Pharmacogenomics Considerations for Clinical Research and Implementation

The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.

Course Description:

This course explains how genetic variation influences the response to drug therapy. From discovery of pharmacogenetic associations to the evaluation of utility in clinical practice. Discussed will be a summary of CYP2C19 genetic variability in acute coronary syndrome (ACS) patients receiving clopidogrel post-percutaneous coronary intervention (PCI). Additionally, a review of available resources and guidelines to design best practices for discovering and translating pharmacogenetic (PGx) research.

Course Topics:

1. Precision Medicine and Pharmacogenomics
2. Pharmacokinetics and Pharmacodynamics
3. Translational Research
   • US FDA Approval of New Drugs
   • Biomarker-drug pairs approved per year
   • Pre-market and Post-market Considerations
4. Percutaneous Coronary Intervention (PCI)
   • Clopidogrel Metabolism
   • Alternatives to Clopidogrel
5. Genetic Sub-studies: Trial to assess improvement in therapeutic outcomes by optimizing platelet inhibition with Prasugrel (TRITON-TIMI 38)
6. Randomized Clinical Studies: TAILOR-PCI Study Design
7. Clinical implementation and feasibility studies (pragmatic trial): IGNITE Pharmacogenetics Working Group

Speaker:

Scott Mosley, PharmD, is an Assistant Professor in the Titus Department of Clinical Pharmacy, School of Pharmacy at USC. His research is focused on pharmacogenomics implementation, which incorporates genetic information with other clinical factors to optimize drug selection. Dr. Mosley received a B.S. in Biochemical/Biophysical Science from the University of Houston in 2006, then worked as an analytical chemist in a core pharmacology lab for MD Anderson Cancer Center in Houston, TX. He received his PharmD degree from the University of Texas in 2013, and then took a position as a pharmacist with MD Anderson Cancer Center. Dr. Mosley completed a postdoctoral research fellowship at the University of Florida College of Pharmacy in the Center for Pharmacogenomics during which he carried out a research protocol to assess the value of utilizing CYP2D6 genotype to guide opioid selection for patients with cancer pain. samosley@usc.edu

Audience:

This symposium is designed for Clinical Research Coordinators, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals or junior faculty with three or more years of experience seeking to further develop clinical research skills and principles. Clinical research professionals should have responsibilities that include clinical trial start up planning, mentoring, and complex issues involving site management, study management, and sponsor / CRO challenges.

Learner Level: Intermediate/Advanced

Learner Disclosures:

• Accreditation Status: Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.
• Financial Relationships: ENPDC has evaluated everyone who has the ability to control content of this activity (planning committee members, subject matter experts, presenters) and found that no relevant financial relationships exist.
• Awarding Contact Hours: To obtain contact hours participants must
  • Review the entire activity
  • Pass the quiz with 100% of questions answered correctly
  • Complete the evaluation at the end
  • Certificates will be distributed at the end of the evaluation.
• Enduring Materials Dates:
  • Start Date: 06/17/2022
  • Expiration Date: 06/16/2025

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.

Program Information: This is the first course in a five (5) course program. To complete the entire program and earn a badge CLICK HERE.