Towards Accelerating Strategies for Hepatitis B Elimination: Increasing Vaccination Among Adults in High-Impact Settings
Overview:
Viral hepatitis B is a blood-borne infection, which primarily occurs in early childhood through unsafe injections and medical procedures, as well as rarely through sexual contact and birth related infections [1]. Although HBV can be prevented by vaccination, about 240- 350 million people are chronically infected with HBV throughout the world, including approximately 2.2 million people living in the United States [2] . Hepatitis B and C represent a significant burden worldwide, leading to a million deaths a year, 78% of world's hepatocellular carcinoma (HCC), and greater than 50% of the world’s fatal cirrhosis [3]. The 2016 WHO report, which focused on global health strategies to end viral hepatitis, indicated that each country should identify its most affected population and adjust their response accordingly [4][2]. Vaccines are a critical component to ending the epidemic of hepatitis B and are identified as a core intervention strategy. Approximately 90% of children in the United States were fully immunized against HBV in 2013; however, only about a 25% of adults over 19 were vaccinated against HBV in 2014 [2].
To tackle the issue of HBV elimination in the United States, it is important to refocus vaccination efforts on the adult population. The Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) recommends that all adults aged 19 through 59 years, and adults aged 60 years or older with risk factors for hepatitis B infection should receive the Hepatitis B vaccine [5]. Specifically, those who are injection-drug users, have multiple sexual partners including men who have sex with men (MSM), live with others who have chronic HBV infection, are developmentally disabled in long-term-care facilities, in correctional facilities, at risk for occupational exposure to HBV, hemodialysis patients, persons with HCV infection, persons with chronic liver disease, traveling to countries where HBV is endemic, persons with HIV, and persons with diabetes, [4] are populations we plan to target as they are more at continued risk of HBV infection and transmission to others. Although the new recommendations are clear in calling for universal hepatitis B vaccination for adults, access to the vaccines will require strategic implementation programs, which should include focused efforts in vaccinating these particular groups.
Although HBV prevention strategies have been implemented successfully in the United States for children, many challenges remain for implementing vaccination in adult populations as a means of eliminating this virus. To address the response in the United States (US) and discuss the various issues related to national planning and policy, the Forum is organizing --the Elimination of Hepatitis B in the US by 2030 Symposium-- as part of its Policy Series under the education area of impact. The Elimination of Hepatitis B in the US by 2030 Symposium is led by a steering committee (SC) and managed by Forum staff. The SC is co-chaired by Drs. Arthur Reingold and Veronica Miller. Additional Scientific Planning Committee Members include:
• John Ward, Coalition for Global Hepatitis Elimination at the Task Force for Global Health
• Chari Cohen, Hepatitis B Foundation
• Judith Feinberg, West Virginia University Medicine
• Kelly Moore, Immunize.org
• Kevin Ault, University of Kansas, School of Medicine
Format:
This symposium will take place on November 1, 2022 in Atlanta Georgia, and will feature comprehensive discussions with high level experts from industry, government, patient advocacy, and academia to produce recommendations regarding how to improve the national adult vaccination strategy. The symposium program will be developed through the guidance of the Scientific Planning Committee, and include representation of experts from local health departments and the following organizations: University of California Berkeley School of Public Health (UCB SPH), the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP); the Coalition for Global Hepatitis Elimination at the Task Force for Global Health; the CDC Division of Viral Hepatitis; HBV vaccine manufacturing companies; and policy advocates from among the National Viral Hepatitis Roundtable (NVHR), HepB United, Hepatitis B Foundation and the National Alliance of State & Territorial AIDS Directors (NASTAD) among others. This event will feature in-depth discussions regarding national goals, prevention, screening and treatment, and vaccination strategies. One major output, among others, of this event will be a manuscript for peer-reviewed publication.
Topics to be discussed at the symposium include:
• Overview on recommendations:
- Advisory Committee on Immunization Practices Updated Recommendations
- Hepatitis B Foundation recommendations on challenges and strategies of vaccine
implementation for different populations
• Focus on How to Reach Critical Populations including:
- General adult populations in the US – all under the age of 60
- People who have immigrated from high prevalence areas such as Asia and Africa
- Injection drug users and active substance users
- Incarcerated populations
• Policy Issues: Screening vs vaccination Implementation Strategies - Sites of focus include:
- STI clinics, Methadone clinics, Pharmacies, Correctional facilities, Community health
centers, All healthcare facilities, Pop up and mobile clinics/health centers
• Resources and funding for vaccinating insured and uninsured adults
• Education - increased awareness and education of recommendations and training on HBV serology among ALL health care providers, including primary care physicians, nurse practitioners, and pharmacists
• Future research and the need for better understanding adverse effects caused by vaccination
• Vaccine hesitancy - Health communications strategies to inform populations to get vaccinated and the role of narrative storytelling in helping people understand the importance of HBV vaccination
Scientific Planning Committee Co-Chairs
• Arthur Reingold, Berkeley School of Public Health
• Veronica Miller, Forum for Collaborative Research & Berkeley School of Public Health
Scientific Planning Committee Members
• John Ward, Coalition for Global Hepatitis Elimination at the Task Force for Global Health
• Chari Cohen, Hepatitis B Foundation
• Judith Feinberg, West Virginia University Medicine
• Kelly Moore, Immunize.org
• Kevin Ault, University of Kansas, School of Medicine
About the Forum:
The Forum for Collaborative Research (Forum) at the University of California Berkeley (UCB) School of Public Health (UCB SPH), founded in 1997, is a public/private partnership that addresses cutting edge science and policy issues through a process of stakeholder engagement. Its impetus was a request from Vice President Al Gore to convene all stakeholder groups to discuss and discover opportunities for cross-sector dialogue and collaboration. The hallmark of the Forum is inclusion of all stakeholder groups, including academia, industry, professional societies, patient representatives, payors, regulatory agencies and other relevant entities.
