Workshop will cover the following topics:

This workshop will address early drug development and CMC for 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 cover chemistry and regulatory aspects 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.

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 RuppOwner & Principal at Thomas Rupp Consulting, Germany

Agenda Sessions

Speakers at this event

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Thomas Rupp
Owner & Principal at Thomas Rupp Consulting, Germany