In 2022, COVAX’s efforts targeting long-term COVID-19 impact and beyond, transitioned into the “mRNA Technology Transfer Programme”, convened by WHO and its partner Medicines Patent Pool (MPP).Five Working Groups (WG) are responsible for the design and coordination of the activities required to fulfill the objectives of the mRNA Technology Transfer Programme.
A Scientific and Technical Review Committee (STeRCO) of independent experts and stakeholders supports the WHO secretariat on aspects of critical importance to the successful accomplishment of the objectives of the mRNA Technology Transfer Programme.
Additionally, a mRNA Scientific Advisory Committee (mSAC) convened by MPP comprising of experts in mRNA vaccine development provides technical input into the programme.
The mRNA Technology Transfer Programme operates in close cooperation with the Biomanufacturing training initiative coordinated by WHO and the WHO Academy, to align training needs for both hub and spokes (manufacturing, good practices, technology transfer) and training offer.
Five Working Groups(WG) are responsible for the design and coordination of the activities required to fulfill the objectives of the mRNA Technology Transfer Programme.
Working Group 1 – Technology selection, technical innovation, and IP |
Working Group 2 – Product development, including clinical development, manufacturing and technology transfer |
Working Group 3 – Regulatory strengthening: support the development of regulatory capabilities and skilled workforce to facilitate regional approvals. |
Working Group 4 – Business modelling & sustainability |
Working Group 5 – Programme funding & governance |
The Scientific and Technical Review Committee (STeRCO) supports the mRNA Technology Transfer Programme to realize the vision of improving health and health security in low- and middle-income countries through sustainable, regional production of mRNA vaccines.
The function of the Scientific and Technical Review Committee is to support the programme on the following areas:
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- Strategic directions, including the technology(ies) to implement and transfer,
- the preclinical and clinical development plans as needed for technology(ies) of interest
- compliance to the regulatory guidelines
- value for money regarding allocation of funds
- other issues of critical importance to the successful accomplishment of the goals of the programme.
The STeRCO shall provide support to WHO Secretariat in consideration of potential programme expansion.
Scientific and Technical Review Committee Current Members:
Marie-Paule Kieny
Chair of the Governance Board of the Medicines Patent Pool
(Steering Committee Chair)
Marie-Paule Kieny
Chair of the Governance Board of the Medicines Patent Pool
(Steering Committee Chair)
Marie-Paule Kieny chairs the Governing Board of the Medicines Patent Pool Foundation (MPPF, Geneva, Switzerland). She is also the Chair of the Board of the Drugs for Neglected Diseases Initiative (DNDi, Geneva, Switzerland), a member of the Board of Fondation Mérieux (France) and a Non-Executive Independent Director of bioMérieux (Lyon, France). She is a member of the scientific advisory group of several organizations working in the area of health. Until May 2022, she was Director of Research at Inserm (Paris, France), a position where she chaired the French Scientific Committee on COVID-19 vaccine.
Until June 2017, Dr Kieny served as the Assistant Director-General for Health Systems and Innovation at the World Health Organization. Key successes under her leadership roles at WHO include coordinating the WHO R&D efforts during the 2014-2016 West-African Ebola epidemic and conceptualizing the WHO R&D Blueprint, a global preparedness plan against emerging diseases’ epidemics.
Before joining WHO, Dr. Kieny held top research positions in the public and private sectors in France.
Mmboneni Muofhe
Deputy Director-General at the Government of South Africa Department of Science and Innovation
(DSI)
Mmboneni Muofhe
Deputy Director-General at the Government of South Africa Department of Science and Innovation
(DSI)
Dr. Mmboneni Muofhe is the Deputy Director-General (DDG) for Socio-Economic Innovation Partnerships at the Department of Science and Innovation in South Africa. He was previously DDG for International Cooperation and for Resources and Technology Innovation. Dr Muofhe has led the implementation of various strategies including the South African Bio-Economy strategy whose one critical pillar is the development of drugs and vaccine manufacturing capacity under the Health Innovation portfolio.
Michel de Wilde
Independent vaccine R&D expert with experience in vaccine development and manufacturing
Michel de Wilde
Independent vaccine R&D expert with experience in vaccine development and manufacturing
Michel De Wilde has a long career in Vaccine Research and Development. He currently consults for the Vaccine Communiuty.
