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Monday, June 15 • 11:00am - 12:00pm
#108 SL: Leveraging Clinical Pharmacology to Transform Real World Data into Real World Evidence for Special Patient Populations

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Component Type: Session
Level: Advanced
CE: ACPE 1.00 Knowledge UAN: 0286-0000-20-642-L04-P; CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Anuradha Ramamoorthy, PhD


Real World Evidence of Male Breast Cancer Patients Treated With Palbociclib in Combination With Endocrine Therapy: Extension of Indication
Keith D. Wilner, PhD

Leveraging Real World Data to Support the Development of Precision Medicines
Frederick Joseph Derosier, DO

Using Real World Data to Support Drug Development in Pediatric Patients: C.E.R.A. Case Study
Pascal Chanu, PharmD

Use of Real World Data to Advance the Mission of Clinical Pharmacology
Qi Liu, PhD


Keith Wilner

Executive Director, Oncology, Global Product Development, Pfizer Inc
Dr. Wilner received his Ph.D. in pharmacology from the University of Texas Health Science Center at Houston. He joined Pfizer in 1986. Dr. Wilner’s past experiences at Pfizer included overseeing the early development of new drugs in Inflammation, CNS, CV, Metabolism, and Infectious... Read More →
avatar for Pascal Chanu

Pascal Chanu

Modeling and Simulation Expert, Genentech, A Member of the Roche Group
Pascal Chanu has a Pharm.D., he started modeling with drug monitoring during hospital residency. He joined Roche Modeling & Simulation (M&S) group in 2003 as a postdoc and grew professionally up to Disease Area M&S expert. He moved to consultancy working for Pharsight (now Certara... Read More →

Qi Liu

Senior Science Advisor, Office of Clinical Pharmacology, OTS, CDER, FDA
Dr. Qi Liu is a Senior Science Advisor in the Office of Clinical Pharmacology (OCP), FDA. At FDA, Qi contributed to the review of over 200 NDA/sNDA, 20 BLA/sBLA, and numerous IND. Qi co-authored about 40 manuscripts and presented on many topics at Advisory Committee meetings and scientific... Read More →

Anuradha Ramamoorthy

Policy Lead, OCP, OTS, CDER, FDA, United States
Anuradha Ramamoorthy, Ph.D. is a Policy Lead at the Office of Clinical Pharmacology (OCP), Food and Drug Administration (FDA). She received her Ph.D. in Medical and Molecular Genetics from Indiana University and was a postdoctoral fellow at the NIH and FDA. In her current role, she... Read More →
avatar for Frederick Derosier

Frederick Derosier

Executive Director, Rare Diseases, Covance
Dr. Frederick Derosier, D.O., joined Covance Inc. as an Executive Medical director for Rare Diseases in 2017 and has over 10 years of private practice experience (internal medicine) and nearly 19 years of clinical development experience, primarily in neurosciences and rare diseases... Read More →

Monday June 15, 2020 11:00am - 12:00pm EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session
  • Featured Topics Real World Evidence,Patient Focused
  • Credit Type ACPE, CME, IACET, RN
  • Tags Session