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Project Information

Project Information


Clinical Trials During the 2014-2015 Ebola Outbreak


Project Scope:

An ad hoc committee of the IOM will review and conduct an analysis of the clinical trials conducted during the 2014-2015 Ebola virus disease (EVD) outbreak in West Africa. The final deliverable from this committee will be a consensus report that explores and analyzes the scientific and ethical issues related to clinical trial design, conduct, and reporting. Particular emphasis will be given to clinical trials for vaccine and therapeutic candidates for EVD conducted by the international community in settings where there is limited healthcare and research infrastructure.

The IOM committee will achieve its objectives by organizing and conducting meetings, interviews, and discussions with key informants in the international research community and in affected countries, including perspectives from government agencies, non-governmental entities, and others. The final report of the committee will be based on the information gathered at these meetings and key informant interviews, and review of the literature and other relevant documentation and communications.

In summary the report will:

      Assess the scientific value of the different EVD vaccine and therapeutic clinical trials conducted in Liberia, Sierra Leone, and Guinea and the data derived from them.

o   Describe the specific context (such as disease pathogenicity, high case fatality, political and health system context, and public opinion) and the ethical and scientific practices and considerations related to the design and conduct of each EVD clinical trial.

o   To the extent possible, characterize how these considerations have been addressed in similar contexts previously, drawing on case studies of clinical trials conducted during prior disasters to identify transferable best practices.

o   Compare pragmatic, ethical, and scientific practices and considerations made in the context of each EVD clinical trial against existing best practices to identify additional best practices and make recommendations on opportunities for improving future clinical research conducted during public health emergencies.

      Make recommendations for how, in the context of an international emerging or re-emerging infectious disease event, clinical trials can best be prioritized and conducted to (1) speed data collection; (2) inform clinical management of patients; (3) assess the safety, efficacy, and effectiveness of therapeutics and vaccines; and/or (4) improve/augment outbreak control efforts.

o   Where possible, identify scientific and ethical principles and practical guidance for clinical trial practices and protocols that balance the rapid need for new, useful information with ethical considerations and scientific rigor amid an emerging and rapidly evolving infectious disease event.

o   Where possible, identify new ideas for innovative approaches to research in emergency contexts and to alternative methods to evaluate treatments and vaccines.

o   Such guidance should include options that facilitate a more flexible and accelerated approach.

      Address whether adjustments to scientific or ethical standards are appropriate in the conduct of research in outbreak settings, and if so, under what circumstances. If such adjustments are found to be appropriate, specify:

o   How those adjustments should be decided and implemented; and

o   Current and/or future consequences of any such adjustments to patients themselves, or to prevention and treatment strategies.

      Identify opportunities for collaborative investment to achieve long-term ethical and scientific gains from clinical trials conducted during emerging infectious disease events. 

Status: Completed

PIN: IOM-HSP-15-08

Project Duration (months): 18 month(s)

RSO: Claiborne, Anne

Topic(s):

Health and Medicine
Policy for Science and Technology



Geographic Focus:
Global

Committee Membership

Committee Post Date: 02/01/2016

Gerald T. Keusch - (Co-Chair)
Boston University Schools of Medicine & Public Health

Dr. Keusch is a graduate of Columbia College and Harvard Medical School. He has been involved in academic medicine for his entire career, currently as Professor of Medicine and International Health at Boston University where he serves as an Associate Director of the National Emerging Infectious Diseases Laboratory. Prior to this he was Chief of the Division of Geographic Medicine and Infectious Diseases at Tufts Medical Center in Boston from 1979-1998, and Associate Director for International Research and Director of the Fogarty International Center at the U.S. National Institutes of Health from 1998 to 2004. Dr Keusch is a fellow of the Infectious Diseases Society of America, and an elected member of the American Society for Clinical Investigation, the Association of American Physicians, and the National Academy of Medicine, where he has served on the Board on Global Health, the Forum on Microbial Threats, and Co-Chaired an IOM/NRC report, “Sustaining Global Surveillance and Response to Emerging Zoonotic Diseases”, released in September 2009. His research experience spans both laboratory and clinical field research on infectious diseases in Latin America, Africa and Asia. He has been a member of multiple committees for the Tropical Diseases Research Program at WHO, and served on a review committee for the Wellcome Trust on Global Clinical Trials.
Keith McAdam - (Co-Chair)
London School of Hygiene and Tropical Medicine

Dr. Keith McAdam is the founding director of the Infectious Diseases Institute (IDI) (2004-7) at Makerere University. He is emeritus professor of clinical tropical medicine at the London School of Hygiene and Tropical Medicine, a position he held from 1985 to 2004. From 1994 to 2003, Dr. McAdam was seconded to West Africa to serve as director of the UK Medical Research Council Laboratories in the Republic of The Gambia. Dr. McAdam grew up in Uganda, where his father, Sir Ian McAdam, was Professor of Surgery at Makerere. He did his schooling in Kenya and went on to study medicine at Cambridge University and the Middlesex Hospital in London. After training in internal medicine in London, he spent three years at the Institute of Medical Research in Papua New Guinea working on leprosy, malaria, and filariasis as causes of secondary amyloidosis. Two years, from 1975 to 1977, Dr. McAdam developed his laboratory and clinical research focus on inflammation, acute phase proteins, and cytokines, at the Immunology Branch of the National Cancer Institute in Bethesda, Maryland, and continued this focus over the next seven years in Boston as a clinical scientist in the Department of Medicine at Tufts New England Medical Center. Professor McAdam was medical advisor to the UK Parliamentary Select Committee on AIDS in 1987 and a member of the Nuffield Council on Bioethics working party that produced an authoritative publication The Ethics of Healthcare Related Research in Developing Countries. He has been associate international director at the Royal College of Physicians in London and is currently their special advisor on East Central and Southern Africa. He has just rotated off the International Board of the African Medical and Research Foundation (AMREF) and is currently on the Board of Trustees of the charity BBC Media Action.
Abdel Babiker
University College London

Professor Abdel Babiker completed a PhD in mathematical analysis at the University of London. In the 1980s he worked on a number of cancer trials at the Institute of Cancer Research (ICR) and with the Imperial Cancer Research Fund.

He joined the MRC HIV Clinical Trials Centre (HIV CTC) as Deputy Head in 1992 and was directly responsible for overseeing all statistical aspects of the Centre's research programme. When the HIV CTC became part of the MRC Clinical Trials Unit in 1998, he was appointed Head of the HIV Group. HIV research has expanded greatly since 1998, through wider national and international collaborations addressing key questions in treatment and prevention of HIV and has impacted on international guidelines for the treatment of HIV.

Mohamed B. Barrie
The Wellbody Alliance

Dr. Mohamed Bailor Barrie grew up in poverty in rural Sierra Leone. After finishing secondary school, he received one of two scholarships in the country to study medicine at the College of Medicine and Allied Health Sciences in Freetown, Sierra Leone. Dr. Barrie trained in general medicine, building his skills in all areas of medicine. The civil war in Sierra Leone forced him to suspend his studies and, after one year as a refugee in neighboring Guinea, he graduated with his degree in medicine in 2004. After obtaining his degree Dr. Barrie worked as a medical officer at a rural nonprofit hospital and was one of four physicians in his graduating class to continue to practice medicine in Sierra Leone. He has also acted as a consultant for UNICEF and World Health Organization. In 2006 Dr. Barrie co-founded and became the executive and medical director of Wellbody Alliance, a nonprofit healthcare organization based in Kono District, Sierra Leone. His current role is as chief strategic officer. Dr. Barrie is the recipient of the 2013 Grace Humanitarian Award from Thomas Jefferson University. For 2013-2015, Dr. Barrie was awarded a prestigious Fulbright Fellowship to study global health delivery at Harvard University.
Janice Cooper
Liberia Mental Health Initiative

Dr. Janice L. Cooper is the country lead for the Liberia Mental Health Initiative. She oversees a national training, policy, and support program to expand capacity for mental health services delivery. She also is responsible for interacting with national and international colleagues and partners of the program. A native Liberian and health services researcher specializing in children's mental health, Dr. Cooper has worked in the private, public, and nonprofit sectors in the United States and Liberia. Prior to joining The Carter Center in 2010, Dr. Cooper was the interim director of the National Center for Children in Poverty as well as an assistant clinical professor in health policy and management at Columbia University's Mailman School of Public Health. From 2005-2009, she also served as the Center's director of child health and mental health, receiving the distinguished Calderone Prize for Junior Faculty in 2007. Dr. Cooper received her Ph.D. in health policy from Harvard University. She was a 2001 fellow in medical ethics at Harvard Medical School and a 1999 Archibald Bush Foundation Leadership Fellow. She holds additional undergraduate and graduate degrees from the University of Essex in Colchester, England, and Columbia and Harvard universities in the United States.
Sheila Davis
Partners in Health

Dr. Sheila Davis is the Chief of the Ebola Response and Chief Nursing Officer at Partners In Health (PIH) where she led the Ebola response efforts in West Africa for PIH in Sierra Leone and Liberia. At peak of the effort, PIH was operating in collaboration with the Ministries of Health at over 20 facilities for screening and treatment of Ebola. Currently she is leading the effort to transition from Ebola response to health system strengthening in Liberia and Sierra Leone as part of PIH’s long term commitment to both countries. Sheila has been a nursing leader in the in the field of HIV/AIDS since its emergence in the mid-1980's and served on the National Board of the Association of Nurses AIDS Care (ANAC). She entered the global health arena in 1999 when she began working for Partners AIDS Research Center as part of Massachusetts General Hospital on community outreach and HIV treatment efforts. Partnering with global nursing colleagues, she co-founded a small NGO that worked in South Africa and Boston from 2004-2010 on health projects including a rural village nurse clinic and urban vulnerable children feeding program.

