ARTICLES BY PETER H. CALCOTT
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![judges gavel on great britain flag-GettyImages-184134541]( "7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene Therapies")
7 New MHRA Guidances To Help You With Decentralized Manufacturing For Cell And Gene Therapies7/3/2025The U.K.'s MHRA has followed through on its promise to issue guidances to aid industry in understanding the recent changes to regulations for licensure of medicines employing cell and gene therapy technology.
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![FDA Approved GettyImages-1215516118]( "FDA Issues Bioresearch Monitoring Technical Specifications Document To Help You Organize Your Submission")
FDA Issues Bioresearch Monitoring Technical Specifications Document To Help You Organize Your Submission10/18/2024The FDA has issued the latest version of Bioresearch Monitoring Technical Conformance Guide: Technical Specifications Document: version 3.1. This version will likely be in place for a significant length of time as a road map for constructing this part of the NDA or BLA that you submit.
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![growth success increasing business-GettyImages-1319849784]( "Strategies To Tackle CAR-T Product Challenges")
Strategies To Tackle CAR-T Product Challenges6/24/2024This article describes strategies for scaling up production of CAR-T products, including the hub model, bedside model, innovation of process strategy, and more.
Peter H. Calcott
LinkedIn
Calcott Consulting LLC, is focused on delivering solutions to pharmaceutical and biotechnology companies in the areas of corporate strategy, supply chain, quality, clinical development, regulatory affairs, corporate compliance, and enterprise e-solutions. He is also an academic program developer for the University of California, Berkeley in biotechnology and pharmaceutics postgraduate programs. Previously, he was executive VP at PDL BioPharma, where he was responsible for development and implementation of quality and compliance strategy across the corporation. He has held numerous positions in quality and compliance, research and development, regulatory affairs, process development and manufacturing at pharmaceutical companies including Chiron, Immunex, SmithKline Beecham, and Bayer. He has successfully licensed products in the biologics, drugs, and device sectors on all six continents. Dr. Calcott holds a doctorate in microbial physiology and biochemistry from the University of Sussex in England.