About Aethlon The Aethlon Medical mission is to create innovative medical devices that address unmet medical needs in cancer, infectious disease, and other life-threatening conditions. Our Aethlon ADAPT™ System is a revenue-stage technology platform that provides the basis for a new class of therapeutics that target the selective removal of disease enabling particles from the entire circulatory system. The Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome™ to address HER2+ breast cancer, and a medical device being developed under a contract with the Defense Advanced Research Projects Agency (DARPA) that would reduce the incidence of sepsis in combat-injured soldiers and civilians.
SAN DIEGO, Oct. 3, 2011 /PRNewswire/ -- Aethlon Medical, Inc. (OTCBB: AEMD), the pioneer in developing therapeutic filtration devices to address infectious disease and cancer, announced today that it has been awarded a $6.8 million contract from the Defense Advanced Research Projects Agency (DARPA) to develop a therapeutic device to reduce the incidence of sepsis, a fatal bloodstream infection that is often the cause of death in combat-injured soldiers. The contract program will utilize the Aethlon ADAPT™ system as a core technology component underlying an extracorporeal blood purification device that selectively clears multiple sepsis-enabling particles from circulation to promote recovery and prevent sepsis. The resulting device, which is being advanced under DARPA's Dialysis Like Therapeutics (DLT) program, is expected to dramatically decrease the morbidity and mortality of sepsis, thereby saving thousands of lives and billions of dollars in the United States each year. Under the DLT program, Aethlon will also introduce a novel blood pump strategy to reduce or eliminate the systemic administration of anticoagulants normally required during extracorporeal device therapies. Worldwide, more than 18 million cases of sepsis are reported every year, with more than six million resulting in death.
"We are truly honored to receive this contract award and look forward to working with DARPA and other DLT team participants to advance this important therapeutic endeavor," stated Aethlon Medical Chairman and CEO, Jim Joyce. "The award also reinforces the expansive capabilities of our ADAPT™ system, increases the breadth of our product pipeline, and transitions us from a development-stage to revenue-stage organization."
The Aethlon ADAPT™ system, introduced earlier this year, is an adaptive dialysis-like affinity platform technology that provides the foundation for a new class of therapeutics that selectively target the clearance of harmful agents from the entire circulatory system without the loss of essential blood components. Therapies that evolve from the Aethlon ADAPT™ system overcome the historic limitation of extracorporeal strategies that indiscriminately adsorb or remove particles solely by molecule size. In function, the device platform allows the immobilization of single or multiple affinity drug agents in the outer-capillary space of plasma membrane technology as a means to provide rapid real-time clearance of corresponding targets without adding drug toxicity or interaction risks to established therapies. Beyond providing a novel regulatory and commercialization pathway for affinity drug agents, Aethlon ADAPT™ therapies can be implemented for use within the global infrastructure of dialysis machines and CRRT systems already located in hospitals and clinics. As Aethlon advances its current pipeline of therapies toward market, the company will seek to further leverage its ADAPT™ system to generate revenue through future government contracts or grants, and collaborations with organizations representing the pharmaceutical, biotechnology and medical device industry. The Aethlon award from DARPA is a fixed price five-year contract valued at $6,794,389 with year one revenues of approximately $2 million.
Aethlon Medical Reports Undetectable Hepatitis C Virus (HCV) in Genotype 1, Genotype 3, and Genotype 5 Patients Treated with Hemopurifier® Therapy
Aethlon Medical, Inc. (AEMD.OB), the pioneer in developing selective therapeutic filtration devices to address infectious disease, cancer and other life-threatening conditions, reported today that the presence of Hepatitis C virus (HCV) is currently undetectable in all infected patients that have been treated with the Aethlon Hemopurifier® in combination with peginterferon+ribavirin (PR) drug therapy and monitored for at least ninety days.
