DIALLO Alpha OB

A Medical International Consulting, current Member of the ANRS MIE Pandemic Contingency Plan for Emerging or Re-emerging Infectious Diseases Keynote on EXPERTISE AREAS–Background and Motivation: Trained as a Medical doctor including in internal medicine and epidemiologist, I have more than 20 years of experience in managing national and international clinical trials, both as an investigator and as a sponsor's representative. I have medical and scientific expertise in oncology, infectious diseases and emerging infectious diseases, pediatric specialties, neuroscience and cardiology. I am currently Head of the Global Vigilance and Participant Safety Department of ANRS | EID and Inserm | PRC. I have completed my M.D. degree from the Medical University of Oran, Algeria, followed by a number of interuniversity diplomas in France. I have a Master's degree (Universities of Paris) in Public Health and in Clinical Pharmacology. Before joining ANRS in 2006, I practiced in the Medical Oncology Department of the Tenon Teaching Hospital in Paris. As Chief Senior Manager and Director of the Global Vigilance Department over 16 years of experience, my group and I have been working to consolidate international clinical collaboration on research initiatives by ensuring better safety for participants enrolled in clinical trials. I have developed with my team a centralized pharmaco-vigilance system for the platform clinical trials during the covid-19 pandemic and the pan-European clinical trials network called c4c: conect4children and more recently with the Mpox outbreak. As a safety working group leader and vaccine safety specialist, I am currently leading several safety expert groups in vaccine development including Ebola (PREVAC in Africa), HIV (VRI and EHVA: France and Europe) and covid-19 (Covicompare program: France and Africa. I am an academic researcher and university lecturer at several pharmacy and medicine faculties, the Pasteur Institute of Paris, the Vaccine Research Institute Creteil Paris. I am an expert in drug safety and regulatory science; I am actively involved in the training of physicians and investigators in LMIC. I am co-authored more than 100 publications in peer-reviewed journals and a frequent speaker at national and international meetings. My research interests include clinical pharmacology, antimicrobial resistance, drug safety, vaccine safety and co- morbidities, pharmacokinetics, HIV, viral hepatitis, TB and EID. I am a member of numerous national and international committees, advisory groups and clinical trials network groups. I am currently the representative of ANRS | EID in the Glopid-R funders clinical trials network group. I am also a member of the French Academic Sponsors Group, the French Pediatric Network, the EU Response Consortium, and a member of numerous leading medical and scientific organizations and associations. During the Covid-19 pandemic, on behalf of IMG (NGO of Guinean health workers), I organized a webinar in Guinea (February 2022 in Conakry) on the lessons learned with 98% Guinean experts as speakers worldwide. In addition to my medical and scientific background, I have extensive experience in administration, personnel management and evaluation, board and scientific council meetings, coordination of research programs and project management, institutional communication, relations with governments, regulatory agencies, policy makers and many technical and financial partners (public and private), foundations, research agencies, research funding agencies, and bilateral cooperation within the ANRS | MIE and Inserm network including in the African health sector . As researcher (Inserm Research Fellow CR1): As a researcher, I lead the ANRS-EID coordinated action on mother-to-child transmission in order to stimulate transversal and innovative projects in this field. As an epidemiologist by training, I have extensive experience in regulatory affairs, medical affairs, drug development, including clinical trials for vaccine development, and have authored over 120 scientific publications, including over 100 peer-reviewed papers published in top-tier scientific journals. I currently lead a group of over 18 drug safety experts within ANRS-EID and over 15 outside my institutions. As an expert in regulatory affairs, I have managed a number of early phase clinical trials, including the first in humans, in oncology and most importantly in infectious diseases and EID (list available upon request). Having graduated from one of the most advanced training programs in Vaccinology, ADVAC, I am a member of the innovative Vaccine Development Program with ANRS | MIE. As expert in public health, global health and pandemic preparedness: I am an expert in public health policy program implementation including health systems analysis, health policy, management and global health with pandemic research preparedness. I have advised number of international partners on how to build pharmacovigilance system, national health authorities. As an expert in capacity building and knowledge transfert: I am the leader of the ANRS | MIE group for strengthening capacity building, knowledge transfert on clinical trial sponsorship. Transfer of knowledge is ongoing with several partners on how to build a pharmacovigilance system and particularly in AFRICA. I am actually conducting a transfert in clinical trial sponsorship for the LMIC countries in the context of Integrate, Lassa fever clinical trial. As an ANRS | EID coordinator of the scientific research group: Scientific animation/brainstorming is one of the pillars of ANRS | MIE, I am piloting the Coordinated Action on Mother-to-Child Transmission regardless of the pathogen. With the presidents of this Coordinate action, we are keen to bring to fruition important, large-scale, multi-disciplinary and structuring projects. Detail-oriented team player with strong organizational skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Hardworking and passionate job seeker with strong organizational skills eager to secure entry-level [Job Title] position. Ready to help team achieve company goals. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.

