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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

ON DEMAND - Quality Considerations for Complex Drugs

Session Chair(s)

M. Scott  Furness, PhD

M. Scott Furness, PhD

Deputy Director, Office of New Drug Products, OPQ, CDER

FDA, United States

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 Objective : 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.

Speaker(s)

Charles G. Wu, PhD

Unique CMC Challenges Associated With Botanical Drug Review

Charles G. Wu, PhD

FDA, United States

Expert Pharmacologist, OPQ, CDER

Cameron J Smith, PhD

Complex Peptide ANDAs: Test and Reference Product Comparability Studies from a Quality Perspective

Cameron J Smith, PhD

FDA, United States

Senior Chemist, OLDP, OPQ, CDER

Nanda K. Subbarao, PhD

Quality Considerations for Oligonucleotide Therapeutics

Nanda K. Subbarao, PhD

Biologics Consulting, United States

Group Leader, CMC Development

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