DEVELOPMENT & DELIVERY
Julia Lynch, M.D.
Deputy Director General, Development & Delivery Unit
Dr. Lynch is the Deputy Director General of Development & Delivery. Prior to IVI, she served 29 years in the U.S. Army. Dr. Lynch first served as Director of the Division of Viral Diseases at the Walter Reed Army Institute of Research, during which time significant studies were conducted for Japanese encephalitis, adenovirus and dengue vaccines. She was appointed Director of the Military Infectious Disease Research Program at Fort Detrick, Maryland; a product development program targeting vaccines against malaria, dengue and enteric pathogens, as well as new anti-parasitic drugs and infectious disease diagnostics for resource-limited settings. She later became the Science Director for the Armed Forces Research Institute of Medical Sciences in Bangkok, Thailand where she was responsible for activities spanning eight countries in South-East Asia which included biosurveillance, basic science, pre-clinical studies, and human clinical trials. Dr. Lynch received her M.D. from Columbia University and completed a Pediatric Residency and Infectious Disease fellowship at the Walter Reed Army Medical Center.
Sushant Sahastrabuddhe, MBBS, MPH, MBA
Director, Enteric Fever
Vaccine Development Department
Sushant Sahastrabuddhe, MBBS, MPH, MBA, is the Director of the Enteric Fever Program at IVI. Dr. Sahastrabuddhe has been with IVI for the past 8 years, and is currently leading the typhoid conjugate vaccine development program involving multiple manufacturers. He is a medical graduate from India with a Master’s degree in Public Health from Johns Hopkins Bloomberg School of Public Health in Baltimore, Maryland, U.S.A. Before joining IVI, he was working with the National AIDS Research Institute (NARI) under the umbrella of the Indian Council of Medical Research (ICMR) for 4 years. He has been involved in many phase I/II trials, including those for HIV vaccines. During his previous assignment at NARI, he was also involved in the monitoring of the HIV Sentinel Surveillance system under the National AIDS Control Organization (NACO) for the western states of India. Owing to his extensive experience in conducting and managing clinical trials and major public health initiatives, he has authored more than 10 publications and 2 book chapters.
T. Anh Wartel, M.D.
Head, Clinical Development and Regulatory
Dr. T. Anh Wartel has 20 years of experience in epidemiological studies, clinical research from phase I to phase IV studies, and CTD development. She earned her MD at the Paris XII Medical School, France and completed a post-graduate diploma in Public Health from the University of Liverpool, UK. She has extensive experience in the fields of epidemiological and clinical research within both academia and the pharmaceutical industry during her 15 year-long career with Sanofi Pasteur before joining IVI in 2018. After having started her research career as a co-investigator in drugs and therapeutic vaccine trials in HIV infected patients at the French National Agency of Research on HIV/AIDS (ANRS) at Kremlin Bicetre University Hospital in Paris, she then joined Sanofi Pasteur in 2003. Her responsibilities grew over the course of 15 years to include Epidemiology and Clinical R&D activities (e.g., Japanese encephalitis, Pneumococcal Disease, Dengue Disease); Medical Affairs activities as the Regional Medical Expert for enteric, endemic and travelers vaccines (e.g., rabies, cholera, typhoid fever, hepatitis A, yellow-fever, dengue, Japanese encephalitis vaccines); and Country Medical Head for Vietnam and Cambodia. She joined IVI in September of 2018 as the Head of Clinical Development and Regulatory.
EPIDEMIOLOGY & OUTCOMES
Florian Marks, Ph.D.
Deputy Director General of Epidemiology and Outcomes
Dr. Florian Marks, MPH, Ph.D. has over 18 years of experience conducting epidemiological studies and providing technical expertise in the field of global health; particularly in low-income countries. As the Deputy Director General of Epidemiology and Outcomes at IVI, he designs and oversees epidemiological studies investigating a wide range of bacterial and viral infectious diseases. His duties include overall coordination, organization, supervision, and management of standardized surveillance studies, executing mass vaccination campaigns, and conducting associated effectiveness studies to generate high quality data for vaccine introduction recommendations and improvement of existing programs. His expertise includes the execution of large, multi-center studies, such as the Typhoid Fever Surveillance in Africa Program (TSAP), that generated incidence data on invasive bacterial bloodstream infections from 13 African sites and provided unique data pertinent to include typhoid conjugate vaccines into the Gavi portfolio. Subsequently, Dr. Marks has obtained funding to initiate the Severe Typhoid Surveillance in Africa Program (SETA), which further characterizes the severity and long-term health outcomes of typhoid fever in six African countries. He has recently received two Fleming Regional Grant awards to expand knowledge on antimicrobial resistance in 12 Asian countries. He’s also currently leading IVI’s program on the clinical development of schistosomiasis vaccines, jointly with the Texas Tech University Health Sciences Center and PAI Life Sciences.
