ARTICLES BY MARK F. WITCHER
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![iStock-649107516]( "How To Evaluate & Manage Safety Risks In Biopharma")
How To Evaluate & Manage Safety Risks In Biopharma5/2/2022Safety 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).
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![Iceberg Below and Above Water]( "2 (Major) Impediments To Faster Biopharmaceutical Product Development")
2 (Major) Impediments To Faster Biopharmaceutical Product Development5/29/2020As 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.
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![Bridge Over Water]( "Can Biosimilars Be The Bridge To More Widespread Continuous Bioprocessing?")
Can Biosimilars Be The Bridge To More Widespread Continuous Bioprocessing?5/19/2020This 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.
Mark F. Witcher
Mark F. Witcher, Ph.D., has over 35 years of experience in biopharmaceuticals. He currently consults with a few select companies. Previously, he worked for several engineering companies on feasibility and conceptual design studies for advanced biopharmaceutical manufacturing facilities. Witcher was an independent consultant in the biopharmaceutical industry for 15 years on operational issues related to: product and process development, strategic business development, clinical and commercial manufacturing, tech transfer, and facility design. He also taught courses on process validation for ISPE. He was previously the SVP of manufacturing operations for Covance Biotechnology Services, where he was responsible for the design, construction, start-up, and operation of their $50-million contract manufacturing facility. Prior to joining Covance, Witcher was VP of manufacturing at Amgen. You can reach him at witchermf@aol.com or on LinkedIn (linkedin.com/in/mark-witcher).