東京大学 大学院理学系研究科化学専攻化学科 教授
Vice President, Antisense Drug Discovery
Ionis Pharmaceuticals, Inc.
Professor of Biomolecular Structure, Institute for Molecular Bioscience
University of Queensland
Senior Vice President, Head of RNAi Platform
Alnylam Pharmaceuticals
大阪大学 大学院薬学研究科 教授
アジェンダ 1日目 -
アジェンダ 1日目 -
- Thomas Rupp - Owner & Principal, Thomas Rupp Consulting, Germany
- Marc Lemaitre, PhD - Consultant, ML Consult
Workshop Overview:
This workshop will address early drug development and CMC of oligonucleotide therapeutics. Preparing for IND/IMPD is a critical and strategic step for successful start of clinical development. A detailed discussion of moving oligonucleotide therapeutics from discovery to clinical trials will include a description of CMC strategies for early clinical development, process development, raw materials selection and control, GMP synthesis, analytical controls and specifications. The workshop will be split into a chemistry part from early synthesis to initial scale-up, addressing impurities and their control and a regulatory part addressing what is needed for the preparation of IND-IMPD dossiers based on existing guidelines. Participants will gain a basic understanding of the considerations and requirements for taking an oligonucleotide therapeutic into first-in-human clinical trials. After the presentations the speakers will jointly chair a panel discussion on CMC aspects.
Topics to be covered and format:
- 2 presentations, 45-minutes each followed by a 15-minute open discussion
- 30 - 60-minute panel discussion on CMC aspects
- CMC activities for complex and emerging oligonucleotide therapeutics
- Impurities and their control
- Preparation of an IND and regulatory aspects
Who should attend?
Anyone interested in development of complex oligonucleotide therapeutics; Anyone interested in outsourcing the manufacturing of oligonucleotide therapeutics to a CMO / CRO. This includes R&D Researchers, Manufacturing Personnel, Quality Assurance, Project Management, Business Development and Scientific Management
- Thomas Rupp - Owner & Principal, Thomas Rupp Consulting, Germany
- Marc Lemaitre, PhD - Consultant, ML Consult
Workshop Overview:
This workshop will discuss a variety of strategies and techniques to improve the drug-like properties of peptides throughout the product lifecycle from discovery through development and chemical synthesis. Developability and manufacturability considerations will also be discussed. Examples and case studies from a variety of peptide programs will be presented along with challenges encountered, successes achieved and lessons learned.
- Bruce Morimoto, PhD - Vice President, Drug Development, Alto Neuroscience
- Robert Hagopian - Director Business Development, PolyPeptide Group
- David Craik, PhD - Professor of Biomolecular Structure, Institute for Molecular Bioscience, University of Queensland
- Alastair Hay, PhD - Vice President, Peptides, Almac
- Bruce Morimoto, PhD - Vice President, Drug Development, Alto Neuroscience
- El Djouhar Rekai, PhD - Head of Business Unit Peptide Process Development, PolyPeptide Group
- Hiroaki Suga, Ph.D. - Professor of Chemistry, School of Science, University of Tokyo, Japan
- Shuling Guo, PhD - Vice President, Antisense Drug Discovery, Ionis Pharmaceuticals, Inc.
- David Craik, PhD - Professor of Biomolecular Structure, Institute for Molecular Bioscience, University of Queensland
- Vasant Jadhav, PhD - Senior Vice President, Head of RNAi Platform, Alnylam Pharmaceuticals
- Satoshi Obika, PhD - Professor, Graduate School of Pharmaceutical Sciences, Osaka University
* 不測の事態により、事前の予告なしにプログラムが変更される場合があります。