The Forum focuses on three areas of impact: 1) Practice - to address gaps and unmet needs in each disease area by convening disease specific forums; 2) Research -to sponsor research collaborations across multiple disciplinesincorporating science into the policymaking and regulatory processes for emerging therapeutics and technologies; and 3) Education - to train the next generation of leaders in drug development and health policy and help inform health policy via its Policy Series.
Practice: The Forum has and continues to address specific hurdles in drug development for human immunodeficiency virus (HIV), hepatitis B (HBV), transplantation associated virus infections (TAVI), primary sclerosing cholangitis (PSC), non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH), genetically based rare diseases, and ocular diseases. We addressed an 8th disease area, HCV infection, through the HCV Forum, initiated in 2007 and completed in 2017. To carry out the work of the drug development-oriented disease specific Forums, we work closely with the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), among other regulatory agencies in the world providing a trans-Atlantic regulatory scope and breadth to scientific based deliberations. Collaborating experts are individuals with significant experience and expertise in understanding the science, disease process, clinical research from one of the stakeholder group’s perspectives and in senior positions within their organizations.
Research: Building on its extensive knowledge base, stakeholder network and strong UC Berkeley faculty connections, the Forum fosters research collaborations across multiple disciplines via its Data center for collaborative Data Analyses by: 1) promoting Innovation in Regulatory Science toaid in the development and use of new tools, standards, and approaches to more efficiently evaluate product safety, efficacy and quality; and 2) establishing Standards for Science in Regulation by exploring multi-disciplinary approaches to regulatory decision making, and impact of regulatory decisions on individuals and societies. The Forum’s interdisciplinary data center facilitates data analyses from housed placebo arm databases across different disease areas and a network of information sharing among stakeholders including FDA, EMA, other national regulatory agencies, NIH and other federal health agencies, academic content experts, Academy of Medicine, professional organizations, patient representatives and industry participants.
Education: The Forum’s commitment to teaching and training aims to ensure that the next generation of experts and leaders in health policy and drug/diagnostic development can meet the public health needs of the nation and the world. The Forum offers educational and training opportunities in an environment of hands-on experience and exposure to current experts, issues, and solutions through formal classroom and online coursework and internships and fellowships. Forum students range from undergraduates to senior post-doctoral fellows.
Students learn to identify and examine innovative approaches to incorporating science into the policymaking and regulatory processes for emerging technologies and recommend agile adaptive regulatory approaches for assessing critical applications of innovative healthcare technologies.
The Policy Series, brings together the brightest minds of experts from relevant local, regional, national, and international public health organizations, including governmental and non-for profits, industry, and patient organizations. Our hallmark policy projects include the National Summit series, [sharing of best practices – collectively of organizations working in HIV (states had policies preventing them from following CDC universal guidelines for testing for HIV, which led to the recommendations on HIV screening and testing algorithms; [7] and guidance on HCV screening and testing algorithms. Impact in terms of advancing the national HIV policy [7].
Bay area health disparity offshoot from the national summit efforts - program on overcoming health disparities in the bay area – led to CA HIV research program which provides major grant to UCSF and UCLA (CFARs) to work in the US inequities across the bay area– bridging academia to community.
Co-located at the University of California campus in Washington, DC and at the UC Berkeley School of Public Health in California, the Forum is well positioned to stimulate joint research, crystallize new approaches to regulate and train the next generation of scientifically fluent policymakers and regulators.
About University of California Berkeley School of Public Health:
The University of California Berkeley School of Public Health (BPH) is at the forefront of solving complex public health problems through groundbreaking research, world-class education and community-engaged action.For more than 75 years, its faculty, students, and more than 18,000 alumni have put their education and skills into practice to improve the health and welfare of countless communities, the state and the world.The Center for Disease Control and Prevention recognizes BPH as one of nine health promotion and disease prevention research centers around the nation. BPH’s mission is to improve population health, especially for the most vulnerable, through:
• Radical collaborations to meet priority health needs and achieve health equity in increasingly diverse communities.
• Preeminent education that challenges convention and develops diverse leaders who transform the health of communities.
• Transformational research on the major public health threats and opportunities of today and tomorrow.
In the area of infectious diseases BPH’s division of Infectious Disease and Vaccinology promotes public health through better understanding of infectious diseases and human immunology based on the interaction of basic and translational research that contributes to the development of new diagnostics, treatment, prevention, and the control of human infectious diseases.
The Forum’s presence at BPH provides its stakeholders access to the deep, innovative and multi-disciplinary contributions that the Berkeley faculty, centers, and schools can offer. Across the Berkeley campus, researchers work in the cutting edge of bioscience and related disciplines in foundational research in molecular and cell biology, bioengineering, informatics, and statistics, and on the most critical matters in policy, law, and economics. There is no university better situated to bring the consideration of regulatory science and policy together.
HBV can be prevented through vaccinations, making it possible to not only eliminate, but prevent unnecessary disease development in vulnerable populations. The Forum’s Elimination of Hepatitis B in the US by 2030 Symposium, will bring together Berkeley’s expertise along with national experts and key opinion leaders to inform on what is the best strategy for a robust and efficient national adult vaccination needed to ensurethe elimination of HBV in the US.
Sponsors and Partners:
    
References:
(1) Buckley, G. J., & Strom, B. L. (Eds.). (2017). A National Strategy for the Elimination of Hepatitis B and C. National Academies Press. https://doi.org/10.17226/24731
(2) CDC. (2015). Epidemiology and Prevention of Vaccine-Preventable Diseases (E. J. Hamborsky, A. Kroger, and S. Wolfe (Ed.). CDC.
