James A. Joyce
Co-founder, Chairman, and CEO Inventor
James “Jim” Joyce has more than two decades of public company CEO and Corporate Board leadership experience. He is also an inventor or co-inventor of ~20 pending or issued patents, including those underlying ImmunePrep™, ChemoPrep™, ChemoPure™ and Sigyn Therapy™.
Prior to establishing Sigyn Therapeutics, Mr. Joyce was the founder and former Chairman and CEO of Aethlon Medical, a therapeutic technology company that he navigated from single shareholder start-up to Nasdaq-traded Company with 8000+ shareholders. During his tenure at Aethlon, Mr. Joyce oversaw the development of the Hemopurifier®, a first-in-class blood purification technology to address life-threatening viruses and cancer-promoting exosomes. Under his leadership, the Hemopurifier® became the first therapeutic candidate to be awarded two FDA “Breakthrough Device” designations and was the first and only device to receive “Emergency Use Authorization” (EAU) approval from the FDA, Health Canada, and the Government of Germany to treat Ebola virus. Time Magazine named the Hemopurifier® one of the “11 Most Remarkable Advances in Healthcare” and designated the device to its “Top 25 Best Inventions” award list.
Under Mr. Joyce’s leadership, Aethlon Medical was awarded multiple U.S. government contracts, including a contract with the National Cancer Institute (NCI) and two contracts with the Defense Advanced Research Projects Agency (DARPA), a U.S. Department of Defense (DOD) entity. While at Aethlon, Mr. Joyce also led the completion of five human clinical studies, the closing of approximately $100 million of equity financings, and the establishment of preclinical and clinical collaborations with more than twenty government and non-government research institutes.
Based on the use of the Hemopurifier® to treat HIV and Hepatitis-C infected individuals in India, Mr. Joyce was the recipient of the “Spirit of India Award” sponsored by the Bill & Melinda Gates Foundation and awarded each year by the American India Foundation to the American business leader who has demonstrated a commitment to accelerate social and economic change in India.
Mr. Joyce testified before Congress and lobbied Capitol Hill to promote the use of medical devices as candidate treatment countermeasures against emerging bioterror and pandemic threats, which contributed to expanding the countermeasure definition to be inclusive of medical devices under U.S. law. Previously, a treatment countermeasure was defined solely as a drug or vaccine. Subsequently, medical device therapies were among the first to receive Emergency-Use Authorization from FDA during the Ebola and COVID-19 outbreaks.
Mr. Joyce was also the founder and former Executive Chairman of Exosome Sciences, Inc. (ESI), a company that focused on the discovery of exosomal biomarkers. Inspired by the death of a former teammate, Mr. Joyce established a collaboration with the Boston University CTE Center to test his hypothesis that circulating exosomes transporting tau protein cargos (exosomal tau or TauSome) might provide a basis for a non-invasive blood test to diagnose or monitor neurological tauopathies, including chronic traumatic encephalopathy (CTE) and Alzheimer’s disease. As a result, ESI was invited to participate in the first NIH funded clinical study of CTE, which revealed exosomal tau levels to be approximately 9x higher in 78 former NFL players as compared to same age group control subjects. The study results (co-authored by Mr. Joyce) were published in the Journal of Alzheimer’s Disease. In a follow-on study, Exosome Sciences reported exosomal tau levels to be similarly elevated in diagnosed Alzheimer's patients. Researchers at Johns Hopkins would subsequently report exosomal tau to be the basis for a blood test that could diagnose Alzheimer's disease up to four years before first symptoms.
Prior to founding Aethlon Medical and Exosome Sciences, Mr. Joyce operated James Joyce & Associates. He was the founder and former CEO of Mission Labs, Inc. and a principal at London Zurich Securities. Upon graduating from the University of Maryland, Mr. Joyce was first employed as a member of the Denver Broncos Football Club of the National Football League.
Annette Marleau, Ph.D.
Chief Scientific Officer
Dr. Marleau is a recognized thought leader in the development of therapeutic blood purification technologies to address cancer. Prior to joining Sigyn Therapeutics, Dr. Marleau was Chief Technology Officer at Immunicom, Inc., where she led R&D endeavors to establish a pipeline of blood purification candidates to treat cancer. She also served as Director of Research at Aethlon Medical, Inc., where she oversaw preclinical programs that facilitated the first-in-human clinical investigation of the Aethlon Hemopurifier® as an adjunct cancer therapy.
