AKAGERA Medicines
 
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Science/Clinical Advisory Board

 
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 THE SCIENCE / CLINICAL ADVISORY BOARD

We are grateful to these scientists who are renowned in the field of nano-science and infectious disease. They allow us to test our work with them whilst sharing their knowledge from “bench to bedside” for both therapeutics and vaccines: pure science, discovery, pre-clinical models, international regulatory agencies, patient needs and clinical protocols.


Anne Lenaerts, PhD

Leading Preclinical Expert in Mycobacterial Infections

Anne Lenaerts, Ph.D./ Akagera Medicines

Anne Lenaerts, PhD

Anne is a tenured Professor in the Department of Microbiology, Immunology, and Pathology at Colorado State University since 2001. She is an internationally recognized expert in preclinical development of antituberculosis drugs. 

Lenaerts’ research activities focused on development and application of novel preclinical animal models to further both anti-tuberculosis drug discovery, and study mycobacterial persistence and resistance.  She led the NIH/NIAID Contract for Mycobacterial Infections for 18 years and was further independently funded by programs from the NIH/NIAID, the TB Alliance, and the Bill and Melinda Gates Foundation. Her programs have assisted in the preclinical evaluation of pretomanid, moxifloxacin, bedaquiline, next generation quinolones, clofazimine analogues, and more, to advance these TB drugs into clinical trials.


Andreas Diacon, MD/ PhD

Associate Professor, Stellenbosch University

Andreas Diacon, M.D., Ph.D./ Akagera Medicines

Andreas Diacon, MD/PhD

Consulting pulmonologist and principal investigator on the largest and most successful tuberculosis drug trials over the past ten years has contributed significantly to the development of the first new anti-tuberculosis drugs since the 1960s.

In addition to Diacon’s work as principal investigator on these studies, his work has led to numerous scientific publications in the field of TB research over the past years. These articles have contributed to the changing landscape of the fight against TB. In South Africa alone over 450,000 cases of TB are registered each year.

Founder/CEO of TASK, his research group, focuses on clinical drug trials to accelerate the development and evaluation of novel anti-tuberculosis drugs. TASK provides assistance to efficiently conduct studies for diagnosis, treatment or prevention of tuberculosis, as well as for other prevalent diseases such as asthma and chronic obstructive pulmonary disease, where new and improved treatments are urgently needed.


Khisimuzi (Khisi) Mdluli, PhD

Discovery Project Leader, Bill & Melinda Gates Medical Research Institute

Khisimuzi (Khisi) Mdluli, Ph.D./ Akagera Medicines

Khisimuzi (Khisi) Mdluli, PhD

Khisi Mdluli, PhD is a Microbiologist with pharmaceutical industry experience in antibiotic development, and anti-TB drug development in particular. He has extensive experience in early drug discovery and development with skills ranging from as early in the development pipeline as target discovery, target validation and assay development, all the way through lead optimization to pre-clinical drug development. He has been instrumental in defining the mechanism of action for both clinically important anti-TB drugs and novel antibiotics.

He has a keen interest in defining the contribution of individual drugs in clinical TB regimens. As the Discovery Project Leader at Bill & Melinda Gates Medical Research Institute, he manages various drug development projects, including collaborations with academic scientists, pharmaceutical partners and contract research organizations. Previously, while with the TB Alliance, Khisi managed the TB Alliance-JHU Pre-Clinical Drug Combination Testing project since its inception to the current stage where a number of novel drug combinations have been identified that have demonstrated improved sterilizing activity compared to the standard of care, RHZE, requiring shorter durations of therapy to achieve a sustainable, relapse-free cure in mice. Some of the regimens are have demonstrated clinical efficacy, including against XDR-TB.


William Zamboni, Pharm.D./PhD

Research Associate Professor, Pharmacology UNC

William Zamboni, Pharma D, Ph.D. /Akagera Medicines

William Zamboni, Pharm.D., Ph.D.

William Zamboni, Pharm.D., PhD., received his bachelor of science, doctor of pharmacy and doctor of philosophy from the University of Pittsburgh School of Pharmacy in Pittsburgh, Pennsylvania. He completed his oncology residency at the Warren G. Magnuson Clinical Center, National Institutes of Health, in Bethesda, MD and his research fellowship at the Department of Pharmaceutical Sciences, St. Jude Children’s Research Hospital, in Memphis, Tennessee.

Currently, he is an associate professor in the UNC Eshelman School of Pharmacy and UNC Lineberger Comprehensive Cancer Center. Zamboni’s research program is part of the Division of Pharmacotherapy and Experimental Therapeutics n the UNC Eshelman School of Pharmacy and Molecular Therapeutics in the UNC Lineberger Comprehensive Cancer Center. He is the director of UNC GLP Bioanalytical Facility and the director of the Translational Oncology and Nanoparticle Drug Development Initiative (TOND2I) Lab at the University of North Carolina in Chapel Hill. He is also the codirector of the North Carolina Biomedical Innovation Network (NCBIN) for GLP toxicology and pharmacology studies of small molecule and nanoparticle agents.