In a study conducted at the Medanta Medicity Institute (Medicity), HCV-infected individuals were enrolled to receive up to three, six-hour Hemopurifier® treatments during the first three days of PR drug therapy. The Medicity is a $360 million multi-specialty medical institute established to be a premier center for medical tourism in India. The Aethlon Hemopurifier® is a first-in-class medical device that selectively targets the rapid clearance of HCV from the entire circulatory system to improve benefit, dose, duration and tolerability of drug therapies.
In the Medicity study, Aethlon reported that Hemopurifier® therapy has been well tolerated and without device-related adverse events in nine treated patients. Of these nine patients, six patients were infected with HCV genotype-1; two patients were infected with HCV genotype-3; and one patient was infected with HCV genotype-5. Of the nine reported patients, seven have been monitored for more than ninety days. All seven currently maintain undetectable viral load, including three patients who have been monitored for 48-weeks. Two patients initiated Hemopurifier® therapy on April 18th and April 30th, and therefore have not yet been monitored for extended viral load suppression.
The Immediate Impact of Hemopurifier® Therapy
In addition to demonstrating safety and early efficacy against multiple HCV genotypes, a clinical objective of the Medicity study was to evaluate whether the Hemopurifier® could accelerate HCV eradication to levels associated with treated patients who achieve the highest rate of viral cure, including individuals that previously failed or relapsed PR drug regimens. In the study, Aethlon observed that viral load depletion during the Hemopurifier® + PR drug therapy phase was greatest in hard-to-treat genotype-1 patients with high viral load. In one treated patient, baseline HCV RNA dropped from 5,800,000 IU/ml to 1,840 IU/ml when measured after the third day of Hemopurifier® + PR therapy, representing a 3.49 log or 99.96% reduction of viral load. In another patient, baseline HCV RNA dropped from 8,760,000 IU/ml to 4,665 IU/ml when measured on day-3, representing a 3.27 log or 99.96% reduction. By contrast, a moderate viral load Hemopurifier® patient with baseline HCV RNA of 1,340,000 IU/ml dropped to 54,900 IU/ml when measured on day-3, representing a 1.38 log or 95.9% reduction.
As a point of reference, the landmark IDEAL Study of 3,070 HCV genotype-1 patients documented that less than 5% of treated patients will achieve a 2-log or greater reduction of viral load when measured 7-days after the start of PR drug therapy. While the IDEAL study did not report day-3 viral load, a 2-log+ reduction at day-7 is a rare occurrence defined as an immediate virologic response (IVR). The IDEAL study confirms the viral cure or sustained virologic response rate of IVR patients to be greater than 90%. Based on Medicity treatment outcomes, Hemopurifier® therapy had a significant impact in accelerating HCV eradication in high viral load patients.
Capacity of the Hemopurifier® to Capture HCV During Treatment
As the result of discussions with reviewers at the Center for Devices and Radiological Health (the FDA branch responsible for approving medical devices in the US), Aethlon recently expanded the Medicity protocol to establish a data point that would quantify the amount of HCV captured within the Hemopurifier® during a single treatment. In one analyzed cartridge, researchers recovered and measured that approximately 300 billion (300,000,000,000) copies of HCV had been captured within the Hemopurifier® during a single six-hour treatment at the Medicity. Beyond the impact of inhibiting progeny virus replication, the viral capture data point defines the contribution Hemopurifier® therapy can provide to current and future antiviral drug treatment regimens. Aethlon considers this data point to be unprecedented as the previous ability to measure the benefit of HCV therapies has primarily been limited to measuring changes in the amount of virus that can be detected in circulation.
As a result of Hemopurifier® + PR therapy outcomes, Aethlon has requested permission from the Medicity internal review board (IRB) to begin offering Hemopurifier® therapy to HCV-infected individuals that reside outside of India. The Company has also requested IRB permission to expand the treatment protocol to allow for up to seven Hemopurifier® treatments to be administered during the first week of PR drug therapy. Based on previous three-treatment protocol outcomes, Aethlon anticipates an expanded Hemopurifier® dosing schedule could establish new milestones for early undetectable viral load achievement. The Company also disclosed it will resubmit an investigational device exemption (IDE) which incorporates the Medicity data as part of its effort to gain FDA approval to initiate clinical programs in the U.S.