Dr. Davis received her BSN from Northeastern University in 1988, her Masters in Nursing as an Adult Nurse Practitioner from the MGH Institute of Health Professions in 1997, and her Doctorate in Nursing Practice with a concentration in global health in 2008 also from the MGH Institute of Health Professions. Sheila was a faculty member at the School of Nursing at the MGH Institute of Health Professions for 4 years and an Adult Nurse Practitioner at MGH Infectious Diseases outpatient practice for over 15 years. She is currently adjunct faculty at the University of California San Francisco School of Nursing.

Inducted as a Fellow into the American Academy of Nursing in 2008, Dr. Davis is a frequent national speaker on global health, clinical topics including Ebola, HIV/AIDS, and role of nursing in human rights. In 2009, she was inducted as one of the inaugural class of 12 Carl Wilken’s Fellows working on anti-genocide global efforts as part of the Genocide Intervention Network. Dr. Davis has published in number of domestic and global journals and is on the editorial board of the Health and Human Rights: An International Journal. She was part of the 2012 cohort of the Robert Wood Johnson Executive Nurse Fellowship, a three year fellowship that prepares 20 national nursing leaders to contribute to the national health care strategy.

Kathryn M. Edwards
Vanderbilt University School of Medicine

Kathryn M. Edwards, MD, the Sarah H. Sell and Cornelius Vanderbilt Professor of Pediatrics, has had an extensive experience in leading NIH-funded multicenter initiatives and in designing, conducting, and analyzing pivotal Phase I, II, and III clinical studies on vaccines and therapeutics. She initially focused her efforts on conducting studies of Haemophilus influenzae, type b capsular polysaccharide protein conjugate vaccines in infants. In 1985, she received NIH-funding to conduct a comparative influenza efficacy trial of live attenuated and inactivated influenza vaccines in 3000 children and adults each year for five years. In 1990, she coordinated the NIH-funded Multicenter Acellular Pertussis Trial comparing acellular pertussis vaccines and whole cell pertussis vaccines. In the late 1990s, she conducted additional studies on bacterial vaccines when she studied pneumococcal conjugate vaccines in young infants and determined their role in preventing colonization and disease.

In 1998, Dr. Edwards was awarded a contract from the Centers for Disease Control and Prevention (CDC) to conduct active population-based surveillance to monitor the impact of newly licensed vaccines. She has also led the CDC-funded Center for Immunization Safety Assessment (CISA). In 2012 Dr. Edwards conducted comprehensive pneumonia surveillance studies in over 2000 adults and children admitted to Vanderbilt. Dr. Edwards has served on many CDC, NIH, WHO, and IDSA committees. In 2008 she was elected to the Institute of Medicine of the National Academy of Sciences. She also recently served as chief of a DSMB for Ebola trials in Mali.

Susan S. Ellenberg
University of Pennsylvania School of Medicine

Susan Ellenberg joined the biostatistics faculty at the University of Pennsylvania as Professor of Biostatistics in the fall of 2004. She also has a secondary appointment in the Department of Medical Ethics and Health Policy. Dr. Ellenberg directs the Biostatistics Core for the Penn Center for AIDS Research, and is also collaborating on projects in pulmonary research, breast cancer, anesthesiology,
endocrinology and HIV. Prior to arriving at Penn, Dr. Ellenberg held leadership positions at the National Institutes of Health and the Food and Drug Administration. Her areas of research have included surrogate endpoints for treatment effects in clinical trials, operational issues for data monitoring committees, clinical trial designs, adverse event monitoring, vaccine safety and special issues in cancer and AIDS trials. Dr. Ellenberg is a Fellow of the American Statistical Association, the Society for Clinical Trials and the American Association for the Advancement of Science, and is an elected member
of the International Statistical Institute. She has served as President of the Eastern North American Region (ENAR) of the International Biometric Society, and of the Society for Clinical Trials, and as Chair of the Board of Trustees of the National Institute of Statistical Sciences. She is an Associate Editor of
Clinical Trials and the Journal of the National Cancer Institute. Her book, Data Monitoring Committees in Clinical Trials: A Practical Perspective, co-authored with Drs. Thomas Fleming and David DeMets,
was named Wiley Europe Statistics Book of the Year for 2002.

Roger J. Lewis
Harbor-UCLA Medical Center

Dr. Lewis received his PhD in Biophysics and MD from Stanford University. He is a Professor at the David Geffen School of Medicine at UCLA and Chair of the Department of Emergency Medicine at Harbor-UCLA Medical Center. Dr. Lewis’s expertise centers on adaptive and Bayesian clinical trials, including platform trials; translational, clinical, health services and outcomes research; interim data analysis; data monitoring committees; and informed consent in emergency research studies.

In 2009, Dr. Lewis was elected to membership in the National Academy of Medicine (formerly the Institute of Medicine). He is a Past President of the Society for Academic Emergency Medicine (SAEM), currently a member of the Board of Directors for the Society for Clinical Trials, and the Senior Medical Scientist at Berry Consultants, LLC, a group that specializes in adaptive clinical trials.

Dr. Lewis has served as a grant reviewer for the Agency for Healthcare Research and Quality (AHRQ), the Canadian Institutes of Health Research (CIHR), the Centers for Disease Control and Prevention (CDC), the National Cancer Institute of France, the National Institutes of Health (NIH), the Patient Centered Outcomes Research Institute (PCORI) and foundations. He is also a member of the Medicare Evidence Development & Coverage Advisory Committee of the Centers for Medicare & Medicaid Services. Dr. Lewis serves as the chair of data and safety monitoring boards (DSMB) for both federally-funded and industry-sponsored clinical trials, including international trials. He is a research methodology reviewer for JAMA and an editor of the JAMA series entitled “JAMA Guides to Statistics and Methods.” He has served as a content reviewer for many other peer reviewed journals. He has authored or coauthored over 200 original research publications, reviews, editorials, and chapters.

Alex London
Carnegie Mellon University

Alex John London is Professor of Philosophy and Director of The Center for Ethics and Policy at Carnegie Mellon University. Professor London is an elected Fellow of the Hastings Center and recipient of the Distinguished Service Award from the American Society of Bioethics and Humanities (ASBH).

Professor London's research focuses on foundational ethical issues in human-subjects research, issues of social justice in the trans-national context, and on methodological issues in theoretical and applied ethics. His papers have appeared in Mind, Science, The Lancet, PLoS Medicine, Statistics In Medicine, The Hastings Center Report, and numerous other journals and collections. He is co-editor of Ethical Issues in Modern Medicine, one of the most widely used textbooks in medical ethics.

In 2012 he joined the Working Group on the Revision of the CIOMS 2002 International Ethical Guidelines for Biomedical Research Involving Human Subjects and in 2011 he was appointed to the Steering Committee on Forensic Science Programs for the International Commission on Missing Persons (ICMP). Since 2007 he has served as a member of the Ethics Working Group of the HIV Prevention Trials Network. He has testified before the Presidential Commission for the Study of Bioethical Issues and has been commissioned to write papers for the Centers for Disease Control and Prevention (CDC) and the Institute of Medicine (IOM). He has served as an ethics expert in consultations with numerous national and international organizations including the U.S. National Institutes of Health, the World Health Organization, the World Medical Association and the World Bank.

