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Nov 06
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10:00 - 10:30 30 mins
10:30 - 10:40 10 mins
Chairperson’s Opening Remarks
  • Thomas Rupp - Owner & Principal, Thomas Rupp Consulting, Germany
10:40 - 16:30 350 mins
Risk-Based Approaches to CMC Development of Therapeutic Oligonucleotides
  • Thomas Rupp - Owner & Principal, Thomas Rupp Consulting, Germany

There is a growing trend in the pharmaceutical industry towards accelerated development of therapeutics to address unmet medical needs. The shorter timelines coupled with increasing complexity of the development candidates and/or delivery systems presents extraordinary challenges for managing the chemistry, manufacturing and controls activities. Key to regulatory and operational success is a risk based approach to management of manufacturing, product quality and supply chain. This workshop will address important concepts for balancing and mitigating a variety of risks (safety, economic or regulatory, etc.) towards successful clinical development, regulatory approval and commercialisation of therapeutic oligonucleotides.

  • Selection and Justification of Regulatory Starting Materials
  • Impurities in Oligonucleotide Drug Substances and Drug Products: Safety Considerations
  • Planning for Oligonucleotide Supply: Personalised Medicine to Large Scale Markets
  • Case Study: Evolution of the Rent, Buy or DIY Strategy
  • CMC Perspectives on Oligonucleotides
  • Interactive Panel Discussion: Ensuring Raw Material Supply Chain Quality for Oligonucleotides
16:30 - 16:35 5 mins
End of Day One