Carole Mitnick, ScD

Assoc. Prof. of Global Health and Social Medicine, Harvard Medical School; Department of Global Health and Social Medicine

Carole Mitnick, ScD/ Akagera Medicines

Carole Mitnick, ScD

Dr. Mitnick is also Associate Epidemiologist in the Division of Global Health Equity at Brigham & Women’s Hospital, and Senior Research Fellow at Partners In Health. She has more than 20 years of experience in programmatic support, research, policy, and advocacy related to increased access to high-quality, appropriate treatment for TB, especially for drug-resistant TB. Dr. Mitnick’s contributions to the field have come through observational and experimental research. She is currently the co-PI of two multi-country, Phase III, randomized, controlled, clinical trials of all-oral, shortened, novel regimens for rifampin-resistant TB.

She has worked extensively in Peru and as a consultant to the WHO, contributing to global scale up of drug-resistant TB treatment.

Dr. Mitnick received her doctoral training in international health epidemiology and ecology at the Harvard TH Chan School of Public.


Andrew Nunn

Senior Scientist & Professor of Epidemiology at MRC Clinical trials Unit at UCL

Andrew Nunn/ Akagera Medicines

Andrew Nunn

Andrew Nunn joined the MRC’s Tuberculosis & Chest Diseases Unit as a statistician in 1966. During the next 20 years he was directly involved in the design, conduct and analysis of the programme of trials conducted under the leadership of Professors Wallace Fox and Denny Mitchison in East Africa, Hong Kong and Singapore which led to the worldwide adoption of short course chemotherapy for tuberculosis.

Following the closure of that unit he joined the MRC’s Uganda AIDS Programme which researched the dynamics of the HIV epidemic in a rural African environment. On his return to the UK he became head of the Division Without Portfolio within the newly formed MRC Clinical Trials Unit with responsibility for developing trials in neglected areas.

Currently, he is an investigator and senior statistician on three international Phase III trials of tuberculosis treatment one of which, STREAM, is the first Phase III trial in multidrug-resistant TB.


Michael Slater

REGULATORY AFFAIRS CONSULTANT

Michael Slater/ Akagera Medicines

Michael Slater

Mr. Michael Slater has more than 35 years of regulatory experience including hands-on preclinical and clinical regulatory strategy development from pre-investigational new drug (IND) application through drug marketing approvals. He has been a part of more than 100 IND filings and 14 successful marketing approvals during his distinguished career.  Mr. Slater was the Head of Regulatory Affairs and later, Development Operations at Merrimack Pharmaceuticals from 2010 to 2019. At Merrimack, Mr. Slater led the regulatory strategy resulting in the 2015 U.S. NDA approval of Onivyde® (irinotecan liposome injection), an orphan drug for the treatment of metastatic pancreatic cancer. In addition, he worked with Baxalta who acquired certain ex-US rights to Onyvide, to achieve approval in Europe and other countries. Prior to Merrimack, Mr. Slater held various regulatory roles in several biotech and pharmaceutical companies, including Millennium Pharmaceuticals, Acusphere, Inc., Anika Therapeutics, Inc., ImmuLogic Pharmaceuticals, Biogen and Hoechst Marion Roussel. With a background in applied biology, Mr. Slater also holds a B.Sc. in information science from Leeds Beckett University, U.K. and was a Fellow of The Organization for Professionals in Regulatory Affairs.


Vance G Fowler, MD

Florence McAlister Distinguished Professor of Medicine, Duke University (MRSA)

Vance Fowler, M.D./ Akagera Medicines

Vance Fowler, MD

Vance Fowler’s research interest focuses on S. aureus clinical epidemiology and pathogenesis. He has approached this question using a combination of clinical epidemiology and laboratory investigation. Dr. Fowler created the Staphylococcus aureus Bacteremia Group (SABG), a registry of clinical data, bacterial isolates, and patient DNA from ~2000 patients with S. aureus bacteremia. Using this resource, he addressed fundamental clinical questions involving S. aureus bacteremia, including the risk of infectious complications and the importance of transesophageal echocardiography and the impact of bacterial characteristics on clinical outcome.

Most recently, he is evaluating the role of host genetic characteristics in determining infection severity using a murine sepsis model and the patient DNA from the SABG cohort. He co-founded the International Collaboration on Endocarditis, a prospective cohort of over 3,000 patients from 28 countries with endocarditis. Using this resource, he made the critical observation that S. aureus is now the most common cause of endocarditis throughout much of the world. He has led important clinical trials testing new therapies for S. aureus bacteremia, including a randomized, controlled trial comparing daptomycin to standard therapy.