Jens Lundgren
University of Copenhagen

Jens Lundgren is Professor of Viral Diseases and a practicing infectious disease specialist. He founded, and heads, the Centre for Health and Infectious Disease Research and PERSIMUNE (Centre of Excellence for Personalised Medicine of Infectious Complications in Immune Deficiency) at the department of infectious diseases (CHIP/ PERSIMUNE), based at the Copenhagen University Hospital (Rigshospitalet), University of Copenhagen. Jens Lundgren is a member of the Executive Committee of the NIH/NIAID funded INSIGHT network (International Network for Strategic Initiatives in Global HIV Trials), chairs its scientific steering committee and is Co-PI for the START study. He is Co-editor-in-chief of the "HIV Medicine" journal, Chair of the Steering Committee for the “D:A:D study”; founder and current member of the steering committee for the EuroSIDA study; founder and current member of the steering committee of the “HIV In Europe” initiative focused on early testing and care for HIV+ persons across Europe, and chairs the EACS non-infectious co-morbidity guidelines panel, and was awarded the EACS Award for Excellence in HIV Medicine in 2015. He is member of American Society of Clinical Investigation (ASCI) and Association of American Physicians (AAP), and honorary life-long member of IAPAC. His list of publications in scientific literature is extensive, and he has mentored several younger colleagues in their research development.
Michelle M. Mello
Stanford University School of Medicine

Michelle Mello is Professor of Health Research and Policy at Stanford University School of Medicine and
Professor of Law at Stanford Law School. She holds doctoral degrees in law and health policy, and conducts research on issues at the intersection of health policy, law, and bioethics. Mello’s scholarship includes work on ethical issues arising in industry-sponsored clinical trials; legal and ethical barriers to clinical trial data sharing; legal concerns as a hindrance to clinical volunteerism during the Ebola epidemic; and a range of legal and ethical issues in pharmaceutical regulation and human subjects research. For 7 years, she served as Chair of the institutional review board at the Harvard School of Public Health, which is responsible for oversight of numerous clinical trials in African countries.

Olayemi Omotade
Institute of Child Health

Olayemi Omotade is a Professor of Paediatrics and Child Health and the Director of the Institute of Child Health, College of Medicine, University of Ibadan. He is a Consultant Paediatrician to the University College Hospital, Ibadan Nigeria. As part of his residency training in Paediatrics at the University College Hospital, he was on attachment to the University Hospital of Wales, Cardiff where he was trained as a clinical geneticist.

At the Institute of Child Health, his research interests spans Community/Preventive Paediatrics and while combining this with his clinical genetics, he has been able to carry out research on infectious and communicable diseases. He has been involved in Program planning and monitoring with international Organizations including WHO, UNICEF and UNDP both at the country and international levels.

Through a Fogarty Fellowship (2001-2) he was able to undertake a course of study leading to the award of a Master of Arts at the Case Western Reserve University Cleveland, Ohio during which he was instrumental to the drawing up of the initial works for Nigeria’s National Ethical Guidelines. He was for some time a member of the National Ethics Review Board for Nigeria as well as for the Joint IRC University of Ibadan/University College Hospital. He has over eighty publications in international and regional journals and he is a member of many professional associations including the Paediatrics Association of Nigeria, American Society for Bioethics and Humanities, Member, Puebla Group of Networks Collaborating on Health Research for Development, Member, Clinical Genetics Society of Great Britain and International Association for Tropical Paediatrics to mention a few. He is the foundation Director for Centre for HIV-AIDS Intervention, Nigeria (CEHAIN). He has also coordinated several studies for the Nigerian Academy of Sciences and he has been a reviewer for several bodies and journals including reviewing some chapters of two books for the Institute of Medicine (IOM) February 2015.

He is also a member of the Task Force MIM/TDR/WHO. Member, Scientific Review Committee for the European &Developing Countries Clinical Trials Partnership (EDCTP) for the EDCTP Senior Fellowships Training Awards 2005 and Member of WHO/MIM/TRD Task Force on Malaria Research Capability Strengthening in Africa (WHO/TDR Steering Committee) 2003 – 2011. Dr. Omotade is also a member of several Expert Technical groups including WHO Expert Technical group on IPTi. Member, International Advisory Board, Institute for Research on Unlimited Love, Altruism Compassion Service, Case Western Reserve University, Cleveland, Ohio, USA Fogarty Fellowship for Bioethics at the Case Western Reserve University Cleveland Ohio 2001

He has been on the University College hospital Board of Management 2010 -2015 and he is member of the National Child Health Technical Working Group 2015 – to date. He has been the Chairman of the College of Medicine, University of Ibadan Post graduate Committee since 2010 – to date.

David Peters
Johns Hopkins Bloomberg School of Public Health

David H. Peters, MD, MPH, DrPH, is Professor and Chair of the Department of International Health at Johns Hopkins Bloomberg School of Public Health. He is a specialist in international health systems who has worked as a researcher, policy advisor, educator, bureaucrat, manager, and clinician in a number of developing countries over the last two decades. He previously worked as a Senior Public Health Specialist at the World Bank, and as the Director of the Health Systems Program at Johns Hopkins. He is Research Director for the Future Health Systems research consortium, which is working to improve access, affordability and quality of health services for the poor, with field sites in five countries in Africa and Asia. He pioneered the development of Sector Wide Approaches (SWAps) in health, and created the first national Balanced Scorecard to assess and manage health services (in Afghanistan). He is currently leading a program to strengthen public health systems in Liberia in the wake of the Ebola epidemic. He has written seven books and over 100 scientific articles, mostly focusing on health systems in low and middle-income countries. His teaching and research focus on the performance of health systems, implementation research methods, poverty and health systems, innovations in organization, technology, and financing of health systems, the role of the private sector, human resource management, and ways to use donor assistance to strengthen local capacity in low-income countries.
Fred Wabwire-Mangen
Makerere University

Dr. Fred Wabwire-Mangen was trained in Human Medicine at Makerere University, in Tropical Medicine at Liverpool University and in Immunology and Infectious Diseases and Infectious Disease Epidemiology at Johns Hopkins University where he obtained a PhD in 1994. He is an Associate Professor of Epidemiology and Public Health at the Makerere University School of Public Health, where he teaches infectious disease epidemiology, intervention trials, and health services research. He is also has a secondary appointment as a senior research scientist and executive chair at the Makerere University Walter Reed Project (MUWRP). MUWRP is one of the few projects that is conducting Ebola and Marburg vaccine trials in Uganda. Dr Wabwire-Mangen has over 25 years of conducting research on emerging and re-emerging diseases of public health importance in Uganda including malaria, STIs, HIV/AIDS, influenza and other emerging viral infections. He also has demonstrated experience leading and managing multi-disciplinary research teams. He served as a co-investigator on a cluster randomized trial on STD control for AIDS prevention and an individual randomized controlled trial on male circumcision for HIV prevention while working at the Rakai Health Sciences Project between 1994 and 2008, and as co-investigator of a Phase I and a Phase II-a HIV vaccine trial at MUWRP. As Principal Investigator of the Surveillance of Influenza Viruses among Human and Non-Human Hosts in Uganda study and the GEIS-funded Antimicrobial Resistance Surveillance in Uganda study, Dr Wabwire-Mangen leads a team of medical doctors, laboratorians, epidemiologists, veterinarians, ornithologists and other scientists. Dr Wabwire-Mangen has published widely on public health issues and has over 150 journal publications in peer reviewed journals.
Charles D. Wells
Infectious Disease Therapeutic Strategic Unit

Charles D. Wells, MD, currently serves as Head of Development and Associate Vice President for the Infectious Diseases Therapeutic Unit at Sanofi based in Bridgewater, NJ, having joined the organization in September 2015. Prior to joining Sanofi he served as the Senior Medical Director for the tuberculosis products development group at Otsuka Pharmaceuticals in Rockville, MD. He joined Otsuka in May 2007 to provide the medical and clinical leadership for developing Otsuka’s anti-tuberculosis compound, delamanid, which was successfully registered as Deltyba® in 2014 in the E.U., Japan and Korea for treatment of multidrug resistant (MDR)- tuberculosis (TB). In his role at Otsuka he oversaw the clinical development program for delamanid, including clinical operations charged with conducting the global clinical trials in 14 countries across 5 continents, and served on the regulatory submission team responsible for the product’s registration. Additionally, he led the publication strategy for reporting results from the clinical development trials for delamanid and led the data submission process to the World Health Organization required for development of interim global guidelines for the use of delamanid in MDR-TB treatment.