• Throughout my career to date, I have never ceased to campaign energetically for the notion of diversity, inclusion and fairness
• As such, I coordinate training in the sponsorship of health research for African research institutions
• I am fully involved in data sharing and open science, as shown by the recent publications I have coordinated
• As head of department, it is important for me to nurture new talent, and recently two of my colleagues were awarded the title of Young Champions on behalf of the c4c European paediatric consortium
• During the Ebola crisis, I measured the societal impact of conducting clinical research in the context of a pandemic, and I was in regular contact with civil society organisations in the countries affected by the pandemic
• 6 months Internship and Master 2 thesis: Feedback on the management of a health crisis linked to Covid-19 by a pharmacovigilance department of an institutional sponsor, Inserm
• 6 months Internship thesis: Vigilance of clinical research for two institutional sponsors 6 months Internship and Master 2 thesis: Evaluation of the hepatotoxicity of anti-tuberculosis drugs combined with ARVs 6 months Internship thesis and Master 2 thesis: Study of the risk of occurrence of hypertension or worsening of hypertension in patients treated with antivirals.6 months Internship and Master 2 thesis on metrics and quality criteria for AE/SAE reporting in clinical trials
• 6 months Master 2 thesis: Complexity of the application of Directive 2001/20/EC in the vigilance of a European clinical trial NEAT 001/ANRS 143 trial
• MENTORSHIP OF TALENTScurrent c4c project Young Talents award Programme 2023
• Through the mentorship I have implemented, two of my young researchers have been awarded as European
• Young Researchers Champions for the Connect for Children (c4c European Project): LL, PharmD and MF, 2023-current Capacity building in Pharmacovigilance and mentoring: Integrate clinical knowledge transfer to the staff of ISTH Irrua, Nigeriacurrent In collaboration with AFRAMED, sponsorship of clinical for the ANRS | EID international partners and network.current Basics on clinical trials methodology for projects mangers and drugs safety officerscurrent Clinical trials training for West African pediatricians in conjunction with
• Pedstartcurrent c4c’s lead and coordinator of the module 6 training (Pharmacovigilance in paediatric)2021 Pharmacovigilance of Vaccines (Vaccine Research Institute)current Pharmacovigilance of clinical trials in Europe and in Low and
• Middle Income countries Institute Pasteur doctoral schoolcurrent Inter-university diploma on clinical trial training for investigators (DU-FIEC)2018 Master of therapeutics Bichat teaching hospital Pariscurrent Pharmacovigilance training (annual meeting with the ANRS | EID and
• CTUS)
• SAMPLE OF Funded Research ProjectsStructuring Funded projects (as partner or work package leader)
• Funding Agency Project Title Role
• ANRS |EID and EDCTP INTEGRATE TRIAL :Efficacy, tolerability and safety of new or repurposed drugs against Lassa fever in West African countries
• WP leader an adaptive phase II-III platform trial (ANRS 0409S INTEGRATE)
• Inserm, NIH and
• London School
• Randomized Trial of Vaccines for PREVAC Study Team
• Governance
• Safety working group Lead
• Inserm EU-Response DisCoVeRy 1 et 2 trials Sponsorship task co-lead
• Safety working group lead
• OUH EU-Response Bari-SolidACT trial Safety working group Lead
• Inserm and OPBG C4c EU paediatric clinical trial network Co-lead of WP 7-2
• HUG, EU Mpox response related trials (UNITY, MOSA and EPOXY) Task lead
• COMMITTEES
• Committee Organizer Year(s)
• Member of the ANRS | EID scientific days meeting ANRS | MIE Sept
• 2022 – current
• ANRS | EID representative in Glopid R, pandemic preparedness and response https://www.glopid-r.org/wp- content/uploads/2023/05/glopid-r-funders-living- roadmap-for-clinical-trial-coordination.pdf
• Oxford 2021 – current
• Member of the French clinical trial academic network
• French hospitals organization– current
• Member of covid-19 nasal vaccine development group
• University of Tours, INRA and ANRS | EID
• Voting member of clinical trials sponsored by ANRS | EID and Inserm, PRC, mostly in Guinea (the focal point between Guinean civil society organizations and the president's special envoy for public diplomacy in Africa: 2021 to July 2022).

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I love reading fiction, detective novels and political essays. I love football and have a passion for theatre that goes back to high school. I love walking and I'm a music lover.