Guest Columns

  1. Could Microbiome-Based Therapies Upend The Asthma And COPD Markets?
    5/28/2019

    Respiratory diseases are an appealing target for future microbiome development, with the combined asthma and chronic obstructive pulmonary disease (COPD) market approaching $30 billion by 2020 in the U.S. alone, and with significant unmet needs remaining in both markets. 

  2. Will Biosimilars Solve The Insulin Cost-Conundrum In The U.S.?
    5/28/2019

    The debate on drug pricing is raising questions about why U.S. patients pay some of the highest fees in the world to access prescription medicines. Politicians are putting manufacturers of insulins under particular scrutiny.

  3. “Work Harder” — And Other Ways To Completely Miss The Mark On Quality
    5/24/2019

    Why does “Quality” seem like such a slippery, elusive term? The answer is easy: It’s because the people who claim to know it really don’t. And everyone seems to go along with the rhetoric.

  4. Mystery And Danger: Flammables And Oxidizers In Pharma Filling Operations
    5/21/2019

    BPO, benzyl peroxide, a compound that has both a fuel source and oxygen (two legs of the fire triangle) built into it, can make handling of a purified version of this compound very interesting. 

  5. Gene Therapy: Commercial Challenges And Strategic Choices
    5/16/2019

    Innovation in gene therapy brings the potential for transforming patient care and obviating the need for chronic therapy through single-dose cures. Despite the potential long-term benefits of this new therapeutic modality, gene therapy companies face a number of underappreciated challenges.

  6. The China Biosimilars Market: Rise Of A Potential Powerhouse
    5/14/2019

    Since 2004, biosimilars markets and their regulation have been evolving with the rise of two powerhouses: Europe and the US. How does the rise of the China biosimilars market fit this established picture?

  7. 4 Approaches To Data Access Strategy — And How To Apply Them Throughout Drug Development
    5/14/2019

    It will be increasingly important for biopharma companies to employ ingenious strategies to access data already existing in the healthcare environment, moving away from solely building and owning data sets. 

  8. Military Tool For Vulnerability Assessment: The CARVER + Shock Technique
    5/13/2019

    CARVER + Shock is a vulnerability assessment tool that can help manufacturers of medicinal products protect their products from deliberate contamination. Originally developed by the U.S. military, the technique can also be applied to raw/starting materials, production, distribution, and commercial and retail sales.

  9. Techniques For Risk-Based Validation Using ASTM E2500
    5/10/2019

    This article explores validation’s role in efficiency and cost management, in an approach to ASTM E2500 from a scientific, value-added perspective

  10. To Err Is Human: Contextual Communication’s Impact On Data Integrity
    5/8/2019

    Despite the best efforts of those responsible for data integrity, the potential for human error is directly and indirectly impacted by the corporate, the national/regional , and quality culture of an organization.