(3) WHO. (2016). Global health sector strategy on viral hepatitis, 2016-2021: Towards ending viral hepatitis.
(4) Kowdley, K. V., Wang, C. C., Welch, S., Roberts, H., & Brosgart, C. L. (2012). Prevalence of chronic hepatitis B among foreign-born persons living in the United States by country of origin. Hepatology, 56(2), 422–433. https://doi.org/10.1002/hep.24804
(5) Schillie S, Vellozzi C, Reingold A, et al. Prevention of Hepatitis B Virus Infection in the United States: Recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep 2018;67(No. RR-1):1–31.
(6) Ott, J. J., Stevens, G. A., Groeger, J., & Wiersma, S. T. (2012). Global epidemiology of hepatitis B virus infection: New estimates of age-specific HBsAg seroprevalence and endemicity. Vaccine, 30(12), 2212–2219. https://doi.org/10.1016/j.vaccine.2011.12.116
(7) Panneer N, Lontok E, Branson BM, Teo CG, Dan C, Parker M, Stekler JD, et al. HIV and hepatitis C virus infection in the United States: whom and how to test. Clin Infect Dis 2014;59:875-882.
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PH290: Diagnostics in Infectious Diseases: Development and Regulatory Challenges
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 Syllabus
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
PH 236 - US FOOD AND DRUG ADMINISTRATION, DRUG DEVELOPMENT, PUBLIC HEALTH AND HEALTH POLICY SPRING 2023
2023 Spring Semester **Thursday 6:00pm-8:00pm**
Course Description
In this interdisciplinary course, we review the history and evolution of the US Food and Drug Administration (the most influential public health and scientific regulatory agency worldwide, overseeing more than 25% of the US economy) and other major regulatory agencies in the world. We will discuss the concept of regulatory science and how it affects health policy and public health. We present the principles and process of drug development and illustrate the evolution of regulatory policies through the Forum for Collaborative Research’s experience in HIV, HCV, HBV, CMV, liver diseases and rare diseases. We demonstrate the interdisciplinary nature of the regulatory agencies’ mandate (basic sciences, statistics, toxicology, pharmacology, clinical medicine, ethics, policy, law, political science, economic, foreign policy), and their responsiveness to public health needs. Topics include the paradigm changing impact of HIV on drug regulation and approval, biomarker qualification programs, expedited approval mechanisms, the Orphan Drug Act, and innovation in addressing unmet medical needs of great public health significance. Biotech and pharmaceutical industry experts will participate as guest lecturers to illustrate the ongoing need for interaction between the agency, academia, industry and public health community. The course will be of interest to students in public health, law, medicine, business or policy interested in biotech and the pharmaceutical industry.
Context
Regulatory science concerns “the development and use of tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality with the overarching objective of improving global health”. With the increasing role of regulatory agencies as knowledge stewards and broker's (data sets), comes the expansion of the regulatory mission, from solely protection, to the protection and promotion of the health of the public.
Innovation to address the 21st century’s evolving regulatory landscape, in the context of new technologies, new understanding of diseases and a sharpened lens on safety -- is an exciting new area of science, one that requires a new generation of trained regulatory experts and professionals in academic, government, industry and public health sectors. Moreover, innovations in drug development offer great opportunities for treatments to address unmet medical needs worldwide. Corresponding innovations in regulation of drug products are essential to evaluate their efficacy and safety and provide a more efficient path to ensure access for patients who need them.
Instructor Information
Dr. Miller is a leading expert in the process of advancing regulatory science and facilitating a development path through collaborative engagement of stakeholders from both sides of the Atlantic. She has extensive experience in addressing regulatory issues in several key disease areas, working closely with experts from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in these projects.
Dr. Miller is the Director of the Forum for Collaborative Research, 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 this course based on case studies from the Forum's rich history in facilitating drug development.
Dr. Miller mentors interns and fellows pursuing regulatory, biotech, and translational medicine careers. Dr. Miller has published over 100 peer-reviewed publications on treatment and regulatory strategies.
Course Objectives
By the end of this course, students will be expected to be able to: 1. Understand the concept of regulatory science and how it does (or not) keep pace with innovation in the biotech sector. 2. Describe and discuss the policies underlying current drug and biomarker regulation and the impact on clinical trial design and statistics, benefit-risk analysis, drug safety, medical ethics, as well as global health and foreign policy.
- Understand the historical progression to the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) and the 21st Century Cures Act, including mechanisms for expedited approval.
3.Understand the role of the private sector, community and patient advocacy, and academic medicine in the evolving development of regulatory science. 4.Understand how regulatory science plays out in the international context.
