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

  • Not Just Another Article About Pharma Employees At Work: What’s <i>Your</i> Differentiator?
    Not Just Another Article About Pharma Employees At Work: What’s Your Differentiator?

    How often do you hear pharma companies (your company?) pride themselves with trite phrases like “our people are our differentiating factor.” Sounds good. Yet the reality in the trenches is far from this panacea — most industry talent reports refer to disgruntled staff who are poorly managed and organized into factions that are out for their own discrete success.

  • Teva’s Unorthodox Strategy For The Respiratory Market — Will It Work?
    Teva’s Unorthodox Strategy For The Respiratory Market — Will It Work?

    GlaxoSmithKline’s (GSK’s) blockbuster Advair (salmeterol/fluticasone) is a long-acting beta2 agonist/inhaled corticosteroid fixed-dose combination (LABA/ICS FDC) therapy used in the treatment of asthma and chronic obstructive pulmonary disease (COPD). Advair is one of GSK’s best-performing drugs, garnering more than $2 billion in company-reported U.S. sales in 2017, despite intense competition from other LABA/ICS FDC brands.

  • An Introduction To Pharmaceutical Facility Commissioning & Qualification
    An Introduction To Pharmaceutical Facility Commissioning & Qualification

    The commissioning of a facility, equipment, or system for operation under GMP regulations involves qualification that all operations are suitable for the intended purpose. The facility owner must have traceable verification of the systems, minimizing punchlist items to improve start-up and eliminate problems up front.

  • FY2017 FDA Drug Inspection Observations And Trends

    This article presents the most recent publication of GMP drug product inspection data from the FDA's Center for Drug Evaluation and Research (CDER), which addresses drug inspections conducted in FY2017. It looks at five years of data from the FDA, examines data from 2017, and evaluates five years’ worth of trends in GMP inspection enforcement.

  • How AI Tools Will Transform Quality Management In The Life Sciences

    FDA officials and leaders in the pharma and medical device spaces agree artificial intelligence (AI) tools could enable a step change in quality management in those industries. Areas that could be impacted include supply chain management, lot release, manufacturing, compliance operations, clinical trial end points, and drug discovery, among others.

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PHARMA ONLINE WHITE PAPERS

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INDUSTRY INSIGHTS

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PHARMA INDUSTRY EVENTS

The Top Method Validation Mistakes – And How to Avoid Them April 26 - 26, 2018
1pm-2:30pm EST, Online Training
Bioanalytica-2018 April 27, 2018
Hyderabad
Gene Therapy for Rare Disorders Summit April 30, 2018 - May 2, 2018
Boston, MA
Gene Therapy for Rare Disorders Summit - Boston April 30, 2018 - May 2, 2018
Boston, MA
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