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Leveraging Clinical Pharmacology to Transform Real World Data into Real World Evidence for Special Patient Populations
Session Chair(s)
Anuradha Ramamoorthy, PharmD, PhD
Policy Lead, OCP, OTS, CDER
FDA, United States
At the time of drug approval, information on optimal use of the drug may not be available for the entire range of patients who might need the drug. This includes certain ‘special populations’ who may be unstudied or understudied at the time of approval, for e.g., pediatrics, pregnant or lactating women, patients with compromised kidney or liver function, etc. This session will discuss opportunities for leveraging real-world data (RWD) to generate real-world evidence (RWE) to help personalize treatment for these special populations. The speakers will also highlight how clinical pharmacology-relevant (e.g., pharmacokinetic, pharmacodynamic, and pharmacogenomic) RWD can generate RWE to promote therapeutic individualization and supplement clinical trial and modelling and simulation data in special populations to make drug development and approval decisions. Case examples will be used to illustrate the key concepts.
Learning Objective : Describe the potential role for RWD and RWE in promoting therapeutic individualization in unstudied/understudied special patient subpopulations (e.g. pediatrics, compromised kidney/liver function); Discuss the opportunities and challenges in leveraging clinical pharmacology-relevant RWD to generate RWE.
Speaker(s)
Real World Evidence of Male Breast Cancer Patients Treated With Palbociclib in Combination With Endocrine Therapy: Extension of Indication
Keith D. Wilner, PhD
Pfizer Inc, United States
Executive Director, Oncology, Global Product Development
Leveraging Real World Data to Support the Development of Precision Medicines
Frederick Joseph Derosier, DO
Covance, United States
Executive Director, Rare Diseases
Using Real World Data to Support Drug Development in Pediatric Patients: C.E.R.A. Case Study
Pascal Chanu, PharmD
Genentech, A Member of the Roche Group, France
Modeling and Simulation Expert
Use of Real World Data to Advance the Mission of Clinical Pharmacology
Qi Liu, PhD
FDA, United States
Assoc Director for Innovation and Partnerships, OCP, OTS, CDER
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