Weeks at a Glance
Week 1: Introduction to Regulatory Science and Forum for Collaborative Research model Week 2: Ethics in the Regulatory Context Week 3: Standards of Evidence: Efficacy and Safety Week 4: Surrogate markers; Expedited Approval Mechanisms Week 5: Long-term Safety: REMS and Pharmacovigilance Week 6: New Frontiers – HBV Week 7: New Frontiers – Liver disease: NASH Week 8: Deconstructing the Regulatory Path for Diagnostics Week 9: Diagnostics and Global Health Week 10: New Frontiers – HIV Prevention Week 11: New Frontiers – Primary Sclerosing Cholangitis Week 12: New Frontiers – Rare Diseases – Orphan Drug Act Week 13: Final Group Presentations
PH 236 - US FOOD AND DRUG ADMINISTRATION, DRUG DEVELOPMENT, PUBLIC HEALTH AND HEALTH POLICY SPRING 2020
2020 Spring Semester **Thursday 6:30-8:30pm**
COURSE DESCRIPTION
In this interdisciplinary course, we review the history and evolution of the US Food and Drug Administration (the most influential public health and scientific regulatory agency worldwide, overseeing more than 25% of the US economy) and other major regulatory agencies in the world. We will discuss the concept of regulatory science and how it affects health policy and public health. We present the principles and process of drug development and illustrate the evolution of regulatory policies through the Forum for Collaborative Research’s experience in HIV, HCV, HBV, CMV, liver diseases and rare diseases. We demonstrate the interdisciplinary nature of the regulatory agencies’ mandate (basic sciences, statistics, toxicology, pharmacology, clinical medicine, ethics, policy, law, political science, economic, foreign policy), and their responsiveness to public health needs. Topics include the paradigm changing impact of HIV on drug regulation and approval, biomarker qualification programs, expedited approval mechanisms, the Orphan Drug Act, and innovation in addressing unmet medical needs of great public health significance. Biotech and pharmaceutical industry experts will participate as guest lecturers to illustrate the ongoing need for interaction between the agency, academia, industry and public health community. The course will be of interest to students in public health, law, medicine, business or policy interested in biotech and the pharmaceutical industry.
CONTEXT
Regulatory science concerns “the development and use of tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality with the overarching objective of improving global health”. With the increasing role of regulatory agencies as knowledge stewards and broker's (data sets), comes the expansion of the regulatory mission, from solely protection, to the protection and promotion of the health of the public.
Innovation to address the 21st century’s evolving regulatory landscape, in the context of new technologies, new understanding of diseases and a sharpened lens on safety -- is an exciting new area of science, one that requires a new generation of trained regulatory experts and professionals in academic, government, industry and public health sectors. Moreover, innovations in drug development offer great opportunities for treatments to address unmet medical needs worldwide. Corresponding innovations in regulation of drug products are essential to evaluate their efficacy and safety and provide a more efficient path to ensure access for patients who need them.
INSTRUCTOR
Dr. Miller is a leading expert in the process of advancing regulatory science and facilitating a development path through collaborative engagement of stakeholders from both sides of the Atlantic. She has extensive experience in addressing regulatory issues in several key disease areas, working closely with experts from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in these projects.
Dr. Miller is the Executive Director of the Forum for Collaborative Research, 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 this course based on case studies from the Forum's rich history in facilitating drug development. She mentors interns and fellows pursuing regulatory, biotech, and translational medicine careers. Dr. Miller has published over 100 peer-reviewed publications on treatment and regulatory strategies.
UC-China Regulatory Science, Drug Development and Public Health Online Course
UC-CHINA REGULATORY SCIENCE, DRUG DEVELOPMENT AND PUBLIC HELATH ONLINE COURSE
COURSE DESCRIPTION
Regulatory science concerns "the development and use of tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality". With the increasing role of regulatory agencies as knowledge stewards and broker's (data sets), comes the expansion of the regulatory mission, from solely protection, to the protection and promotion of the health of the public.
Innovation to address the 21st century's evolving regulatory landscape, in the context of new technologies, new understanding of diseases and a sharpened lens on safety -- is an exciting new area of science, one that requires a new generation of trained regulatory experts and professionals in academic, government, industry and public health sectors. This basic and introductory course in regulatory science sponsored by the UC-Mexico Initiative, addresses the demand for increased training in the US and Mexico by providing an overview of the basic elements of regulation of health practice and health products.
The aim of the Regulatory Science, Drug Development and Public Health Online Course is to provide students with information needed to understand the most important health practice and product regulation issues in China and abroad from the perspective of current regulatory standards, their standards for evidence and the role of innovation in regulatory science. Building regulatory capacity is important for US and Mexico as well as regional context.
The faculty for the course are leading experts in various areas that are affected by regulation from binational institutions including the University of California at Berkeley, Tsinghua University, and the China Food and Drug Administration (CFDA). Regulatory agency and Biotech and pharmaceutical industry experts participate as guest lecturers to illustrate the ongoing need for interaction between the agency, academia, industry and public health communities.
The course is of interest to participants in regulatory agencies, public health, law, medicine, business or policy interested in biotech and the pharmaceutical industry, working in the settings of industry or regulatory agencies. As the biomedical industry continues to rapidly grow, the demand for professionals in the regulatory sciences does so as well, nationally, bi-nationally and globally. The course will be also offered as a component of the UC Berkeley Online MPH program.
INSTRUCTOR INFORMATION
Veronica Miller is a leading expert in the process of advancing regulatory science and facilitating a development path through collaborative engagement of stakeholders from both sides of the Atlantic. She has extensive experience in addressing regulatory issues in several key disease areas, working closely with experts from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in these projects.
Dr. Miller is the Executive Director of the Forum for Collaborative Research, 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 a course on FDA and Drug Development based on case studies from the Forum's rich history in facilitating drug development. She mentors interns and fellows pursuing regulatory, biotech, and translational medicine careers. Dr. Miller has published over 100 peer-reviewed publications on treatment and regulatory strategies.
COURSE OBJECTIVES/GENERAL COMPETENCIES
By the end of the course, participants will be expected to be able to:
• Demonstrate knowledge of the basic concepts of a regulatory path, regulatory science, innovation and ethical principles, and their application in areas of public health need from a global, regional and national perspective.
• Identify, asses, think critically about the basic tenets of regulation in public health settings, including infectious diseases and regulation of controlled substances.
• Explain and critically evaluate the clinical research process and asses the underlying mandate for evidence, for benefit and for risk, at each stage of the process.
