tuberculosis header image.jpg

PRIMARY COLLABORATORS

– New Jersey Medical School (RU-NJMS) is the prime awardee of the FEND for TB Consortium program. Jerrold Ellner, MD (PI), David Alland, MD (Co-PI & Scientific Director) and Susan Dorman (Co-PI & Clinical Director from Medical University of South Carolina) direct the overall program with a consortium of experienced investigators and clinical sites, advice/direction from NIAID (Dr. Karen Lacourciere, NIH Program Officer), and External Advisory Committee. This program benefits from experience gained during the successful 7-year tenure of the NIH DMID-funded TB-Clinical Diagnostics Research Consortium (TB-CDRC), with overlap in leadership, investigators and sites. This program has been improved in numerous ways to further enhance our capacity to meet the current challenges in the field ─ the successful collaboration with the Foundation for Innovative New Diagnostics (FIND) has now been strengthened to a full partnership that will facilitate access to cutting edge technologies and alignment of FEND-TB work with global stakeholder priorities; clinical study sites in Vietnam and Moldova have been added to those in South Africa, Uganda, and Peru to accelerate recruitment and augment capacity to enroll patients with co-morbidities and drug-resistance; inclusion of an analytic laboratory and revised technology evaluation strategy that together allow for rational, nimble, step-wise evaluation of early-stage diagnostics; and inclusion of an economic analysis and transmission modeling core to inform optimal diagnostic strategies in TB endemic settings and to promote policy change and implementation

The Medical University of South Carolina (MUSC), located in Charleston, South Carolina serves as the Clinical Support Core for the FEND-TB program, with Dr. Susan Dorman as lead investigator, and Co-PI of the FEND-TB Consortium. Dr. Dorman is an infectious diseases-trained physician scientist with expertise and experience in conducting laboratory and clinical assessments of new TB diagnostic tests. Dr. Dorman served for six years as Director of Clinical Studies for the TB-Clinical Diagnostics Research Consortium. She has experience managing large multicenter research endeavors and federally funded research contracts. Along with Dr. Dorman, Christie Eichberg, CCRP serves as Clinical Manager of the FEND-TB protocols, and Ms. Kelly Stinson, a microbiologist with extensive experience in mycobacteriology laboratory-based research in international settings, as Laboratory Coordinator. The Clinical Support Core (Section F) will provide a comprehensive support team for the coordination of functions at individual enrollment sites to facilitate multiple study procedures related to recruitment, enrollment, data & biological samples collection and laboratory testing.

The Foundation for Innovative New Diagnostics (FIND) is a global non-profit organization driving innovation in the development and delivery of diagnostics to combat major diseases affecting the world’s poorest populations. Diagnostics often do not exist, are inaccessible, or cost too much. They remain under-resourced and overlooked, despite being pivotal for guiding the best treatment for individual patients; for preventing the spread of disease and antimicrobial resistance; and for enhancing surveillance for early disease detection and monitoring. With priorities aligned to those of the global public health community, we turn complex diagnostic challenges into simple solutions through unique partnerships with the public, private and non-profit sectors. FIND is a WHO Collaborating Centre for Laboratory Strengthening and Diagnostic Technology Evaluation. Our work bridges R&D to access: we have deep technical and practical experience in the definition of needs, development of fit-for-purpose products, generation of evidence for regulators and policy-makers, analysis of market dynamics, the introduction of new products, and strengthening of laboratory systems. Based in Geneva, Switzerland, staff of 120 and regional hubs in India, Kenya, South Africa, Viet Nam, with six disease programmes, FIND conducts over 70 projects worldwide.

