EDITORS' DESK

  • A Glimpse Into Thailand’s Ongoing Life Sciences Transformation
    A Glimpse Into Thailand’s Ongoing Life Sciences Transformation

    During my visit to Thailand, I was privy, not only to the particularly innovative research goals being pursued, but also to a number of challenges the country has recognized and hopes to address within the next few years to encourage a stronger, more diverse industry.

What Thailand Revealed About U.S. Pharma R&D

A few weeks ago, I was invited by the Thailand Board of Investment to attend a media trip to learn about the country’s budding life sciences industry. Entering Thailand, a country in which the government is pushing more investment and education in the sciences, was even more striking and meaningful to me given the current scientific climate in the U.S.

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.

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GUEST CONTRIBUTORS

  • Responding To Regulatory Inspection Observations: Do’s and Don’ts
    Responding To Regulatory Inspection Observations: Do’s and Don’ts

    It’s Friday, it’s late, and you are just leaving for the weekend. The inspection you hosted two weeks ago remains a painful memory. The exit meeting didn’t go well — five major observations, all relating to your quality system. When your boss enters your office, you know it’s not to wish you a good weekend. 

  • An Introduction To Process Analytical Technology
    An Introduction To Process Analytical Technology

    Our industry is engaged in the discovery, development, and production of high-quality, safe, and efficacious medicines intended for reducing the suffering and improving the lives of our patients. Ensuring medicinal product quality is our responsibility, and the FDA has written that “quality cannot be tested into products; it should be built in by design.” Many of our medicines are structurally complex or are made via complex processes (which include the use of hazardous materials). So, end-product testing alone is an insufficient measure of product quality, from our patients’ perspectives.

  • The Basics Of Cleanroom Design & Material Transfer For Microbial Control
    The Basics Of Cleanroom Design & Material Transfer For Microbial Control

    Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This foundational introduction to cleanroom microbiology discusses some of those aspects

  • Using Risk-Based Thinking To Manage Suppliers

    Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system (QMS) is the integration of risk-based thinking. While the concepts of risk management are not new, previous practice was more reactionary, primarily focusing on detection after the fact, root cause analysis, corrective actions, and preventing recurrence of the failure. Contemporary thinking places the emphasis on considering risks up front (prevention) and having a solid approach to address risk in planning, managing, and driving actions.

  • Making Last-Minute Serialization Preparations For The Nov. 2017 DSCSA Deadline

    Starting on Nov. 27, 2017, pharmaceutical manufacturers are required to begin marking all saleable units and homogeneous cases of prescription drugs with a unique serial identification code (product identifier), as stipulated by the Drug Supply Chain Security Act. Many drug makers have been preparing for this so-called “serialization” deadline for years by implementing new processes and systems in their internal operations, or by ensuring efficient transfer of serialization data from their contract manufacturing/packaging partners. However, some manufacturers — in particular, smaller or virtual firms — are now engaged in a mad scramble to meet all the requirements of the deadline.

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PHARMA ONLINE WHITE PAPERS

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INDUSTRY INSIGHTS

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PHARMA INDUSTRY EVENTS

Microbiome Drug Development Summit June 27 - 29, 2017
Boston, MA
Rational Combinations 360° June 28 - 29, 2017
New York, NY
Rational Combinations 360° June 28 - 29, 2017
New York, NY
How To Establish The Number of Runs Required For Process Validation June 28, 2017
1:00 - 2:00 PM EDT, Online Training
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TRAINING COURSES

How To Establish The Number of Runs Required For Process Validation June 28, 2017
1:00 - 2:00 PM EDT, Online Training
Quality Risk Management Post ICH GCP E6 R2 Addendum June 29, 2017
11:00am- 12:00pm EDT, Online Training
CRO Oversight Post ICH GCP E6 (R2) Addendum July 10, 2017
11:00am- 12:00pm EDT, Online Training
Certified Copies and ALCOA-C: Essentials Post ICH GCP E6 (R2) Addendum July 10, 2017
11:00am- 12:00pm EDT, Online Training
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