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

  • What Value-Based Reimbursement Means For Drug Development
    What Value-Based Reimbursement Means For Drug Development

    Pharmaceutical reimbursement historically has largely been a process of first determining the efficacy and safety profile of a therapy and then deciding its ultimate coverage level based on its price. But now, payers are taking a cue from their European peers and beginning to do the sophisticated number-crunching and cost-effectiveness studies to take a more holistic approach to drug coverage.

  • Using Risk-Based Thinking To Manage Nonconformances And Deviations
    Using Risk-Based Thinking To Manage Nonconformances And Deviations

    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-based thinking and 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.

  • 7 Surefire Ways To Motivate A Life Science Consultant
    7 Surefire Ways To Motivate A Life Science Consultant

    Consultants play a significant role in the pharmaceutical, biopharmaceutical, vaccine, and medical device industries. They are experienced resources in crisis situations; when new facilities are being installed; under circumstances requiring technical expertise; and during regulatory emergencies, remediations, consent decrees, and other planned and unplanned situations. Problems often occur between clients and consultants, and both contribute to them. Motivational enablers/drivers increase the probability that a project will be completed successfully, provided the consultant acquires their own motivational abilities coupled with experience that meets the project requirements.

  • Emerging Best Practices For Contamination Management In Pharmaceutical Manufacturing

    Despite quality audits and third-party oversight, contamination of prescription and over-the-counter (OTC) pharmaceutical products is still prevalent. This is despite the adoption of cGMP practices, SOPs, risk mitigation methods, and metrics such as key performance indicators. We evaluated various emerging practices to overcome contamination issues. Novel batch concentration tests and dedicated capacity utilization have proven to overcome the source of contaminants. For technology adoption in continuous manufacturing, which is unclear in terms of compliance, the FDA Emerging Technology Team could be used for advisory oversight.

  • Big Data Vs. Small Data: What’s The Proper Prescription For You?

    This article will explain what Big Data and small data are, build your fluency with the benefits and risks of each, and provide recommendations to improve our data-rich future.

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PHARMA ONLINE WHITE PAPERS

  • Safety Is Not An Option - Improved Principles of Biological Safety Cabinet Design

    Effective Biological Safety Cabinet performance can be greatly affected by different laboratory conditions: Size of laboratory, location of cabinet within a room, traffic patterns of laboratory personnel, electrical variations, airflow ducts and grills, and other equipment. The greater the extremes, the increased likelihood a cabinet will pass-the safer the cabinet design.

  • 7 Things To Know When Selecting An Electronic Lab Notebook

    Electronic lab notebooks (ELNs) are one of the primary scientific informatics solutions for helping scientists design, execute, analyze and report on experiments—but selecting the right ELN can be a challenge.

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INDUSTRY INSIGHTS

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PHARMA INDUSTRY EVENTS

Annual World Congress on Biomarkers & Clinical Research November 27 - 28, 2017
Atlanta, GA
euroPLX 65 London Pharma Partnering November 27 - 28, 2017
London
Safina Robinson November 27 - 28, 2017
London
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TRAINING COURSES

Implementing the ASTM E2500 Validation Method: 10 Years of Key Learnings November 28, 2017
1pm-2:30pm EST, Online Training
The Top Method Validation Mistakes – And How to Avoid Them November 29, 2017
1pm-2:30pm EST, Online Training
An Introduction to Good Laboratory Practices (GLP) December 5, 2017
1pm-2:30pm EDT, Online Training
Quality by Design (QbD): Making Sense of the ICH Q8, Q9, Q10 Puzzle December 6, 2017
1pm-2:30pm EST, Online Training
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