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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![UK flag icon with a DNA sign-GettyImages-478760944]( "MHRA Issues New Regulation On Modular And Point Of Care Manufacture Of ATMPs")
MHRA Issues New Regulation On Modular And Point Of Care Manufacture Of ATMPs3/11/2025The U.K.'s MHRA has issued a new regulation to allow for decentralized manufacturing of cell and gene therapies (advanced therapeutic medicinal products), describing modular and point of care manufacturing. It becomes effective July 23, 2025.
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![FDA headquarter iStock-1213293784]( "FDA Issues New Guidance: Nonclinical Safety Assessment Of Oligonucleotide-Based Therapeutics")
FDA Issues New Guidance: Nonclinical Safety Assessment Of Oligonucleotide-Based Therapeutics12/11/2024FDA's CDER recently issued a draft guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics. This article provides a summary and analysis. The public comment period ends January 14, 2025.
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![DNA Code-GettyImages-165657815]( "EMA Issues Draft Guideline On The Development And Manufacture Of Oligonucleotides")
EMA Issues Draft Guideline On The Development And Manufacture Of Oligonucleotides9/26/2024The EMA recently issued a draft guidance, Guideline on the Development and Manufacture of Oligonucleotides. It includes requirements and considerations related to conjugation, active substance in solution, and more. The consultation period ends Jan. 31, 2025.
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.