Quote:it could be the FDA moving the goal posts, it COULD also be CYDY not really having the knowledge to give the FDA what it wants. I know we hate to consider that as an option, but the couple of employees still part of CYDY are not really skilled in science
Oh Really? Are you a new investor? You don't seem to know much about Cytodyn.
Salah Kivlighn, PhD
Clinical and Strategic Advisor
Dr. Kivlighn, who is currently President and Managing Member of The Kivlighn Group, LLC, a company that provides strategic consulting services to companies across the biotech and pharmaceutical industry, brings to the Company more than 30 years of industry experience.
Dr. Kivlighn began his career at Merck & Co. (“Merck”) where he held positions of increasing responsibility during his 15-year tenure. While at Merck, Dr. Kivlighn was the lead scientist for the discovery and development of Cozaar® (losartan), and later helped to lead the massive growth of Cozaar® to $3.5B in worldwide revenue. As a scientist and marketer, Dr. Kivlighn contributed to the successful launch of a number of trials. At Merck, he also co-led the development and commercialization of RotaTeq® leading to an $800M franchise; RotaTeq® was awarded universal recommendation by the Advisory Committee on Immunization Practices.
Scott Hansen, PhD
Head of Research & Basic Science
Dr. Hansen has 25 years of experience in the field of virology and immunology, 17 of which were focused on the development and utilization of the non-human primate (NHP) model for the study of host vs. pathogen interactions, disease state modeling, and vaccine development. He is currently an Associate Professor at OHSU, where he has earned recognition for his strong publication record. The majority of this published work focused on the development of a novel vaccine platform based on Cytomegalovirus.
Bernie Cunningham, PhD, MRPharmS, PMP
Vice President of Operations
Dr. Cunningham, a certified Project Management Professional with extensive experience in development of investigational medicinal products (IMP) including solid oral dosage forms, cell therapies, radiopharmaceuticals and monoclonal antibodies,
Prior to joining the Company, she held positions of increasing responsibilities at OSI Pharmaceuticals, Mesoblast and Actinium Pharmaceuticals. She possesses extensive knowledge of pharmaceutical product development and has expertise in establishing systems and processes in growing companies.
Joseph Meidling
Senior Director of Clinical Operations
Prior to joining CytoDyn, Mr. Meidling spent nearly 22 years at Merck where he held various positions of increasing responsibilities in Drug Development. He was a director in Clinical Pharmacology and Translational Medicine and led the Pharmacogenomics and Biorepository group before moving on to become the site lead for Merck’s Kenilworth facility and was responsible for Merck’s Early-Stage Development portfolio and resource planning.
Scientific Advisory Board
Lishomwa C. Ndhlovu, MD, PhD
Director
Appointed to Weill Cornell Medicine in 2019 as Professor of Immunology in Medicine and Neuroscience, Dr. Ndhlovu has served on the Company’s Scientific Advisory Board since July 2020. Before joining Weill Cornell Medicine, Dr. Ndhlovu was a Professor at the University of Hawaii from 2011 to 2019, where he retains an adjunct appointment. As Co-leader of the $26.5 million NIH—Martin Delaney Collaboratory for HIV Cure “HOPE.”, he is a recognized expert in basic and complex immunology and immunotherapy research.
Mazen Noureddin, MD, MHSc
Dr. Noureddin is the current Director of the Houston Liver Institute and former founding Director of the Fatty Liver Program at Cedars-Sinai. He completed his residency at the University of Southern California and completed a hepatology fellowship at the NIH and gastroenterology fellowship at University of California San Diego.
Dr. Noureddin has led efforts in several breakthrough clinical trials targeting new therapies in patients with non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), including those with advanced fibrosis and cirrhosis. He also focuses on the underlying mechanisms of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), liver transplant, liver cancer, new imaging modalities, and exploring new treatments.
Dr. Noureddin has conducted more than 40 investigational clinical studies of novel treatments for non-alcoholic steatohepatitis (NASH). Dr. Noureddin has published 180 papers in the field of NASH in many journals including: The Lancet, Lancet Gastroenterology & Hepatology, Science Trinational Medicine, Gastroenterology, Journal of Hepatology, Journal of Clinical Investigation, Hepatology, Clinical Gastroenterology and Hepatology and others.
Jordan E. Lake, MD, MSc
Dr. Lake is Associate Professor of Medicine with Tenure at UTHealth McGovern Medical School. She completed both medical school and Internal Medicine residency at Baylor College of Medicine in Houston, Texas, followed by an Infectious Diseases fellowship and Master of Science in Clinical Research degree program at the University of California, Los Angeles. Dr. Lake’s outpatient practice focuses on adults living with HIV, and gender care for transgender women with HIV. Her translational research portfolio focuses on the treatment of metabolic complications of HIV and antiretroviral therapy, with particular expertise in translational clinical trials. Dr. Lake also serves leadership positions in the NIH-funded MACS/WIHS Combined Cohort Study and AIDS Clinical Trials Group.
Hope Rugo, MD
Dr. Hope Rugo is the Director of the Breast Oncology Clinical Trials Program at UCSF. She is the principal investigator for multiple clinical trials studying novel targeted therapeutics combined with standard treatments to improve clinical results in early and late-stage breast cancer. She is also researching cognitive function in patients receiving chemotherapy for breast cancer as well as ways to reduce toxicity from therapy.