Frontier Science Foundation (FSF) is a non-profit organization whose stated mission is to collaborate with investigators and sponsors to conduct scientifically meaningful clinical trials, while advancing the application of statistical science and data management techniques in science, health care and education. Since its founding and incorporation in 1975, Frontier Science has provided high-quality, cost-effective data management and biostatistical services to research networks, pharmaceutical companies and investigators. The organization collaborates with investigators, clinical sites, academic institutions, laboratory centers and technicians in more than 1,200 establishments around the world. FSF is an established and reputable provider of services focused on clinical trials and observational studies. Frontier Science’s primary services include data management and scientific, biostatistical expertise, as well as software development and maintenance for the collection, processing, derivation and analysis of data. The organization has developed and managed software and supported data management projects for studies funded by NIH, pharmaceutical companies and other private organizations, both commercial and nonprofit. Since its inception, Frontier Science has provided the core data management for more than a dozen multi-site, multi-trial networks including the ACTG; the Pediatric AIDS Clinical Trials Group (PACTG) and its successor, IMPAACT, the Eastern Cooperative Oncology Group (ECOG), the International Breast Cancer Study Group (IBCSG), the Pediatric HIV/AIDS Cohort Study (PHACS), the Cancer Prevention Clinical Trials Network (CP-CTNet) and the Collaborating Consortium of Cohorts Producing NIDA Opportunities (C3PNO). Of note, the goal of the C3PNO project is to bring nine distinct HIV cohorts together to centralize, standardize and harmonize data, coordinate research efforts, and stimulate new research by facilitating data sharing through an interactive virtual data repository platform.

 

The FEND-TB team includes statisticians from Frontier Science and epidemiologists with complementary expertise. Dr. Soyeon Kim has extensive experience working in clinical trials and observational studies, with specific expertise in TB research, including pediatric TB. She has collaborated with Drs. Alland and Ellner for 14 years. Dr. Schumacher is an epidemiologist with expertise in infectious disease diagnostic evaluations and latent class modelling. The Economic Analysis and Transmission Modelling Core has a complementary analytic plan. These scientists have experience working in collaborative team environments and together bring unique skills required to accomplish FEND-TB work. Dr. Kim will be responsible for designing the evaluation of studies using classical methods and will coordinate activities with the Economic Analysis and Transmission Modeling Core.

University of Oxford is a higher education institution, and the Oxford Vaccine Group is a vaccine design, development, clinical trials and laboratory evaluation research group in the Department of Paediatrics of the University Oxford. The Oxford Vaccine Group conducts studies of new and improved vaccines for children and adults and provides a base for over 100 vaccine researchers working on epidemiology of vaccine-preventable diseases, laboratory evaluation of vaccines, statistical methods, and clinical trials of vaccines. The multidisciplinary group includes consultants in vaccinology, a Director of Clinical Trials, a Senior Clinical Trials Manager, adult and pediatric clinical research fellows, adult and pediatric research nurses, project managers, statisticians, QA manager, IT manager, and an administration team. The team also includes postdoctoral scientists, research assistants and DPhil students and collaborates with scientists from a range of specialties such as immunologists, microbiologists, epidemiologists, a community pediatrician, the local Health Protection team and a bioethicist.

 

Dr. Rinn Song is a Clinician-Scientist in the Department of Paediatrics at the University of Oxford and completed training in pediatrics, pediatric infectious diseases, applied epidemiology, public health, and immunology of infectious diseases. He have worked closely with the team of Principal Investigators in the past. Before joining Oxford University, I was faculty in the Department of Pediatrics at Harvard Medical School where I was awarded a K23 for a study on novel diagnostics for pediatric TB. This study was successfully completed in collaboration with the Kenya Medical Research Institute and the CDC, where I trained as an EIS Officer in the TB Division and subsequently served as an affiliated scientist for 8 years. As part of this study, I collaborated with Dr. Alland and Dr. Ellner an on a novel stool Xpert MTB/RIF protocol and with Dr. Salgame on a transcriptomic analysis on this cohort, using RNAseq. The proposed study will use specimens from a comprehensive biorepository which was established as part of the project in Kenya Prior to joining Oxford University, I also conducted research on TB diagnostics with the Foundation for Innovative New Diagnostics (FIND). Dr. Song and his team will work with the Clinical Support Core on the clinical conduct, focusing on the pediatric component and the proposed diagnostics.

