Day 1: Pre-Conference Workshops and Main Conference Keynotes
Day 1: Pre-Conference Workshops and Main Conference Keynotes
Workshop Description:
This workshop will address different strategies for overcoming manufacturing challenges of synthetic RNA therapeutics. It will also discuss methods for defining CMC control strategies along the development pathway from early clinical development through later stages of development. A variety of different examples and case studies will be presented to give attendees a good understanding of the current bottlenecks, potential solutions and future directions in oligonucleotide CMC and manufacturing.
Who Should attend?
Anyone interested in development of 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 - Managing Director Operations, Axolabs
- Thomas Rupp - Managing Director Operations, Axolabs
The purpose of this workshop is to introduce scientists to therapeutic oligonucleotides. This workshop will discuss the different types of therapeutic oligonucleotides and how they work in the body to treat disease. Difference modalities such as SiRNA, ASO, MiRNA and Aptamer will be covered. The key factors for the design of the molecules will be described. The workshop will also discuss the challenges of delivery to the appropriate tissue and into the appropriate cell, and the strategies currently employed to address these. The toxicology, metabolism and clearance in the body will be covered. Finally, the workshop will discuss formulation options and how the drug substances and drug products are manufactured and controlled.
- Mike Webb, Ph.D. - Founder and CEO, Mike Webb Pharma
- Mike Webb, Ph.D. - Founder and CEO, Mike Webb Pharma
This workshop will provide an overview of peptide preformulation strategies and technologies for early development. By performing preformulation and early formulation studies on a peptide, their complex architecture may be stabilized in an intended media thereby improving solubility and shelf life. Having access to expertise and a broad set of tools to investigate the physicochemical properties of a peptide, investigate solubility in likely media, and evaluate risk of precipitation in intended media is vital for effective therapeutic peptide delivery. A variety of topics will be presented via examples and case studies illustrating the current bottlenecks, potential solutions and future directions in developing a robust peptide preformulation approach.
- Jonathan Loughrey, Ph.D. - SC CR Physical Sciences Manager, Almac Sciences
- Jonathan Loughrey, Ph.D. - SC CR Physical Sciences Manager, Almac Sciences
- Marco Minuth, PhD - Director Oligo R&D II, Bachem
- Charlotte LeKieffre, PhD - LC/MS Field Application Specialist, Agilent Technologies
- Ossian Saris - Market Specialist Europe, Agilent Technologies
- Mimoun Ayoub, PhD - Senior VP, Global Head of Sales and Key Account Management, CordenPharma International
- Sudhir Agrawal - President and Founder, Arnay Sciences
- David Craik, PhD - Professor of Biomolecular Structure, University of Queensland
- Akshay Vaishnaw, MD, PhD - President, Alnylam Pharmaceuticals
- Karina Thorn - Corporate VP, RNA and Gene Therapies, Novo Nordisk
- Christian Heinis, Ph.D. - Associate Professor, Ecole PolyTechnique Federale de Lausanne
- Nina Hartrampf, Ph.D. - Assistant Professor, Department of Chemistry, University of Zurich
- Theo van Berkel, Ph.D. - Retired Head of Division, Leiden University