It is estimated that approximately 4 million Americans and 170 million people worldwide are infected with HCV, which leads to chronic liver disease or cirrhosis, and is the leading cause of liver transplant in the U.S. To date, almost 100 Hemopurifier® treatments have been administered in human studies. Previously, studies of the Hemopurifier® have been conducted at the Apollo, Fortis, and Sigma New Life hospitals in India. These studies demonstrated that Hemopurifier® therapy could safely reduce viral load in both HIV and HCV-infected dialysis patients without the administration of antiviral drug therapies. The Medicity study represents the first Hemopurifier® study in non-dialysis patients. In vitro studies have further validated the ability of the Hemopurifier® to capture a broad-spectrum of viral pathogens classified as bioterror or pandemic threats.
The Aethlon ADAPT™ System
The Aethlon ADAPT™ system is an adaptive dialysis-like affinity platform technology that provides the foundation for an entirely new class of therapeutics that target the selective clearance of harmful agents from the entire circulatory system. Therapies that evolve from the Aethlon ADAPT™ system overcome the historic limitation of extracorporeal strategies that indiscriminately adsorb or remove particles solely by molecule size. In function, our device platform allows the immobilization of single or multiple affinity drug agents in the outer-capillary space of plasma membrane technologies as a means to provide rapid real-time clearance of corresponding targets without adding drug toxicity or interaction risks to established therapies. Beyond providing a novel regulatory and commercialization pathway for affinity drug agents, Aethlon ADAPT™ therapies can be implemented for use within the global infrastructure of dialysis machines and CRRT systems already located in hospitals and clinics.
At present, the Aethlon ADAPT™ product pipeline includes the Aethlon Hemopurifier® to address infectious disease and cancer; HER2osome™ to target HER2+ breast cancer, and a medical device being developed under a $6.8 million contract with the Defense Advanced Research Projects Agency (DARPA) that would reduce the incidence of sepsis in combat-injured soldiers and civilians. As we advance our current pipeline of therapies toward market, we plan to further leverage our ADAPT™ system to generate new revenue sources through future government contracts or grants, and collaborations with organizations representing the pharmaceutical, biotechnology and medical device industry
The Aethlon Hemopurifier® is a first-in-class medical device with broad-spectrum capabilities against viral pathogens, including the human immunodeficiency virus (HIV), hepatitis C virus (HCV) and numerous bioterror and pandemic threats. Human studies have demonstrated the Hemopurifier® to be safe and provide average viral load reductions of greater than 50% during four-hour treatment periods in both HCV and HIV infected individuals without the administration of antiviral drugs. The device is currently the subject of a human clinical study in India to evaluate its ability to accelerate viral load depletion when utilized in combination with HCV standard of care drug therapy. An investigational device exemption (IDE) to initiate clinical studies in the United States is pending with The Food and Drug Administration (FDA).
In vitro studies have also documented that the Hemopurifier® captures exosomes underlying cancer, including colorectal, lymphoma, melanoma, ovarian, and breast cancer. We have expanded our exosome research programs through a collaborative agreement with the Sarcoma Oncology Center (SOC), based in Santa Monica, California. The SOC collaboration is studying the ex vivo effectiveness of the Aethlon Hemopurifier® to remove immunosuppressive exosomes from the blood of advanced-stage cancer patients. The study will evaluate 25 patients, five patients with metastatic cancer of the following types; non-small cell lung cancer, prostate cancer, melanoma, head and neck cancer, and sarcoma. Exosomes released by cancers have emerged to become an important therapeutic target in cancer care, as they are implicated in cancer survival, growth, and metastasis. Researchers have also identified that cancer-released exosomes assist tumors in evading the response of the immune system.