• Describe and apply regulatory science concepts and be able to think critically about the role for innovative regulatory science for specific health products, including small molecules, biologics, vaccines, medical devices and diagnostics, cellular tissue and genetic engineering.
UC-China Regulatory Science, Drug Development and Public Health Online Course
UC-CHINA REGULATORY SCIENCE, DRUG DEVELOPMENT AND PUBLIC HELATH ONLINE COURSE
COURSE DESCRIPTION
Regulatory science concerns "the development and use of tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality". With the increasing role of regulatory agencies as knowledge stewards and broker's (data sets), comes the expansion of the regulatory mission, from solely protection, to the protection and promotion of the health of the public.
Innovation to address the 21st century's evolving regulatory landscape, in the context of new technologies, new understanding of diseases and a sharpened lens on safety -- is an exciting new area of science, one that requires a new generation of trained regulatory experts and professionals in academic, government, industry and public health sectors. This basic and introductory course in regulatory science sponsored by the UC-Mexico Initiative, addresses the demand for increased training in the US and Mexico by providing an overview of the basic elements of regulation of health practice and health products.
The aim of the Regulatory Science, Drug Development and Public Health Online Course is to provide students with information needed to understand the most important health practice and product regulation issues in China and abroad from the perspective of current regulatory standards, their standards for evidence and the role of innovation in regulatory science. Building regulatory capacity is important for US and Mexico as well as regional context.
The faculty for the course are leading experts in various areas that are affected by regulation from binational institutions including the University of California at Berkeley, Tsinghua University, and the China Food and Drug Administration (CFDA). Regulatory agency and Biotech and pharmaceutical industry experts participate as guest lecturers to illustrate the ongoing need for interaction between the agency, academia, industry and public health communities.
The course is of interest to participants in regulatory agencies, public health, law, medicine, business or policy interested in biotech and the pharmaceutical industry, working in the settings of industry or regulatory agencies. As the biomedical industry continues to rapidly grow, the demand for professionals in the regulatory sciences does so as well, nationally, bi-nationally and globally. The course will be also offered as a component of the UC Berkeley Online MPH program.
INSTRUCTOR INFORMATION
Veronica Miller is a leading expert in the process of advancing regulatory science and facilitating a development path through collaborative engagement of stakeholders from both sides of the Atlantic. She has extensive experience in addressing regulatory issues in several key disease areas, working closely with experts from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in these projects.
Dr. Miller is the Executive Director of the Forum for Collaborative Research, 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 a course on FDA and Drug Development based on case studies from the Forum's rich history in facilitating drug development. She mentors interns and fellows pursuing regulatory, biotech, and translational medicine careers. Dr. Miller has published over 100 peer-reviewed publications on treatment and regulatory strategies.
COURSE OBJECTIVES/GENERAL COMPETENCIES
By the end of the course, participants will be expected to be able to:
• Demonstrate knowledge of the basic concepts of a regulatory path, regulatory science, innovation and ethical principles, and their application in areas of public health need from a global, regional and national perspective.
• Identify, asses, think critically about the basic tenets of regulation in public health settings, including infectious diseases and regulation of controlled substances.
• Explain and critically evaluate the clinical research process and asses the underlying mandate for evidence, for benefit and for risk, at each stage of the process.
• Describe and apply regulatory science concepts and be able to think critically about the role for innovative regulatory science for specific health products, including small molecules, biologics, vaccines, medical devices and diagnostics, cellular tissue and genetic engineering.
UC-Mexico Regulatory Science, Drug Development and Public Health Online Course
UC-MEXICO REGULATORY SCIENCE, DRUG DEVELOPMENT AND PUBLIC HEALTH ONLINE COURSE
COURSE DESCRIPTION
Regulatory science concerns "the development and use of tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality". With the increasing role of regulatory agencies as knowledge stewards and broker's (data sets), comes the expansion of the regulatory mission, from solely protection, to the protection and promotion of the health of the public.
Innovation to address the 21st century's evolving regulatory landscape, in the context of new technologies, new understanding of diseases and a sharpened lens on safety -- is an exciting new area of science, one that requires a new generation of trained regulatory experts and professionals in academic, government, industry and public health sectors. This basic and introductory course in regulatory science sponsored by the UC-Mexico Initiative, addresses the demand for increased training in the US and Mexico by providing an overview of the basic elements of regulation of health practice and health products.
The aim of the Regulatory Science, Drug Development and Public Health Online Course is to provide students with information needed to understand the most important health practice and product regulation issues in México and abroad from the perspective of current regulatory standards, their standards for evidence and the role of innovation in regulatory science. Building regulatory capacity is important for US and Mexico as well as regional context.
The faculty for the course are leading experts in various areas that are affected by regulation from binational institutions including the University of California at Berkeley, the National Autonomous University of México (UNAM by its Spanish acronym), the National Institute of Public Health (INSP), and the Federal Commission for the Protection against Sanitary Risks (COFEPRIS). Regulatory agency and Biotech and pharmaceutical industry experts participate as guest lecturers to illustrate the ongoing need for interaction between the agency, academia, industry and public health communities.
The course is of interest to participants in regulatory agencies, public health, law, medicine, business or policy interested in biotech and the pharmaceutical industry, working in the settings of industry or regulatory agencies. As the biomedical industry continues to rapidly grow, the demand for professionals in the regulatory sciences does so as well, nationally, bi-nationally and globally. The course is also offered as a component of the UC Berkeley Online MPH program.
INSTRUCTOR INFORMATION
Veronica Miller is a leading expert in the process of advancing regulatory science and facilitating a development path through collaborative engagement of stakeholders from both sides of the Atlantic. She has extensive experience in addressing regulatory issues in several key disease areas, working closely with experts from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in these projects.