From 2001 till June 2013, Michel De Wilde was Senior Vice President, Research & Development, at sanofi pasteur. While at sanofi pasteur, Michel drove the development and licensure by the FDA and other Regulatory bodies of a number of products. Sanofi Dengue vaccine was developed under his supervision. Michel was also instrumental in driving the acquisition of and defining the integration model for two biotech companies: Acambis and VaxDesign.
Michel has played a key role as a research scientist in the development of several new vaccines, most notably the recombinant Hepatitis B vaccine, as well as GSK’s Malaria vaccine candidate.
Nicaise Ndembi
Senior Science Advisor at Africa Centres for Disease Control and Prevention
(ACDC)
Nicaise Ndembi
Senior Science Advisor at Africa Centres for Disease Control and Prevention
(ACDC)
Dr. Nicaise Ndembi is the Director of Laboratory Research at IHVN. As a virologist and public health expert, he is applying his wealth of experience in molecular virology to coordinate and carry out quality laboratory research in HIV diversity, resistance to anti-retroviral therapy, genomics epidemiology, emerging and re-emerging infectious diseases amongst other areas.
Dr. Ndembi is also Adjunct Associate Professor, Division of Epidemiology and Prevention at the Institute of Human Virology, University of Maryland School of Medicine, USA. He serves as Collaborative Professor of Virology in the Department of Viral Infection and International Health, Graduate School of Medical Science, Kanazawa University, Japan. and a Research Professor, Global Affairs Section at the same university.
Marion Gruber
Vice President Public Health and Regulatory Science AIDS
Marion Gruber
Vice President Public Health and Regulatory Science AIDS
Marion Gruber, Ph.D., M.S., leads the development and execution of IAVI’s public health and regulatory science efforts to advance product development programs to facilitate global access to preventive and therapeutic products critical for global public health.
Prior to joining IAVI, from 1992 to 2021, Gruber served as a public health official at the U.S. Food & Drug Administration (FDA), where she held positions of increasing leadership responsibility in research, regulatory affairs, and policy. From 2011 to 2021, she was the director of the FDA’s Office of Vaccines Research and Review (OVRR). She was responsible for the review, planning, development, and administration of OVRR’s national and international programs directing a multi-disciplinary team engaged in vaccine and related biological product development, regulation, and licensure, including overseeing licensure and approval for COVID-19 vaccines.
Nadia Tornieporth
University of Applied Sciences and Arts in Hannover
Nadia Tornieporth
University of Applied Sciences and Arts in Hannover
Nadia G. Tornieporth, MD, DTM&H, is Professor of Clinical Research and Pharmacovigilance at the University of Applied Sciences and Arts in Hannover, Germany, and currently serves as acting Head, Clinical Development, for the Coalition of Epidemic Preparedness Innovations (CEPI). Previously, Dr. Tornieporth led the Global Clinical Research and Development teams at both Sanofi Pasteur and GlaxoSmithKline Biologicals. Over the course of her career, Dr. Tornieporth contributed to the successful licensure of more than 20 vaccines. She holds clinical patents for malaria and dengue vaccines and has co-authored more than 60 peer-reviewed publications in infectious diseases and vaccine development.
Mark Feinberg
President and CEO of IAVI
Mark Feinberg
President and CEO of IAVI
Mark Feinberg, M.D., Ph.D., is President and CEO of IAVI where he leads a global team working to advance the development of vaccines and other biomedical innovations to protect against infection with HIV, TB, and other infectious diseases that disproportionately impact low-income countries.
Prior to joining IAVI in late 2015, Feinberg served as chief public health and science officer with Merck Vaccines. In this role, he helped advance the development and global availability of vaccines against rotavirus, human papillomavirus, and other infectious diseases. He also led a range of research initiatives to address unmet health needs in low-income countries including the establishment of the MSD-Wellcome Trust Hilleman Laboratories and the coordination of a private-public partnership to expedite Ebola vaccine development. Previously, he spent more than 20 years exploring HIV/AIDS pathogenesis, treatment, and prevention research and the biology of emerging diseases in both academia and government.
Feinberg holds an M.D. and a Ph.D. from Stanford University, and B.A. degree from the University of Pennsylvania. He pursued post-graduate medical training in internal medicine at the Brigham and Women’s Hospital and postdoctoral fellowship training in the laboratory of Dr. David Baltimore at the Whitehead Institute. He has previously served as a faculty member at the University of California, San Francisco and the Emory University School of Medicine and as a medical officer in the Office of AIDS Research at the National Institutes of Health (NIH) and as a fellow in the Advanced Leadership Initiative at Harvard University.
