• 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.

More From Our Editors


  • A Tale Of Two Annexes: Analyzing EMA’s Revisions To Annex 1 & 13
    A Tale Of Two Annexes: Analyzing EMA’s Revisions To Annex 1 & 13

    As I hope you will see in this article, A Tale of Two Annexes would actually start “It was the best of times, it was almost the worst of times.” And that is because the two courses eventually taken by the agency were actually the best outcomes for the two annexes.

  • How An Emerging Biopharma Changed Its Supply Chain Methodology — And What It Learned
    How An Emerging Biopharma Changed Its Supply Chain Methodology — And What It Learned

    When Trevena, Inc. needed to establish a supply chain for its lead compound, OLINVO (oliceridine injection) — a pain-management product expected to make the transition from clinical trial material to full-blown commercial manufacturing — executives at the emerging biopharma decided to try a new framework. Instead of simply relying on decades of collective experience in managing drug supply chains, they augmented that experience with a new set of tools developed by FDA officials and industry professionals under the Xavier University Supply by Design (SbD) Initiative.

  • The Value Of Standardizing Risk Assessment Across Quality Systems
    The Value Of Standardizing Risk Assessment Across Quality Systems

    In recent years, the trend in the pharmaceutical, biopharma, and device industries has been to devote more attention to holistic quality systems and to ensure standardization of the company’s overall quality systems rather than using process-by-process policies that may or may not align completely. The 2015 changes to ISO 9001 and ISO 14644-1 and -2 standards have magnified the industry’s focus on risk assessment and quality management systems, integrating and unifying our approach to ensuring quality across all aspects of pharmaceutical, biopharma, and medical device manufacturing.

  • Using Lean Strategy To Improve Efficiency In Pharmaceutical QC Labs

    The QC lab is often seen as outside of the pharmaceutical production process, and, as a result, opportunities for improved efficiency and operational excellence are missed. A major source of complexity and poor utilization of resources is often lab throughput time — the time between the arrival of a test sample in the lab, completion of testing, and release of the data.

  • 3 Prerequisites To Establishing An Environmental Monitoring Sampling Plan

    This article is the first in a three-part series describing an engineering approach to establishing an environmental sampling plan for a new pharmaceutical or biopharmaceutical manufacturing facility. The series assume the facility has just been built and no manufacturing of batches have been run, despite being associated with other corporate sites. Simulations of dynamic conditions analogous to producing a batch will be factored in. This article will cover phase 1 in the development of such a sampling plan, and future installments will cover phases 2 through 6.

More From Guest Contributors


  • NuAire Incubator Sterility Test

    Incubator contamination is inherently a potential for all incubator manufacturers. Typical laboratories have thousands of airborne contaminants that may enter a tissue cell culture incubator during a door opening, and enter the perfect growth environment to survive and reproduce.

  • Technology Overview: How To Leak Test Blister Packaging

    Most current test methods for blister packages are destructive, time consuming, not sensitive, unreliable, and dependent on the properties of the package lidding material. Small semi-rigid, flexible, and multi-cavity blister packages do not have enough air inside the package to reliably detect defects by simple vacuum decay methods. Submitted by PTI - Packaging Technologies & Inspection

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