Prior to joining Otsuka, he served as Chief of the International Research and Programs Branch of the Division of Tuberculosis Elimination at the U.S. Centers for Disease Control and Prevention (CDC) during 2000-2007. The branch he led at CDC conducted extensive epidemiologic, clinical, and diagnostics research on TB which fed supportive data into evolving global policy and provided direct technical assistance internationally for implementation and scale up of public health programs for control of TB, HIV-associated TB, and MDR-TB in sub-Saharan Africa, Southeast and South Asia, Eastern Europe, as well as South America. During this time he also served as CDC’s lead representative on the Strategic Advisory Group for the STOP-TB Department at the World Health Organization (WHO) and also the United States Agency for International Development (USAID)-supported TB Coalition for Technical Assistance. Additionally, he served as a technical expert on disease control program reviews in numerous countries for WHO, USAID, and the President’s Emergency Plan for AIDS Relief (PEPFAR).

Early in his career, he began work in clinical development serving as a research associate at Burroughs Wellcome and Glaxo in Research Triangle Park, NC, in the late 1980’s and as an associate medical director at PathoGenesis Corporation in Seattle, WA, in the late 1990’s working on clinical development for anti-infectives, including new drugs for TB.

He is a native of North Carolina and attended North Carolina State University where he received a Bachelor of Science in Chemical Engineering in 1987. He then completed his medical studies at the University of North Carolina at Chapel Hill in 1992 and his post-graduate medical training in internal medicine and infectious diseases at Emory University and the CDC in Atlanta during 1992-1998.

Events



Location:

None: teleconference
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Michael Berrios
Contact Email:  mberrios@nas.edu
Contact Phone:  202-334-3494

Agenda
No part of this meeting was open to the public.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Babiker
Abdel
Barrie
Mohamed
Cooper
Janice
Davis
Sheila
Edwards
Kathryn
Ellenberg
Susan
Keusch
Gerald
Lewis
Roger
London
Alex
Lundgren
Jens
McAdam
Keith
Mello
Michelle
Omotade
Olayemi
Peters
David
Wabwire-Mangen
Fred
Wells
Charles

The following topics were discussed in the closed sessions:

Report composition

The following materials (written documents) were made available to the committee in the closed sessions:

Report draft chapters

Date of posting of Closed Session Summary:
December 21, 2016
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Michael Berrios
Contact Email:  mberrios@nas.edu
Contact Phone:  202-334-3494

Agenda
No part of this meeting is open to the public.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Abdel Babiker
Janice Cooper
Sheila Davis
Kathryn Edwards
Susan Ellenberg
Gerald Keusch
Roger Lewis
Alex John London
Jens Lundgren
Keith McAdam
Michelle Mello
Olayemi Omotade
Fred Wabwire-Mangen

The following topics were discussed in the closed sessions:

Report content and editing. Also discussed report release and dissemination.

The following materials (written documents) were made available to the committee in the closed sessions:

Draft report chapters.

Date of posting of Closed Session Summary:
December 02, 2016
Publication(s) resulting from the event:

-


Location:

None - Teleconference
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Michael Berrios
Contact Email:  mberrios@nas.edu
Contact Phone:  202-334-3494

Agenda
No portion of this meeting was open to the public.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Kathryn Edwards
Michelle Mello
Gerald Keusch
Keith McAdam

The following topics were discussed in the closed sessions:

Draft report content.

The following materials (written documents) were made available to the committee in the closed sessions:

Draft report chapters.

Date of posting of Closed Session Summary:
November 08, 2016
Publication(s) resulting from the event:

-


Location:

None - Teleconference
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Michael Berrios
Contact Email:  mberrios@nas.edu
Contact Phone:  202-334-3494

Agenda
No part of this meeting was open to the public.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Janice Cooper
Sheila Davis
Olayemi Omotade
Gerald Keusch
Keith McAdam


The following topics were discussed in the closed sessions:

Report chapter content.

The following materials (written documents) were made available to the committee in the closed sessions:

Draft report material.

Date of posting of Closed Session Summary:
November 02, 2016
Publication(s) resulting from the event:

-


Location:

None - Teleconference
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Michael Berrios
Contact Email:  mberrios@nas.edu
Contact Phone:  202-334-3494

Agenda
There are no open portions of this meeting.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Fred Wabwire-Mangen
Gerald Keusch
Keith McAdam
Charles Wells
Roger Lewis
Alex John London
Jens Lundgren

The following topics were discussed in the closed sessions:

Report chapters

The following materials (written documents) were made available to the committee in the closed sessions:

Draft report chapters

Date of posting of Closed Session Summary:
October 27, 2016
Publication(s) resulting from the event:

-


Location:

None - Teleconference
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Michael Berrios
Contact Email:  mberrios@nas.edu
Contact Phone:  202-334-3494

Agenda
No open sessions.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

David Peters
Mohamed Bailor Barrie
Janice Cooper
Keith McAdam
Gerald Keusch

The following topics were discussed in the closed sessions:

Draft report recommendations

The following materials (written documents) were made available to the committee in the closed sessions:

Draft report chapters

Date of posting of Closed Session Summary:
October 25, 2016
Publication(s) resulting from the event:

-


Location:

None - Teleconference
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Michael Berrios
Contact Email:  mberrios@nas.edu
Contact Phone:  202-334-3494

Agenda
There were no open parts of the meeting.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Kathryn Edwards
Susan Ellenberg
Fred Wabwire-Mangen
Alex John London
Roger Lewis
Gerald Keusch
Keith McAdam

The following topics were discussed in the closed sessions:

Draft report recommendations

The following materials (written documents) were made available to the committee in the closed sessions:

Draft report chapters.

Date of posting of Closed Session Summary:
October 25, 2016
Publication(s) resulting from the event:

-


Location:

National Emerging and Infectious Diseases Laboratory
620 Albany Street
Boston, MA 02118
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Michael Berrios
Contact Email:  mberrios@nas.edu
Contact Phone:  202-334-3494

Agenda
The meeting was closed in its entirety.
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Abdel Babiker
Mohamed Bailor Barrie
Janice Cooper
Kathryn Edwards
Susan Ellenberg
Roger Lewis
Alex john London
Jens Lundgren
Keith McAdam
Gerald Keusch
Michelle Mello
David Peters
Fred Wabwire-Mangen
Charles Wells

The following materials (written documents) were made available to the committee in the closed sessions:

Briefing book

Date of posting of Closed Session Summary:
October 03, 2016
Publication(s) resulting from the event:

-


Location:

Bella Casa Hotel
3rd Street Sinkor
Monrovia, Liberia
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Michael Berrios
Contact Email:  mberrios@nas.edu
Contact Phone:  202-334-3494

Agenda
West Africa Public Workshop of the Committee on Clinical Trials During the 2014–2015 Ebola Outbreak
Bella Casa Hotel
2nd Street Sinkor Tubman Blvd
Monrovia, Liberia
August 15–16, 2016
August 15, 2016
Day ONE
SETTING RESEARCH PRIORITIES DURING EMERGENCY INFECTIOUS DISEASE EVENTS
Day One Meeting Objective:
• Explore lessons learned from the 2014-2015 Ebola outbreak to best prioritize, design and implement clinical research during public health emergencies

8:30 a.m. Meeting Registration

9:00 a.m. Welcome by Committee Co-Chairs
Gerald Keusch, Committee Co-Chair
Keith McAdam, Committee Co-Chair

Welcome and Perspectives from the Ministries of Health
Co-Moderators: Janice Cooper, Carter Center Liberia
M. Bailor Barrie, Wellbody Alliance
Speakers: (10 minutes prepared remarks each, followed by Q&A)
• Bernice Dahn, Minister of Health and Social Welfare, Ministry of Health and Social Welfare of the Republic of Liberia (invited)
• Abu Bakarr Fofanah, Minister of Health and Sanitation, Ministry of Health and Sanitation of the Republic of Sierra Leone (invited)
• Abdourahmane Diallo, Minister of Health, Ministry of Health and Public Hygiene of the Republic of Guinea (invited)
10:00 a.m. BREAK

10:15 a.m. Panel 1: Prioritizing Research in Outbreak Response

Co-Moderators: Janice Cooper, Carter Center Liberia
M. Bailor Barrie, Wellbody Alliance

Panelists: (10 minutes prepared remarks each):
• Tolbert Nyenswah, Deputy Minister of Health – Liberia (head of Liberia's Ebola response) (confirmed)
• Sakoba Keita, Ebola Response national Coordinator (Guinea) (invited)