Dr. Marks holds an academic appointment within the Department of Medicine, University of Cambridge, UK and has been instrumental in setting up joint programs leveraging the unique strengths of both the University of Cambridge and IVI. Dr. Marks majored in Pharmacy at the University of Saarland, and holds a Ph.D. from the Bernhard Nocht Institute for Tropical Medicine at the University of Hamburg and a Master of Public Health from the London School of Hygiene and Tropical Medicine. He also holds a position as Visiting Professor within the Department for Health Security at the Graduate School of Public Health, Seoul, Republic of Korea.
Vittal Mogasale, Ph.D.
Head, Policy and Economic Research Department
Vittal Mogasale, M.B.B.S., M.P.H., Ph.D. joined IVI in 2011 as the Head of the Policy and Economic Research Department. He has been involved in infectious disease control and immunization programs in several countries over the course of the past 20 years. His current work focuses on health economics and policy research to support evidence-based decision making at global, regional, and national levels. Dr. Mogasale obtained his Medical Degree in 1997 from Manipal University, India; his International Masters in Public Health from Hebrew University, Israel in 2003, and his Ph.D. from the University of Queensland, Australia in 2010.
SCIENCE / VACCINE PROCESS DEVELOPMENT
Manki Song, Ph.D.
Acting Deputy Director General of Science
Manki Song, Ph.D., Acting Deputy Director General of Science, has had a longstanding interest in public health and threats to health of developing country populations. In the first years of his career, he focused on viral diseases, particularly HIV, HBV and HCV. Most recently, as the Head of the Clinical Research Lab Unit of IVI, he broadened the scope of his studies to include Norovirus and MERS-CoV vaccine development. He looks forward to the continuation of oversight of studies including: field work, clinical medicine, and advanced microbiology, for the betterment of child and general population health. Dr. Song received his B.Sc. from Seoul National University, and M.S. and Ph.D. degrees in viral immunology from Pohang University of Science and Technology (POSTECH) under the mentorship of Prof. Young-Chul Sung. He continued postdoctoral work in Prof. Sung’s laboratory on the development of HBV and HCV vaccines. Dr. Song served as an IVI postdoctoral fellow in 2001 with Prof. Myron Levine at the Center for Vaccine Development (CVD) at the University of Maryland School of Medicine in Baltimore, Maryland. During this period, he focused on the development of new-generation measles vaccines using naked DNA, attenuated Shigella, and Salmonella. Dr. Song has also actively served on steering committees of many academic societies including the Korea Association of Immunologists, the Korean Vaccine Society, and the Korean Dendritic Cell Academic Society. Since 2008, he has acquired a number of Korean government grants (over US$11 million in total) as the principal investigator, and initiated collaboration with Celltrion, a leading Korea-based biotech company, for influenza and pneumonia vaccine development. During this time, he served two years as a Review Board member of the Korea National Research Foundation (Immunology in Medical Science); and since 2015, he has maintained his position as a Program Manager of the state-run Korea Health Industry Development Institute (KHIDI).
Jae Seung Yang, Ph.D.
Senior Research Scientist, Clinical Immunology
Jae Seung Yang joined IVI in 2004 after receiving his Ph.D. in Biology from the Korea Advanced Institute of Science and Technology (KAIST). His research interests focus on the development, standardization and validation of assays for measuring vaccine-induced immune responses, particularly against enteric and respiratory pathogens. He has developed a miniaturized ELISPOT assay which can be used in infants for detecting vaccine-specific antibody-secreting cells in a small (< 1ml) volume of blood, in addition to functional assays for cholera and typhoid vaccines. His laboratory has also contributed to the WHO prequalification of cholera vaccines (Shanchol and Euvichol) by assessing immune responses in several clinical studies.