Stefan Glück, MD, PhD, FRCPC
Dr. Glück is a medical oncologist and was V.P. Global Medical Affairs at Celgene Corporation from October 2014 until December 2019. He oversaw oncology activities worldwide and the Immuno-Oncology program in solid tumors and hematology. He also contributed to Celgene’s activities around the acquisition of early assets.
From 2003–2008, Dr. Glück was the Clinical Director of the Braman Family Breast Cancer Institute. From January 2009 - December 2010, he served as the Assistant Director of the Sylvester Comprehensive Cancer Center and Associate Chief Division of Hematology & Medical Oncology. He then served as a Sylvester Professor in the Department of Medicine at Miller School of Medicine, University of Miami, Florida, until September 2014. He has been a principal investigator of 37 breast cancer studies in Miami and numerous scientific and translational projects.
Naoto T. Ueno, MD, PhD, FACP
Dr. Ueno is a Professor of Medicine at The University of Texas MD Anderson Cancer Center. He is the Executive Director of the Morgan Welch Inflammatory Breast Cancer Program and Clinic and Section Chief of the Translational Breast Cancer Research at the Department of Breast Medical Oncology. His research is in the area of inflammatory breast cancer/triple-negative breast cancer. In particular, he focuses on the molecular mechanism of metastasis and tumorigenicity driven by cancer microenvironment.
Dr. Ueno is best known for his preclinical/clinical development for E1A, EGFR, HER2, MAPK pathway targeting therapy leading to novel clinical trials. His research determined the immune response that predicts sensitivity to anti-epidermal growth factor receptor (EGFR) therapy for inflammatory breast cancer (IBC) and developed novel treatment strategies by modulating the IBC microenvironment. He has conducted numerous phase 1/2 clinical trials of targeted therapy in patients with aggressive breast cancer.
Kabir Mody, MD
Dr. Kabir Mody is the Medical Director at IMV, Inc. and a board-certified medical oncologist. He brings a wealth of experience and knowledge in oncology and immuno-oncology accumulated while working at Mayo Clinic as an academic oncologist focused on GI oncology, in particular cancers of the liver and the pancreas.
Eric D. Mininberg, MD
Dr. Eric Mininberg is a board-certified medical oncologist at Piedmont Cancer Institute and a Diplomat of the American Board of Internal Medicine. He graduated from Dartmouth College in 1993 with a degree in government and obtained a medical degree from the University of Virginia School of Medicine. He completed his residency at the University of Virginia Medical Center. He was a Hematology fellow at Baylor University and a Medical Oncology fellow at the University of Texas MD Anderson Cancer Center.
Dr. Mininberg is the recipient of numerous honors and awards. He was inducted in 1989 as a member of Cum Laude Society with St. Albans School in Washington, DC. While at The University of Texas MD Anderson Cancer Center, he was honored with the Elsa U. Pardee Foundation Grant for Community Oncology.
Jonah B. Sacha, PhD
Dr. Sacha graduated cum laude from the University of Missouri-Columbia in 2003 with a B.A. in German and B.S. in Biology. After receiving his Ph.D. in Medical Microbiology & Immunology from the University of Wisconsin-Madison in 2007, he joined the faculty at UW-Madison, where he researched the characteristics of effective retrovirus-specific CD8+ and CD4+ T cells. In 2011, he joined the Oregon Health & Science University and has appointments in both the Vaccine & Gene Therapy Institute and Oregon National Primate Research Center.
Otto O. Yang, MD
Dr. Otto Yang is a Professor of Medicine, Infectious Diseases, Microbiology, Immunology & Molecular Genetics at UCLA and has a background in clinical infectious diseases. His laboratory specializes in T cell immunology in HIV infection, relevant to developing immune therapies and vaccines for HIV and potentially other diseases including cancer and other viral infections. He received his MD degree from Brown University, with subsequent residency training at NYU-Bellevue Hospital and subspecialty/postdoctoral training at Harvard-Massachusetts General Hospital. He then pursued fellowship at Massachusetts General Hospital, where he developed a research program studying the role of CD8+ T lymphocytes (CTL, which are killer T cells that can destroy cells infected with viruses or which are malignant) in HIV-1 pathogenesis.
Jacob (Jay) Lalezari, MD
Dr. Lalezari has agreed to serve as an outside Scientific Advisor to CytoDyn without compensation. Dr. Lalezari has been the CEO and Medical Director of Quest Clinical Research since 1997. He received his MD degree from the University of Pennsylvania and his MA from the University of Virginia. He also received a BA from the University of Rochester. He received his board certification from the American Board of Internal Medicine. He briefly served as interim Chief Medical Officer of CytoDyn during 2020, as well as Chief Medical Officer of Virion Therapeutics. Dr. Lalezari has served as Principal Investigator for Phase I, II, and III clinical studies of new therapies for such viral diseases as HIV/AIDS, CMV, HPV, HSV, Hepatitis B and C, Influenza, RSV, and COVID-19, including clinical trials conducted by the Company. He has published extensively and is a well-regarded international speaker and patient advocate.
26