In design, our Hemopurifier® is a selective filtration device containing affinity agents that tightly bind to high-mannose structures unique to the surface of exosomes produced by cancer and glycoproteins residing on the envelope of viruses. These agents are immobilized around approximately 2800 porous hollow fibers that run the interior length of our device. The resulting design provides us the novel ability to separate both exosome and viral targets away from blood cells so they can then be selectively and permanently removed from the circulatory system. In application, blood circulation is established into the Hemopurifier® via a catheter or other blood access device. Once blood flow has been established, treatment benefit is immediate as the entire circulatory system can pass through the Hemopurifier® in as little as 15 min.
Scientific articles classify the Hemopurifier to be both an immunotherapy and fusion inhibitor treatment. The Food And Drug Administration (FDA) has indicated that the Hemopurifier will be treated as a Class III Medical Device in U.S. regulatory submissions. Pre-clinical human blood studies have documented the effectiveness of the Hemopurifier in capturing HIV (The AIDS Virus), HCV (Hepatitis-C), and Orthopox Viruses related to human Smallpox. The mechanism of capture has been shown to be via the polysaccharide chains that reside on the surface glycoproteins of envelope viruses. Since the polysaccharide portions of the viral glycoproteins are attached via normal host cell (functions not under control of the virus), they are highly invariant. Moreover, the high abundance of polysaccharides allows viruses to escape immune surveillance. Thus, while many viral proteins are highly variable in their primary structure, the polysaccharide chains are nearly invariant, allowing for the capture of all strains and clades of many viruses. In fact, lectin derived affinity agents immobilized within the Hemopurifier have been shown to inhibit the growth of all tested strains of HIV and can capture of inhibit the growth of other envelope viruses including SIV, FIV, HCV, Measles, Mumps, Influenza, Ebola, Marburg, and Orthopox viruses. Recent studies indicate that the Hemopurifier affinity agent is also able to capture Dengue hemorrhagic fever virus. In conclusion, the Hemopurifier has expansive therapeutic capabilities that address: global pandemics (HIV-AIDS); chronic infectious diseases (Hepatitis-C); naturally evolving pathogens; and pathogens weaponized for bioterrorism attacks against U.S. military and civilian populations.
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HER2osome™ provides a therapeutic strategy to maximize the ability of the immune system and established drug therapies to combat HER2+ breast cancer, which is characterized by aggressive growth and poor prognosis resulting from the over-expression of HER2 protein. HER2osome™ is a novel medical device, whose goal is to inhibit HER2+ breast cancer progression by reducing the circulatory presence of HER2 protein and tumor-secreted exosomes that contribute to the development and progression of breast cancer. Research publications indicate that breast cancer exosomes suppress the immune response, stimulate angiogenesis, contribute to the spread of metastasis, and inhibit the therapeutic benefit of Herceptin® (trastuzumab), a leading monoclonal antibody treatment against the HER2+ breast cancer. As an adjunct therapeutic candidate, HER2osome™ offers to fill an unmet medical need and enhance the benefit of Herceptin® and standard of care chemotherapies without adding drug toxicity or interaction risks.
HER2osome™ leverages our Aethlon ADAPT™ system to allow the immobilization of a HER2 antibody and an exosome targeted affinity agent to provide a mechanism to clear both targets from the circulatory system of HER2+ breast cancer patients. Like all Aethlon ADAPT™ derived therapies, HER2osome™ will operate dialysate free, will not require replacement fluids, and can be utilized on dialysis machines or CRRT systems already located in hospitals and clinics worldwide.
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ELLSA™ Exosome Assay
To support our therapeutic advances to eliminate the presence of deleterious exosomes from circulation, our researchers needed to create a diagnostic tool that would provide greater detection sensitivity than other products available in the marketplace. The result was ELLSA™, an enzyme-linked lectin-specific assay that has demonstrated the ability to identify and quantify the presence of exosomes underlying human immunodeficiency virus (HIV), tuberculosis (TB), and all forms of cancer tested to date. As our focus is directed towards advancing the pipeline of Aethlon ADAPT™ system therapies, we plan to license or sell this technology to an organization already established in the research diagnostics field.
