Clinical Pharmacology Considerations for Novel Therapeutic Modalities

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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