EDITORS' DESK

  • New U.S And Canadian Facilities Boosting Biologics Capacity
    New U.S And Canadian Facilities Boosting Biologics Capacity

    Biopharma executives have warned they need more biologics development and manufacturing capacities, particularly in North America. They haven’t been howling at the moon. Four announcements – within two days of each other – offer a sign of relief. And Amgen has provided Outsourced Pharma with its first public estimate of costs for one of those facilities.

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.

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GUEST CONTRIBUTORS

  • Single-Use Systems: The Benefits, The Challenges, And Selection Considerations
    Single-Use Systems: The Benefits, The Challenges, And Selection Considerations

    The drive to reduce costs, increase speed to market, and meet regulatory requirements has led many pharmaceutical companies to look at single-use, pre-sterilized, plastic equipment systems as an alternative to stainless steel lines. Single-use equipment makes the biomanufacturing process increasingly efficient and less costly.

  • Targeted Therapy In Bacterial Infections: Taking A Page From Oncology’s Playbook
    Targeted Therapy In Bacterial Infections: Taking A Page From Oncology’s Playbook

    This article will focus on approaches used to manage infections caused by common pathogens, the current landscape of targeted antibacterial therapy, and the challenges and areas of opportunity for both developers of antibacterial therapies and manufacturers of medical devices.

  • EMA’s Revised Format For Risk Management Plans – What You Need To Know
    EMA’s Revised Format For Risk Management Plans – What You Need To Know

    The revised format for the EU Risk Management Plan sets a new milestone in a progressive approach to risk management. The new RMP template is a straightforward and well-structured document that can be used by RMP experts, and the concepts behind risk management have been justified to better reflect the stages of the life span of a medicinal product.

  • Should You Rotate Disinfectants? Industry Experts Weigh In

    Whether to rotate disinfectants has been debated in the pharmaceutical industry for years. If disinfectants are not used properly, microorganisms may remain on surfaces and proliferate in the environment. This article discusses the concept of disinfectant rotation and the current mainstream industry practice regarding it.

  • Regulatory GMP Expectations For Learning, Training, & Performance In Pharma/Biopharma

    Having a competent, professional workforce is essential to meeting the dual goals of business requirements and regulatory expectations. With a coherent plan and a well-structured learning system that is focused on performance, a pharma firm can efficiently accomplish both.

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PHARMA ONLINE WHITE PAPERS

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INDUSTRY INSIGHTS

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PHARMA INDUSTRY EVENTS

16th Annual Pharmaceutical IT Congress September 25 - 26, 2018
London
Digital Health and Digital Technologies Congress September 25 - 26, 2018
London
The MENA Health Insurance Congress September 25 - 26, 2018
Dubai
PAP Legal Update September 25 - 26, 2018
Arlington, VA
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The Top Method Validation Mistakes – And How to Avoid Them October 8 - 8, 2018
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Certified Copies and ALCOA-C: Essentials Post ICH GCP E6 (R2) Addendum October 9 - 9, 2018
October 9, 2018 | 1:00 - 2:30 PM EDT
How FDA and MHRA Decide Which Drug Facilities to Inspect – and at What Frequency October 16 - 16, 2018
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CRO Oversight Post ICH GCP E6 (R2) Addendum October 24 - 24, 2018
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