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.

• 3 Keys To Realizing FDA's Vision For CAR-T And Other ATMPs

  12/12/2019

  While cell therapy remains a very promising approach to developing much-needed new immunotherapies, significant challenges will have to be overcome in order to realize the FDA’s twenty-first century vision of making complex ATMPs widely and cost effectively available to patients.

• Are Good Manufacturing Practices No Longer Good Enough?

  10/28/2019

  Janet Woodcock’s recent comment on the state of pharmaceutical development,“It’s not working…,” should not surprise anyone. Her continuation, “and, it won’t work in the future," is the more surprising, and particularly troubling statement. What must we change?