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Workshop #1: Accelerating Oligonucleotides to IND and Beyond

Tuesday, February 26 | 9:00am - 12:45pm 

Workshop Overview:

This workshop will address early drug development and CMC of oligonucleotide therapeutics. A detailed discussion of moving oligonucleotide therapeutics from discovery to clinical trials will include a description of strategies for early clinical development, including GMP synthesis, analytical controls and specifications; nonclinical, CMC, manufacturing and scale-up and the regulatory framework for preparation of IND-IMPD dossiers. Participants will also gain a basic understanding of the considerations and requirements for taking an oligonucleotide therapeutic into first-in-human clinical trials.


Speakers:

  • Marc M. Lemaitre, Ph.D., Principal, ML Consult, USA
  • Thomas Rupp, Owner & Principal, Thomas Rupp Consulting, Germany

Workshop #2:

Tuesday, February 26 | 9:00am - 12:45pm

Workshop Overview:
This practical, introductory workshop will address early drug development of peptide therapeutics. A detailed discussion of moving peptide therapeutics from discovery to clinical trials will include a description of strategies for early clinical development, including GMP synthesis, analytical controls and specifications; formulation strategies; pharmacokinetics and toxicology study designs and requirements; and the regulatory framework for preparation of IND-IMPD dossiers. Participants will gain a basic understanding of the considerations and requirements for taking a peptide therapeutic into first-in-human clinical trials. 

Who Should Attend?
Anyone interested in preclinical/clinical development of peptide therapeutics including scientists in discovery research, manufacturing, project management, drug development, business development and regulatory affairs. 

Speakers: 

  • Bruce Morimoto, Ph.D, Vice President, Drug Development-Operations
  • Christopher Rhodes, Ph.D., President & CEO, Drug Delivery Experts