Respondents: (5 minutes each, reaction to panelists)
• Moses Massaquoi, National Chair, Case Management at the Ebola Incident Management System in Monrovia (Liberia) (confirmed)
• Vuyu Golakai, Dean, College of Health Sciences (confirmed)
Moderated Discussion with Committee and Participants
11:45 a.m. LUNCH
12:45 p.m. Panel 2: Perspectives from the Research and Training Community
Moderator: Fred Wabwire Mangen, Makerere University – Uganda
Panelists: (10 minutes prepared remarks each)
• Stephen Kennedy, Co-PI, PREVAIL & Coordinator, EVD Research, Incident Management System (IMS), Liberia (confirmed) – PREVAIL Trials
• Mohamed Samai, Director of Non-communicable Diseases, Acting Provost – College of Medicine and Allied Health Sciences (Sierra Leone) – STRIVE Vaccine Trial (confirmed)
• Mandy Kader Konde, Center Of Excellence For Training, Research On Malaria & Priority Diseases in Guinea (Guinea) Guinea Ring Vaccine (confirmed)

Respondents: (5 minutes each, reaction to panelists)
• Bartholomew Wilson, Social Mobilization – PREVAIL Trials (confirmed)
• Foday Sahr, College of Medicine and Allied Health Sciences, University of Sierra Leone –TKM-Ebola (invited)
• Abdoul Habib Beavogui, National Center for Education and Research in Rural Health Maferinyah, Conakry, Republic of Guinea – JIKI (favipiravir) (confirmed)
Moderated Discussion with Committee and Participants
2:45 p.m. BREAK

3:00 p.m. Panel 3: Perspectives from Regulatory Authorities

Moderator: Susan Ellenberg, University of Pennsylvania

Panelists: (10 minutes prepared remarks each)
• Onome Thomas Abiri, Head, Pharmacovigilance/Safety Monitoring and Clinical Trial Department, Pharmacy Board Sierra Leone (invited)
• Nagnouma Sano, Health Products and Medical Technologies Thematic Group, Ministry of Health and Public Hygiene (Guinea) (invited)
• David Sumo, Managing Director, Liberian Medicines Health Products Regulatory Authority (LMHRA) (Liberia) (invited)
Moderated Discussion with Committee and Participants

4:00 p.m. Panel 4: Perspectives from the Ethics Review Board

Moderator: Olayemi Omotade, University of Ibadan

Panelists: (10 minutes prepared remarks each)
• Hector Morgan, Director, Sierra Leone Ethics and Scientific Review Committee (Sierra Leone) (confirmed)
• Fatorma Baloy, Chairperson, Liberia Institute for Biomedical Research Ethics Committee (Liberia) (confirmed)
• Oumou Bah Sow, Comité National d'Ethique pour la Recherche en Santé (Guinea) (confirmed)
Respondent: (5 minutes each, reaction to panelists)
• Tumani Corrah, Director, Africa Research Development (confirmed)
Moderated Discussion with Committee and Participants


5:30 p.m. ADJOURN
West Africa Public Workshop of the Committee on Clinical Trials During the 2014–2015 Ebola Outbreak
Bella Casa Hotel
2nd Street Sinkor Tubman Blvd
Monrovia, Liberia
August 15–16, 2016
August 16, 2016
Day TWO
ENGAGING COMMUNITIES IN RESEARCH DESIGN AND IMPLEMENTATION DURING OUTBREAKS
Day Two Meeting Objective:
• Explore lessons learned from the 2014-15 Ebola outbreak to best engage communities in the design and implementation of clinical research during future outbreaks.
• Discuss opportunities for community involvement in planning activities to better prepare and build local research capacity for future epidemics.

8:30 a.m. Meeting Registration

9:00 a.m. Welcome by Committee Co-Chairs
Gerald Keusch, Committee Co-Chair
Keith McAdam, Committee Co-Chair


Panel 5: Community Mobilizer's Perspectives
Moderator: Charles Wells, Sanofi
Panelists: (10 minutes prepared remarks each)
• Mohammad B. Jalloh, CEO, Focus 1000 (Sierra Leone) (confirmed)
• Reverend John Sumo, head of social mobilization, Liberia (confirmed)
• Alpha M. Barry, Public health Consultant, Senior Manager, Santé Plus Guinea (confirmed)
Respondents: (5 minute each, reaction to panelists)
• George Ferguson, Country Director Sierra Leone, BBC Media Action
• Luke Bawo, Coordinator for Health Management Information Systems (HMIS), Research and Monitoring and Evaluation (M&E), National Ministry of Health in Liberia
Moderated Discussion with Committee and Participants

10:30 a.m. BREAK

10:45 a.m. Panel 6: Patient and Clinician Perspectives
Moderator: David Peters, Johns Hopkins University
Panelists: (10 minutes prepared remarks each)
• Patrick Faley, president, Liberia Survivors Network (confirmed)
• Achille Diona Guemou, Chairman,Ebola Association Network; Physician with Association des Personnes Guéries et Affectées d'Ebola en Guinée (Association of Persons Affected and Cured of Ebola in Guinea) (confirmed)
Moderated Discussion with Committee and Participants


12:15 p.m. LUNCH

1:15 p.m. Panel 7: Perspectives from Civil Society
Moderator: TBD
Panelists: (10 minutes prepared remarks each)
• Ambassador Juli Endee, CEO, Liberia Crusaders for Peace (invited)
• Chief Zanzan Kawa, Chairman of the Council of Chiefs, Liberia (invited)
• Abdoulaye Toure, Chaire de Santé Publique, Département de Pharmacie, Université de Conakry, Guinea (confirmed)
• Fayiah Tambah, Secretary General of the Liberia National Red Cross Society (invited)
Moderated Discussion with Committee and Participants


2:30 p.m. BREAK











2:45 p.m. Panel 8: Building Local Research Capacity
Panelists and Group Leads: (10 minutes prepared remarks followed by breakout groups with facilitated discussion)
• Mosoka Fallah, Ebola Emergency-Response Program Manager, Action Contre la Faim (ACF) – LIBERIA (confirmed)
• Oyewale Tomori, President, Nigerian Academy of Science (invited)
• Tumani Corrah, Director, Africa Research Development (confirmed)
3:15 p.m. Breakout groups with facilitated discussion

4:30 p.m. Reconvene in plenary session
• Recap breakout group discussions
• Open comment period

5:00 p.m. ADJOURN
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Abdel Babiker
Janice Cooper
Susan Ellenberg
Roger Lewis
Keith McAdam
Olayemi Omotade
David Peters
Fred Wabwire-Mangen
Charles Wells

The following topics were discussed in the closed sessions:

There was discussion about what findings and recommendations to include in the report based on the evidence gathered and discussions had at the previous meetings.

The following materials (written documents) were made available to the committee in the closed sessions:

Briefing book

Date of posting of Closed Session Summary:
August 25, 2016
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Michael Berrios
Contact Email:  mberrios@nas.edu
Contact Phone:  202-334-3494

Agenda
Public Workshop of the Committee on Clinical Trials
During 2014 – 2015 Ebola Outbreak
DRAFT AGENDA
Third Committee Meeting
June 13--15, 2016
Keck Center: 500 5th St. NW
Washington, D.C. 20001
Room 208

Day ONE
June 13, 2016

Meeting Objectives:
• Consider how to best align the missions and values of international stakeholders (governments, regulatory agencies, NGO’s, academic and industry researchers) to engender a rapid, robust, and sustained public health and research response.
• Explore strategies and identify resources needed to effectively conduct clinical trials during an emergency without negatively impacting the public health and humanitarian response.
• Discuss the ethical and scientific considerations in the design and implementation of clinical trials during the 2014-2015 Ebola outbreak; identify challenges and lessons learned, including issues around consent, community engagement, managing data, etc.
• Explore the full economic impact of outbreaks, and discuss how sustainable funding for clinical research during public health outbreaks can be established and managed.