Currently, his lab is supporting clinical studies of typhoid conjugate vaccine in collaboration with SK Bioscience, and is funded by the Bill & Melinda Gates Foundation (BMGF). Recently, Dr. Yang participated in NIBSC/WHO collaborative studies funded by BMGF, a multi-national project involving seven laboratories from six countries, to evaluate an international standard serum for Typhoid Vi-conjugate vaccines. IVI’s in-house assay has been demonstrated to be the best non-commercial alternative among seven laboratories’ methods for typhoid vaccine clinical trials. As a result, a further collaborative study is planned in 2018 with all participants set to use IVI’s in-house ELISA as the standard method. In addition, MFDS requested that his team lead a project to develop additional human standard serum for a typhoid vaccine.
Jae-Ouk Kim, Ph.D.
Head of Molecular Immunology
Jae-Ouk Kim, Ph.D. is the Head of Molecular Immunology at IVI. Throughout her career, she has pursued pathogen- and vaccine-related research. She is interested in the elucidation of protective immune mechanisms against pathogens, and adjuvants that enhance T cell immune responses. As a research scientist in the neonatal vaccinology program at IVI in 2010, she led the assessment of the maternal effect on specific immune responsiveness to BCG, a number of candidate TB vaccines, and respiratory syncytial virus glycoprotein core fragment in neonatal mice. She also studied the role of neonatal NKT cell sensitization in RSV disease in mice. Currently, her research has focused on the development of a universal Shigella vaccine targeting conserved outer membrane proteins. Dr. Kim is also leading a project involving the development of neutralizing antibodies against hemorrhagic fever viruses, such as the Ebola virus.
Besides serving as the as the principal investigator in various research projects, Dr. Kim led the strategic study on the establishment and management of the Reference Lab for Clinical Evaluation of Vaccines, funded by the Korean Ministry of Food and Drug Safety. She is also involved in establishing a MERS-CoV vaccine evaluation system.
Dr. Kim graduated from the College of Pharmacy at Seoul National University (SNU) and continued her graduate studies, majoring immunology under the mentorship of Prof. Chang-Yuil Kang at SNU and completing her Ph.D. She then served as a postdoctoral fellow in Dr. Gary J. Nabel’s lab at the Vaccine Research Center/NIAID/NIH, USA, before joining IVI in 2008.
Ravi Ganapathy, Ph.D, PGDBA (Ops).
Head of Vaccine Process Development
Ravi Ganapathy has more than 25 years of professional work experience in the hospital, biotech research & vaccine industry. He has hands-on experience in development, manufacturing and testing of recombinant (bacterial/yeast-derived), bacterial and viral vaccines. Having led R&D, Production and Quality Assurance teams he has an extensive understanding of manufacturing and R&D-related quality & regulatory requirements for commercialization of biotech products, especially vaccines, and the related GLP & GMP documentation. He joined IVI as the Head of Vaccine Process Development in May 2019.
Immediately prior to joining IVI he was with Biological E. Ltd., Hyderabad, India for over 5 years. While there he helped set-up laboratories, built and led the Manufacturing Sciences team providing full-fledged support to the commercial manufacturing divisions (production & QC) -including Life-Cycle Management involving the introduction of new delivery systems, and technology transfers. Based on the work done under his leadership at BE, two international patents have been filed; one involving a novel adjuvant preparation process (published), and the other pertaining to an alcohol-free polysaccharide purification process (currently under review).
Before joining BE, Dr. Ganapathy spent 2 years at Shantha Biotechnics (a Sanofi company), where he led the scale-up of the manufacturing process of a tetravalent rotavirus vaccine from Phase-I to Phase-III and oversaw the Ph-III material production and delivery. His first vaccine industry experience, however, was with Bharat Biotech International Ltd., where he worked for 14 years, and also completed his PhD through his work on a CDC-NIH-sourced multi-epitope, recombinant malarial vaccine candidate against Plasmodium falciparum. At BBIL Dr. Ganapathy spearheaded teams on projects for manufacturing vaccines for use in several clinical trials (supported by PATH/BMGF, MVI/EVI and DBT-India) and for commercial supplies. He also played a crucial role in product and process development, and in the approval of the first cell culture-derived Pandemic H1N1 Influenza vaccine in India (2009).
Dr. Ganapathy graduated as a double-gold medalist for his post-grad work in `Medical Entomology’ from VCRC (ICMR) in 1993. Prior to that, he obtained his bachelor’s degree in `Medical Laboratory Technology’ from JIPMER (1991). He has been a lead- or co-author of 8 research papers and has delivered talks at several international conferences.