Feinberg is a fellow of the American College of Physicians and a member of the Council on Foreign Relations and the Association of American Physicians. He served as the chair of the Interim Scientific Advisory Committee of the Collaboration for Epidemic Preparedness Innovations (CEPI) and currently serves as a member of the CEPI Joint Coordinating Group.
Achal Prabhala
Coordinator of the AccessIBSA project
Achal Prabhala
Coordinator of the AccessIBSA project
Achal Prabhala runs the AccessIBSA project, which is an inter-disciplinary campaign for access to medicines in India, Brazil and South Africa. Over the course of the last 20 years, he has worked with civil society and governments across several countries in Africa, Asia and Latin America on pharmaceutical monopolies, and in South Africa and India, on knowledge monopolies. In the recent past, he served on the Advisory Board of the Wikimedia Foundation (2006-2018) and the Expert Advisory Group of the Medicines Patent Pool (2010-2019); he was the Carnegie Resident Equity Scholar at the University of the Witwatersrand in Johannesburg in 2015, and held a Shuttleworth Fellowship (2016-2019) and a Mellon Foundation Fellowship at the University of the Witwatersrand in 2020. His current research includes analysing the intellectual property and regulatory landscapes of biologics and vaccines, as well as the existing global manufacturing potential for mRNA technology.
The mRNA Scientific Advisory Committee (mSAC) is an independent committee convened by the Medicines Patent Pool (MPP) to deliver answers, on a consultative basis, to specific questions on scientific matters addressed to them relating to the mRNA Technology Transfer Programme.
mRNA Scientific Advisory Committee Members:
Martin Friede, Ph.D.
Coordinator, Initiative for Vaccine Research at the World Health Organization
(mSAC Chair)
Martin Friede, Ph.D.
Coordinator, Initiative for Vaccine Research at the World Health Organization
(mSAC Chair)
Friede is the scientific officer responsible for vaccine delivery systems within the Initiative for Vaccine Research (IVR) at the World Health Organization in Geneva, Switzerland. In this position he is the WHO focal point for matters related to the development of technologies to improve vaccines including adjuvants, stabilization methods needle-free vaccine delivery systems.
Prior to joining WHO Dr Friede held several positions in the vaccine industry: He was Vice President of Development for Apovia Inc. a Californian vaccine development company, prior to which he was responsible for vaccine formulation and vaccine delivery research at Smithkline Beecham Biologicals (now GlaxoSmithKline).Martin Friede received his PhD in biochemistry from the University of Cape Town in South Africa.
Dr. Danilo Casimiro, Ph.D.
Chief Science Officer & Global Head, External Scientific Affairs, Sanofi Vaccines
Dr. Danilo Casimiro, Ph.D.
Chief Science Officer & Global Head, External Scientific Affairs, Sanofi Vaccines
Danilo is Chief Science Officer and Global Head, External Scientific Affairs for Sanofi Vaccines since October 2021. He is responsible for external-facing functions of the Vaccines R&D unit, including teams for search-and-evaluation of vaccine candidates and vaccine innovations, scientific network development & partnerships, and external financing. He has over 25 years of experience in research and development of vaccines and biologics in both pharmaceutical and non-profit sectors. Prior to joining Sanofi in November 2017, he was the Chief Scientific Officer at Aeras, a non-profit vaccine R&D organization funded by the Bill and Melinda Gates Foundation. During his 19 years at the Merck Research Laboratories, Danilo contributed to the licensure of Merck’s human papillomavirus (HPV) vaccines, and the development of novel vaccine candidates and antibodies against multiple viral pathogens and novel immunotherapeutic approaches against cancer and neurodegenerative diseases. He also served on numerous advisory committees to the Bill & Melinda Gates Foundation Global Health Program, International AIDS Vaccine Initiative, NIH Integrated Preclinical/Clinical AIDS Vaccine Development Program, USAID Malaria Vaccine Development Program, and HIV Vaccine Enterprise. He received his Ph.D. degree in chemistry and post-doctoral training from the California Institute of Technology and the Scripps Research Institute-La Jolla, respectively.
Barney Graham, M.D., Ph.D.
Former Deputy Director of the Vaccine Research Center at the National Institutes of Health and the Chief of the Viral Pathogenesis Laboratory.
Barney Graham, M.D., Ph.D.
