12 Design-"Georgia-Institute-of-Technology" Fellowship positions at Center for Drug Evaluation and Research (CDER) in USA

FDA Bioinformatics Fellowship

on the following topics: The fundamentals of how FDA CDER reviewers interpret toxicology study results The SEND data standard and how it maps onto toxicology study design and results Development of R scripts

Clinical Pharmacology of Therapeutic Biologics and Biosimilars Fellowship

depends on the characteristics of PK (and PD when appropriate). Given the diversity of therapeutic proteins in structural features and in the PK properties, the study design characteristics for the PK

FDA Bioequivalence of Complex Generic Products Fellowship

products with device components that may themselves have degrees of complexity in design. In addition, the participant will gain knowledge in collaborating with cross-disciplinary teams to develop novel in

FDA Fellowship in Comparative Gaps Analysis in Sickle Cell Disease

the SCD community. The project is designed to address these gaps through strategic analysis between the clinical trial data that supported FDA approved for SCD therapeutic products and real world data

FDA In Vitro and In Vivo Bioequivalence Fellowship

polymer-based drugs, oral inhaled and nasal products, topical and transdermal drugs, and combination drug-device products with device components that may themselves have degrees of complexity in design. In

FDA-CDER Fellowship in the Intranasal Administration of Monoclonal Antibodies and other Biological Therapeutics

thinking, experimental design and aseptic technique and gain specialized skills including cell culture, immunohistochemistry, real-time PCR, and western blotting. Additionally, the participant will have

CDER Fellowship in Natural History for Rare Pediatric Viral Disease

events and clinical response to the duration of antiviral treatment course and c) obtain insights for possible endpoints, including biomarkers (e.g. CMV viral load) that might help future study designs

Anti-infective Fellowship: Pediatric Clinical Pharmacology

the development of anti-infective drugs for pediatric use. Specifically, the results of the project are expected to provide best practices for designing and evaluating pediatric drug development programs, and to

FDA Pharmacovigilance Fellowship: Methodological Assessment of Causal Associations

, interpret, and assimilate pharmacoepidemiologic literature to frame, design, and inform research questions. 2. Develop transferable skills in conducting methodological assessments that may be expanded

FDA Research Fellowship in Large Language Models for Clinical Pharmacology

language models (LLMs) for internal use, collaborate to design, develop, and refine large language models and generative models for various applications. Under the guidance of the mentor, the participant