En 2022, les efforts menés dans le cadre du Mécanisme COVAX pour faire face sur le long terme aux répercussions de la COVID-19 et envisager l’avenir ont donné naissance au Programme de transfert de la technologie à ARNm, sous la direction de l’OMS et de son partenaire le Medicines Patent Pool (MPP).Cinq Groupes de travail sont responsables de la conception et de la coordination des activités nécessaires pour réaliser les objectifs du Programme de transfert de la technologie à ARNm.
Le Comité de pilotage conseille le Secrétariat de l’OMS sur des aspects essentiels à la concrétisation des objectifs du Programme.
En outre, un Comité consultatif scientifique indépendant composé de spécialistes de l’élaboration de vaccins à ARNm apporte une contribution technique au Programme.
Le Programme de transfert de la technologie à ARNm collabore étroitement avec le Centre mondial de formation à la bioproduction établi par l’OMS et par l’Académie de l’OMS dans le but de faire correspondre les formations proposées aux besoins du Centre (donneur) et des receveurs (bonnes pratiques, transfert de technologies).
Cinq Groupes de travail sont responsables de la conception et de la coordination des activités nécessaires pour réaliser les objectifs du Programme de transfert de la technologie à ARNm.
Groupe de travail 1 – Choix de la technologie, innovation technique, et propriété intellectuelle |
Groupe de travail 2 – Développement de produits, dont développement clinique, fabrication et transfert de technologie |
Groupe de travail 3 – Renforcement réglementaire : appui au renforcement des capacités dans le domaine réglementaire et constitution d’effectifs qualifiés pour obtenir les autorisations régionales nécessaires |
Groupe de travail 4 – Modélisation de l’activité et stratégies/politiques d’approche du marché |
Groupe de travail 5 – Financement et gouvernance du Programme |
Le Comité de pilotage joue le rôle d’organe consultatif auprès du Centre de transfert de la technologie à ARNm de l’OMS (Afrique du Sud) dans le but de parvenir à une meilleure santé et une plus grande sécurité sanitaire dans les pays à revenus faible et intermédiaire, en produisant à l’échelle régionale et de manière durable des produits biologiques de santé essentiels.Le Comité de pilotage aura pour fonction de conseiller l’OMS sur les questions suivantes, en lien avec le fonctionnement du Centre de transfert de la technologie à ARNm :
- les orientations à suivre, y compris concernant la/les technologie(s) retenue(s) ;
- la conception de plans d’évaluation préclinique et clinique, selon les besoins, pour les technologies à développer ;
- les différentes étapes réglementaires pour chaque technologie ;
- l’allocation de fonds d’emploi flexible, et l’approbation de décaissements par le Medicines Patent Pool dans le respect des conditions de l’accord de financement concerné ;
- autres sujets d’une importance déterminante pour la réalisation des objectifs du Programme.
Membres
Le Comité de pilotage conseillera le Secrétariat de l’OMS qui supervise l’initiative multilatérale de transfert de technologies pour les produits biologiques de l’OMS.
Membres du Comité de pilotage – Juillet 2022
La gouvernance et l’équipe » Conseil de fondation
Marie-Paule Kieny
Président du Conseil de gouvernance du Medicines Patent Pool
(Président du comité de pilotage)
Marie-Paule Kieny
Président du Conseil de gouvernance du Medicines Patent Pool
(Président du comité de pilotage)
Marie-Paule Kieny préside le conseil d’administration de la Medicines Patent Pool Foundation (MPPF, Genève, Suisse). Elle est également présidente du conseil d’administration de la Drugs for Neglected Diseases Initiative (DNDi, Genève, Suisse), membre du conseil d’administration de la Fondation Mérieux (France) et administrateur indépendant non exécutif de bioMérieux (Lyon, France). Elle est membre du groupe consultatif scientifique de plusieurs organismes oeuvrant dans le domaine de la santé. Jusqu’en mai 2022, elle était directrice de recherche à l’Inserm (Paris, France), poste où elle présidait le Comité scientifique français sur le vaccin COVID-19.
