Introduction to Pharmacogenomics & Precision Medicine for Pharmacoepidemiologists

Course Aim
This course, sponsored by the Genomics & Precision Medicine SIG will focus on the essentials every pharmacoepidemiologist should know about real world applications of pharmacogenomics epidemiology including: (1) the role of epidemiology in pharmacogenomics; (2) definitions of genetic terms and basic genetic concepts; (3) quality control and analytical procedures required in a pharmacogenetic analysis; (4) step-by-step planning guide to designing a pharmacogenomic analysis; (5) phenotyping considerations and breaking down examples of pharmacogenomic successes; (6) databases available to study pharmacogenomics; (7) designing a companion pharmacogenomic diagnostic in drug development; (8) designing a prospective observational cohort or case-control study of pharmacogenomics; (9) designing a clinical utility trial: a guide with examples; (10) collecting health related quality of life data using an innovative role playing game.

Requisites Statement
Attendees should have basic knowledge of pharmacogenomics or have watched the pre-course videos (available online only) with links sent to registered attendees.
· The convergence of Pharmacoepidemiology and Precision Medicine [Gillian Bartlett]
· A Primer on Genetic Terms and Basic Concepts [Geoffrey Liu]

Course Objectives
· To understand basic genetic and pharmacogenomic terminology.
· To understand how pharmacogenomics research relates to the current focus on Precision Medicine (aka Personalized Medicine), using real world examples.
· To better understand the study design and methodologic approaches, their strengths and weakness used in pharmacogenomic epidemiology, specifically in relation to clinical applications.
· To understand the role that pharmacogenomics can play in pharmacovigilance and comparative effectiveness research
· To gain knowledge about some available databases with linkage with genomic information
· To understand the benefits and challenges of pharmacogenomics in pharmacoepidemiology in both research and clinical practice applications.

Syllabus Outline
Welcome and Introduction to the Course 5 min [Amalia M. Issa]
Presentations (30 minutes each — 2.5 hours):

Lecture 1: Precision Medicine in the Real World Needs Pharmacogenomic Epidemiology [Leah Sansbury] This module Will provide an overview of pharmacogenomics and how pharmacoepidemiologists can contribute meaningfully to precision medicine, including the methodologies, current status, and future direction.s Will discuss real-world examples, and share the experience of working as a pharmacoepidemiologist in industry and with government.

Lecture 2: What You Need to Consider When Applying Pharmacogenomic Research into Clinical Practice [Bruce Carleton]This module Will present up-to-date state of the science and describe real-world and up to date clinical applications.

Lecture 3: Pharmacoepidemiologic Methods in Precision Medicine Research: It's all about the application [Anke-Hilse Maitland van der Zee] This module will discuss robust pharmacoepidemiologic methods for use in pharmacogenomics research and will introduce different databases with both rich clinical, treatment, outcomes information and genomic information Will compare the pros and cons of different databases to guide future database selection and research.

Lecture 4: Clinical Utility Research and Pharmacogenomics: Trials and Tribulations [Stephen Kimmel] This module will share the roles, responsibilities and contributions of a pharmacoepidemiologist in pharmacogenomic clinical trials and provide up-to-date examples of recent and ongoing trials.

Lecture 5: Innovative Role-Playing Game: How pharmacoepidemiologists can collect real world health related quality of life data for pharmacogenomic applications [Gillian Bartlett]. This module will go over the development of a ‘serious' game as a novel data collection strategy.

Q&A Session with Course Faculty (25 minutes) [Amalia M. Issa] Facilitator and Moderator with all speakers; we may use cases depending on attendee interest.

Entering Anthony's World (30 minutes) [Gillian Bartlett] This interactive and fun feature gives the attendees with the opportunity to play an interactive innovative role-playing game. Through play and post play discussion, attendees will gain important insights about how to collect useful health related quality of life data for pharmacogenomic applications from patient-participants in real world clinical settings.

Conclusion (5 minutes) [Amalia Issa] Concluding notes and reminder to complete the course evaluations and to attend Genomics & Precision Medicine SIG meeting and Poster Walk