Good morning!
Hope this email finds you well. We are currently recruiting candidates for the
FDA Clinical Pharmacology of Therapeutic Biologics Fellowship at the Office of
Clinical Pharmacology, Center for Drug Evaluation and Research (CDER), FDA in
Silver Spring, Maryland. I would greatly appreciate if you can help let all
NONMEM users on the network know
The Center for Drug Evaluation and Research (CDER) performs an essential public
health task by making sure that safe and effective drugs are available to
improve the health of people in the United States. As part of the U.S. Food and
Drug Administration (FDA), CDER regulates over the counter and prescription
drugs, including biological therapeutics and generic drugs. This work covers
more than just medicines.
The participants will gain in-depth knowledge on (1) clinical pharmacology of
therapeutic proteins by reviewing the PK characteristics of approved products
(CDER BLAs) and PD properties based on treatment responses measured using
various biomarkers, (2) regulation and regulatory considerations for biosimilar
drug development, (3) current practice of study design for clinical
pharmacology studies in biosimilar programs, (4) information needed to support
study design, and (5) similarities/dis-similarities in PK and PD among protein
products.
Qualifications
The qualified candidate should have received a PhD, Pharm D, or MD in one of
the relevant fields. Degree must have been received within five years of the
appointment start date.
Computer skills for data manipulation and analysis, experience with
pharmacokinetic modeling tools is preferred.
Please feel free to reach out to the Fellowship Directors for additional
questions
Yow-Ming C. Wang, Ph.D.
Associate Director for Biosimilars and Therapeutic Biologics
Therapeutic Biologics Program
Office of Clinical Pharmacology
Office of Translational Sciences
Center for Drug Evaluation and Research
Food and Drug Administration
Phone number: 301-796-0387
Email: [email protected]<mailto:[email protected]>
Peter ID Lee, PhD
Associate Director, KM
OCP, OTS, CDER, FDA
(301) 796-1561
[email protected]<mailto:[email protected]>
Best,
Anh