Jusqu’en juin 2017, le Dr Kieny a occupé le poste de sous-directeur général pour les systèmes de santé et l’innovation à l’Organisation mondiale de la santé. Parmi ses principaux succès dans le cadre de ses rôles de direction à l’OMS, citons la coordination des efforts de R&D de l’OMS pendant l’épidémie d’Ebola en Afrique de l’Ouest de 2014-2016 et la conceptualisation du Plan directeur de R&D de l’OMS, un plan mondial de préparation contre les épidémies de maladies émergentes.
Avant de rejoindre l’OMS, le Dr Kieny a occupé des postes de recherche de haut niveau dans les secteurs public et privé en 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.
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.
Le Comité consultatif scientifique pour la technologie à ARNm est un comité indépendant établi par le Medicines Patent Pool (MPP) pour apporter, à titre consultatif, des réponses à des questions scientifiques précises en lien avec le Programme de transfert de la technologie à ARNm.
Membres du Comité consultatif scientifique pour la technologie à ARNm:
Composition du Comité consultatif scientifique pour la technologie à ARNm en septembre 2022, d’autres membres arrivant prochainement
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.
Research Center, National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH). Chief, Viral Pathogenesis Laboratory and Translational Science Core
Dr. Barney Graham is an immunologist, virologist, and clinical trials physician whose primary interests are viral pathogenesis, immunity, and vaccine development. His work is focused on HIV, respiratory syncytial virus (RSV), and emerging viral diseases. After graduating from Rice University, he obtained his MD from the University of Kansas School of Medicine in 1979. He then completed residency and two chief residencies in Internal Medicine, a fellowship in Infectious Diseases, and a Ph.D. in Microbiology & Immunology at Vanderbilt University School of Medicine, where he rose to the rank of Professor of Medicine with a joint appointment in the Department of Microbiology & Immunology.
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.
Amin Khan, Ph.D.
Chief Scientific Officer, Human Health at GreenLight
Amin Khan, Ph.D.
Chief Scientific Officer, Human Health at GreenLight
Dr. Khan joined GreenLight Biosciences in April, 2021 as Chief Science Officer for Human Health. Prior to joining this mRNA-based biotech company, he spent 30 years working in pharmaceutical and vaccines R&D, encompassing small and large molecule drugs and vaccines. The last decade of his career has been focused on vaccines R&D at premier global enterprises. At GSK, he and his technical R&D team’s recent contributions enabled the development and launch of Bexsero® and Shingrix®, vaccines for meningitis B and shingles, respectively. He has also contributed to the development of mid-stage vaccines assets at GSK (RSV, HSV, CMV vaccines), and held accountability for scientific gating and prioritization of GSK’s vaccine discovery portfolio.
Dr. Khan led GSK Vaccines R&D Acceleration (March 2019 – March 2021) where he had accountability for the end-to-end acceleration of the vaccine portfolio. He joined GSK as part of the company’s acquisition of Novartis Vaccines in March 2015, when he became the head of the Technical R&D organization. At Novartis Vaccines Dr. Khan held the position of Global Head of Technical Development, and Global Head of Technical Development and Manufacturing Sciences & Technology (2011-2015). Prior to joining the vaccines industry Dr. Khan spent more than 20 years working on small molecule drug, and biotherapeutic product, process and analytical development; Trinity Biosystems, Inc (2008-2010), Eli Lilly and Company (1998-2008), West Pharmaceutical Services (1993-1998), and Enzytech, Inc (1989-1993). He holds a Ph.D., in Pharmaceutical Sciences from the University of Nottingham, U.K.
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.
Drew Weissman, MD, PhD
MD, PhD, Co-Director, Penn Center for AIDS Research, Immunology Core Director of Vaccine Research, Infectious Diseases Division
Drew Weissman, MD, PhD
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.