SESSION I – FOSTERING INTERNATIONAL COORDINATION AND COLLABORATION
Session Objectives:
• Explore how nations with strong response capacity can work more effectively together under the leadership of international organizations like WHO.
• Consider how U.S. and other international institutions can cede the role of lead coordinating organization for emergency response while still maintaining their autonomy.
8:30 a.m. Welcome by Committee Co-Chairs
• Gerald Keusch, Committee Co-Chair, Boston University Schools of Medicine and Public Health
• Keith McAdam, Committee Co-Chair, London School of Hygiene and Tropical Medicine

8:45 a.m. Opening Presentation:
(15-20 minutes presentation followed by Q&A)

Lessons from Past Epidemics
• Adel Mahmoud, The Woodrow Wilson School of Public and International Affairs and The Department of Molecular Biology, Princeton University

9:15 a.m. Moderator: Kathryn M. Edwards, Vanderbilt University School of Medicine
Panelists:
(90 minutes; 10 minutes opening remarks by each panelist, followed by discussion and Q&A)
• Margaret A. Hamburg, Foreign Secretary, National Academy of Medicine
• Inger K. Damon, Ebola Response Team Incident Commander, Centers for Disease Control and Prevention

10:45 a.m. BREAK
SESSION II – THE FEASIBILITY OF CLINICAL RESEARCH DURING HUMANITARIAN EMERGENCIES
Session Objectives:
• Explore strategies and identify resources needed to effectively conduct clinical trials during an emergency without overburdening clinical care givers.
• Consider the feasibility of using existing clinical care facilities established by NGOs/non-research based organizations for research activities during an emergency
• Discuss approaches to bridge the divide between clinical care and medical research staff to find commonalities and improve the research response.
• Consider how resources to support clinical trials in humanitarian emergencies might be prepositioned. Could there be a team of neutral ethics experts assembled to help low-resource countries review and approve trials when a myriad of requests are received?
11:00 a.m. Moderator: Janice Cooper, Liberia Mental Health initiative
Panelists:
(90 minutes; 10 minutes opening remarks by each panelist, followed by discussion and Q&A)

• Nahid Bhadelia, Assistant Professor of Medicine, Director of Infection Control, National Emerging Infectious Disease Laboratories (NEIDL), Boston University
• Peter Kilmarx, Deputy Director, Fogarty International Center, National Institutes of Health
• Matthew Barnhart, Senior Science Advisor, Bureau for Global Health, USAID

12:30 p.m. LUNCH BREAK
SESSION III – THE ECONOMIC IMPLICATIONS OF OUTBREAKS
Session Objectives:
• For low-resource countries with fragile economies, explore the full economic impact of outbreaks, including how low income countries can best cope and how international assistance can be provided for recovery in the short term as well as the long term.
• Discuss how sustainable funding for clinical research during public health outbreaks can be established and what an efficient mechanism for their allocation and use might be. How could the promising therapeutic and vaccine interventions be delivered and who should pay?
• Is there a reasonable source of sustainable funding for stockpiling interventions for emerging infectious diseases? How would such a fund be managed and by whom? What would be a workable mechanism for decision making about which products to store and when to release them?

1:00 p.m. Moderator: Gerald Keusch, Committee Co-Chair, Boston University Schools of Medicine and Public Health
Panelists:
(60 minutes; 10 minutes opening remarks by each panelist, followed by discussion and Q&A)
• Ok Pannenborg, Retired Chief Health Advisor, World Bank
• Mead Over, Senior Fellow, Center for Global Development
2:00 p.m. ADJOURN public session
Public Workshop of the Committee on Clinical Trials
During 2014 – 2015 Ebola Outbreak
DRAFT AGENDA
Third Committee Meeting
June 13--15, 2016
Keck Center: 500 5th St. NW
Washington, D.C. 20001
Room 208

Day TWO
June 14, 2016

SESSION IV – CLINICAL TRIALS CONDUCTED DURING THE 2014—2015 OUTBREAK
Session Objectives:
• Discuss the considerations that were taken into account in the design of the trial (i.e. meeting scientific and ethical standards, health systems infrastructure, time to trial launch, public opinion, need of the affected population, etc.).
• Discuss any alternative trial designs considered leading up to implementation of the trial; explore why particular designs were selected.
• Explore the role of the trialist, if any, in selecting the interventions used in the EVD trials; discuss the considerations that go into advancing experimental compounds into clinical trials.
• Discuss the trial results, where available, and explore the scientific and public health value in the data derived from each study. What, if anything, would you do differently next time to achieve greater gains from trials?
8:30 a.m. Welcome by Committee Co-Chairs
• Gerald Keusch, Committee Co-Chair, Boston University Schools of Medicine and Public Health
• Keith McAdam, Committee Co-Chair, London School of Hygiene and Tropical Medicine

8:45 a.m. Opening Presentation:
(15-20 minutes presentation followed by Q&A)

Looking Forward: Principles for Conducting Research during Emergencies, Lessons Learned through the Liberia-U.S. Joint Clinical Research Partnership
• Elizabeth Higgs, Global Health Science Advisor, Division of Clinical Research, National Institute of Allergy and Infectious Disease (NIAID), National Institutes of Health (NIH)
9:15 a.m. Moderator: Jens Lundgren, University of Copenhagen
Panel 1 – Vaccine Trials Conducted During the Ebola Outbreak
(90 minutes; 10 minute opening remarks by each trial team followed by discussion and Q&A)
• PREVAIL I
o Jerome F. Pierson, Chief, Regulatory Compliance & Human Subjects Protection Branch, NIAID, NIH;
o James Neaton, Professor of Biostatistics, Adjunct Professor of Medicine, Distinguished International Professor, University of Minnesota
• STRIVE:
o Anne Schuchat, Principal Deputy Director, Centers for Disease Control and Prevention (CDC)
10:45 a.m. BREAK
11:00 a.m. Moderator: Roger J. Lewis, Harbor-UCLA Medical Center
Panel 2 – Therapeutic Trials Conducted During the Ebola Outbreak
(90 minutes; 10 minute opening remarks followed by discussion and Q&A)
• PREVAIL II:
o Richard T Davey, Senior Investigator, Laboratory of Immunoregulation, NIAID, NIH
o John Beigel, Leidos Biomedical Research, Inc. in support of Clinical Research Section, LIR, NIAID, NIH;
o Mike Proschan, Mathematical Statistician, Biostatistics Research Branch, NIAID, NIH
o Lori Dodd, Mathematical Statistician, Biostatistics Research Branch, NIAID, NIH

12:30 p.m. Closing Presentation:
(15-20 minutes presentation followed by Q&A)

Fostering International Cooperation and Collaboration
• Gray Handley, International Office Director at NIAID

1:00 p.m. ADJOURN Public Session Day 2

Public Workshop of the Committee on Clinical Trials
During 2014 – 2015 Ebola Outbreak
DRAFT AGENDA
Third Committee Meeting
June 13--15, 2016
Keck Center: 500 5th St. NW
Washington, D.C. 20001
Room 208

Day THREE
June 15, 2016
SESSION V – DECISION MAKING DURING EMERGENCIES
Session Objectives:
• Discuss the ethical imperatives present during an international humanitarian emergency and the role of local and international health officials, regulatory agencies, research and clinical staff in determining an ethical course of action.
• Explore how ethical and human rights considerations regarding clinical research can be assessed in the midst of an emerging outbreak.
• Identify the appropriate role of international organizations and national/district level health, research, and regulatory agencies in decision making.
8:30 a.m. Welcome by Committee Co-Chairs
• Gerald Keusch, Committee Co-Chair, Boston University Schools of Medicine and Public Health
• Keith McAdam, Committee Co-Chair, London School of Hygiene and Tropical Medicine

8:45 a.m. Opening Presentation:
(15-20 minutes presentation followed by Q&A)

Aligning Regulatory and Public Health Goals During an Epidemic Crisis
• Jesse Goodman, Professor, Director Center on Medical Product Access, Safety and Stewardship (COMPASS), Georgetown
9:15 a.m. Moderator: Charles D. Wells, Sanofi
Panelists:
(90 minutes; 10 minutes opening remarks by each panelist, followed by discussion and Q&A)
• Ross Upshur, Canada Research Chair in Primary Care Research; Professor, Department of Family and Community Medicine and Dalla Lana School of Public Health, University of Toronto
• Christine Grady, Chief Clinical Center's Department of Bioethics, National Institutes of Health Clinical Center
• John David Pringle, Postdoctoral Fellow in humanitarian health ethics, McGill University, Vice Chair MSF Ethic’s review board 2015

10:45 a.m. BREAK
SESSION VI – MANAGING GROUP DYNAMICS DURING CRISES
Session Objectives:
• Examine how global institutions can respectfully prioritize and align the interests and expertise of organizations (including public health professionals, clinical care providers, and academic/medical research staff) to design and implement a coordinated course of action to achieve the greatest benefit, whilst respecting the opinions of local institutions and communities.
• Provide examples of best practices used to address, prevent and overcome disagreements within and between large institutions in order to reach agreeable compromises. .
11:00 a.m. Moderator: Keith McAdam, Committee Co-Chair, Emeritus Professor of Clinical and Tropical Medicine, London School of Hygiene and Tropical Medicine
Panelists:
(90 minutes; 10 minutes opening remarks by each panelist followed by discussion and Q&A)

• David Cooperrider, Fairmount Santrol-David L. Cooperrider Professor of Appreciative Inquiry at the Weatherhead School of Management, Case Western
• Howard Gadlin, Retired Ombudsman and Director of the Center for Cooperative Resolution, NIH


SESSION VI1 – PUBLIC COMMENT
12:30 p.m. Open Public Comment (30 minutes)
• Members of the public are invited to sign up to provide comments geared toward the session topic.

