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ABOUT THIS EVENT (Hosted by CDER SBIA)

This webinar will discuss the clinical pharmacology considerations for the development of novel therapeutic modalities. To support the growing number of novel therapeutics, the final guidances on oligonucleotide therapeutics and antibody-drug conjugates will be highlighted and described in detail.

Our FDA subject matter experts will also address 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. The presenters will communicate when the recommendations described in the guidances should be considered and what types of assessments are suitable to address the topics listed above during drug development.

INTENDED AUDIENCE

• Scientists in pharmaceutical companies, contract research organizations, and consultant firms who work on developing novel therapeutic modalities
• Regulatory reviewers and policy makers working in those areas

TOPICS COVERED

• Overview of novel therapeutics
• Clinical pharmacology considerations for oligonucleotide therapeutics
• Clinical pharmacology considerations for antibody drug conjugates

LEARNING OBJECTIVES

• To gain an understanding of the clinical pharmacology considerations and recommendations for the development of:
  • oligonucleotide therapeutics
  • antibody-drug conjugates

SPEAKERS

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

Panelists Names

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
Division of Cardiometabolic and Endocrine Pharmacology | OCP | OTS | CDER | FDA

FDA RESOURCES