Educational activities

The researchers and institutions participating in the Expanded Access Program (EAP) for the treatment of COVID-19 are committed to facilitating the growth of medical knowledge in a timely manner. The tabs below list the educational activities presented by the EAP protocol team.

Innovations in Regulation & Regulatory Science — what we learned from the COVID-19 pandemic

Experts

Michael J. Joyner, M.D. and DeLisa Fairweather, Ph.D.

Date

August 19, 2021

Location

Mayo Clinic Innovations in Regulatory Science Course (CTSC 5025), Rochester, Minnesota (virtual)

Summary

Drs. Joyner and Fairweather present regulatory hurdles occurring with the Mayo Clinic-led EAP for convalescent plasma for COVID-19; and how innovative solutions were devised in collaboration with the FDA to overcome these issues during a pandemic, which led to successful distribution of convalescent plasma nationwide.

Convalescent Plasma and COVID-19

Expert

Michael J. Joyner, M.D.

Date

August 25, 2021

Location

Duke University Medical Center, Durham, North Carolina (livestream and online)

Summary

Providing access to convalescent plasma during a pandemic was a remarkable logistic and humanitarian effort. Learn how Mayo Clinic adopted and led the EAP.

Sex Differences and COVID-19

Expert

Michael J. Joyner, M.D.

Date

June 11, 2021

Location

Transforming Women’s Health CME Courses, Rochester, Minnesota (livestream and online)

Summary

Dr. Joyner describes the basic epidemiology of COVID-19 in the US, summarizes the main risk factors for poor outcomes and assesses the role biological sex plays as a risk factor.

COVID-19 Plasma Biostatistics Team

Expert

Rickey E. Carter, Ph.D.

Date

May 20, 2021

Location

Mayo Clinic Applied Statistics Seminar 2021 Series, Jacksonville, Florida (webinar)

Summary

Dr. Carter and team provide an overall description of the EAP project and the role Mayo Clinic biostatisticians played in making this project a huge success.

Update on the Use of Convalescent Plasma for COVID-19

Expert

DeLisa Fairweather, Ph.D.

Date

April 23, 2021

Location

Baptist Heart & Vascular Institute Cardiovascular Symposium (virtual)

Summary

This update covers the history of using convalescent plasma and the expanded access program (EAP), key findings of the EAP, where convalescent plasma transfusion stands today, and effects on cardiovascular disease.

The Expanded Access Program (EAP) for COVID-19

Expert

DeLisa Fairweather, Ph.D.

Date

Feb. 27, 2021

Location

International Society of Cardiomyopathy, Myocarditis and Heart Failure: Kyoto, Japan (livestream)

Summary

Dr. Fairweather discusses COVID-19 clinical trials investigating the cardiac-related complications of COVID-19.

The US Convalescent Plasma Program and Mayo Clinic

Experts

R. Scott Wright, M.D., Michael J. Joyner, M.D., DeLisa Fairweather, Ph.D., and Rickey E. Carter, Ph.D.

Date

Feb. 24, 2021

Location

Mayo Clinic Medical Grand Rounds (livestream)

Summary

Providing access to convalescent plasma during a pandemic was a remarkable logistic and humanitarian effort. Learn how Mayo Clinic adopted and led the EAP.

US COVID-19 Convalescent Plasma Expanded Access Program (EAP): Creation and Implementation

Expert

Katelyn A. Bruno, Ph.D.

Date

Feb. 12, 2021

Location

Children's Health Transfusion and Laboratory Medicine annual conference (virtual)

Summary

Dr. Bruno describes the formation of the EAP and the development of the database used to register sites and physicians, enroll patients, collect events and outcome data, and show some of the initial results.

State of Pandemic Preparedness That Has Characterized the US Over the Past Year

Expert

Michael J. Joyner, M.D.

Date

Feb. 12, 2021

Location

Arizona State University honors course (virtual)

Summary

COVID-19 has underscored several truths about pandemics and revealed important shortcomings in current global and national capacities to prepare for, detect and respond to them. To better prepare for the next crisis, and future waves of the current one, the United States will need to devote considerable political capital and economic resources to reducing the domestic and global vulnerabilities that jeopardize individual, national and global health security.

2020 Report Card on Expanded Access to COVID-19 Therapeutics, Vaccines and Diagnostics

Expert

Michael J. Joyner, M.D.

Date

Feb. 11, 2021

Location

Ax-S Pharma (virtual)

Summary

Learn about the experience of coordinating the largest EAP in history: the 2020 treatment-use trial for COVID-19 convalescent plasma, which treated over 105,000 people. Scalable EAPs need to be easy for both the health care provider and the provider's institution.

Delivery System Reform Options — Redesigning the Practice

Expert

Michael J. Joyner, M.D.

Date

Feb. 5, 2021

Location

Arizona State University (webinar)

Summary

Delivery system reform options could support participating hospitals' programs to enhance access to care, the quality of care, and the health of the patients and families they serve.

Relationship Between Antibody Titers and Death in COVID-19 Patients

Expert

Michael J. Joyner, M.D.