1:00 p.m. ADJOURN Public Session
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Abdel Babiker
Mohamed Bailor Barrie
Janice Cooper
Kathryn Edwards
Susan Ellenberg
Gerald Keusch
Roger Lewis
Alex John London
Michelle Mello
Olayemi Omotade
David Peters
Charles Wells

The following topics were discussed in the closed sessions:

Subgroup discussions, report and discussion of Ebola meeting in London, Commissioned paper update, discussion of economic implications of outbreaks, subgroup reports and committee discussion of draft findings, conclusions, and recommendations.

The following materials (written documents) were made available to the committee in the closed sessions:

Briefing books

Date of posting of Closed Session Summary:
July 20, 2016
Publication(s) resulting from the event:

-


Location:

WebEx meeting
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Michael Berrios
Contact Email:  mberrios@nas.edu
Contact Phone:  202-334-3494

Agenda

Public Webinar of the Committee on Clinical Trials During 2014 – 2015 Ebola Outbreak

DRAFT AGENDA

May WebEx Session
May 19, 2016
11:00 a.m. – 1:00 p.m. ET

REGULATORY CONSIDERATIONS
Session Objectives:
• Determine whether standards of evidence for experimental products may differ in an emergency rapidly progressing situation compared to a non-epidemic clinically significant condition, and if so in what ways.
• In such situations with multiple experimental agents at relatively early stages of development consider how regulators should prioritize which agent to advance.
• Identify the key considerations for prioritizing and implementing clinical trials when there is a limited supply of product available or the potential of insufficient participants (as in the waning of an outbreak) for a statistically valid analysis. Is randomization imperative in this setting?
• Explore whether regulatory agencies, key funders, and other stakeholders based in different countries with different rules of procedure can collaborate, coordinate, and streamline the assessment and implementation of clinical trials for experimental products in the context of their organizational mandates.

Panelists:
• Robert Hemmings, Unit Manager, Statistics and Pharmacokinetics Unit, Medicines and Healthcare Products Regulatory Agency (MHRA) UK (confirmed)
• Peter Marks, Director, Center for Biologics Evaluation and Research, U.S. FDA (confirmed)
Edward M. Cox, Director of Antimicrobial Products (OAP), FDA (confirmed)
• Dirceu Brás Aparecido Barbano, Director- President, Brazilian Health Surveillance Agency (ANVISA) (invited)
• G.N. Singh, Drugs Controller General, Central Drugs Standard Control Organization, Government of India (invited)
• European Medicines Agency (EMA) representative


11:00 a.m. Welcome by Moderator and Speaker Introductions

Moderator: Michelle Mello, Professor of Law, Professor of Health Research and Policy, Stanford University School of Medicine

11:05 a.m. Discussion: Standards of Evidence (45mins)
• Each speaker has 5mins for opening remarks, followed by 20mins committee Q&A

11:50 a.m. Discussion: Prioritization and Collaboration (45mins)
• Each speaker has 5mins for opening remarks, followed by 20mins committee Q&A

12:35 p.m. Open discussion and Q&A with committee (25mins)


1:00 p.m. Adjourn Session







Supporting File(s)
-
Is it a Closed Session Event?
No

Publication(s) resulting from the event:

-


Location:

BMA House
British Medical Association, Tavistock Square, London, WC1H 9JP

Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Michael Berrios
Contact Email:  mberrios@nas.edu
Contact Phone:  202-334-3494

Agenda
Public Workshop of the Committee on Clinical Trials During 2014—2015 Ebola Outbreak

Second Committee Meeting
March 22–24, 2016
British Medical Association
BMA House
Tavistock Square
London WC1H 9JP
United Kingdom

Day ONE
March 22, 2016

Meeting Objectives:
• Explore the design and implementation of clinical trials during the 2014-2015 Ebola outbreak.
• Examine the cultural, public health, and ethical context surrounding the respective designs of EVD clinical trials; highlight important takeaways for future trials in a similar emergency context.
• Discuss the scientific and public health gains from clinical trials during the EVD outbreak and identify lessons learned to improve a future international response to a public health emergency in a low-resourced country.
• Consider the role of international bodies (governments, regulatory agencies, NGO’s, academicians, and others) in a rapid, robust, and sustained response.

9:45 a.m. Welcome by Committee Co-Chairs

• Keith McAdam, Committee Co-Chair, Emeritus Professor of Clinical and Tropical Medicine, London School of Hygiene and Tropical Medicine
• Gerald Keusch, Committee Co-Chair, Professor of Medicine and International Health, Boston University Schools of Medicine and Public Health

10:00 a.m. Opening Presentation: Presentation and Q&A

Bridging the Divide: Connecting Clinician, Patient, and Researcher
• Ian Crozier, Infectious Disease Specialist, Physician

SESSION I – PERSPECTIVES ON THE COMMUNICATION OF CLINICAL RESEARCH DURING AN EMERGENCY
(60min; 10min panelist presentations followed by 30min discussion and Q&A).

10:30 a.m. Objectives:
• Explore the role of public trust and rumor management in the communication and implementation of clinical trials.
• Examine how local understanding of existing clinical care and clinical research influence community acceptance of trials.

Moderator: Sheila Davis, Chief Nursing Officer, Partners In Health

Panelists:
• James Fairhead, Chair Social Anthropology, University of Sussex
• Heidi Larson, Senior Lecturer, London School of Hygiene and Tropical Medicine






























SESSION II – CLINICAL TRIAL DESIGN AND IMPLEMENTATION:
REFLECTIONS ON THE CLINICAL TRIALS CONDUCTED DURING THE
2014 – 2015 EBOLA OUTBREAK
(Session II will consist of three panels and extend after lunch; speakers are encouraged to stay throughout the entire session)

Objectives:
• Discuss the considerations that were taken into account in the design of the trial (i.e. meeting scientific and ethical standards, health systems infrastructure, time to trial launch, public opinion, need of the affected population, etc.).
• Discuss any alternative trial designs considered leading up to implementation of the trial; explore why particular designs were selected.
• Explore the role of the trialist, if any, in selecting the interventions used in the EVD trials; discuss the considerations that go into advancing experimental compounds into clinical trials.
• Discuss the trial results, where available, and explore the scientific and public health value in the data derived from each study. What, if anything, would you do differently next time to achieve greater gains from trials?

Moderators: Janet Darbyshire, Emeritus Professor of Epidemiology, University College London and;

Abdel Babiker, Professor of Epidemiology and Medical Statistics, Medical Research Council Clinical Trials Unit, University College London

11:30 a.m. Overview Presentation: (20mins)
• Peter Smith, Professor, London School of Hygiene and Tropical Medicine

11:50 a.m. Panel 2A. Vaccine Trials Conducted During the Ebola Outbreak.
(60min; 10min panelist presentations followed by 40min discussion and Q&A).

• Johan van Hoof, Global Therapeutic Area Head, Infectious Diseases and Vaccines, Janssen Research & Development, LLC. – EBOVAC-Salone
• Ana Maria Henao-Restrepo, Medical Officer at the Initiative for Vaccine Research (IVR), Department of Immunization Vaccines and Biologicals, WHO – Guinea Ring Vaccine


12:50 p.m. LUNCH


1:50 p.m. Panel 2B. Therapeutic Trials Conducted During the Ebola Outbreak.
(85min; 10min panelist presentations followed by 45min discussion and Q&A).

• Trudie Lang, Professor, University of Oxford;
John Whitehead, Emeritus Professor, Lancaster University – RAPIDE-BCV; TKM-Ebola
• Annick Antierens, Medical Department, Médecins Sans Frontières
• Johan van Griensven, Professor, Institute of Tropical Medicine – Antwerp, – Ebola-Tx
• France Mentre, Professor of Biostatistics, Université Paris Diderot, Paris, France – JIKI


3:15 p.m. BREAK


3:30 p.m. Panel 2C. Panel Reflections and Considerations for the Design of Clinical Trials. (60min; 10min panelist presentations followed by 40min discussion and Q&A).

Objectives:
• Discuss lessons learned and explore how future approaches to clinical trials in a public health emergency may be similar and/or different.
• Identify innovative approaches to research in emergency contexts; consider options that facilitate flexible and accelerated approaches.
• Consider whether adjustments to research standards in an outbreak are appropriate.

Panelists:
• Peter Smith, Professor, London School of Hygiene and Tropical Medicine
• Geneviève Chêne, Professor, University of Bordeaux














SESSION III – PUBLIC HEALTH CONTEXT
(30min; 10min panelist presentation followed by 20min discussion and Q&A).

