Agenda Speaker Biographies Speaker Presentations
Overview
Therapeutic peptides and oligonucleotides are rapidly growing product classes; however, novel modifications and formulations present new challenges for the products. Therefore, additional best practices and guidance are critically needed to expedite quality products coming to the global market.
USP will continue to support therapeutic peptides and oligonucleotides by gathering experts from the analytical, process development, and regulatory communities to share best practices and success stories.
The presentations and Panel discussions with experts across the globe will provide opportunities for attendees to ask questions and dig deeper into the presented content.
Key session topics
(See Call for Abstracts for additional details)
- Drug formulation and design
- Manufacturing technologies
- Analytical development, characterization, and validation
- Control strategies
- Regulatory aspects
- Raw materials for drug substance
Workshop Steering Committee
- Michael De Felippis, Ph.D., Chair, Distinguished Research Fellow, Eli Lilly & Co.
- Marc Lemaître, Ph.D., Principal, ML Consult LLC
- Antonio Ricci, Ph.D., VP Innovation & Development API, Fresenius Kabi
- Gerhard Haas, Ph.D., VP of Quality, Bachem
- Julie Zhang, Ph.D., Principal Scientist, USP
- Bruno De Carvalho, Ph.D., Stakeholder Engagement Manager, USP
Who should participate?
- Scientists developing peptides and oligonucleotides
- QA/QC analysts
- Manufacturing and process development scientists, managers
- Quality and regulatory staff supporting supplier evaluation, agreements and audits
- Contract research organizations
- Contract manufacturing organizations
- Raw material vendors
Day One
- Standards USP to Support Quality of Peptide and Oligonucleotide Therapeutics, Kevin Carrick, Senior Director Biologics Science & Standards, USP
- CMC Challenges in FDA-approved Synthetic Oligonucleotide Drugs, Lawrence Perez, Senior Pharmaceutical Quality Assessor, U.S. Food and Drug Administration
- CMC Regulatory Experiences and Expectations for Peptides, Katharine Duncan, Senior Pharmaceutical Quality Assessor, U.S. Food and Drug Administration
- Framework for Evaluating Impurity Risks in Starting Materials for Oligonucleotide API Manufacturing, David Butler, Chief Technology Officer, Hongene Biotech Corporation
- Holistic control strategy of oligonucleotides starting materials, Martina Austeri, Director of Quality Control, Bachem AG, Switzerland
- Analytical toolbox to enable the synthesis and release of complex synthetic peptides, Tim Hellebrand, Senior Group Leader for Analytical Development, Bachem
- Synthetic Oligonucleotide Impurity Analysis: Enhancing the Conventional Single Quad Method Using UPLC-ToF-MS, Ying Qing Yu, Biopharmaceutical Program Science Team Leader, Waters
- Improving TIDES product risk assurance with NMR spectroscopy, Anna Codina, Senior Director Biopharma and Strategic Market Development, Bruker BioSpin
- LC-HRMS-based Multi-attribute Method for Oligonucleotides (MAMO): Characterization and Impurity Profiling, Kui Yang, Senior Research Scientist, U.S. Food and Drug Administration
Day Two
- Process improvements to effect more efficient and greener peptide synthesis, Mohan Dhote, Head of Department, Synthetic Peptide, Enzene Biosciences and Chandrakant Kulkarni, Principal Scientist – Synthetic Peptide Department R&D Center
- Immunogenicity Risk Assessment of Peptide Drugs and their Impurities, Annie De Groot, Chief Science Officer, and Chairman of the Board, EpiVax
Questions? Please contact Bruno.decarvalho@usp.org