2016 Spring Semester **Thursday 6:30-8:30 PM**
SYNOPSIS
This interdisciplinary course reviews the history, authorizing statute and regulatory authority of US Food and Drug Administration (the most influential public health and scientific regulatory agency worldwide, overseeing more than 25% of the US economy). We demonstrate the interdisciplinary nature of the agency’s mandate (basic sciences, statistics, clinical medicine, ethics, toxicology, pharmacology, policy, law, foreign policy) and its influence on public health policy and responsiveness to public health needs. We present the principles and process of drug development and illustrate the evolution of regulatory policies through the Forum for Collaborative HIV Research’s experience in HIV/AIDS, HCV, CMV and liver diseases. Real-time examples such as HIV cure research, biomarker acceptance pathways for liver fibrosis, and responses to global epidemics serve as case studies illustrating 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. Biotech and pharmaceutical industry experts will participate as guest lecturers, providing opportunities for direct interactions. The course will feature three special networking receptions.CONTEXT
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)
INSTRUCTORS
Jur Strobos, MD JD, a specialist in Food and Drug Law, served as Director of Policy Research under FDA Commissioner Kessler, has held VP positions in Clinical Research and Regulatory Affairs for various pharmaceutical companies. He served as deputy director of the Forum for Collaborative HIV Research from January 2010 to December 2011, and is currently Of Counsel with Olsson Frank Weeda Terman Matz PC.
Veronica Miller, PhD, the Executive Director of the Washington-based Forum for Collaborative HIV Research, 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, CMV and liver fibrosis drug development in collaboration with the FDA, the European Medicines Agency, pharmaceutical and diagnostic industry, community and academia.
COURSE EVALUATIONS
Nice lecture.
I am very interested in learning more aspects of global health; however, I don't have the financial means to attend all courses for credit. Therefore I truly appreciated the opportunity to officially participate as a postdoc and still get a certificate at the end. I hope there will be more options for postdocs as there are currently very few such opportunities. Great course!
This course provided helpful insight into both the FDA and pathways for drug development. The topics discussed were enriching.
The course was quite intense and covered many areas of the drug development process. It was interesting meeting professionals that are actually working in the field.
This course was incredibly insightful into the process of approving a drug through the FDA process. I recommend this course specifically to those in the sciences who work on drug discovery to gain a better understanding and appreciation for what it takes for a drug to be approved and the immense work required to ensure our medicines are safe and effective. – Corinne Sadlowski, UC Berkeley
If you are interested in getting more insight into how FDA/clinical trial and pharmaceutical company work this course represents a good opportunity to attend. – Roberto Sessa, UC Berkeley