4:30 p.m. Objectives:
• Explore strategies for how different stakeholders (ex: NGO’s, clinicians, health ministers, and international researchers) could work together to address a public health emergency.
• Consider how best incorporate research into the public health response in the event of an outbreak in a low resource setting.
• In the context of a public health emergency in a low resource setting, examine where international organizations can best cooperate and invest to build sustainable in-country clinical research systems.
• Discuss lessons learned from other outbreak situations, ex. SARS, and explore how those experiences could have informed the Ebola response, reflect on strategies for applying lessons learned in the future.

Moderator: David Peters, Professor, Johns Hopkins Bloomberg School of Public Health

Panelist:
• David Heymann, Head of the Centre on Global Health Security, Chatham House


5:00 p.m. ADJOURN




Public Workshop of the Committee on Clinical Trials During 2014—2015 Ebola Outbreak

Second Committee Meeting
March 22–24, 2016
British Medical Association
BMA House
Tavistock Square
London WC1H 9JP
United Kingdom


Day TWO
March 23, 2016

SESSION IV – ETHICAL CONSIDERATIONS IN THE CONDUCT OF CLINICAL TRIALS DURING AN EMERGENCY
(60min; 10min presentations followed by 40min discussion)

10:00 a.m. Objectives:
• Explore how the ethical principles for clinical trial conduct are applied in a low resource outbreak setting, consider:
o Scientific validity and health value of the study
o Fair subject selection and subject respect
o Risk-benefit ratio; equipoise
o Informed consent
• Discuss how a public health emergency may impact the ethical considerations involved in clinical trial design and conduct – explore what, if any of the principles are inviolable.

Moderator: Olayemi Omotade, Professor of Pediatrics and Child Health, University of Ibadan

Panelists:
• François Hirsch, Senior Research Director, Institut National de la Santé et de la Recherche Médicale INSERM
• Jonathan Montgomery, Professor of Health Care Law, University College London, Chair, Nuffield Council on Bioethics


CLOSED SESSION – COMMITTEE ONLY
11:15 – 1:25 P.M.

SESSION V – PREPARING FOR AND FINANCING CLINICAL TRIALS
(60min; 10min panelist presentations followed by 40min discussion and Q&A).

1: 30 p.m. Objectives:
• Explore how the broader research community can work together during the interepidemic period to prepare for and improve the execution of clinical trials.
• Identify the biggest local and international road-blocks in designing and implementing clinical trials in West Africa. Discuss how international bodies be better situated to respond next time.
• Consider methods to develop a sustainable research system, ex. standard implementable clinical trial protocols, training local research staff, establishing regional health technologies and infrastructure.

Moderator: Fred Wabwire-Mangen, Associate Professor of Epidemiology and Public Health, Makerere University

Panelists:
• Jimmy Whitworth, Professor, London School of Hygiene and Tropical Medicine
• Marguerite Koutsoukos, Director Ebola and HIV programs, GlaxoSmithKline (GSK)

CLOSED SESSION – COMMITTEE ONLY
2:35 – 3:15 P.M.

OPEN SESSION

3:30 p.m. Q&A with Jeremy Farrar, Director, Wellcome Trust

4:00 p.m. ADJOURN

Public Workshop of the Committee on Clinical Trials During 2014—2015 Ebola Outbreak

Second Committee Meeting
March 22–24, 2016
British Medical Association
BMA House
Tavistock Square
London WC1H 9JP
United Kingdom


Day THREE
March 24, 2016

SESSION VI – ETHICAL AND SCIENTIFIC CONSIDERATIONS FOR PRIORITIZING RESEARCH DURING OUTBREAKS
(60min; 10min panelist presentations followed by 40min Q&A).
10:00 a.m. Objectives:
• Explore what evidence is needed when evaluating potential treatment options to determine the most viable candidates for further development and advancement to clinical trials.
• Discuss how, in the context of an international emerging or re-emerging infectious disease event, clinical trials can best be prioritized.
• Explore the common goals and trade-offs in health care and clinical research.

Moderator: Alex John London, Professor, Carnegie Mellon University

Panelists:
• Miles Carroll, Head of Research Microbiology Service, Public Health England (PHE)
• Carel IJsselmuiden, Executive Director, The Council on Health Research for Development (COHRED) Group South Africa



11:00 a.m. ADJOURN
Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Abdel Babiker
Mohamed Bailor Barrie
Sheila Davis
Kathryn Edwards
Susan Ellenberg
Gerald Keusch
Roger Lewis
Alex John London
Jens Lundgren
Keith McAdam
Michelle Mello
Olayemi Omotade
David Peters
Fred Wabwire-Mangen
Charles Wells

The following topics were discussed in the closed sessions:

Discuss upcoming WebEx meeting, Plan Washington DC meeting, discussion of preliminary report recommendations and workshop preparation.

The following materials (written documents) were made available to the committee in the closed sessions:

Briefing books

Date of posting of Closed Session Summary:
May 02, 2016
Publication(s) resulting from the event:

-


Location:

Keck Center
500 5th St NW, Washington, DC 20001
Event Type :  
-

Registration for Online Attendance :   
NA

Registration for in Person Attendance :   
NA


If you would like to attend the sessions of this event that are open to the public or need more information please contact

Contact Name:  Michael Berrios
Contact Email:  mberrios@nas.edu
Contact Phone:  202-334-3494

Agenda
Day ONE
Monday, February 22

CLOSED COMMITTEE SESSION
8:00 a.m. – 4:00 p.m.

OPEN SESSION

4:00 p.m. Opening Remarks to Public Audience

Gerald Keusch, Committee Co-Chair, Professor of Medicine and International Health, Boston University Schools of Medicine and Public Health

Keith McAdam, Committee Co-Chair, Emeritus Professor of Clinical and Tropical Medicine, London School of Hygiene and Tropical Medicine


4:05 p.m. Delivery of Study Charge and Q&A/Discussion with Committee
Objectives:
• Receive study background and charge from NIH—NIAID.
• Discuss Task with the sponsor and determine scope of committee’s work (i.e., what is in and what is out).
• Clarify issues identified by the committee and seek answers to questions.
• Discuss report audience and expected products.


Moderators: Gerald Keusch and Keith McAdam, Committee Co-Chairs



Sponsor Panelists:
TONY FAUCI
Director
National Institute of Allergy and Infectious Diseases (NIAID)

CLIFF LANE
Deputy Director for Clinical Research and Special Projects, Director, Division of Clinical Research
NIAID

5:00 Adjourn Open Session



Clinical Trials During the 2014-15 Ebola Outbreak
First Committee Meeting
February 22–23, 2016
Keck Center – Room 101
500 5th Street, NW
Washington, DC 20001


Day TWO
Tuesday, February 23

OPEN SESSION

9:00 a.m. Opening Remarks to Public Audience

Gerald Keusch, Committee Co-Chair, Professor of Medicine and International Health, Boston University Schools of Medicine and Public Health

Keith McAdam, Committee Co-Chair, Emeritus Professor of Clinical and Tropical Medicine, London School of Hygiene and Tropical Medicine


9:05 a.m. Delivery of Study Charge and Q&A/Discussion with Committee
Objectives:
• Receive study background and charge from ASPR, FDA.
• Discuss Task with the sponsor and determine scope of committee’s work (i.e., what is in and what is out).
• Clarify issues identified by the committee and seek answers to questions.
• Discuss report audience and expected products.


Moderators: Gerald Keusch and Keith McAdam, Committee Co-Chairs








Sponsor Panelists:
NICOLE LURIE
Assistant Secretary for Preparedness and Response
The Office of the Assistant Secretary for Preparedness and Response (ASPR)

LUCIANA BORIO
Acting Chief Scientist
U.S. Food and Drug Administration (FDA)

10:00 a.m. Adjourn Open Session

CLOSED COMMITTEE SESSION
10:00 a.m. – 4:00 p.m.

Supporting File(s)
-
Is it a Closed Session Event?
Yes

Closed Session Summary Posted After the Event

The following committee members were present at the closed sessions of the event:

Mohamed Bailor Barrie
Janice Cooper
Susan Ellenberg
Gerald Keusch
Roger Lewis
Alex John London
Keith McAdam
Michelle Mello
Olayemi Omotade
Fred Wabwire-Mangen
Charles Wells

The following topics were discussed in the closed sessions:

Bias and conflict of interest discussion; overview of study process; discussion of study charge, background discussion, and upcoming meetings were discussed during the closed session.

The following materials (written documents) were made available to the committee in the closed sessions:

Briefing book

Date of posting of Closed Session Summary:
March 04, 2016
Publication(s) resulting from the event:

-

Publications

  • Publications having no URL can be seen at the Public Access Records Office