Date

Jan. 29, 2021

Location

University of Kansas (virtual)

Summary

Patients receiving the plasma with low antibody levels had the highest mortality rate. Mortality for those receiving the medium-level antibody convalescent plasma was lower, and high antibody convalescent plasma showed the lowest mortality rate.

US Convalescent Plasma Program — Insights and Observations

Expert

R. Scott Wright, M.D.

Date

Jan. 19, 2021

Location

Richard Doll Virtual Seminar Series: University of Oxford, U.K. (livestream)

Summary

What is convalescent plasma and the history of its use in medicine? Learn how a multidisciplinary team responded to a request from the Food and Drug Administration to rapidly develop an expanded access program to collect and distribute convalescent plasma for the treatment of COVID-19.

Providing Expanded Access to Convalescent Plasma During a Pandemic

Expert

DeLisa Fairweather, Ph.D.

Date

Jan. 15, 2021

Location

Mayo Clinic Grand Rounds: Jacksonville, Florida (livestream)

Summary

Dr. Fairweather describes Mayo Clinic's charge from the Food and Drug Administration, the Biomedical Advanced Research and Development Authority, and the cohort that joined the expanded access program (EAP).

Providing Expanded Access to Convalescent Plasma During a Pandemic

Expert

DeLisa Fairweather, Ph.D.

Date

Jan. 11, 2021

Location

University of Puerto Rico School of Medicine: San Juan, Puerto Rico (livestream)

Summary

Dr. Fairweather describes Mayo Clinic's charge from the Food and Drug Administration, the Biomedical Advanced Research and Development Authority, and the cohort that joined the EAP.

Challenges in Health Disparities Research

Expert

Michael J. Joyner, M.D.

Date

Jan. 11, 2021

Location

University of Puerto Rico faculty research program (virtual)

Summary

Dr. Joyner discusses challenges in discovering, addressing and resolving health disparities in COVID-19 research. During the EAP, the recruitment of a diverse population improved over the course of the study.

Convalescent Plasma: What We Have Learned From COVID-19

Expert

Michael J. Joyner, M.D.

Date

Jan. 9, 2021

Location

University of Toronto (St. George Campus) Research Symposium — COVID-19: Investigating a Viral Phenomenon(virtual)

Summary

Convalescent plasma gave hope to patients and physicians at a time when there was little more available for treating people with COVID-19 than supportive therapy. The patients treated under the EAP were geographically and ethnically diverse. The EAP created access to the therapy for many patients in the United States who would not otherwise have had access to clinical trials.

Expanded Access Program (EAP) for Convalescent Plasma

Expert

Michael J. Joyner, M.D.

Date

Dec. 17, 2020

Location

Mayo Clinic Research Gathering: Rochester, Minnesota (virtual)

Summary

The EAP mobilized and launched nationally in days. Hear what we've learned about the urgency needed in pandemic response.

COVID-19 Podcast Update

Expert

Michael J. Joyner, M.D.

Date

Nov. 13, 2020

Location

Mayo Clinic Anesthesiology & Perioperative Medicine podcast, episode 17 (podcast)

Summary

Dr. Joyner provides an update on convalescent plasma and emergency use authorization as well as the status of vaccinations.

Weathering a Pandemic: COVID-19 and Research Activities at Mayo Clinic

Expert

Rickey E. Carter, Ph.D.

Date

Nov. 10, 2020

Location

Florida Department of Health Grand Rounds: Jacksonville, Florida (webinar)

Summary

Dr. Carter describes the structure of the EAP both in terms of the study objectives and implementation characteristics and provides insights on how the EAP directly reached residents of Florida.

The Convalescent Plasma EAP: From Concept to Execution

Expert

DeLisa Fairweather, Ph.D.

Date

Nov. 10, 2020

Location

Florida Department of Health Grand Rounds: Jacksonville, Florida (livestream)

Summary

This presentation provides an overview of how a multidisciplinary team responded to a request from the Food and Drug Administration to rapidly develop an expanded access program to collect and distribute convalescent plasma for the treatment of COVID-19.

Perspectives of Real-World Data From Expanded Access During COVID-19

Expert

Michael J. Joyner, M.D.

Date

Oct. 9, 2020

Location

New York University-University of Arizona (webinar)

Summary

By analyzing trends in COVID-19 data sets, the research community helped rapidly fill in knowledge gaps around disease symptoms, risk factors, racial disparities and more. Such observational methods also hinted at which treatments seemed to be making an impact — and which were not — all in near real time.

COVID-19 and Bioethics

Experts

DeLisa Fairweather, Ph.D., Michael J. Joyner, M.D., and R. Scott Wright, M.D.

Date

Oct. 2, 2020

Location

Mayo Clinic School of Continuous Professional Development (livestream)

Summary

Learn about the impact of the coronavirus pandemic on the health care system through specific examination of the effects on the workforce, research and the regulatory environment, vaccines, potential cures, and epidemiologic tracking. The Mayo Clinic experience and adaptive response to the pandemic are highlighted.

How the Urgency of the Public Health Emergency Meant We Had To Do Things Differently

Expert

DeLisa Fairweather, Ph.D.

