This webinar discussed the clinical pharmacology considerations for the development of novel therapeutic modalities. FDA subject matter experts addressed the unique considerations for oligonucleotide therapeutics and antibody-drug conjugates with respect to topics such as dose selection, exposure/response analysis, organ impairment, drug interactions, QTc assessment, and immunogenicity.
Timestamps
04:22 – Intro – Novel Therapeutic Modalities
08:21 – Final Guidance: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics – Part 1
15:28 – Final Guidance: Clinical Pharmacology Considerations for the Development of Oligonucleotide Therapeutics – Part 2
26:13 – Q&A Session 1
01:00:16 – Final Guidance: Clinical Pharmacology Considerations for Antibody-Drug Conjugates
01:10:27 – Final Guidance: Clinical Pharmacology Considerations for Assessment of Intrinsic Factors QTC, Immunogenicity, and DDI
01:23:18 – Q&A Session 2
Speakers | Panelists:
Rajanikanth Madabushi, Ph.D.
Associate Director
Guidance & Policy Team
Office of Clinical Pharmacology (OCP)
Office of Translational Sciences (OTS) | CDER
Anuradha Ramamoorthy, Ph.D. FCP
Master Scientist & Policy Lead
Guidance & Policy Team
OCP | OTS | CDER
Hobart Rogers, Pharm.D, Ph.D.
Captain, United States Public Health Service
Reviewer
Division of Translational and Precision Medicine (DTPM)
OCP | OTS | CDER
Sarah Ridge, Ph.D.
Policy Analyst
Guidance & Policy Team
OCP | OTS | CDER
Qin Sun, Ph.D.
Biologics Lead
Therapeutic Biologics Program
OCP | OTS | CDER
Wendy Wu, Ph.D.
Senior Pharmacokineticist
Division of Applied Regulatory Sciences
OCP | OTS | CDER
Oluseyi Adeniyi, Pharm.D, Ph.D.
Reviewer
DTPM | OCP | OTS | CDER
Brian Booth, Ph.D.
Director
Division of Cancer Pharmacology I
OCP | OTS | CDER | FDA
Learn more at: https://www.fda.gov/drugs/news-events-human-drugs/clinical-pharmacology-considerations-novel-therapeutic-modalities-12042024
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