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: yowming.w...@fda.hhs.gov<mailto:yowming.w...@fda.hhs.gov> Peter ID Lee, PhD Associate Director, KM OCP, OTS, CDER, FDA (301) 796-1561 ider....@fda.hhs.gov<mailto:ider....@fda.hhs.gov> Best, Anh