The Modeling (Economic Analysis & Transmission) Core represented by Drs. Anna Vassall (London School of Hygiene & Tropical Medicine), Ted Cohen (Yale School of Public Health), Nick Menzies (Harvard School of Public Health)) will use a range of approaches to: explore the potential impact of new tests and strategies on health outcomes, costs, and value, and identify drivers of impact; provide support for analysis of novel assays in situations in which the reference standard is imperfect (e.g. latent class analyses applied to studies of test accuracy for pediatric TB detection); and explore and identify optimal approaches for using multiple tests in combination to address limitations in TB diagnosis. The Core will bridge the gap between clinical science and policy by examining the potential impact of novel diagnostics on the TB care cascade, long-term outcomes, and cost-effectiveness.

Dr. Clifton Barry (Chief and Senior Investigator, Tuberculosis Research Section, NIAID, NIH) leads the Tuberculosis Research Section (TBRS) at NIAID, which is a multidisciplinary group of research scientists comprised of biologists, chemists, and clinical researchers who share a common interest in TB. TBRS projects focus on understanding the scientific issues that facilitate the development of drugs that will make a genuine difference in the outcome for TB subjects globally. Dr. Barry serves as collaborator on the FEND-TB Executive Committee to assist with technology scouting and in discussions concerning evaluation of proposed new technologies.

 

Dr. Kathleen Eisenach (Senior Clinical Microbiologist Consultant) was Professor of Pathology at the University of Arkansas for Medical Sciences (UAMS) until 2017. She has over 30 years in tuberculosis research in the area of clinical microbiology and provided expertise to CDC, NIH, TB Alliance, National TB Programs. She has served as Co-Director of the TBRU at Case Western Reserve University, and the Global Consortium for Drug Resistant TB Diagnostics. She brings an understanding of the procedures and processes required for translation of new technologies to the filed and harmonization of laboratory methods across multicenter studies. As her role as Senior Clinical Microbiologist, Dr. Eisenach will take a leadership role in FEND-TB with the development of laboratory procedures, quality control/quality assurance of methods and conduct in the clinical laboratories. She will visit the sites to help establish standard best practices and uniformity across the five clinical sites.

 

Dr. Mark Nicol (University of Western Australia, Pediatric TB Diagnostics Consultant) is a medical microbiologist in the Division of Infection and Immunity in the School of Biomedical Sciences at the University of Western Australia. He holds an honorary appointment at the University of Cape Town, South Africa, where until 2018 he served as Professor at the Institute of Infectious Disease and Molecular Medicine. He has a passion for using modern molecular tools to understand complex microbial communities, investigating how imbalances in these communities cause illness and to develop and test better diagnostics for infections, particularly for diseases relating to poverty. Specific focus areas are the pathogenesis and diagnosis of respiratory infection in children, development, evaluation and implementation of novel diagnostic tests for tuberculosis, the cascade of care for patients with drug-resistant tuberculosis and the role of the microbiome in early childhood development and illness. Professor Nicol has done seminal work on diagnostics for TB in children and adults, which has provided an evidence base for the new molecular tuberculosis tests used worldwide, and has contributed to many WHO policy recommendations and guidelines. Dr. Nicol will provide expert consultation in evaluation diagnostics, especially pediatric diagnostics, in which he worked with Drs. Ellner, Dorman and Alland in the TB CDRC contract as PI of the University of Cape Town site.

 

Dr. Rodrigo Rodrigues (Federal University of Espirto Santos, Brazil, Immunology Consultant) has extensive experience in immunology, infectious diseases and parasitology, with an emphasis on immunology and cellular immunology. He has been a Co-Investigator and Collaborator on the TBRU program, the CDRC program and the ICIDR program with Drs. Ellner, Salgame and Alland. He will provide host-based advice/expertise in the FEND-TB program.

 

Ms. Kelly Stinson (Cultura Incorporated, Microbiology Laboratory Coordinator) is a microbiologist with extensive experience in mycobacteriology laboratory-based research in international settings. She served as Clinical Manager for Microbiology for Otsuka Pharmaceuticals and in that capacity led the Otsuka global microbiology program that supported the clinical trials of delamanid. She was the lead editor of the “Mycobacteriology Laboratory Manual” that provided a set of standard, harmonized procedures for conduct of mycobacterial laboratory testing for delamanid trials. She will serve as Laboratory Coordinator for the FEND for TB program. In that capacity she will have a leadership position within the Clinical Support Team.