Highlights of the Hemopurifier®
- Multi-patented first-in-class medical device to selectively capture viruses and immunosuppressive toxins from the entire circulatory system
- Preserves immune cells needed to combat cancer and viral infections
- Inhibits viral replication by clearing viruses prior to cell and organ infection
- Provides expansive treatment pipeline into both cancer and infectious disease
- Establishes first therapeutic strategy to address the immunosuppression caused by cancer
- Safety of the device has been demonstrated in human studies
- Significant reduction of viral load demonstrated in both Hepatitis-C virus (HCV) and Human Immunodeficiency Virus (HIV) infected patients
- Demonstrated improved immune function of HIV patient clinically defined with AIDS
- Near-term commercialization strategy established in India
- Investigational device exemption (IDE) on file with FDA
- GMP manufacturing has been established
- Positioned as an adjunct to accelerate the benefit of HCV drug regimens
- Provides candidate treatment solution for drug resistant HIV/AIDS patients
- Leading broad-spectrum countermeasure against bioterror and pandemic threats
- Treatment mechanism is being leveraged to create high-sensitivity diagnostic and biomarker discovery productsutes.
Exosome Sciences, Inc. (EXSCI), a wholly owned subsidiary of Aethlon Medical, Inc., creates diagnostic tools to detect and quantify the presence of exosomes in blood and other fluids. Our lead product, the Enzyme Linked Lectin Specific Assay (ELLSA) has been validated to identify the presence of exosomes underlying the human immunodeficiency virus (HIV), tuberculosis (TB), and various forms of cancer, including ovarian, melanoma, breast, lymphoma, and colorectal. Headlines
9/26/12 - Aethlon Medical Announces the Appointment of Dr. Stephen Z. Fadem to its Extracorporeal Science Advisory Board
9/25/12 - Aethlon Medical To Present at the Exosomes and Microvesicles 2012 Conference
9/11/12 - Aethlon Medical Discloses MD Anderson Cancer Center Presentation
9/10/12 - ThisweekinMedIT.tv features the Aethlon Medical Hemopurifier
8/23/12 - Aethlon Medical Discusses Therapeutic Device Strategies to Address Cancer, Hepatitis-C and Sepsis with the Wall Street Transcript 7/21/12 - Aethlon Medical Announces Renewal of DARPA Dialysis-Like Therapeutics Contract
7/9/12 - Aethlon Medical Announces Expanded Access to Hemopurifier® Therapy For Individuals Infected with Hepatitis C Virus (HCV) 7/31/12 - Aethlon Medical Reports Undetectable Hepatitis C Virus (HCV) Seven Days After Initiation of Hemopurifier® Therapy in Genotype-1 Patients 7/27/12 - Aethlon Medical (AEMD) Note: Cancer Treatment Publication Authored by Aethlon Medical Researchers Now Available 7/19/12 - Aethlon Medical Announces Notice of Allowance of U.S. Patent Application Covering a Medical Device to Remove Microvesicular Particles, Including Exosomes 4/24/12 - Aethlon Medical Note: An Unprecedented Data Point, The Single-Treatment Capture of Hepatitis C Virus (HCV) by the Aethlon Hemopurifier®
1/12/12 - Aethlon Medical Establishes Sepsis & Inflammation Scientific Advisory Board 10/3/2011 - Aethlon Medical Receives Government Contract Award from DARP 9/27/2011 - "A Medical Device Strategy To Inhibit HER2+ Breast Cancer Progression" Released by Aethlon Medical, Inc.
9/21/2011 - Aethlon Medical Introduces HER2osome™, A Novel Therapeutic Device Strategy to Address Breast Cancer 8/24/2011 - Aethlon Medical Announces Sarcoma, Lung Cancer, Prostate Cancer, Metastatic Melanoma, and Head and Neck Cancer Studies 6/02/2011- http://aethlonmedical.investorroom.com/index.php?s=43&item=88 -Aethlon Medical President Rodney S. Kenley to Present at the 20th International Vicenza Course on Hemodialysis and CKD
5/19/2011 - http://finance.yahoo.com/news/Aethlon-Medical-Introduces-prnews-1372058460.html?x=0&.v=1 -introduction of the ADAPT system.
