- August 12, 2019
08:00 AM - 05:00 PM EDT
- Organized By:
Food and Drug Administration
Office of Clinical Pharmacology, Office of Translational Sciences
Yaning Wang, PhD
Raj Madabushi, PhD
University of North Carolina
Bob Powell, PharmD
The Food and Drug Administration in collaboration with the University of North Carolina will host a 1-day public workshop, “Precision Dosing: Defining the Need and Approaches to Deliver Individualized Drug Dosing in the Real-World Setting.”
Date: August 12, 2019
Time: 8:00am to 5:00pm
Location: Food and Drug Administration White Oak Campus
Great Room, Building 31, Room 1503 (B and C)
10903 New Hampshire Avenue
Silver Spring, MD 20993
Some clinical trials in drug development are conducted to optimize the dosing regimen of a new drug for the target patient population. Clinical pharmacology trials serve as the major source of evidence for dose individualization (precision dosing) taking into account patient factors that can modify drug response. Despite these efforts prior to a drug’s approval, further dose optimization may be required after drug approval (e.g., accounting for extremes of age, body habitus, organ function and complex multiple characteristics including genotype, drug interactions, and co-morbidities). The opportunities and challenges for further dose optimization/individualization will be discussed from multiple perspectives including drug developers, regulators, physicians, pharmacists and patients. These relevant groups will also discuss in what contexts precision dosing may be needed, and the challenges of generating evidence to support precision dosing and applying individualized dosing regimen in clinical practice. In addition to evidence created during the new drug development process, real-world data/evidence will be discussed to address some challenges that cannot be addressed by pre- and post-approval clinical trials. The process of translating the knowledge to tools that can be utilized by the medical community for patient care will also be discussed.
- To explore the need for more precise dosing.
- To investigate opportunities in the drug development and real-world settings to generate the information needed to support precision drug dosing.
- To discuss the translation of the dosing information to electronic drug dosing delivery tools to enable precision dosing in clinical practice.
The FDA will provide a free-of-charge, live webcast of this workshop. Recordings of the webcast can be found at the following links:
- Jelliffe: Individualized, Maximally Precise Drug Therapy: A Physician’s Bedside Viewpoint
- Gonzalez: Pharmacometric Strategy and Tools in the Design of Precision Dosing for the Electronic Patient Care Environment
- Goswami: The evolution of supports tools that enable precision dosing at the point of care
- Cook: Does Drug Development Provide the Information Necessary to Allow Precision Dosing?
- Neely: Are We Really Going to Buy Into Individualized Dosing?
- Peck: Drug Development to Enable Precision Dosing
- Temple: Regulatory Consideration in Determining Optimal Dose for Patients
- Van Driest Using Real World Data to Fill Evidence Gaps for Precision Dosing
- Vinks: Clinical Implementation of PK/PD Model-Informed Decision Support Tools for Precision Dosing
- Zineh: Drug Dosing in the Real World: Challenges and Opportunities
Who should attend:
This workshop will be open to the public. This workshop is intended for diverse groups from academia, industry, regulatory agencies, patient advocacy organizations, real-world data companies and other individuals who have an interest in approaches to precision dosing and its impact in drug development and patient care.
Bernadette Johnson-Williams, MEd
Senior Regulatory Project Manager
Office of Clinical Pharmacology
Office of Translational Sciences
Center for Drug Evaluation and Research
Food and Drug Administration