PH 236 - US FOOD AND DRUG ADMINISTRATION, DRUG DEVELOPMENT, PUBLIC HEALTH AND HEALTH POLICY
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
If you have any questions, contact Luis Javier Henandez, Senior Teaching Assistant, for assistance at
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, or by phone at (415) 793-1809.
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Registration: 2017 US Food and Drug Administration, Drug Development, Public Health and Health Policy (PH 236)
Briefing: Post-Election Outlook on Hospitals and the 340B Program
I had the opportunity to attend a Congressional briefing on Capitol Hill on the Post-Election Outlook on Hospitals and the 340B Program. This briefing was coordinated by 340B Health, a membership organization that includes more than 1,200 hospital and health systems that participate in the federal 340B drug pricing program. The briefing included panelists that represented public, private, or non-profit hospitals that acted as safety net providers in their communities and was a discussion of how the 340B program enhances care for diverse patient populations and the future implications of adjustments to the program. The program, called 340B, was developed and implemented in 1992. The hallmark of the 340B program is a requirement that drug manufacturers sell pharmaceuticals at an approximate 20 to 50% discount to specific institutions. For the most part, 340B eligible clinics, hospitals, and health systems treat low-income or uninsured patients. A notable participant of the 340B program is the Veterans Health Administration.
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Future Women In Government: Healthcare Summit
On Friday, November 28th, I had the opportunity to attend the Women in Government’s Seventh Annual Healthcare Summit as a part of the Future Women in Government Program. The program selects undergraduate and graduate students who demonstrate a passion for women’s leadership to participate in the conference, as well as network with current legislators. The programming was diverse in nature ranging on talks about rare diseases, Alzheimer’s, and the regulation of medical devices in the European Union. I appreciated being able to hear about different disease areas, as well as hear from a variety of patient advocacy groups. When I reflect upon my experience in the program, the most formative impact comes in the form of a reminder about why I am so passionate about health and, particularly, women’s leadership in health. This reminder came in the form of presentations that were unapologetically focused on women. One particular presentation on bleeding disorders stood out to me. While bleeding disorders can affect both men and women, they are often not correctly diagnosed in women. Many clinicians will miss the warning signs and simply normalize the symptoms as a natural function of menstruation. Due to this, women with undiagnosed bleeding disorders will often suffer from chronic fatigue as a result of anemia, difficulties healing after sustaining cuts of injuries, and heavy and prolonged menstrual periods. While this is just one example, it reminded me of how fundamentally underrepresented and understudied women’s health issues are. So often in society women’s voices are lost or are systematically unheard. In the healthcare field it manifests in the lack of studies about women’s health, the lack of women in clinical trials, or how women’s pain is often downplayed. According to a study “The Girl Who Cried Pain,” there is a definitive gender bias when it comes to clinical pain management where women are “more likely to be treated less aggressively in their initial encounters with the health-care system until they ‘prove that they are as sick as male patients.’” The pervasive disregard of women’s pain and women’s health issues is a definitive example of how political power, or lack thereof, can have an impact on one’s health outcomes
My Day At The Supreme Court
On October 11, 2016, I went to the Supreme Court to hear oral arguments on two cases: Samsung Electronics Co., Ltd., et al. v. Apple, Inc. and Pena-Rodriguez v. Colorado. My day started at 2 a.m. when I braved the brisk Washington, D.C. air to line up at the Supreme Court. Oral arguments are open to the general public, but seating in the court is available on a first come first serve basis. In addition to this, many of the seats are reserved by members of the Supreme Court Bar, school groups, and special guests of the Justices. Thus, it was crucial that I got in line as early as possible to heighten my chances of getting in. Much to my relief, when I arrived there was only one other person in line. Armed with a sleeping bag and a yoga mat, the person at the beginning of the line was infinitely more prepared than I was for the coming hours ahead. Within five minutes, two other people joined, and, within the next hour, there were at least thirty more individuals in line. As the sun slowly rose, the line outside the Court continued to grow. By 6 a.m. the line wrapped around the building, filled with enthusiasts eager to discover whether or not they would be seated for the case. At around 8 a.m., the security guards began handing out note cards that designated one’s place in line; I was second! Seating for the first argument began at 9:30 a.m. and the case promptly started at 10 a.m. After waiting for approximately 8 hours, I was seated in the Supreme Court ready to listen to the oral arguments.
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The Brookings Institution: Protecting Patients From Surprise Medical Bills
On October 13, 2016, the Brookings Institution hosted an event called “How To Protect Patients From Surprise Medical Bills.” As someone deeply interested about the effects on healthcare access and how, ultimately, healthcare access is a proxy for positive health outcomes, I wanted to gain more perspective on how healthcare coverage does not necessarily equal care; having health care insurance does not mean that you will receive adequate care. Surprise medical bills are the product of gaps in coverage or gaps in knowledge of insurance plans. They can also be a by-product of patients purposefully going out-of-network for care without realizing the full consequence of that action. This results in patients being saddled with unexpected medical expenses. The event was structured around two presentations and two panel discussions, all of which centered on proposing solutions for surprise medical billing. Panelists and presenters consisted of individuals representing health insurance providers, policymakers, and physicians.
