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