Dr. Marleau has been awarded more than $6 million in NIH grants and contracts to serve as Principal Investigator for pre-clinical and clinical programs to advance blood purification technologies. Additionally, she co-authored two FDA-cleared Investigational Device Exemptions, co-authored a regulatory submission that resulted in an FDA “Breakthrough Device” award, and is an inventor on pending and issued patents underlying blood purification therapies targeting cancer, inflammatory disorders, and life-threatening infectious diseases.
Dr. Marleau completed a fellowship in immunology at Scripps Research Institute in La Jolla, CA. She is a graduate of Western University (PhD), Ontario Veterinary College at University of Guelph (Master of Science), and University of Waterloo (Bachelor of Science) in Canada.
Jeremy Ferrell, CPA, MBA
Chief Financial Officer
Mr. Ferrell has more than 25 years of finance and operations leadership experience, with expertise in venture capital; mergers and acquisitions; due diligence; initial public offerings; strategic alliance negotiation; and financial planning and reporting. He was most recently CFO at Miku, Inc, a privately held consumer hardware and tele-health company, where he managed a successful seed financing round and led Miku’s transition from its parent to an independent company. Previously, he founded a Fractional CFO Services firm, where he served as CFO for various life sciences and technology companies, including Singular Genomics, Inc., Aspen Neuroscience, Inc., and Hyduro, Inc. Before that, he served as Corporate Controller for ecoATM, Inc., which was acquired by Outerwall, Inc. in 2013. Earlier in his career, Mr. Ferrell practiced as a certified public accountant. Mr. Ferrell received his Bachelor of Science degree in Accountancy from Liberty University and his Master of Business Administration degree in International Finance from the Thunderbird School of Global Management.
Craig P. Roberts
Co-founder and Chief Technology Officer
Mr. Roberts is an inventor of life-saving therapeutic technologies, which includes a Percutaneous Adult Extracorporeal Membrane Oxygenation (ECMO) system that was licensed and subsequently sold to C.R. Bard. Mr. Roberts is also an inventor of the IMPACT System, which received CE Mark clearance in the European Union and was subsequently registered in 32 countries and deployed to treat cytokine storm associated conditions, including sepsis, acute respiratory distress syndrome (ARDS), acute liver failure, severe pneumonia, and H5N1 bird flu virus infection. The IMPACT system was comprised of multiple cartridges and designed to reduce the presence of inflammatory cytokines from human blood plasma. As a Clinical Perfusionist, Craig has conducted more than 4,000 extracorporeal procedures, including adult and pediatric cardiopulmonary bypass, cardiac assist devices, ECMO (artificial lung), vascular access catheter systems, and continuous renal replacement therapy.
Director of Clinical Affairs
Mr. Lynam has played key roles in developing, contracting and conducting over 190 clinical trials and will oversee clinical studies of Sigyn Therapy™ in the United States and abroad. Previously, Mr. Lynam was the Director of Scientific and Medical Affairs for Pharmatech Incorporated until its recent acquisition by Caris Life Sciences. While at Pharmatech, Mr. Lynam pioneered a high efficiency, patient centered clinical trials system, providing on-demand trial access to a network of more than 1,500 investigators.
Charlene R. Owen
Director of Operations
Charlene Owen has over two decades of complex administrative and operations experience at publicly-traded Biotechnology and Medical Device organizations. In her previous role at Aethlon Medical, Ms. Owen supported all C-Suite professionals while managing the smooth flow of corporate activities, including Human Resources, Facilities, and Information Technology (IT). At Hollis-Eden Pharmaceuticals, Ms. Owen was the Executive Administrator to the founder and CEO and played a critical role in the growth and expansion of the company as the fifth (#5) employee hired. Widely seen as a problem solver and key “corporate in-filler,” Charlene’s versatility and collaborative nature make her a valued part of our team. Charlene holds a Bachelor of Arts degree in Communications /Psychology from Western Washington University, as well as significant post-baccalaureate work in Instructional Technology.