Despite being from different backgrounds and representing different interest groups in the matter, the panelists and presenters wholly agreed that requiring consumers to go to mediation about their medical bills is bad idea. Presenters offered slightly different solutions to the issue. Some solutions set forth included:
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Outcomes from Durban International AIDS Conference
 The CSIS Global Health Policy Center hosted an event entitled, “Outcomes from the Durban International AIDS Conference” on Wednesday August 3, 2016. I went to this event to hear updates from the 2016 International AIDS Conference from some of the key players in attendance and to hear a perspective on what the outcomes of this conference were. Overall, the speakers seemed to have a message of positivity, and of moving in the right direction, despite some setbacks in the field which includes a decrease in worldwide funding.
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Life & Career Planning Workshop
Jeff Oxendine, the President and one of the founders of Health Career Connection (HCC) led a workshop at the HCC Mid-Summer Conference that I attended from July 21-22nd, 2016. The workshop was on Life and Career Planning. This workshop greatly benefited me because I am in a stage in my life that revolves around making decisions that shape my future. Jeff Oxendine went through several activities that challenged my current thoughts on how to approach setting goals and making future plans. I will be graduating in May of 2017. I plan to take a year off in order to obtain work experience in my field before going to graduate school.
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2016 Washington Area Interns Networking Day
On Monday, August 1st, the Forum for Collaborative HIV Research hosted its 4th annual Washington Area Interns Networking Day. The purpose of the event is to allow interns working in the Washington area a chance to hear from and converse with experts in the fields of public health and policy in HIV/AIDS and Viral Hepatitis. Various organizations were represented by the attending interns, including The American Chemical Society, The American Psychological Association’s Office of AIDS, HealthHIV, The AIDS Institute, The Global Liver Institute, and the National Association of Social Workers. The event consisted of a panel, followed by a light reception and networking period.
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Briefing: An Update on Hepatitis C in the United States
On Tuesday August 4th, I attended the Update on Hepatitis C in the United States. The event took place in the US Capitol Building Visitor Center in Washington and was held by the AIDS Institute. Presentations were given by four panelists encompassing academia, government, and patient representation. The panel was moderated by Carl Schmid, Deputy Executive Director of the AIDS Institute.
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2016 WASHINGTON AREA INTERNS NETWORKING DAY
On August 1, 2016, the Forum for Collaborative HIV Research hosted the 4th annual Washington Area Interns Networking Day 2016. Leading experts from government and advocacy organizations in HIV/AIDS and Viral Hepatitis gathered for a panel discussion in which they provided career advice and shared their personal experiences navigating the fields of Public Health and Public Policy at the UCDC Washington Center on 1608 Rhode Island Avenue NW, Washington DC 20036. Highlights from this session are included below.
Panelists:
- Veronica Miller, PhD, Executive Director, Forum for Collaborative HIV Research [Moderator]
- Gina Brown, MD, Medical Officer, Office of AIDS Research, National Institutes of Health
- Corinna Dan, MPH, RN, Viral Hepatitis Policy Advisor, Office of HIV/AIDS and Infectious Disease Policy, Department of Health & Human Services
- Kimberly Struble, PharmD, Medical Team Leader, Center for Drug Evaluation and Research, Division of Antiviral Products, U.S. Food & Drug Administration
- Isha Weerasinghe, MSc, Director of Policy and Advocacy, Association of Asian Pacific Community Health Organizations
- Sue Zelt, DrPH, Senior Health Policy Fellow, Forum for Collaborative HIV Research; and Senior Director, U.S. Health Outcomes, ViiV Healthcare
 The 2016 Panelists from left to right: Veronica Miller, Gina Brown, Corinna Dan, Kimberly Struble, Isha Weerasinghe, Sue Zelt
This event was attended by interns from around the DC area. Host organizations represented by interns in attendance include The AIDS Institute, American Chemical Society, American Psychological Association's Office of AIDS, HealthHIV, The Global Liver Institute, and the National Association of Social Workers.
 Question and Answer Session
Networking Reception
Some memorable advice shared by panelists:
Don't over-promise and under-deliver. Be honest about your abilities and the time you have.
When making big career decisions, trust your gut.
Enjoy what you are doing.
When discussing heath issues, it is important to communicate in a way that affects change.
If there is a problem or issue, come to the table with a possible solution.
Identify skillsets where you feel uncomfortable or less secure and seek opportunities to practice those skills. Push yourself to explore these areas because it is the best way to grow. And, you may find a surprising new strength.
Find graduate schools with a strong networking structure. It will help you find positions after graduation.
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