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

  • How To Catalyze & Sustain Continuous Improvement In Pharmaceutical Operations
    How To Catalyze & Sustain Continuous Improvement In Pharmaceutical Operations

    While other industries have learned from the principles of quality and statistical control methodology, (bio)pharma has been slow on the uptake. This article proposes tactic designs that utilize collaboration tools to facilitate Kaizen/continuous improvement in quality management systems (QMSs).

  • Integrated Delivery Networks & The Future Of Drug Development
    Integrated Delivery Networks & The Future Of Drug Development

    Integrated delivery networks (IDNs) were among the earliest adopters of Medicare accountable care organization (ACO) programs. The Centers for Medicare and Medicaid Services (CMS) releases results specific to these programs on an annual basis, creating opportunities for new drug development.

  • Are You Prepared For The EU’s FMD Safety Features Delegated Regulation?
    Are You Prepared For The EU’s FMD Safety Features Delegated Regulation?

    The European Union’s (EU) Falsified Medicines (FMD) Directive 2011/62/EU amends Directive 2001/83/EC to safeguard public health by protecting the pharmaceutical supply chain from infiltration by falsified (or counterfeit) medicines. It also introduces new rules to more rigorously regulate the supply chain.

  • Validation Of Visual Inspection As An Analytical Method For Cleaning Validation

    It has never been clear whether visual inspection is reliable since it has never actually been validated. If it can be validated, then the use of this technique for release of equipment would be justified and might even be used in place of traditional swab methods, which take substantial amounts of time and resources to develop, validate, and perform.

  • Using Trending As A Tool For Risk-Based Thinking

    Probably the most significant concern for anyone responsible for implementing, deploying, and maintaining a quality management system is the integration of risk-based thinking. While the concept of risk management is 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.

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PHARMA ONLINE WHITE PAPERS

  • Best Of Both Worlds: Lyophilization For Purification

    For many years lyophilisation, or freeze drying, has been used to dry samples in the laboratory. By Rob Darrington, Genevac

  • Understanding Ultrasound Technology To Inspect Pouch Seals

    A pouch seal is a structural element that joins flat film material, and a component designed to close a pouch airtight. Traditional test methods e.g. peel strength or burst, can measure the joint strength of the seal, using destructive methods. However, this type of testing is often unreliable. Submitted by PTI - Packaging Technologies & Inspection

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INDUSTRY INSIGHTS

  • Characterizing Drug Substance Properties Early Can Optimize Drug Product Formulation
    Characterizing Drug Substance Properties Early Can Optimize Drug Product Formulation

    Molecules continue to get more challenging from the perspective of solubility, bioavailability, and exposure. Advances in formulation technologies continue to provide more solutions. Establishing effective communications between DS chemists and DP formulators manage the risks and maximize the rewards of transforming less soluble and less bioavailable molecules into effective new drugs.

  • Regulatory Guidance and Engineering For Sterile Drug Manufacturing Facilities
    Regulatory Guidance and Engineering For Sterile Drug Manufacturing Facilities

    This article provides an overview of the regulatory guidelines and the fundamental GMP requirements with regards sterile manufacturing of medicinal products, with a particular focus on engineering aspects.

  • Ensuring Efficient Electrical System Design
    Ensuring Efficient Electrical System Design

    Over the past decade, 3-phase, low-voltage, dry-type transformer efficiency has become a hot topic for owners and specifying engineers seeking to save money on the long-term operational costs within a facility. Understand how to implement them into facilities, taking into consideration all of the parameters of the transformer designs, to make a safe and effective electrical distribution system.

  • Blender Selection And Sizing For Powders
    Blender Selection And Sizing For Powders

    The key to selecting a blender that will blend powders together into uniform mixes, also called "bulk solids," are the material's flow characteristics.

  • Which Laboratory Software Is The Right One For Your Lab?
    Which Laboratory Software Is The Right One For Your Lab?

    To ensure that your requests for specific software and systems receive full consideration, it pays to fully understand the types of lab management software available.

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PHARMA INDUSTRY EVENTS

12th Annual Pharma Middle East Congress September 25 - 27, 2017
Dubai
FierceBiotech 2nd Drug Development Forum September 25 - 27, 2017
Boston, MA
CBI's Product Recalls Summit for Life Sciences September 25 - 27, 2017
Arlington, VA
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