Diagnostics in Infectious Diseases: Development and Regulatory Challenges (PH290) will be offered by the UC Berkeley School of Public Health in the Spring of 2023
Please view the course flyer for additional information on the course and how to register.
Course Description
Diagnostics represent 3% of health care expenditure, yet direct 65% of health care spending. Diagnostics are indispensable for clinical management and if appropriate tests are available and used, can reduce late-stage health care spending. Accurate diagnostic tests are the cornerstone of global health programs, but tests need to be approved by regulatory authorities before they can be used. In this course we review domestic and global regulatory oversight and explore how tests are marketed around the world. Students will learn about the challenges to innovation generalizability and best practices to develop and translate a diagnostic test into clinical practice. Focused on diagnostics in infectious diseases, the course features ongoing epidemics and pandemics such as HIV, TB and COVID-19. Topics range from the role of diagnostics in global health, to the basics of regulatory approval and oversight, innovation in analytics, to best practices for bringing a test from the lab bench to domestic and global markets.
This highly interactive seminar course is based on discussions of assigned readings, short presentations by course instructors and/or guests from diagnostic industry in the Bay Area, online discussion forums, and written “peer-review” style critiques of published articles.
Instructor Information
Veronica Miller, PhD
Dr. Veronica Miller is a leading expert in the process of engaging stakeholders from both sides of the Atlantic to resolve significant health policy and public health issues. She has extensive experience in addressing regulatory issues in six disease areas, working closely with the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as partners in these projects.
Dr. Miller is the Director of the Forum for Collaborative Research (The Forum), a public and private partnership addressing cutting edge science and policy issues through a process of stakeholder engagement and deliberation. Dr. Miller is also Professor (Adjunct) at the UC Berkeley School of Public Health. She developed and teaches two courses on Drug Development - PH236 and PHW236A -- based on case studies from the Forum's rich history in facilitating drug development.
Dr. Miller joined The Forum in 2001 after having directed the interdisciplinary HIV Research Group at the HIV Outpatient Clinic of the JW Goethe University in Frankfurt, Germany. Together with Dr. Joep Lange, she co-founded and chaired the Euro-Guidelines Group on HIV Drug Resistance, the first pan-European group established for the purpose of assuring a common standard-of-care for patients in all European states. She has also served on numerous industry and government advisory boards.
Dr. Miller mentors interns and fellows pursuing regulatory, biotech, and translational medicine careers and she has published over 100 peer-reviewed publications on HIV treatment strategies and regulatory strategies for various disease areas.
Peter J. Dailey, PhD
Dr. Peter J. Dailey is a microbiologist who serves as a Senior Technical Officer for the Foundation for Innovative Diagnostics (FIND). Dr. Dailey received his PhD in Microbiology and MPH at UC Berkeley and his bachelor’s degree in Bacteriology at UC Davis. He has 35 years of experience in infectious disease, primarily in the research and development of infectious disease molecular diagnostics. He has worked for the California Public Health Department (Viral & Rickettsial Disease Laboratory), hospital and medical center clinical laboratories, and in the molecular diagnostics biotechnology industry. Previously he was the senior vice president of Research & Development at Cepheid, a molecular diagnostics biotechnology company in Sunnyvale, California, and he has also held R&D leadership positions at Roche Molecular Systems and Chiron Diagnostics. He has led the research and development of over 20 diagnostic and blood-screening assays for infectious diseases including TB, MRSA, West Nile Virus, viral meningitis, HPV, HIV, SIV and HCV.
John Sninsky, PhD
John Sninsky, PhD is a Translational Science and Medicine consultant with a comprehensive and deep understanding of the development and application of pioneering molecular procedures to the translation of research-grade biomarker assays into clinical-grade clinically adopted diagnostic tests. Following a faculty appointment at Albert Einstein College of Medicine, John joined the team at Cetus that developed polymerase chain reaction (PCR) and applied the powerful technology to clinical virology diagnostics, notably HIV. He has held senior management positions at Roche, Celera, Quest Diagnostics and CareDx.
He is the author of more than 110 scientific papers including advanced methods in molecular biology, application of the polymerase chain reaction (PCR) to virology and cancer, and genome-wide genetic association studies for multiple common, complex diseases. John advises commercial translation efforts at Stanford University (SPARK) and University of California, San Francisco (CATALYST) and lectures in Diagnostic Regulatory Science at University of California, Berkeley. He is a member of Coronavirus Standards Working Group, an organization focused on developing molecular standards for SARS-CoV-2 (COVID-19).
John serves as a technical advisor for Stop the Spread, with a focus on diagnostics.
Course Learning Objectives
After successfully completing this course, you will be able to:
- Identify the role of diagnostics in health care, including domestic, global health, with specific application to pandemics of international concern
- Describe the regulatory pathways for diagnostics
- Interpret key test parameters, such as analytic validity, clinical validity, and clinical utility
- Evaluate and interpret data on diagnostic tests in peer-reviewed publications and technical reports
- Recognize the challenges of bringing a research test to market
