Pharmacogenomics, Precision Medicine and Oncology

1. 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) collecting health related quality of life data using an innovative role playing game;

2. 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]
• Cancer Terminology and the Science of Cancer Drug Development [Geoffrey Liu]

3. Course Objectives
• To understand basic genetic and pharmacogenomic terminology.
• To understand how pharmacogenomics research relates to the current focus on Precision Medicine using real world examples.
• To acquire an overview of genomics in cancer research, and how epidemiologists and real-world studies make contributions.
• To better understand the study design and methodologic approaches, their strengths and weakness used in pharmacogenomic epidemiology, specifically in relation to clinical applications of cancer.
• To understand the benefits and challenges of pharmacogenomics in pharmacoepidemiology in both research and clinical practice applications.

4. Syllabus Outline

Module 1: The Present and Future of Precision Medicine and Pharmacogenomic Epidemiology [Amalia M. Issa] This module will provide an overview of pharmacogenomics and how pharmacoepidemiologists can contribute meaningfully to precision medicine as well as updates on the field and a horizon scan of where it is going.

Module 2: Pharmacoepidemiology and Molecular Genetic Data: Why Bother? [Bruce Carleton] This module will present up-to-date state of the science and describe real-world and up to date clinical applications relevant to the pharmacoepidemiologist. This module will describe many of the analytical techniques in genomic research which rely on pharmacoepidemiologic methods and how pharmacoepidemiologists can contribute to improving the quality of pharmacogenomic research and its value in clinical practice.

Module 3: Cancer Pharmacoepidemiology and Pharmacogenomics in Oncology Drug Development: Real World Study Design & Analysis [Geoff Liu]
• Will present a case study of the development of an anti-cancer agent.
• Using this case example, we will discuss the epidemiologist’s contribution in different phases oncology drug development and includes important study design and evaluation concepts during the oncology drug pipeline with special consideration of pharmacogenomics and target therapy.
• Using this case example, we will provide considerations to how to efficiently approach a real-world evidence study of an approved cancer therapy for effectiveness in different populations, sub-populations and additional clinical indications. There will be a particular focus on design, conduct and analysis, and discuss unique aspects of somatic cancer pharmacogenomics, focusing on somatic biomarkers including mutations, gene or protein expressions.

Module 4: Serious Gaming: Collecting real world health related quality of life data in cancer pharmacoepidemiology and pharmacogenomics. [Gillian Bartlett].
[Gillian Bartlett]. This interactive module will share the development of a ‘serious’ game as a novel data collection strategy and demonstrate with attendees actively participating. 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.

Interactive Q&A Session with Course Faculty [Amalia M. Issa] Facilitator and Moderator with all speakers, with possible use of case study examples.
Conclusions (5 minutes) Concluding notes and reminder to complete the course evaluations and to attend Genomics & Precision Medicine SIG meeting and Poster Walk