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Thursday, June 18 • 5:00pm - 6:00pm
#558 OD: ON DEMAND - Quality Considerations for Complex Drugs

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Component Type: Session
Level: Intermediate

Complex drugs can often have unique scientific and regulatory challenges related to product quality that are not commonly encountered with more conventional small molecule drugs. Examples of such complex drugs include botanicals, oligonucleotides, and generic peptides.

Learning Objectives

Discuss some of the unique scientific and regulatory challenges associated with botanicals, oligonucleotides, and generic peptides drugs including navigating frequently seen quality issues that may arise during later phases of drug development; Outline how to proactively identify critical quality attributes associated with these drugs to help mitigate product risk.

Chair

M. Scott Furness, PhD

Speaker

Unique CMC Challenges Associated With Botanical Drug Review
Charles G. Wu, PhD

Complex Peptide ANDAs: Test and Reference Product Comparability Studies from a Quality Perspective
Cameron J Smith, PhD

Quality Considerations for Oligonucleotide Therapeutics
Nanda K. Subbarao, PhD


Speakers
MS

M. Scott Furness

Deputy Director, Office of New Drug Products, OPQ, CDER, FDA, United States
Scott Furness, Ph.D., Deputy Director, ONDP, OPQ, joined CDER’s OPS/OGD in 2000, serving as a Chemistry reviewer and team leader. In 2007, he was named Director of the Division of Nonprescription Regulation Development in the Office of New Drugs’ (OND). During his time in OND... Read More →
avatar for Charles Wu

Charles Wu

Expert Pharmacologist, OPQ, CDER, FDA
Dr. Charles Wu is an Expert Pharmacologist at Center for Drug Research and Evaluation of the FDA. He was trained in clinical medicine including the Traditional Chinese Medicine and earned his Ph.D. from University of Amsterdam. He has been working at the FDA since 2001 after a fellowship... Read More →
avatar for Cameron Smith

Cameron Smith

Senior Chemist, OLDP, OPQ, CDER, FDA
Cameron Smith is a Senior CMC Review Chemist in the Division of Liquid-Based Products, Office of Lifecycle Drug Products, OPQ. He serves as an assessor and technical lead on quality assessment teams for liquid-based product ANDAs with a specialty in injectable complex peptide and... Read More →
NS

Nanda Subbarao

Group Leader, CMC Development, Biologics Consulting
Dr. Subbarao is currently the Group Leader for Analytics CMC Group and Senior Consultant with the Biologics Consulting Group. She has assisted pharma and biotech organizations in evaluation of analytical methods and method validation for a wide range of products from pre-clinical... Read More →

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044
  10: RegCMC-Product Quality, Session