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DTSTART;TZID=America/New_York:20220228T100000
DTEND;TZID=America/New_York:20220304T130000
DTSTAMP:20260415T115209
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SUMMARY:USP Workshop on Therapeutic Peptides and Oligonucleotides
DESCRIPTION:In this three-day workshop\, USP will host a gathering of experts from the analytical\, process development\, and regulatory communities to share best practices and success stories. In addition\, panel discussions will allow attendees to join in-depth conversations with the speakers. \nKey session topics we’ll be covering include:\n• Raw material considerations for drug substance\n• Drug products: novel formulation approaches and delivery systems\n• Molecular design: improving stability\, bioavailability\, half-life extension\n• Analytical development\, characterization and validation\n• Green chemistry approaches for synthesis and/or analysis\n• Advances in manufacturing and purification technologies: strategies and novel methods\n• Control strategies and comparability\n• Current and future documentary standards and reference standard materials to support peptides and oligonucleotides\n• Regulatory aspects and compliance\n• CMC strategies including case studies\n• Drug conjugates\n• Personalized medicines for both peptide vaccines and oligonucleotides\n• Structure-function studies and new targets \nSpeakers Include:\nFouad Atouf Vice President\, Global Biologics\, USP \nMichael De Felippis Chair\, USP Therapeutic Peptides and Oligonucleotides Workshop Steering Committee\, and Chair\, USP BIO1 Expert Committee \nDeyi Zhang\, CDER\, US FDA \nRené Thürmer\, BfArM\, Germany \nJulie Zhang and Sarita Acharya\, USP \nNadim Akhtar\, USP Therapeutic Peptides and Oligonucleotides Workshop Steering Committee member\, and on behalf of EPOC Working Group \nElaine Fowler\, AstraZeneca \nGerhard Haas\, USP Therapeutic Peptides and Oligonucleotides Workshop Steering Committee and USP BIO1 Expert Committee member \nDennis Rhodes\, Ionis \nBaole Zhang\, Hybio Pharmaceutical \nKui Yang\, Division of Complex Drug Analysis\, Office of Testing & Research\, OPQ\, CDER\, US FDA \nPhilip Ross\, Wave Life Sciences \nGiovanni Calderisi\, Bachem\, Switzerland \nAndrew Argo\, Biogen \nVed Srivastava\, Member of USP Therapeutic Peptides and Oligonucleotides Workshop Steering Committee and USP BIO1 Expert Committee \nMark Kerr\, Eli Lilly & Company \nMatteo Villain\, Bachem Americas \nHagen Cramer\, QurAlis Corporation \nMark Strege\, Eli Lilly & Company \n
URL:https://www.mdtechcouncil.com/membership/events/calendar/usp-workshop-on-therapeutic-peptides-and-oligonucleotides/
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