Biotech Showcase™ 2012
http://aethlonmedical.investorroom.com/index.php?s=19 RedChip Small-Cap Equities Virtual Conference VII http://aethlonmedical.investorroom.com/index.php?s=19
20th International Vicenza Course of Hemodialysis and Chronic Kidney Disease
ICNNfn Interview with the CEO, James Joyce
Scientific Advisory Board
Extracorporeal Therapy Advisory Board Gregory T. A. Kovacs, M.D., Ph.D.
John A. Kellum, M.D.
Nathan W. Levin, M.D.
Claudio Ronco, M.D.
David M. Ward, M.D.
Sepsis & Inflammation Advisory Board
Irshad H. Chaudry, Ph.D.
Larry D. Cowgill, D.V.M., Ph.D.
Charles J. Fisher, Jr., M.D.
Geert Schmid-Schönbein, Ph.D.
Irshad H. Chaudry, Ph.D.
Dr. Chaudry is the Editor-in-Chief of the journal SHOCK®, a leading research publication that reviews novel therapeutic advances to address shock, trauma, sepsis, inflammation, ischemia, and related pathobiological states, with particular emphasis on the biologic mechanisms that determine the response to such injury. Dr. Chaudry received a B.S. as well as a M.S. with honors from Sind University, and a Ph.D. from Monash University, Australia. After his postdoctoral training atToronto University, Canada, he was appointed Instructor and subsequently an Assistant Professor at the Jewish Hospital and Washington University School of Medicine. He then moved to Yale University as an Associate Professor and subsequently became a Professor. He moved to Michigan State University in 1986 as Professor and Director of Research and in 1996 became the Director of the Center for Surgical Research at Brown University. In 2000, he became the Director of the Center for Surgical Research at the University of Alabama at Birmingham, and the Vice Chairman of the Department of Surgery. He has over 500 publications to his credit and is a recipient of the NIH MERIT award.
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Larry D. Cowgill, D.V.M., Ph.D.
Dr. Cowgill received his DVM degree from the University of California at Davis and completed his internship and residency training at the University of Pennsylvania. He was a National Institutes of Health Special Research Fellow at the Renal and Electrolyte Section of the University of Pennsylvania School of Medicine and earned a PhD in Comparative Medical Sciences. He is Board Certified in Small Animal Internal Medicine and is Associate Dean for Southern California Clinical Programs, Co-Director of the UC Veterinary Medical Center-San Diego (UCVMC-SD), and Professor in the Department of Medicine and Epidemiology. He oversees the Clinical Nephrology programs and the Companion Animal Hemodialysis Units at the Veterinary Medical Teaching Hospital at Davis and the UCVMC-SD. Dr. Cowgill has more than 35 years of experience in veterinary internal medicine, nephrology, and teaching and has trained many of the leading veterinary nephrologists throughout the world. He is a pioneer in the application of hemodialysis in companion and remains a leading authority in the development of blood purification therapies for renal diseases in animals and people. Back to Top
Charles J. Fisher, Jr., M.D.
