Cancer Pharmacoepidemiology and Genomics: What You Should Know in the Era of Precision Medicine

‎1. Course Aim ‎
This course, co-sponsored by the "Molecular Epidemiology, Biomarkers, and Pharmacogenomics" and "Cancer" ‎SIGs, will focus on the essentials every pharmacoepidemiologist should know about study design, databases and ‎real-world applications of cancer personalized medicine including precision medicine, companion diagnostics, ‎biomarkers and the biomarker development pipeline, diagnosis and treatment coding, drug and cancer risk ‎associations and linking databases with genomic information.‎

‎2. Requisites Statement ‎

Entry level. Attendees should have basic knowledge of pharmacogenomics, or have watched the pre-course ‎videos available online only ‎
--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 acquire an overview of genomics in cancer research, and how epidemiologists and real-world studies make ‎contributions.‎
‎-To attain a better understand of methodological issues related to pharmacoepidemiology studies of cancer risk.‎
‎-To improve an understanding of cancer diagnosis and treatment coding in administrative claims, EHR and ‎clinico-genomic databases. ‎
‎-To understand better target therapy for application in pharmacoepidemiology cancer research designs and ‎oncology drug development, including the use of biomarkers and companion diagnostics. ‎
‎-To understand the benefits and challenges of pharmacoepidemiology study designs in oncology research and ‎their impact on clinical practice applications.‎

‎4. Syllabus Outline‎
Introduction, Format and Objectives of the Course
Through a series of case study-based lectures and a panel discussion this course will enhance your ‎understanding of the important role pharmacoepidemiologist’s play in the design, analysis, evaluation, ‎database utilization and interpretation of
--medication exposure and cancer risk
--oncology drug development, ‎
--real-world evidence studies cancer drug effectiveness, and ‎
--real-world evidence studies of adverse events

Speakers will start with a case study, and weave their talk through the case study, using the study to ‎introduce key challenges and potential solutions and may include alternative approaches, and ‎individualization based on characteristics of the clinical situation.‎

A.‎ Designing and Analysing Pharmacoepidemiology Studies in Cancer Research
--Will present an introduction to cancer genomics - using both somatic and germline genomic data as ‎examples

B.‎ Clinical Evidence Generation in Oncology: Real World Data Designs and Approaches
o Will provide an overview of the current RWE Guidances as well as foundational approaches to study ‎design and selection of RWD sources (administrative claims, EHRs, registries) in oncology, as well as ‎the limitations of various sources. Additionally, the discussion will include novel designs for clinical ‎evidence generation with examples.‎

C.‎ Cancer Pharmacoepidemiology and Pharmacogenomics in Oncology Drug Development
• Will present a case study of the development of an anti-cancer agent.‎
o Examples of a case study may include: a PD-1/PD-L1 drug (such as Keytruda) or an anti-cancer ‎targeted therapy or immunotherapy (such as a anti- B-Cell Maturation Antigen) or another ‎example chosen by the speakers.‎
• 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. ‎

BREAK and Networking

D.‎ Designing Cancer Pharmacoepidemiology-Pharmacogenomics Studies to study Adverse Events
• Will present a case study for the design, analysis and interpretation of an adverse event for an anti-‎cancer agent.‎
o Examples of a case study will include: platinum chemotherapy and ototoxicity.‎
• Using this case example, we will provide considerations to how to efficiently approach the study of ‎cancer therapy-induced adverse events with a particular focus on genomics study design, conduct and ‎analysis to be derived from pharmacoepidemiological data and DNA-based genomics analyses. ‎Techniques to use include rapid cycle analysis to identify AEs of concern, case series and verification ‎through medical record review, then genome-wide association studies based on validated phenotypes. ‎Validation methods other than independent replication are discussed and why replication studies are ‎problematic. This example will help illustrate how the pharmacoepidemiological study of adverse ‎events and pharmacogenomics can help improve the safety of cancer therapy. ‎

E.‎ Real-World Study Design and Analysis of Cancer Drug Effectiveness
• Will present a case study for the design, analysis and interpretation of the effectiveness of a currently ‎approved anti-cancer agent in different populations or for additional indications.‎
o Examples of a case study may include: a PD-1/PD-L1 drug or another anti-cancer targeted or ‎immunotherapy or another example chosen by the speakers.‎
• 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. ‎

F.‎ ‎ Interactive session
An opportunity to develop an approach to the design of cancer pharmacoepidemiology and genomics studies

G.‎ ‎ Panel Discussion
a.‎ Five-minute summary of the main points of the course; emerging topics
b.‎ Focus some questions on AI
c.‎ Get audience involved