Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources December 12 - 13, 2023

Virtual | Virtual

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• Date: December 12 - 13, 2023
• Day1: Tue, Dec 12 12:00 PM - 2:00 PM ET
• Day2: Wed, Dec 13 1:00 PM - 3:00 PM ET

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Topics & Presentations Day 1	Speakers
Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources – Day 1
Overview.pdf	Rajanikanth Madabushi Associate Director Guidance & Policy Team Office of Clinical Pharmacology (OCP) Office of Translational Sciences (OTS) CDER | FDA
Health Communications for Optimal Drug Therapy: Examples of Drugs That Interact with CYP Enzymes & Transporter Systems.pdf	Joseph A. Grillo Associate Director Labeling and Health Communication Team OCP | OTS | CDER | FDA
Q&A Discussion Panel 1	Rajanikanth Madabushi, Joseph A. Grillo And Xinning Yang Policy Lead Guidance & Policy Team OCP | OTS | CDER | FDA
Clinical Drug Interaction Studies with Combined Oral Contraceptives (COCs).pdf	Yanhui Lu Team Lead Division of Cardiometabolic and Endocrine Pharmacology (DCEP) OCP | OTS | CDER |FDA Li Li Senior Clinical Pharmacologist DCEP | OCP | OTS | CDER
Q&A Discussion Panel 2	Yanhui Lu, Li Li And Gerald D Willett Lead Physician Division of Urology, Obstetrics, and Gynecology (DUOG) Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine (ORPURM) Office of New Drugs (OND) CDER | FDA

 

 

Topics & Presentations Day 2	Speakers
Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources – Day 2
Final Guidance: Evaluation of Gastric pH-DDIs With ARAs: Study Design, Data Analysis, & Clinical Implications.pdf	Anuradha Ramamoorthy Policy Lead Guidance & Policy Team Office of Clinical Pharmacology (OCP) Office of Translational Sciences (OTS) CDER | FDA Xinning Yang Policy Lead Guidance & Policy Team OCP | OTS | CDER | FDA
Q&A Discussion Panel 1	Anuradha Ramamoorthy, Xinning Yang And Fang Wu Senior Pharmacologist Division of Quantitative Methods and Modeling (DQMM) Office of Research and Standards (ORS) Office of Generic Drugs (OGD) CDER | FDA Insook Kim Master Scientist Division of Inflammation and Immune Pharmacology (DIIP) OCP | OTS | CDER | FDA
Drug-Drug Interaction Assessment for Therapeutic Proteins.pdf	Lin Zhou Senior Clinical Pharmacologist Division of Cardiometabolic and Endocrine Pharmacology (DCEP) OCP | OTS | CDER | FDA Raajan Naik Policy Analyst Guidance & Policy Team OCP | OTS | CDER | FDA
Q&A Discussion Panel 2	Lin Zhou, Raajan Naik And Elimika Pfuma Fletcher Policy Lead Guidance & Policy Team OCP | OTS | CDER | FDA Xiaofei Wang Pharmacologist Division of Clinical Evaluation General Medicine (DCEGM) Office of Therapeutic Products (OTP) Center for Biologics Evaluation and Research (CBER)

 

Agenda

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THIS WEBINAR will discuss:

• The importance of assessing the drug interactions involving therapeutic protein products, interactions cause by change of gastric pH level, and interactions affecting combined oral contraceptives.
• How to evaluate those drug interaction potentials for investigational drugs
• General considerations for designing clinical drug interaction studies and how the results may inform drug labeling
• Utility of the lists of drugs available on the FDA drug interaction websites and the relevance to drug development and clinical practice

INTENDED AUDIENCE

• Scientists and consultants involved with drug interaction assessments conducted to support IND/NDA/BLA/ANDA applications
• Academic researchers in fields investigating drugs interactions
• Regulatory reviewers and policy makers
• Healthcare providers prescribing drugs to patients or consulted by patients

TOPICS COVERED

• Updates on the FDA drug interaction websites
• When and how to evaluate the impact of investigational drugs on combined oral contraceptives
• When and how to evaluate the effects of gastric pH elevation caused by acid reducing agents on investigational drugs
• When and how to evaluate the drug interactions involving therapeutic protein drugs.

LEARNING OBJECTIVES

• Describe the FDA drug interaction website, understand the clinical relevance of the tables, and how those tables can be used by drug developer and health care providers to assess drug interaction risks.
• Discuss the framework to determine the need to conduct clinical studies to evaluate the effects of investigational drugs on combined oral contraceptives, how such studies may be performed, and how to communicate recommendations for use in drug labeling to mitigate the risk of drug interactions.
• Address the circumstances when clinical studies are needed to evaluate the impact of acid-reducing agents on investigational drugs and alternative approaches, how such assessments can be conducted, and how the results may inform drug labeling.
• Review various mechanisms of drug interactions involving therapeutic protein drug products, a framework to determine the risk of such interactions, and how to communicate the drug interaction risks and mitigation strategy in drug labeling.

FDA RESOURCES

• FDA website on Drug Interactions & Labeling: Drug Development and Drug Interactions | Table of Substrates, Inhibitors and Inducers
• FDA guidance for industry: Clinical Drug Interaction Studies with Combined Oral Contraceptives
• FDA guidance for industry: Evaluation of Gastric pH-Dependent Drug Interactions with Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications
• FDA guidance for industry: Drug-Drug Interaction Assessment for Therapeutic Proteins