Dr. Fisher, founder & CEO of Margaux Biologics, Inc., is a physician scientist with a distinguished career in both academia and industry spanning over 30 years. Prior to joining industry, Dr. Fisher served as Professor and Head of Critical Care Medicine at The Cleveland Clinic Foundation, and has held professor, division chief and director positions at the University of California at Davis Medical Center, Case Western Reserve University and The Cleveland Clinic Foundation. His research in sepsis, host defense and endothelial dysfunction led to his assisting in the founding of Incyte, and his later recruitment to Eli Lilly & Co, where he led the Xigris (activated Protein C) Global Product Team and successfully registered the first drug approved for the treatment of sepsis. He was recruited to Abbott Laboratories as Vice President for Global Pharmaceutical Development and, among other accomplishments, led the registration of Humira (first fully humanized anti-TNF mab). Other medical firsts include his contributions to the development of, and later approval of, sTNF:fc (Enbrel, 1st soluble anti-TNF tx) and IL-1ra (Kinneret, 1st anti-IL-1 tx). Dr. Fisher has numerous patents and publications to his credit. Prior to founding Margaux Biologics, he was Chief Medical Officer and Executive Vice President of Cardiome Pharma Corp. where he led the team that invented, developed, registered and sold to Merck ($800M) vernakalant, a novel, first in class, multi-ion channel drug for atrial fibrillation (Brinavess).
Additionally, Dr. Fisher is a decorated, multi tour combat veteran, with extensive military experience in special operations. He is a Life Member of the Special Operations Medical Association (SOMA), has served as a member of the Defense Science Research Council and on DARPA panels, including one focused on universal host defense. His unique background of direct patient care, basic and clinical research, on the ground combat experience, and leadership at all levels, has led to an exemplary track record of building teams, delivering results, medical firsts and saving lives.
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Gregory T.A. Kovacs, M.D., Ph.D.
Dr. Kovacs is a Professor of Electrical Engineering at Stanford University with a courtesy appointment in the Department of Medicine. He received a BASc degree in Electrical Engineering from the University of British Columbia, an MS degree in Bioengineering from the University of California, Berkeley, and a PhD and an MD degree from Stanford University. Dr. Kovacs is the Director of Medical Device Technologies for the Astrobionics Program at the NASA Ames Research Center, and Principal Investigator for the NASA/Stanford National Center for Space Biological Technologies. This Center is charged with developing advanced medical devices to enable extended human spaceflight and instrumentation/payloads for biological experiments. Dr. Kovacs also has extensive industry experience including co-founding and providing technical guidance for several companies, including Cepheid in Sunnyvale, CA, supplier of advanced instrumentation for clinical and research nucleic acid diagnostics. Through Northrup Grumman, Cepheid supplies the automated biothreat detection systems in use by the United States Postal Service. He is a long-standing member of the Defense Sciences Research Council (DARPA), and has served as Associate Chair and Chairman. In this capacity, he has led or co-led studies on a variety of topics from chemical and biological agent detection and decontamination, miniaturized biological instrumentation, jungle warfare technologies, and many others. Between 2008 and 2011, Dr. Kovacs was on leave from Stanford University to serve as director of the Microsystems Technology Office at DARPA.
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John A. Kellum, M.D. Dr. Kellum is a tenured professor of Critical Care Medicine at the University of Pittsburgh. He is a clinician scientist whose research interests span various aspects of Critical Care Medicine, but center in critical care nephrology (including acid-base, and renal replacement therapy), sepsis and multi-organ failure (including blood purification), and clinical epidemiology. His research has received continuous funding from the National Institutes of Health since 2001 and he has active funding from multiple different NIH Institutes. Dr. Kellum has authored more than 300 publications and has also edited several major textbooks including Critical Care Nephrology 2nd Edition (WB Saunders), and Stewart's Textbook of Acid-Base, 2nd Edition (www.acidbase.org). He has won several teaching awards, lectures widely, and has given more than 300 seminars and invited lectures related to his research. Dr. Kellum has been involved in the development of several clinical practice guidelines. He is a founding member and past president of the Acute Dialysis Quality Initiative (www.ADQI.net) and is co-chair of the Kidney Diseases Improving Global Outcomes (KDIGO) clinical practice guideline on acute kidney injury (www.kdigo.org). Finally Dr. Kellum is a leader in electronic research especially in critical illness and is the Director of CARe (Center for Assistance in Research using the eRecord) also at the University of Pittsburgh.
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Nathan W. Levin, M.D.