Barney S. Graham

Vaccine Innovator, Immunologist and Clinical Trials Physician

Barney S. Graham

Barney S. Graham is an immunologist, virologist, and clinical trials physician who is a thought leader on structure-based vaccine design, application of mRNA  delivery technology, and pandemic preparedness. He obtained an undergraduate degree from Rice University, a medical degree from the University of Kansas, and completed internal medicine residency, chief residencies, ID fellowship, and PhD in Microbiology and Immunology at Vanderbilt University. He joined the NIAID Vaccine Research Center at NIH as a founding member in 2000 and retired as Deputy Director of the VRC in 2021. He is now Director of the David Satcher Global Health Equity Institute and Professor of Medicine and Microbiology, Biochemistry, & Immunology at Morehouse School of Medicine in Atlanta. He is an inventor on vaccines and monoclonal antibodies approved for human use for the prevention or treatment of RSV, COVID-19, and Ebola. He is a member of the National Academy of Sciences, has received numerous awards for the advancement of science and vaccinology, and has been recognized by Time magazine as one of the world’s 100 most influential individuals and one of the Heroes of the Year in 2021 and one of the 100 most influential in health in 2024.


Tom Scriba

Leading Tuberculosis Immunology and Vaccine Expert

Tom Scriba

Tom Scriba is Professor in the Division of Immunology, Department of Pathology, Faculty of Health Sciences, UCT, and the Deputy Director (Immunology), South African Tuberculosis Vaccine Initiative (SATVI) and Member of the Institute of Infectious Disease and Molecular Medicine (IDM). SATVI’s mission is the development of new and effective prevention strategies against tuberculosis (TB), including vaccination and biomarker-targeted treatment approaches. They are testing multiple new vaccine candidates in clinical trials; and are involved with projects to address critical clinical, epidemiological, immunological and human genetic questions in TB pathogenesis and vaccine development.

Tom Scriba’s particular interests focus on understanding the immunopathology of Mycobacterium tuberculosis infection and TB disease, developing correlates of risk and immunological correlates of protection against TB. He has been co-investigator on more than 20 phase I/II/IIb clinical trials of novel TB vaccines, and has led the design and immunological analyses of vaccine-induced T cell responses for most of these. In the last 5 years he has also been leading studies of correlates of risk of TB in different cohorts.


James Whitney

Preclinical Non-Human Primate Modeling of Vaccines

James Whitney

James Whitney is a virologist and investigator at Boston College. He moved to Boston College in 2021 and is presently a Research Professor in the Department of Biology. His PhD work was conducted at McGill University in the laboratory of the late Dr. Mark Wainberg. He undertook his postdoctoral studies at the Beth Israel Deaconess Medical Center in the laboratory of the late Dr. Norman Letvin. James has maintained a NIH funded laboratory since 2011. His research focuses on HIV remission and emerging infectious diseases.


Michael S. Diamond

The Herbert S. Gasser Professor, Departments of Medicine, Molecular Microbiology, Pathology & Immunology

Michael S. Diamond

Dr. Diamond’s laboratory studies the molecular basis of disease of globally emerging RNA viruses, and focuses on the interface between pathogenesis and host immunity. He identified many of the key innate and adaptive immune system components that define protection against flaviviruses, and the viral genes that antagonize this response. His laboratory made a seminal discovery by identifying a novel pathogen-associated molecular pattern (lack of 2′-O methylation on the 5′ viral RNA cap) and mechanism of innate immune restriction through IFIT1 proteins. His group has used genome-wide screening to identify host factors required by viruses, including novel entry receptors for multiple alphaviruses of global concern. He has led the field in studying mechanisms of pathogenesis of Zika virus infection and disease including in pregnancy, and studied how the microbiome modulates immunity and infection of arthropod-transmitted viruses His group also has generated, characterized, and mapped thousands of neutralizing antibodies against Zika, West Nile, Dengue, Mayaro, and Chikungunya viruses. His work has led directly to the development of antiviral therapeutic antibodies and vaccines against both flaviviruses and alphaviruses. Most recently, his laboratory has studied the biology and pathogenesis of SARS-CoV-2 and is pursuing strategies for developing antibody and vaccine countermeasures and novel mouse models of disease and identifying correlates of immune protection.

Dr. Diamond is an elected member of the American Society of Clinical Investigation, Association of American Physicians, American Association for the Advancement of Science, National Academy of Medicine, and the National Academy of Sciences. He is also a recipient of Stanley J. Korsmeyer Award of the American Society of Clinical Investigation and currently an elected Councilor for the Association of American Physicians.