Thursday, December 17, 2020, 5:00pm - 7:00pm ET
In January 2020, a novel virus thought to originate from zoonotic transmission from bats into humans was reported to be spreading in Asia. In March 2020, a public health emergency was implemented in the United States, and travel restrictions to and from Europe were put in place. Since that time, a substantial yet heterogeneous set of global efforts have been employed with varying degrees of success. These have included:
- A set of protection-oriented measures ranging from public lockdowns, social distancing requirements, and mask/personal protective equipment (PPE) mandates
- Use of its Emergency Use Authorization (EUA) protocols by the U.S. Food and Drug Administration (FDA) with a goal to incentivize rapid development of diagnostics, therapeutics, and vaccines
- Rapid deployment of guidance documents by the FDA to support manufacturers in their development of the aforementioned diagnostics, therapeutics, and vaccines
- A substantial drug-repurposing effort in order to use already-FDA approved drugs and biologics for COVID-19 treatment in an off-label fashion
- A commitment from the Center for Medicare and Medicaid Services to provide coverage for COVID-19 diagnostics and treatments
These measures have been associated with differing, and sometimes unexpected, clinical outcomes. As a result, as of early November 2020, the U.S. Center for Disease Control (CDC) estimates that 10 million people have been infected with COVID-19 SARS-CoV-2 virus in the U.S., causing more than 250,000 deaths.
In this seminar, we will explore the public health policy implications of the COVID-19 pandemic. Through facilitation by a panel of experts coming from various perspectives of the healthcare industry, participants will explore a range of issues, from the prospect of developing an effective vaccine to how long protective measures should be kept in place. More specifically, questions addressed will include the following:
- Should the FDA use its EUA procedures to sanction the use of COVID-19 vaccines?
- Have the public health emergency measures implemented been effective and should they be more standardized from state to state and country to country?
- Why has the pandemic had a disproportionately negative impact on minority populations?
- Assuming that a safe and effective COVID-19 vaccine is developed, how should it be rationed initially, assuming a limited supply?
- How should approved COVID-19 treatments and vaccines be priced and who should pay for their utilization?
- Should reimbursement policy be based on individual factors including the ability to pay?
Given a continued average daily increase in COVID-19 cases in various geographic areas, as well as a shifting geopolitical environment, the critical nature of the answers to these questions cannot be overemphasized. Therefore, participants will come away from this seminar with increased awareness and understanding of the interconnected nature of the COVID-19 pandemic, as well as the public policy debates it has ignited.
This discussion provides a sneak peek of Northeastern University’s Advancing Lifelong Excellence in Regulatory Trades events (ALERT), which you have access to as a student or alumnus. ALERT is a monthly lecture series in which regulatory professionals lead an exploration of evolving global regulatory frameworks and industry trends.
The panel will be moderated by Darin Detwiler, DLP, Associate Teaching Professor, who will also speak to the food safety and supply chain issues caused by the pandemic.
- Stephen Amato, PhD, MBA, RAC –Faculty Director and Teaching Professor, College of Professional Studies, Northeastern University
- Wm (Trey) Putnam, PhD, RAC – Professor, Departments of Pharmacy Practice and Pharmaceutical Sciences, Director, Clinical Pharmacology and Experimental Therapeutics Center, Jerry H. Hodge School of Pharmacy, Texas Tech University Health Sciences Center
- Steven Kates, PhD – Vice President of Regulatory Affairs, Dicerna Pharmaceuticals, Assistant Teaching Professor, College of Professional Studies, Northeastern University
- David Mahoney, JD – Senior Counsel and Patent Attorney, Indigo, Assistant Teaching Professor, College of Professional Studies, Northeastern University
- Sam Rajkumar, RN, MSRA, RAC – Manager, Regulatory Affairs and Quality Assurance, Exact Imaging, Adjunct Faculty, College of Professional Studies, Northeastern University – Toronto Regional Campus
- Kathy Reinke – Consumer & COVID-19 treatment advocate, Executive Assistant, College of Professional Studies, Northeastern University
If you have any questions, please contact us at [email protected]