This non-laboratory based one-year Clinical Pharmacology Fellowship focuses on developing skills of a modern clinical pharmacology scientist. The fellow will be provided opportunities to gain expertise in nonclinical and clinical development through honing skills in areas such as nonclinical pharmacokinetics/toxicokinetics, clinical pharmacology, translational strategies, modeling and simulation/pharmacometrics. As part of the training, the fellow will be provided with opportunities to engage in various activities such as: design and execution of nonclinical pharmacokinetic/toxicokinetic studies, design and execution of clinical pharmacology studies, development of translational strategies in support of target engagement and biomarker/ dose/regimen selection, preparation of regulatory documents, and PK/PD and pop-PK modeling. The candidate will also participate in cross-functional team interactions spanning all of AbbVie’s therapeutic areas. This advanced hands-on training program can be tailored towards the specific needs and background of the candidate.
Collaboratively design and oversee execution of nonclinical pharmacokinetic/toxicokinetic studies and/or clinical pharmacology studies
Analyze, interpret, and present data derived from nonclinical and clinical studies
Serve (alongside a senior mentor) as a representative on nonclinical and clinical project teams to guide clinical pharmacology and translational efforts
Contribute towards drafting regulatory documents
Execute, interpret, and present results from PK/PD and/or pop-PK analyses at internal meetings
If applicable, present work at professional meetings and/or author a scientific publication
The one-year Immunology Fellowship mainly focuses on immunogenicity studies against biologics and toxins to support drug development programs. As part of the training, the fellow will be provided with opportunities to participate in various activities like designing experiments, executing experiments and data analysis. It also involves cross functional team interactions across multiple therapeutic areas within AbbVie. Additionally, interested fellows can gain expertise in flowcytometry, Luminex, ex vivo/in vivo assays. The fellowship is intended to enhance the postdoctoral research training of the applicant and develop the skills required to excel in their field.
Collaborate and conduct a thorough review and build a knowledge base (ARCH/Convergence collaboration) of the immunogenicity data across all internal ophthalmology, Toxin and device programs
Build knowledge base (collect, analyze data) for immunogenicity data and potential risks from publications on commercial biologics across all ophthalmology, Toxin and device areas.
Building knowledge base from literatures around in silico and in vitro assays and identify the most promising ones for immunogenicity prediction specific for different modalities
Proposing fit-for-purpose in vitro/ex vivo/in vivo assays to investigate potential risk evaluation and relevant outcome measures for devices
This one-year Research Pharmacology Fellowship focuses on developing the pre-clinical translational skills required of a pharmacology scientist. As part of the training program, the fellow will participate in pre-clinical study activities including study conceptualization through study design, protocol development, study execution, and cross functional team interactions across multiple therapeutic areas within AbbVie. Additionally, interested fellows can gain expertise in pharmacology sections of regulatory submissions, and interact with scientists from other functions such as formulation development, clinical pharmacology and clinical development. The fellowship is intended to enhance the postdoctoral research training of the applicant with hands-on application of core biological principles and techniques to move programs from preclinical stages to clinical development for key AbbVie programs.
Independently design and conduct pharmacology studies to support program projects
Research, design and validate novel platforms or targets
Be able to execute, interpret, and deliver data analyses
If applicable, present work at internal AbbVie meetings, a professional meeting and/or author a scientific publication
The one-year Toxicology Fellowship focuses on developing the skills needed to identify the toxicology and safety pharmacology studies required to support drug development programs, to independently design toxicology studies and to be able to interpret and integrate data from toxicology studies into risk assessments in support of product safety and dose selection for initiating clinical investigations or regulatory submissions. As part of the training, the fellow will engage as Toxicology Representative on project teams, prepare regulatory documents, learn about the assessment of testing facilities and participate in cross-functional team interactions.
Learn about requirements for nonclinical safety testing of pharmaceutical drugs to support conduct of clinical trials and marketing authorization
Learn how to independently design and conduct toxicology studies
Acquire experience as Toxicology Representative on projects teams to guide the nonclinical safety strategy
Be able to interpret data from toxicology studies
Become familiar with global regulatory agency interactions and regulatory document submissions
Participate in/observe nonclinical safety study activities
The USC Pharmaceutical Industry Fellowship programs are designed to prepare postdoctoral scholars for rewarding careers in the pharmaceutical industry. Fellows work with mentors to participate in activities that enhance the skills required to excel in their field. Graduate-level coursework and seminars at the University of Southern California School of Pharmacy are part of the fellowship along with our industry partners including Abbvie, Inc.