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.

Key session topics we’ll be covering include:
• Raw material considerations for drug substance
• Drug products: novel formulation approaches and delivery systems
• Molecular design: improving stability, bioavailability, half-life extension
• Analytical development, characterization and validation
• Green chemistry approaches for synthesis and/or analysis
• Advances in manufacturing and purification technologies: strategies and novel methods
• Control strategies and comparability
• Current and future documentary standards and reference standard materials to support peptides and oligonucleotides
• Regulatory aspects and compliance
• CMC strategies including case studies
• Drug conjugates
• Personalized medicines for both peptide vaccines and oligonucleotides
• Structure-function studies and new targets

Speakers Include:
Fouad Atouf Vice President, Global Biologics, USP

Michael De Felippis Chair, USP Therapeutic Peptides and Oligonucleotides Workshop Steering Committee, and Chair, USP BIO1 Expert Committee

Deyi Zhang, CDER, US FDA

René Thürmer, BfArM, Germany

Julie Zhang and Sarita Acharya, USP

Nadim Akhtar, USP Therapeutic Peptides and Oligonucleotides Workshop Steering Committee member, and on behalf of EPOC Working Group

Elaine Fowler, AstraZeneca

Gerhard Haas, USP Therapeutic Peptides and Oligonucleotides Workshop Steering Committee and USP BIO1 Expert Committee member

Dennis Rhodes, Ionis

Baole Zhang, Hybio Pharmaceutical

Kui Yang, Division of Complex Drug Analysis, Office of Testing & Research, OPQ, CDER, US FDA

Philip Ross, Wave Life Sciences

Giovanni Calderisi, Bachem, Switzerland

Andrew Argo, Biogen

Ved Srivastava, Member of USP Therapeutic Peptides and Oligonucleotides Workshop Steering Committee and USP BIO1 Expert Committee

Mark Kerr, Eli Lilly & Company

Matteo Villain, Bachem Americas

Hagen Cramer, QurAlis Corporation

Mark Strege, Eli Lilly & Company