Dr. Miller is the Executive Director of the Forum for Collaborative Research, 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 a course on FDA and Drug Development based on case studies from the Forum's rich history in facilitating drug development. She mentors interns and fellows pursuing regulatory, biotech, and translational medicine careers. Dr. Miller has published over 100 peer-reviewed publications on treatment and regulatory strategies.
COURSE OBJECTIVES/GENERAL COMPETENCIES
By the end of the course, participants will be expected to be able to:
• Demonstrate knowledge of the basic concepts of a regulatory path, regulatory science, innovation and ethical principles, and their application in areas of public health need from a global, regional and national perspective.
• Identify, asses, think critically about the basic tenets of regulation in public health settings, including infectious diseases and regulation of controlled substances.
• Explain and critically evaluate the clinical research process and asses the underlying mandate for evidence, for benefit and for risk, at each stage of the process.
• Describe and apply regulatory science concepts and be able to think critically about the role for innovative regulatory science for specific health products, including small molecules, biologics, vaccines, medical devices and diagnostics, cellular tissue and genetic engineering.
PHW 236A - REGULATORY SCIENCE, DRUG DEVELOPMENT AND PUBLIC HEALTH ONLINE COURSE
Regulatory Science, Drug Development, and Public Health (PHW236A) will be offered online by the UC Berkeley School of Public Health in the Fall of 2023
To register, please visit the course catalog here.
Course Description
This interdisciplinary regulatory science course brings together participants working in regulatory agencies, public health, law, medicine, business, and policy to gain an understanding of the most prominent product regulation issues in the US and abroad. Innovation is needed to address the 21st century’s evolving regulatory landscape, in the context of new technologies, new understanding of diseases, and a sharpened lens on safety.
This new exciting area of science requires a new generation of trained regulatory experts and professionals in academic, government, industry, and public health sectors. Building regulatory capacity is important for the US as well as for the rest of the world. Aiming to address this demand for increased training, the course provides the information needed to understand the most important health practice and product regulation issues in the US and abroad from the perspective of current regulatory standards, their standards for evidence, and the role of innovation in regulatory science.
The course features networking opportunities with experts from regulatory agencies, biotech, and the pharmaceutical industry. These guest lecturers will discuss the ongoing need for interaction between government, academia, industry, and the public.
Instructor Information
Dr. 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 resolving 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 a Professor (Adjunct) at the UC Berkeley School of Public Health. She developed and teaches a course on FDA and Drug Development based on case studies from the Forum's rich history in facilitating drug development.
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 HIV and HCV.
Course Objectives
By the end of the course, participants will be expected to be able to: 1. Demonstrate knowledge of the basic concepts of a regulatory path, regulatory science, innovation and ethical principles, and their application in areas of public health need from a global, regional and national perspective. 2. Identify, assess, and think critically about the basic tenets of regulation in public health settings, including infectious diseases and regulation of controlled substances. 3. Explain and critically evaluate the clinical research process and assess the underlying mandate for evidence, for benefit and for risk, at each stage of the process. 4. Understand the concept of level of evidence in the regulatory context, generally and for specific situations, such as products for children, or products to treat rare diseases. 5. Describe and apply regulatory science concepts and be able to think critically about the role for innovative regulatory science for specific health products, including small molecules, biologics, vaccines, medical devices and diagnostics, cellular tissue and genetic engineering.
Weeks at a Glance
Week 1: Introduction to Regulatory Science and Regulation
Week 2: Regulation and Public Health
Week 3: Drug Development Pathway
Week 4: Innovation in Trial Design and Data Use
Week 5: Surrogate Markers, Expedited Approval Mechanisms and Biomarker Qualification
Week 6: Assessing Benefit-Risk and Long-Term Safety
Week 7: Regulation of Biologics, Vaccines, and Medical Devices
Week 8: Final Group Presentations and Proctored Assessment
Student Testimonials
“Dr. Veronica Miller is a highly accomplished researcher and excellent teacher. She is one of the few out there who is able to see the 'big picture' and explain the nuances of the science-policy-practice interface. She also brings to the course unparalleled access to world-leading experts in public health, regulatory science and drug development. The course allowed me to think about things in a more precise and specific way. It also armed me with the knowledge I needed to get my first short correspondence in psychopharmacology published. I now have a second paper underway, and this wouldn't have been possible without the training I received in the course regarding the drug development process.”
- Laurence Wainwright Ph.D, Departmental Lecturer and Course Director, University of Oxford
"Thanks to Dr. Miller's course, I am no longer an outside observer to regulatory science and can see how our organization can have an effective and productive place within the drug development process."
- Rachel Gomel, Registry Director and Coordinator, PSC Partners Seeking a Cure
“Taking this course helped me to develop a clear understanding of the policies underlying current drug and biomarker regulation, its impact on clinical trial design, benefit-risk analysis, drug safety, and medical ethics.”
- Bita Fathipour, Microbial Biology BS, UC Berkeley
“The course has changed my perspective in such a way that I now view regulatory science as a broader scope of disciplines versus a single entity within the FDA.”
- Clarissa Martinez, Public Health MPH, UC Berkeley
“After taking this class, I feel that I have a much better sense of the intricacies of regulatory science, and all the things one must consider when evaluating a product.”
- Alexandra Tsitsiklis, Infec Diseases & Immunity PhD, UC Berkeley
“This course changed my perspective of thinking the regulatory process as a universal and straight-forward process for each drug. I think the course definitely changed my view about the complexity and importance of the regulatory process and I believe that my deeper understanding of regulatory science will be useful for my future bioengineering projects and biotech industry job.”