Dr. Levin is the Chairman, Research Board of the Renal Research Institute and Professor of Clinical Medicine, Albert Einstein College of Medicine. Past Medical and Research Director, Renal Research Institute (1997-2010). Dr. Levin is the Chair of the Selection Committee for the Lillian Jean Kaplan International Prize for Advancement in the Understanding of Polycystic Kidney Disease (PKD). He is the Co-Founder of Sustainable Kidney Care Foundation. Dr. Levin is an advisor to the Board of KidneyTel. He has lectured nationally and internationally on topics relating to chronic kidney disease (CKD) and hemodialysis. He is the Principal Investigator of the NIH sponsored study of Frequent Dialysis. Dr. Levin is currently an adjunct Professor of Medicine at the School of Medicine, The University of North Carolina at Chapel Hill. He is the Honorary Chair, Peking University, in Beijing, China. Dr. Levin contributes to the global CKD community in a variety of functions.
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Claudio Ronco, M.D.
Dr. Ronco is Director of the Department of Nephrology at St. Bortolo Hospital in Vicenza. He is a member of the council of several scientific societies and is Editor in Chief of the International Journal of Artificial Organs. He has received numerous awards and honors, including the International Medal of Excellence from the National Kidney Foundation (NKF) and honorary membership of the Spanish Society of Nephrology (SSN). Dr. Ronco has organized several congresses and meetings in the area of nephrology and intensive care and is a member of several advisory groups for clinical trials and dialysis research. He has co-authored over 650 papers, 36 book chapters, 45 books and seven monographic journal issues, and has delivered more than 450 lectures at international meetings and universities. In 1989, Dr. Ronco was awarded his diploma in pediatric nephrology at the University of Naples, having achieved a specialized diploma in medical nephrology at the Post-graduate School of Internal Medicine at the University of Padua in 1979. He graduated in medicine from the University of Padua, having been an intern at the Institute of Clinical Internal Medicine at the same institution.
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Geert Schmid-Schönbein, Ph.D
Dr. Schmid-Schonbein is Distinguished Professor of Bioengineering, Adjunct Professor in Medicine at the University of California, San Diego (UCSD) and director of the UCSD Microcirculation Laboratory where he and his team are studying organ injury mechanisms, apoptosis in hypertension, and triggers for inflammation in the blood circulation. Dr. Schmid-Schonbein earned his Ph.D. in bioengineering from UCSD in 1976. After a three-year post-doctoral fellowship at Columbia University, he returned to UCSD in 1979 as an assistant professor. Some of Dr. Schmid-Schonbein's early research discoveries involved the behavior of infection-fighting white blood cells. Using engineering techniques, he made the first determination of the force with which white blood cells adhere to the walls of blood vessels as part of the initial process of inflammation. Later, Dr. Schmid-Schonbein concluded that the survival of an acutely ill patient can hinge on the degree to which white blood cells are activated. Recently his group discovered a mechanism that leads to activation of white blood cells, which is due to digestive enzymes and may cause cardiovascular disease. Among his many distinctions, Dr. Schmid-Schonbein is a member of the National Academy of Engineering and a fellow of the American Heart Association. He is a founding fellow of the American Institute for Medical and Biological Engineering, and winner of the Melville Medal from the American Society of Mechanical Engineering.
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David M. Ward, M.D.
Dr. Ward trained in nephrology in Scotland and did a second fellowship in renal immunopathology at Scripps Research Foundation. Since 1977 he has been a member of the Division of Nephrology at UCSD. He directed the dialysis unit and clinical nephrology program at UCSD for 19 years, and has directed the therapeutic apheresis program for the last 22 years. At different times he has served the UCSD Medical School as Assistant Dean for Clinical Affairs, Chief of Staff of the Hospital, and Chairman of the UCSD Medical Group. Special interests include immunological diseases, glomerular diseases, transplantation medicine, apheresis medicine, hemodialysis technology, innovative extracorporeal blood circuits, and general clinical nephrology. He practices, publishes and teaches in these areas, including authoring chapters in standard textbooks such as "Rheumatology" and "Clinical Dialysis".
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