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 To Expect From Artificial Intelligence In Pharma — And How To Get There
    What To Expect From Artificial Intelligence In Pharma — And How To Get There

    Artificial intelligence (AI) has truly moved from concept to reality in the pharmaceutical industry. Many companies are already using AI to pour through mountains of scientific data in an effort to speed and improve the drug discovery process. And the technology is starting to find new applications in areas as diverse as regulatory/compliance, clinical trials, manufacturing, and supply chain.

  • I Don’t Think The Word “Quality” Means What You Think It Means
    I Don’t Think The Word “Quality” Means What You Think It Means

    The word “quality” is bandied about with reckless abandon across the healthcare, clinical practice, pharmaceutical, and biotech industries. Everyone thinks they understand quality at a deep level, just like everyone thinks they are “better than average” drivers.

  • Big Data & Leadership Strategies For Enabling Quality By Design
    Big Data & Leadership Strategies For Enabling Quality By Design

    The biopharmaceutical industry has unique commercial risks, including complex molecule products, costly supply chain infrastructure that takes a long time to construct, and raw material variations’ impact on process quality and yields.

  • Biocontainment: Understanding Biosafety Levels

    This two-part article on biocontainment is a companion to our discussion of potent compounds, which focused primarily on chemically derived drug substances and drug components. While analogous to chemical potent compounds, biologically derived ingredients, intermediates, and products are produced by human manipulation of naturally occurring lifeforms and their byproducts.

  • A Process Capability-Derived Scale For Assessing The Risk Of Compound Carryover In Shared Facilities

    This article presents a new scale for measuring the risk of compound carryover in shared facilities based on the process capability of a cleaning process that can be used to evaluate the probability of cross-contamination by compounds manufactured in a shared facility or equipment train.

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INDUSTRY INSIGHTS

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PHARMA INDUSTRY EVENTS

bioleagues August 18, 2017
chennai
CAPA and Root Cause Analysis Essentials Post ICH GCP E6 (R2) Addendum August 21, 2017
11:00am- 12:00pm EDT, Online Training
IPF Summit August 21 - 23, 2017
Boston, MA
Bio/Pharma Forum on Data Science & Advanced Analytics August 21 - 22, 2017
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Outsourced Pharma August 22 - 23, 2017
San Diego, CA
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CAPA and Root Cause Analysis Essentials Post ICH GCP E6 (R2) Addendum August 21, 2017
11:00am- 12:00pm EDT, Online Training
How To Establish The Number of Runs Required For Process Validation August 23, 2017
1:00 - 2:00 PM EDT, Online Training
The Impact of "Brexit" On Clinical Research – An Operational Readiness Primer August 24, 2017
1:00 - 2:30 PM EDT, Online Training
Monitoring Plan Development: Post ICH GCP E6 (R2) Addendum August 25, 2017
11:00am- 12:00pm EDT, Online Training
FDA GMP Inspections – Proven Preparation & Survival Techniques August 29, 2017
1pm-2:30pm EDT, Online Training
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