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.

More From Our Editors

GUEST CONTRIBUTORS

  • An Analysis Of FDA FY2016 Drug GMP Warning Letters
    An Analysis Of FDA FY2016 Drug GMP Warning Letters

    This article presents a detailed summary of the drug GMP warning letters issued by FDA in FY2016, as well as a comparison of trends in this area since FY2013. Monitoring publicly available enforcement actions and trends as part of a comprehensive GMP intelligence program is crucial, because FDA expects firms to monitor these actions and correct similar deficiencies at their site(s).

  • 4 Major Trends In Pharmaceutical Packaging
    4 Major Trends In Pharmaceutical Packaging

    There are few better places to learn more about the state of an industry than a trade show. This past November’s Pharma EXPO, co-located with PACK EXPO International 2016 at Chicago’s McCormick Place, offered a firsthand look at some of the changes and new trends that are shaping the drug industry — including new serialization technologies and inspection technologies. Additionally, new processing equipment is being developed to handle the novel biological formulations and personalized medicines that are becoming more prevalent in today’s market. This article will discuss some of the important industry trends I observed on the show floor.

  • Is An FDA Pre-IND Meeting Worth It? How To Decide & How To Prepare
    Is An FDA Pre-IND Meeting Worth It? How To Decide & How To Prepare

    If you are considering whether to take the time in advance of your investigational new drug (IND) application submission to meet with FDA for feedback on your development program, here are some thoughts to ponder and reasons not to pass up this valuable opportunity.

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.

  • 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.

More Industry Insights

PHARMA INDUSTRY EVENTS

6th Trial Master File Summit January 17 - 19, 2017
Orlando, FL
Phamraceutical Microbiology January 18 - 19, 2017
London
Remote Monitoring Implementation Post ICH GCP E6 (R2): A Practical Guide January 18, 2017
1pm-2:30pm EST, Online Training
More Industry Events