Date

Sept. 23, 2020

Location

Mayo Clinic Innovation Forum: Jacksonville, Florida (livestream)

Summary

Learn how science can help the world recover from a pandemic.

Update on Safety and Efficacy of COVID-19 Convalescent Plasma 2

Expert

DeLisa Fairweather, Ph.D.

Date

Sept. 16, 2020

Location

The Biosafety Level 4 Zoonotic Laboratory Network (BSL4ZNet) COVID-19 Research Symposium Miniseries: Ottawa, Canada (webinar)

Summary

Dr. Fairweather discusses enhancing scientific knowledge and global capacity for preparedness for current and future high-consequence pathogen needs.

Treatment of COVID-19

Expert

Michael J. Joyner, M.D.

Date

Sept. 15, 2020

Location

American Society of Gene & Cell Therapy (virtual)

Summary

Dr. Joyner presents on the potential use of convalescent plasma in both preventive and treatment applications.

US COVID-19 Convalescent Plasma Expanded Access Program (EAP)

Expert

Katelyn A. Bruno, Ph.D.

Date

Sept. 1, 2020

Location

REDCap Public Health Workgroup (virtual)

Summary

Dr. Bruno describes the use of REDCap for the COVID-19 EAP. She discusses each version of the database along with lessons learned.

Convalescent Plasma and COVID-19

Expert

Michael J. Joyner, M.D.

Date

Aug. 25, 2020

Location

Duke University Department of Anesthesiology Grand Rounds (virtual)

Summary

Dr. Joyner covers what was learned through a study that analyzed the safety of convalescent plasma transfusion in patients who were hospitalized with COVID-19 and received the drug through the expanded access program (EAP) for COVID-19.

Convalescent Plasma: COVID-19 Livestream

Experts

Katelyn A. Bruno, Ph.D., DeLisa Fairweather, Ph.D., Michael J. Joyner, M.D., Jonathan (Jack) Senefeld, Ph.D., and R. Scott Wright, M.D.

Date

Aug. 1, 2020

Location

Mayo Clinic School of Continuous Professional Development (livestream)

Summary

Find information on the treatment of hospitalized patients with severe or life-threatening COVID-19. Topics covered include the history and evolution of convalescent plasma therapies; implementation of the EAP for patients with COVID-19; current data; blood bank and donor recruitment strategies; and world perspectives on treatment patients with COVID-19 with plasma.

How the Urgency of the Public Health Emergency Meant We Had To Do Things Differently

Expert

DeLisa Fairweather, Ph.D.

Date

July 23, 2020

Location

Mayo Clinic Innovation Forum: Jacksonville, Florida (livestream)

Summary

How science can help the world recover from a pandemic.

COVID-19: The US Convalescent Plasma Story

Experts

Michael J. Joyner, M.D., and R. Scott Wright, M.D.

Date

July 20, 2020

Location

Mayo Clinic Cardiovascular Grand Rounds (livestream)

Summary

Learn about what convalescent plasma is, the historical background of convalescent plasma use in infectious disease and use of convalescent plasma in COVID-19.

The Safety of Convalescent Plasma

Expert

Michael J. Joyner, M.D.

Date

May 22, 2020

Location

Mayo Clinic School of Continuous Professional Development; Mayo Clinic Talks COVID-19 Miniseries Episode 31: Rochester, Minnesota (podcast)

Summary

What nuances apply for convalescent plasma's application to treating COVID-19? Dr. Joyner discusses what's known about this treatment option, information currently being gathered and how you can get involved.

COVID-19 Event Update

Expert

Michael J. Joyner, M.D.

Date

May 19, 2020

Location

Mayo Clinic School of Continuous Professional Development (livestream)

Summary

This update covers current research initiatives related to the COVID-19 pandemic, promising innovative solutions for treatment strategies for patients with COVID-19, expedited translational research related to COVID-19 and innovative practice redesign principles to treat patients in a virtual setting.

National COVID-19 Convalescent Plasma Project

Expert

Michael J. Joyner, M.D.

Date

April 27, 2020

Location

Mayo Clinic Anesthesiology and Perioperative Medicine Grand Rounds (podcast)

Summary

What is convalescent plasma and how is it used to treat patients with COVID-19? Dr. Joyner provides an overview of the expanded access program, COVID-19 clinical trials related to convalescent plasma, lessons learned and future directions.

* This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority under Contract No. 75A50120C00096; National Center for Advancing Translational Sciences (NCATS) grant UL1TR002377; Schwab Charitable Fund (Eric E. Schmidt, Wendy Schmidt donors); United Health Group; National Basketball Association (NBA); Millennium Pharmaceuticals, Octapharma USA Inc; and Mayo Clinic.

Disclaimer: The views and opinions expressed in these educational activities are those of the authors and do not reflect the official policy or position of the U.S. Department of Health and Human services and its agencies, including the Biomedical Advanced Research and Development Authority and the Food and Drug Administration, as well as any agency of the U.S. government. Assumptions made within and interpretations from the analysis are not reflective of the position of any U.S. government entity.