Industry Insights

  1. Paper Diaries Should Be Banned

    Every now and then, a shift in technology revolutionizes an entire industry. Consider the advent of email and automatic banking machines. Once the mainstream adopts these processes, it is difficult to imagine how we managed without them. By Valdo Arnera, MD, General Manager of PHT Corporation Europe

  2. Is Your In-House Strategy Ready For The Uncertainties Of Biologic Drug Development?

    A company has to be able to withstand the highs and lows of biologics development. To avoid costly mistakes and wasted efforts, a company must prepare for surprises along the drug development pathway.

  3. Reimagining Aseptic Processing: What Must Change?

    This is the second in a three-part series exploring the need to achieve improvement in aseptic processing of sterile biopharma products. Part 1 presented the current state and opportunity for improvement using innovative technology. Part 2 discusses changes in strategy that might be needed as a result of technology implementations. 

  4. 5 Key Components Of A Compliant Disinfectant Efficacy Testing Package (Part 2)

    This article explains the final three components that can be used to establish a compliant disinfectant efficacy testing package in the U.S. along with tips for assembling the package.

  5. Measuring The Impact Of Recent Regulatory Guidances On Quality Systems

    This article summarizes opinions on how well specific regulations have impacted operations and looks at the general health of some key quality management system (QMS) elements that are described and proposed in these regulations. 

  6. Why Monitoring Cold Chain Data Is Not Enough

    In the cold chain logistics industry there’s a huge change happening. Lots of data is being gathered by wirelessly connected data loggers, sensors and monitoring equipment. By Nitin Dahad, Dyzle

  7. An Analysis Of Recent CDER Observation & Warning Letter Data

    The FDA publishes data on Form 483 inspection observations and warning letters issued by the Center for Drug Evaluation and Research (CDER) during the previous fiscal year. By analyzing this annual data pharmaceutical and biopharmaceutical manufacturers can gain a clearer picture of FDA enforcement trends and their potential impact on business.

  8. Ensuring Adequate Drug Supply In Clinical Studies — Overcoming Logistical Challenges

    While the ability to ship drugs to sites on the surface appears to be simple, failures to meet demand occur, in my view, far too often.

  9. How To Ensure End-To-End Visibility In Pharmaceutical Supply Chains

    The supply chain problems highlighted most frequently include lack of coordination, inventory management, absent demand information, human resource dependency, order management, shortage avoidance, expiration, warehouse management, temperature control, and shipment visibility.

  10. Patient Preferences For ePRO: Eye Opening Facts
    “Computers and the Internet are as much an integral part of our lives as coffee makers. We would not want to live without them.” This is a comment that I heard recently when interviewing elderly cancer patients. By Rauha Tulkki-Wilke, Director Product Management, CRF Health