice Qualification Metrics For Smart Shipping Containers

    Wernher von Braun, the father of modern rocketry famously stated, “one test is worth a thousand expert opinions.” The FDA has put their own regulatory spin on this axiom: “if you didn’t document it; it didn’t happen.” This extends beyond the drug therapies themselves to the packaging and logistics practices that are used to distribute them; what the FDA refers to as the “holding” of a drug.

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PHARMA INDUSTRY EVENTS

DIA BioVenture Day March 28, 2017
Glasgow
The CI+S Event 2017 March 28 - 29, 2017
San Francisco, CA
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