Articles by Mark F. Witcher

  1. System Risk Structures: A New Framework For Avoiding Disaster 7/13/2020

    Risks are ubiquitous, occurring in every aspect of our personal and professional lives. This article describes how pharmaceutical development and manufacturing risks can be easily understood and effectively managed using straightforward concepts.

  2. What Managing Personal SARS-CoV-2 Risks Can Teach Us About Managing Pharma Risks 6/12/2020

    This article describes how the basic principles of managing personal risks of being infected by a respiratory virus can be used to manage risks for developing and manufacturing pharmaceuticals. The goal is to elucidate the basic principles of understanding, managing, and communicating a wide variety of risks from the trivially simple to the very complex.

  3. 2 (Major) Impediments To Faster Biopharma Product Development 5/29/2020

    As pharma products have become more complicated, companies have become bogged down in accomplishing their mission of launching new products because of complex regulatory requirements, convoluted management approaches, and inefficient resources and methods that add time and cost to moving new products from research to patients.

  4. Can Biosimilars Be The Bridge To More Widespread Continuous Bioprocessing? 5/19/2020

    This article will examine the relationship between improved continuous manufacturing (CM) and biosimilar development, paying particular attention to the reasons why biosimilars are especially promising candidates for CM development and innovation.

  5. Why Controlling CQAs Isn't Good Enough For Gene & Cell Therapies 3/31/2020

    It's frequently stated in the biopharma industry that to control a product’s critical quality attributes (CQAs) one must control the process’ critical process parameters (CPPs). While the statement is accurate literally, it does not convey the true technical requirements for controlling product quality.

  6. Straightforward, Risk-Based Approach To Better Quality Management Design 3/18/2020

    As biopharma products and processes gain complexity, so does the design and implementation of the QMS' necessary to support development and manufacturing. This article describes an approach for building a QMS based on the identification of risk exposed to the product, manufacturing process, employees, and patients during development and manufacturing.