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

  • 5 Key Takeaways From The FDA's Revised Quality Metrics Guidance
    5 Key Takeaways From The FDA's Revised Quality Metrics Guidance

    On November 23, 2016, FDA published Submission of Quality Metrics Data, a draft guidance that addresses industry comments on an earlier draft guidance titled Request for Quality Metrics (2015). This article discusses the most significant differences between the two documents  and what pharmaceutical manufacturers and CMOs should take away from these changes.

  • 5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 1)
    5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 1)

    Microbial contamination control is essential in ensuring consumer safety, especially in controlled environments. Disinfectants play an important role in controlling microbial contamination on surfaces. The term disinfectant is often broadly used to describe chemical agents used to reduce the microbial load of controlled environments.

  • 7 Steps To Navigate Six Sigma’s “Improve” Phase
    7 Steps To Navigate Six Sigma’s “Improve” Phase

    In this series, we’ve covered quite a bit of ground in providing a working understanding of Six Sigma and its DMAIC (Define, Measure, Analyze, Improve, Control) roadmap for problem solving and product/process improvement.

  • Survey Says: Pharma Perspectives On Implementation & Impact Of Recent Regulatory Guidances

    Over the past 10 years, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued new and revised regulations and guidances in an attempt to define, clarify, and modernize their requirements. Ideally, these documents would have aided industry in developing new products that take advantage of new technologies, given budget and personnel limitations in both the regulatory agencies and industry. And in fact, many of these documents have proposed or emphasized radical changes in strategy and operations, but unfortunately such changes are often met with skepticism and concern by industry.

  • Launching A New Drug In A Maturing Market — Lessons Learned From Recent COPD Entrants

    Chronic obstructive pulmonary disease (COPD), a global growth market worth well over $15 billion in the U.S. and EU5 in 2016, has long represented a lucrative opportunity for drug manufacturers. However, the proliferation of treatments and increasing number of generics have begun to limit the potential for emerging therapies. A review of the successes and stumbles of the newest class of drugs (LABA/LAMA fixed-dose combinations) illustrates broader lessons manufacturers should consider when launching into a rapidly maturing market.

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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

Communication With FDA: What Do We Say And How Do We Say It? February 23, 2017
1pm-2:30pm EST, Online Training
Laboratory Data Integrity: Current Expectations for OOS Result Investigations February 24, 2017
1pm-2:30pm EST, Online Training
Joint MHRA/DIA Excellence in Pharmacovigilance February 27, 2017 - March 3, 2017
London
CRO Oversight: Risk Assessment & Action Planning March 1, 2017
1pm-2:30pm EST, Online Training
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TRAINING COURSES

Communication With FDA: What Do We Say And How Do We Say It? February 23, 2017
1pm-2:30pm EST, Online Training
Laboratory Data Integrity: Current Expectations for OOS Result Investigations February 24, 2017
1pm-2:30pm EST, Online Training
CRO Oversight: Risk Assessment & Action Planning March 1, 2017
1pm-2:30pm EST, Online Training
Adverse Event Reporting: Avoiding Common Pitfalls March 7, 2017
1pm-2:30pm EST, Online Training
More Upcoming Courses