Pharmacometrics Team Lead
United States FDA
Dr. Justin Earp is a team lead in the Division of Pharmacometrics for anti-viral/anti-infective and metabolic/endocrine products. Dr. Earp joined the Division of Pharmacometrics as a reviewer in 2008 and has served as a primary reviewer on over 150 IND and NDA & BLA reviews. Between 2016 and 2019 he was the scientific lead for biosimilar and biologic products in the division. Over the past 16 years he has also served on a number of working groups including: the ISOP working group for the assessment of PK drug-drug interactions via population PK and the AAPS working group for the assessment of therapeutic protein drug-drug interactions via population PK, as well as the FDA's safety analytics control board, and co-chair for the Office of Clinical Pharmacology's QSP scientific interest group.
Disclosure(s): No financial relationships to disclose
Mind the gap – successful bridging of QSP and PMX in drug development
Monday, November 11, 2024
3:15 PM – 4:45 PM MST
