ARTICLES BY MARK F. WITCHER

• How To Evaluate & Manage Safety Risks In Biopharma

  5/2/2022

  Safety risks can be described and modelled as cause-and-effect relationships using system risk structures. This article structures risks beginning with a defined danger or threat so they can be effectively understood and then managed. Examples include wearing protective gloves (as a simple risk) and handling antibody-drug conjugates (as a complex risk).

• 2 (Major) Impediments To Faster Biopharmaceutical 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.

• 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.