EDITORS' DESK

  • Waldorf Departure Drama For DCAT?
    Waldorf Departure Drama For DCAT?

    I didn’t quite buy into the DCAT announcement regarding its departure from the Waldorf Astoria, the long-time central location for DCAT Week in New York City each spring. Call me cynical—a degree in public relations can do that – but I just couldn’t believe “checking out” of the Waldorf would be as easy as it sounded. I took this cynicism directly to Margaret Timony, Executive Director of the Drug, Chemical & Associated Technologies Association.

FLAG These Biopharma Outsourcing Beliefs

A few weeks away from Outsourced Pharma San Diego, we’re already into provocative discussion on outsourcing of drug development and manufacturing. Everything from the role of finance managers in CMOs; pharmacists in biopharma; Car-T and personalized medicine in development; the FDA in foreign lands; and project managers in situ. Frank Sorgi, Ph.D., President and CEO of FLAG Therapeutics, Inc., leads the charge.

Grunenthal’s Technology Model For The 21st Century

We’re entering our era of technology. It’s transferring preeminence from science to tech innovation. New players will enter; traditional biopharma will retool. Tech implementation of all hues will coalesce in the outsourcing model. Grünenthal of Aachen, Germany, is a leader in this new paradigm. Alexander Kraus, VP Product Development, Technical and Government Affairs, Grünenthal USA, Inc., explains how and why.

Debate On Project Management In Biopharma Gets Heated

Forget presidential elections. We’ve got the debate we were looking for. The one on the professionalism of project management in the biopharma industry. It includes a reader’s comments that start with: “I call BS on this article.” The prosecuting paragraphs are copied below for careful dissecting. Vitriol can be valuable.

Biomanufacturing As Seen From A North Carolina Campus

Gary Gilleskie graduated with a Ph.D. in chemical engineering, went to work at a CMO, and became senior director for downstream manufacturing and process development. Now he’s back on campus to ensure part of his history isn't repeated: obtaining that first job in biomanufacturing without a solid background in the industry.

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GUEST CONTRIBUTORS

  • Managing QMS Disparities Between Drugs And Devices For Combination Products

    Combination products represent a remarkable opportunity to extend the potential patient population for biologics and improve the delivery of drug therapies. This is one of the most dynamic segments in the life sciences , projected to grow to $115 billion by 2019.

  • Data Integrity: Surveying The Current Regulatory Landscape

    This review of recent regulatory actions related to data integrity first explores data integrity deficiencies cited in FDA warning letters issued between FY2013 and FY2015. Then, it moves to a review of the recently published FDA draft guidance on data integrity. Finally, it addresses the finalized version of the WHO guidance on the topic.

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PHARMA ONLINE WHITE PAPERS

  • Successfully Manage The Unique Demands Of Cell Therapy Supply Chains

    Cell therapy professionals joined a specialist webinar by industry experts from PCI Clinical Services and TrakCel, addressing the unique complexity of an autologous therapy supply chain. Hosted by European Pharmaceutical Manufacturer magazine, the webinar was delivered by Rachel Griffiths, Associate Director, Technical Services, PCI Clinincal Services, and Dr. Matthew Lakelin, Vice President, Scientific Affairs and Business Development, TrakCel . Here, we present the white paper from that webinar event.

  • Using A Risk-Based Approach To Plan Your Solid Oral Dosage Scale-Up

    Using a risk-based approach for planning the timeline and strategy for your drug’s development and scale-up can help you avoid very costly delays. Yet, in the race to bring a drug to market, assessing risk can often be overlooked. Each case is going to be different; however, by creating a comprehensive plan for risk management (applying ICH Q9 as a basis), you can lower the overall level of risk from beginning to end. This not only puts you in the best possible position to avoid questions from the FDA at the time of submission but it also results in a more efficient development process and a higher-quality product.  

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INDUSTRY INSIGHTS

  • 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.

  • TAP Certification Program
    TAP Certification Program

    Welcome to the industry’s first Temperature Assurance Packaging (TAP) Certification Program developed by Sonoco ThermoSafe’s ISC-Labs in partnership with The Packaging School, Dr. R. Andrew Hurley, Assistant Professor of Packaging Science at Clemson University, and an advisory panel of pharmaceutical manufacturers, wholesalers, logistics providers, and industry experts.

  • Six Myths About Serialization
    Six Myths About Serialization

    The global countdown to serialization compliance is well underway. Early adopters, such as Turkey and Argentina, required serialization as early as 2010, and were followed by others such as India, China and Korea.  Over the next three years, many other major markets will require adherence to their own serialization requirements, including the United States and the European Union. Expect that by 2018, serialization mandates will govern most of world’s drug supply. Biopharmaceutical companies that don’t comply will find it impossible to market their drugs in countries that have instituted serialization regulations.

  • Veterinary Medicine Is Becoming A Major Player In Regenerative Medicine
    Veterinary Medicine Is Becoming A Major Player In Regenerative Medicine

    As evidenced by the growing number of research publications, clinical trials, newly launched companies, and news stories, the Veterinary space is quickly becoming a major player in the application of regenerative medicine technologies.

  • 4 Questions To Guide Your Laboratory Centrifuge Selection
    4 Questions To Guide Your Laboratory Centrifuge Selection

    A centrifuge is an integral component of a laboratory that is critical to the success of an analysis. They come in a variety of sizes, from mini-centrifuges that hold only a few small tubes and spin a few thousand RPM to high capacity centrifuges that hold up to 6 liters of samples to ultracentrifuges that spin upwards of 100,000 RPM. Multiple options in size as well as other areas can make choosing the right centrifuge for your application an overwhelming task.

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TRAINING COURSES

Effective Clinical Investigator GCP Training - Getting It Right The First Time August 30, 2016
Special Time for EU and US Participants - 10:30am-12pm EDT, Online Training
Analyzing and Understanding ISO 13485 Proposed Changes August 30, 2016
1pm-2:30pm EDT, Online Training
Drug Development 101 – How A Drug Is Made September 13, 2016
1pm-2:30pm EDT, Online Training
Update to ICH GCP E6 (R2) – Proposed Changes You Should Prepare For September 14, 2016
1pm-2:30pm EST, Online Training
More Upcoming Courses