Former Deputy Director of the Vaccine Research Center at the National Institutes of Health and the Chief of the Viral Pathogenesis Laboratory.
Dr. Graham is the former Deputy Director of the NIAID Vaccine Research Center and has developed novel vaccines and monoclonal antibodies for several viral diseases including the COVID-19 mRNA vaccine for which he has been widely recognized.
Barney S. Graham is an immunologist, virologist, and clinical trials physician with an extensive background in basic and translational research applied to vaccine development. He obtained an undergraduate degree from Rice University, a medical degree from the University of Kansas, and residency, ID fellowship, and PhD from Vanderbilt University where he was an R01-funded investigator before joining the NIAID Vaccine Research Center at NIH as a founding member in 2000. He retired as Deputy Director of the VRC in 2021 and is now an independent consultant and Senior Advisor for Global Health Equity at Morehouse School of Medicine in Atlanta.
He is an elected member of ASCI, AAP, and National Academy of Sciences. He is recipient of the Robert M. Chanock Award for lifetime contributions to RSV research, the Albert B. Sabin Gold Medal Award for contributions to vaccinology, the Albany Medical Center Prize in Medicine and Biomedical Research, and the National Academy of Sciences John J. Carty Award for the Advancement of Science. He was named one of the world’s 100 most influential individuals and one of the Heroes of the Year in 2021 by Time magazine and recognized as the Federal Employee of the Year by the Partnership for Public Service.
He is an author on more than 500 scientific publications, and a thought leader on emerging viral diseases and pandemic preparedness. He is best known for his research on RSV pathogenesis, structure-based vaccine design, and application of mRNA delivery technology. He was involved in the advanced evaluation of vaccines and monoclonal antibodies for HIV, Ebola, and Chikungunya, and developed novel vaccines for RSV, influenza, Zika, paramyxoviruses, and coronaviruses including the first COVID-19 vaccine and monoclonal antibody to enter clinical testing and that subsequently achieved Emergency Use Authorization and licensure.
Drew Weissman, M.D., Ph .D.
MD, PhD, Co-Director, Penn Center for AIDS Research, Immunology Core Director of Vaccine Research, Infectious Diseases Division
Drew Weissman, M.D., Ph .D.
MD, PhD, Co-Director, Penn Center for AIDS Research, Immunology Core Director of Vaccine Research, Infectious Diseases Division
Drew Weissman, M.D., Ph.D. is a professor of Medicine at the Perelman School of Medicine, University of Pennsylvania. He received his graduate degrees from Boston University School of Medicine. Dr. Weissman, in collaboration with Dr. Katalin Karikó, discovered the ability of modified nucleosides in RNA to suppress activation of innate immune sensors and increase the translation of mRNA containing certain modified nucleosides. The nucleoside-modified mRNA-lipid nanoparticle vaccine platform Dr. Weissman’s lab created is used in the first 2 approved COVID-19 vaccines by Pfizer/BioNTech and Moderna. They continue to develop other vaccines that induce potent antibody and T cell responses with mRNA–based vaccines. Dr. Weissman’s lab also develops methods to replace genetically deficient proteins, edit the genome, and specifically target cells and organs with mRNA-LNPs, including lung, heart, brain, CD4+ cells, all T cells, and bone marrow stem cells.
Duccio Medini, Ph.D.
R3 Program Director at Wellcome Leap, global ARPA for Health, and Strategic Data Science Director at Toscana Life Sciences Foundation, Siena (Italy).
Duccio Medini, Ph.D.
R3 Program Director at Wellcome Leap, global ARPA for Health, and Strategic Data Science Director at Toscana Life Sciences Foundation, Siena (Italy).
Duccio Medini leads the 60M$ RNA Readiness and Response program, co-funded by CEPI, to develop standardized, multi-product RNA manufacturing capabilities providing increased access to diverse biologics and sustainable pandemic response.
In executive roles of growing responsibility at Chiron, Novartis and GSK corporations, he led hundreds of data scientists in Vaccines R&D across Europe, US and Asia, holding Research Board, Innovation Board, Clinical Quality Board and Data Governance Board responsibilities.
Working across biological discovery, clinical development and public health, he discovered the pangenome concept co-founding the pangenomics discipline, contributed to the successful registration of four novel vaccines, including the first universal vaccine against serogroup B meningitis, led the Meningococcal Antigen Typing System (MATS) platform worldwide, developed transformative corporate data strategies, authored 50+ publications, books and patents in data science for health, population genomics and mathematical vaccinology.