- Charlene Pan, Bioengineering UCSF Joint PhD
“This course highlighted the clinical and social needs behind these regulatory programs, and more importantly, discussed the benefit-risk consideration and risk mitigation measures involved in these programs in a depth greater than all classes that I have previously taken.”
- Raymond Dong, Translational Medicine MTM, UC Berkeley
PH 236 - US FOOD AND DRUG ADMINISTRATION, DRUG DEVELOPMENT, PUBLIC HEALTH AND HEALTH POLICY SPRING 2019
2019 Spring Semester **Thursday 6:30-8:30pm**
COURSE DESCRIPTION
In this interdisciplinary course, we review the history and evolution of the US Food and Drug Administration (the most influential public health and scientific regulatory agency worldwide, overseeing more than 25% of the US economy) and other major regulatory agencies in the world. We will discuss the concept of regulatory science and how it affects health policy and public health. We present the principles and process of drug development and illustrate the evolution of regulatory policies through the Forum for Collaborative Research’s experience in HIV, HCV, HBV, CMV, liver diseases and rare diseases. We demonstrate the interdisciplinary nature of the regulatory agencies’ mandate (basic sciences, statistics, toxicology, pharmacology, clinical medicine, ethics, policy, law, political science, economic, foreign policy), and their responsiveness to public health needs. Topics include the paradigm changing impact of HIV on drug regulation and approval, biomarker qualification programs, expedited approval mechanisms, the Orphan Drug Act, and innovation in addressing unmet medical needs of great public health significance. Biotech and pharmaceutical industry experts will participate as guest lecturers to illustrate the ongoing need for interaction between the agency, academia, industry and public health community. The course will be of interest to students in public health, law, medicine, business or policy interested in biotech and the pharmaceutical industry.
CONTEXT
Regulatory science concerns “the development and use of tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality with the overarching objective of improving global health”. With the increasing role of regulatory agencies as knowledge stewards and broker's (data sets), comes the expansion of the regulatory mission, from solely protection, to the protection and promotion of the health of the public.
Innovation to address the 21st century’s evolving regulatory landscape, in the context of new technologies, new understanding of diseases and a sharpened lens on safety -- is an exciting new area of science, one that requires a new generation of trained regulatory experts and professionals in academic, government, industry and public health sectors. Moreover, innovations in drug development offer great opportunities for treatments to address unmet medical needs worldwide. Corresponding innovations in regulation of drug products are essential to evaluate their efficacy and safety and provide a more efficient path to ensure access for patients who need them
INSTRUCTOR
Veronica Miller is a leading expert in the process of advancing regulatory science and facilitating a development path through collaborative engagement of stakeholders from both sides of the Atlantic. She has extensive experience in addressing regulatory issues in several key disease areas, working closely with experts from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in these projects.
Dr. Miller is the Executive Director of the Forum for Collaborative Research, 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 this course based on case studies from the Forum's rich history in facilitating drug development. She mentors interns and fellows pursuing regulatory, biotech, and translational medicine careers. Dr. Miller has published over 100 peer-reviewed publications on treatment and regulatory strategies.
If you have any questions, contact Luis Javier Henandez, Senior Teaching Assistant, at
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PH 236 - US FOOD AND DRUG ADMINISTRATION, DRUG DEVELOPMENT, PUBLIC HEALTH AND HEALTH POLICY SPRING 2018
2018 Spring Semester **Thursday 6:30-8:30pm**
SYNOPSIS
In this interdisciplinary course, we review the history and evolution of the US Food and Drug Administration (the most influential public health and scientific regulatory agency worldwide, overseeing more than 25% of the US economy) and other major regulatory agencies in the world. We will discuss the concept of regulatory science and how it affects health policy and public health. We present the principles and process of drug development and illustrate the evolution of regulatory policies through the Forum for Collaborative Research’s experience in HIV, HCV, HBV, CMV, and liver diseases. We demonstrate the interdisciplinary nature of the regulatory agencies’ mandate (basic sciences, statistics, toxicology, pharmacology, clinical medicine, ethics, policy, law, political science, economic, foreign policy), and their responsiveness to public health needs. Real-time examples such as maintaining quality of generic drug products distributed through PEPFAR, development of regulatory policy on the use of next-generation sequencing platforms, ethical issues in HIV and HBV “cure” research, qualification of biomarkers for fatty liver diseases, serve as case studies to illustrate the benefits and contribution of a stakeholder engagement process of deliberation. Biotech and pharmaceutical industry experts will participate as guest lecturers to illustrate the ongoing need for interaction between the agency, academia, industry and public health community. The course will be of interest to students in public health, law, medicine, business or policy interested in biotech and the pharmaceutical industry.
CONTEXT
Regulatory science concerns “the development and use of tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality”. With the increasing role of regulatory agencies as knowledge stewards and broker's (data sets), comes the expansion of the regulatory mission, from solely protection, to the protection and promotion of the health of the public. Innovation to address the 21st century’s evolving regulatory landscape, in the context of new technologies, new understanding of diseases and a sharpened lens on safety -- is an exciting new area of science, one that requires a new generation of trained regulatory experts and professionals in academic, government, industry and public health sectors.
