TIDES China Digital Week: Manufacturing Aspects of a Phase 1 Oligonucleotide IND

Manufacturing Aspects of a Phase 1 Oligonucleotide IND: Kathryn L. Ackley, Ph.D., CMC Consultant Specializing in Oligonucleotides

• How to start planning
• Assessing the molecule and the drug product
• Selecting CMOs
• Helpful suggestions
• Preparing the IND

Dr. Ackley earned her doctorate in analytical chemistry from the University of Cincinnati. She spent 16 years working in CDMOs serving the pharmaceutical industry. She has held positions in QC, production management, project management, and business development. Dr. Ackley was the Vice President of Development for Nitto Denko Avecia, one of the leading oligonucleotide CDMOs. Since 2018, Dr. Ackley has served as an independent CMC consultant. She is a member of the scientific advisory boards of the US TIDES conference and Chimica Oggi- Chemistry Today.

TIDES China Digital Week:

1. "Addressing the Challenges in Developing a Control Strategy for Therapeutic Oligonucleotides," with Mike Webb
2. "Take the Wheel and Drive Your Oligo Synthesis Where You Want," with Carina Strand
3. "Your ÄKTA Oligosynt™ System: It’s More Than a Machine," with Peter Guterstam

Click the links above to watch the webcasts