Prof. Medini received his Ph.D. in Physics from the University of Perugia, Italy, with a residency at the Northeastern University in Boston, MA; is habilitated Full Professor of Molecular Biology; has served in international PhD school committees at the Perugia and Turin Universities in Italy; is honorary member of the Cuban Immunology Society, Fellow of the ISI Foundation, Strategic Board member of CINI’s Italian National Digital Health Lab; an IMD, ADVAC and UC Berkley alumnus.
Dr. Connie Schmaljohn
Director, NIAID Integrated Research Facility (IRF-Frederick)
Dr. Connie Schmaljohn
Director, NIAID Integrated Research Facility (IRF-Frederick)
Dr. Connie Schmaljohn is the Director of the NIAID Integrated Research Facility (IRF-Frederick) where she provides overall scientific leadership to research activities and oversees collaborative research programs to advance medical countermeasures for highly pathogenic viruses. In addition, she serves as an expert consultant and advisor both nationally and internationally on the development of novel vaccine strategies for highly pathogenic viruses.
Dr. Schmaljohn earned a BS Degree in Microbiology from the University of Nebraska and a PhD in Virology from Colorado State University, after which she joined United States Army Medical Research Institute of Infectious Diseases (USAMRIID) as a National Research Council postdoctoral fellow. She continued her career at USAMRIID in multiple capacities culminating with a position as the Senior Research Scientist for Medical Defenses against Infectious Disease Threats for the US Army. Dr. Schmaljohn’s research background is in molecular virology and molecular vaccine development. She has served as President of the International Society of Hantaviruses, Chair of the American Society for Microbiology Biodefense Conference, and Chair of the International Committee on the Taxonomy of Viruses Bunyaviridae Study Group. She also has served on the Interagency Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) Viral Hemorrhagic Fevers IPT, the Board of Scientific Counselors for the NIAID Vaccine Research Center, the Scientific Advisory Council for the Coalition of Emergency Preparedness Innovations (CEPI) and the Independent Product Group (IPG) for COVAX. She was elected to the American Academy of Microbiology (2007) and was selected as Fellow of the International Society for Vaccines (2015). She received the Order of Military Merit (2002), the Association of Military Surgeons of the United States Research Award (2002), the University of Nebraska Alumni Achievement Award (2012), and the Presidential Rank Award (2017). Dr. Schmaljohn has published more than 200 peer reviewed journal articles and reference works, has edited many books and special journal issues and holds numerous patent awards for vaccine development efforts.
Suhaib Siddiqui, Ph.D.
Former director of chemistry at Moderna Founder of Antirna Inc
Suhaib Siddiqui, Ph.D.
Former director of chemistry at Moderna Founder of Antirna Inc
Suhaib Siddiqi is a scientist in the field of infectious diseases, nucleic acids and genomics. As a head of the departments, he led the research and development efforts at various biotechnology and pharmaceutical companies. He was the first director of chemistry at Moderna.
He has a doctorate in Chemistry from the University of Technology, Vienna, Austria. He currently serves as a scientific advisor to various biotechnology companies. He was inventor of a potent antiviral agent, (-)-5’-Noraristeromycin and Virtual Terminators for the DNA/RNA sequencing. He has published 31 peer-reviewed papers, and 47 patents.
Kiat Ruxrungtham, M.D.
Professor of Medicine, Department of Medicine Chulalongkorn University; and Scientific Chair of the Chula Vaccine Research Center
Kiat Ruxrungtham, M.D.
Professor of Medicine, Department of Medicine Chulalongkorn University; and Scientific Chair of the Chula Vaccine Research Center
Kiat Ruxrungtham, MD, is a Professor of Medicine, Department of Medicine, Faculty of Medicine, Chulalongkorn University; and Scientific Chair of the Chula Vaccine Research Center (ChulaVRC); and Director of the Covid19 Vaccine Development Program, ChulaVRC. He is providing teaching and patient care on Allergy -Clinical Immunology and HIV Medicine at the King Chulalongkorn Memorial Hospital, Faculty of Medicine, Chulalongkorn University; and is mentoring junior researchers on HIV medicine, vaccine, immunology, and allergy research and also on clinical trials. He is currently leading the Chula-Covid19 mRNA vaccine development program. He has published more than 360 peer review papers on HIV, immunology, allergy, and vaccine.