No other disease offers a better insight into the drug development process and the role of collaborative interactions between regulators, industry, academic research networks and community than HIV infection -- now a chronic disease thanks to the approval of more than 20 different antiretroviral agents in 7 drug classes, focused efforts to end the epidemic and collaborative efforts towards an HIV cure. Involvement of the HIV community led the way to significant changes in the approval process, which benefit all drugs. The HIV experience serves as a model for the development of HCV drugs and treatment of its worldwide epidemic. HCV affects more than 3 million people in the US and up to 170 million worldwide, its morbidity and mortality burden superseding that of HIV. Development of direct acting antivirals occurred at an unprecedented pace, with the first two drugs approved in 2011, two additional drugs reaching the market in 2014, and over 20 agents in phase 2 and/or 3 trials. The resulting treatment paradigm shift presents regulatory challenges and opportunities requiring multiple levels of interaction within the agency, as well as between agency and stakeholders. The multi-stakeholder model is now being applied to the development of new drugs and vaccines to prevent/treat cytomegalovirus (CMV – dubbed the “stealth virus”) disease in transplantation settings, and new therapeutic approaches for the prevention/treatment of liver fibrosis and other consequences of fatty liver disease (affecting 30% of adults and 10% of children/adolescents in the US). “If the prevalence of NASH continues to increase at this current rate and effective treatments are not found, about 25 million Americans will have the disease by 2025, and five million will need new livers” (NY Times, June 13, 2014).
INSTRUCTOR
Veronica Miller, PhD, the Executive Director of the Washington-based Forum for Collaborative Research, and Professor (Adjunct) or Infectious Diseases Vaccinology at UC Berkeley’s School of Public Health. She is an authority in HIV clinical research with over 20 years of experience in HIV clinical and drug development research. She has led numerous projects advancing HIV, HCV, HBV, CMV and liver fibrosis drug development in collaboration with the FDA, the European Medicines Agency, pharmaceutical and diagnostic industry, community and academia.
DRAFT COURSE OUTLINE
(Please see bCourses or Forum Educational Activities: Regulatory Science, Drug Development, Public Health & Health Policy (PH 236) for updated/detailed course schedule).
Session 1 (Jan 18): Introduction: Regulatory Science, Drug Development and Forum Model
Instructor: Veronica Miller
Session 2 (Jan 25): Standards for Efficacy
Instructor: Veronica Miller
Session 3 (Feb 1): Ethics (Case study: HIV and HBV Cure)
Instructor: Veronica Miller + Guests (TBN)
Session 4 (Feb 8): Biomarker Qualification Process
Instructor: Veronica Miller
Session 5 (Feb 15): Surrogate Markers, Expedite Approval Mechanisms (Antiviral Case Studies)
Instructor: Veronica Miller + Guests (TBN)
Session 6 (Feb 22): Diagnostics
Instructor: Veronica Miller
Session 7 (Mar 1): Rare Diseases and Orphan Drug Act
Instructor: Veronica Miller + Guests (TBN)
Session 8 (Mar 8): Benefit Risk (Case Studies: PrEP, Cure)
Instructor: Veronica Miller + Guests (TBN)
Session 9 (Mar 15): Drugs for Children
Instructor: Veronica Miller + Guests (TBN)
Session 10 (Mar 22): New Frontiers: Fatty Liver Disease
Instructor: Veronica Miller + Guests (TBN)
Session 11 (Apr 5): Pharmacovigilance
Instructor: Veronica Miller + Guests (TBN)
Session 12 (Apr 12): Regulation and Global Health
Instructor: Veronica Miller + Guests (TBN)
Sessions 13 (April 19): Student Presentations
Instructor: Veronica Miller
Sessions 14 (April 26): Student Presentations
Instructor: Veronica Miller
EU Efforts and Transatlantic Cooperation in Combating Antimicrobial Resistance
Earlier this week Melissa and I had the opportunity to attend a short seminar on antimicrobial resistance (AMR), hosted by the Global Health Policy Center at CSIS. This involved a keynote address from Dr. Vytenis Andriukaitis, who serves as the Commissioner for Health and Food Safety for the European Union (EU), followed by a panel discussion with Dr. Jean Patel, the Science Lead for Antimicrobial Resistance Coordination & Strategy at the Centers for Disease Control and Prevention (CDC).
Dr. Andri  ukaitis made a very passionate case for continued cooperation globally to combat the propagation of antimicrobial resistant pathogens. No doubt his background as a surgeon has informed his understanding of the burden caused by drug resistance, and it became quite clear that as a politician he planned to put a significant amount of his time and efforts into this “ongoing silent tsunami” of an issue. He advocated for greater education of people not only who dispense antibiotics, but also for those who use them so that the common misconceptions that exist surrounding the capabilities of these drugs can be changed over time. He spoke on the cross-section of animal disease, human disease, and the environment, all of which play into the development of drug-resistant strains of common pathogens, and reminded the audience that change must occur at all levels of regulation to be effective; local, national and international. In a relatively short overview of the challenges that we face with AMR, Dr. Andriukaitis was able to touch on many of the issues that we have discussed in our infectious disease courses at Berkeley; incorrect use of antibiotics in humans and animals, lingering behaviors that exacerbate the issue, and the need for political and intellectual action to not only stop the spread of these strains but also to find new ways of treating disease caused by them. Other students and representatives of local organizations questioned the importance of the internet as a forum for spreading incorrect information, potential for greater school education on preventing resistance, and how specific diseases such as tuberculosis, malaria, and HIV play into worldwide efforts against AMR, though relatively perfunctory answers were given. However, these are all relevant issues to consider as we move forward, and should be addressed as future action plans and initiatives are developed. As Dr. Patel remarked during the panel discussion, we need to start using the term “untreatable infections” because that is the reality of many of these cases. Common, treatable infections are becoming more and more difficult to resolve, especially in the hospital setting. This is why it is more important than ever to have “political will,” as Dr. Andriukaitis put it, as the foundation of new and ongoing initiatives to contain the spread of antimicrobial resistance. Supportive regulatory agencies and leaders not only provide programmatic focus but also lend to perceptions of the credibility and importance of an issue. With the cooperation of governments both domestically and internationally, we can only hope to have some impact on the dispersal of drug-resistant pathogens in the near future.
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