Mark Sawicki, Ph.D.

Articles by Mark Sawicki, Ph.D.

  • Understanding Pharmaceutical Logistics Validation in a Dynamic Environment

    Saturday, February 10, 2018
    Applying validation standards to bio/pharmaceutical logistics, the science of transporting bio/analytical, clinical and manufactured product, is an important and essential challenge as global demand for biotechnology continues to rise.
  • Biostorage: Closing the Loop in Biopharmaceutical Supply Chain Management

    Sunday, November 20, 2016
    Shipping and storing clinical trial therapeutics and biospecimens involve more than moving materials from Point A to Point B. In the biopharmaceutical industry, material transport and storage are especially complex operations because the materials...
  • Barriers to Increased Participation of Minorities in Clinical Trials

    Sunday, November 20, 2016
    Clinical trials are at the heart of the process for bringing new medicines to patients. One of the most critical aspects to the conduct of any clinical trial is identifying the right group of people to include in the study. Unfortunately, many of ...
  • Future Manufacturing Constraints

    Sunday, November 20, 2016
    Around 2003 was a peak crunch-time or period of concern that severe bioprocessing capacity shortages would develop, with utilization rates peaking then at 76% for mammalian systems and many potential blockbusters in the pipeline. The subsequent ...
  • Blinding and Randomization Strategies for Well-Controlled Clinical Studies

    Sunday, November 20, 2016
    Prior to the adoption of newer, more advanced systems we use in clinical trials today, bias was a common theme. As noted in the article: “FDA and Clinical Drug Trials: A Short History” by Suzanne White Junod, Ph.D., this was often observed when ...
  • API Roundtable

    Saturday, January 01, 2011
    What, in your opinion, is currently the single largest trend with respect to active pharmaceutical ingredients outsourcing and manufacture?
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