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Scientific Advisory Board
Stephen Ash Aly El-Banayosy Paul Coussens Joerg Gerlach Michael Ott Zorina Pitkin
Stephen R. Ash, MD, FACP: Hemocleanse, Inc. & Ash Access Technology, Inc.Dr. Stephen R. Ash is co-founder, Chairman of the Board of Directors and the Director, Research and Development of HemoCleanse since its inception and holds the same positions with Ash Access Technology, Inc., a HemoCleanse spin-off.
Since 1975 he has been a practicing physician in Internal Medicine and Nephrology at Clarian-Arnett Health, Lafayette, Indiana. Credited with implementing dialysis in the community, he is Director of Dialysis at Wellbound, Inc. of Lafayette. He is also an adjunct Associate Professor of Comparative Medicine at the Department of Veterinary Medicine, Purdue University, and a Clinical Associate Professor at the Indiana University School of Medicine.
Dr. Ash is the author of over 30 U.S. patents, over 100 publications and 15 text book chapters in the areas of hemodialysis, peritoneal dialysis, vascular access devices, extracorporeal medical devices, computerized medical charting, and sorbent chemicals. He is Past-President of the American Society for Artificial Internal Organs (ASAIO) and a Founding Member of the American Society for Diagnostic and Interventional Nephrology (ASDIN).
Aly El-Banayosy, MD: Heart and Diabetes Center NRW, Bad Oeynhausen, Germany
Dr. Aly El-Banayosy, MD, is a distinguished, internationally recognized authority in artificial organ support. With more than 20 years of clinical expertise of managing patients with cutting-edge circulatory support systems, his research focus is mechanical circulatory support, cell therapy and liver replacement therapy.
He heads the world's most active Ventricular Assist Device program at the Heart and Diabetes Center North Rhine-Westphalia in Bad Oeynhausen, Germany where he is also the Director of the Intensive Care Unit for Thoracic and Cardiovascular Surgery. The Heart and Diabetes Center North Rhine-Westphalia in Bad Oeynhausen, Germany, is a world-leading institution in the fields of cardiac, circulatory and metabolic diseases.
Dr. Banayosy is a widely-published clinical researcher and investigator of more than 20 clinical trials in the field of heart, liver and kidney failure. Among his numerous publications and lectures he also published on the first use of the molecular adsorbent recirculating system technique on patients with hypoxic liver failure after cardiogenic shock.
Paul M. Coussens, Ph.D.:
Michigan State University, Department of Animal Science
Dr. Paul M. Coussens currently serves as Director of the Center for Animal Functional Genomics and the Molecular Pathogenesis laboratory at Michigan State University (MSU). The Molecular Pathogenesis Laboratory is dedicated to understanding the interactions between bacterial and viral pathogens and the host that lead to disease. Current pathogens of focus are M. paratuberculosis or Johne's disease in cattle and the closely related M. avium.
In 1999, Dr. Coussens assumed a leadership role as Director of the MSU Center for Animal Functional Genomics to develop cDNA and oligonucleotide microarray facilities dedicated to physiology, immunology, nutrition, welfare and growth in livestock, companion, and wildlife animal species. In 1987 he joined in the Animal Science Department at Michigan State University, and in 1995, Dr. Coussens founded a biotechnology company focused on development of novel veterinary vaccines, diagnostics, and vaccine production systems, where he served as Chief Technology Officer.
Dr. Coussens has published more than 70 peer-reviewed research articles, book chapters, and symposia papers, presented more than 150 abstracts and invited talks, and authored 12 U.S. patents as well as several international patents.
Joerg C. Gerlach, MD, Ph.D.: University of Pittsburgh, McGowan Institute for Regenerative Medicine
Dr. Joerg C. Gerlach is an internationally renowned authority in liver function and disease, and cutting-edge artificial liver support systems. With formal European training and extensive European and American experience as a medical doctor and bioengineer, he is a specialist in experimental surgery, cell biology, hybrid organ development, bioengineering, and artificial liver devices.
At the University of Pittsburgh’s McGowan Institute for Regenerative Medicine, Dr. Gerlach currently directs the Bioreactor Group, researching stem cell utilization, hybrid organs and bioartificial liver systems. The McGowan Institute is internationally recognized for regenerative medicine research and the clinical translation of emerging therapies. The Institute serves as a single base of operations for the university's leading scientists and clinical faculty working to develop tissue engineering, cellular therapies, and artificial and biohybrid organ devices.
Dr. Gerlach is a patent-holder in the field, and a published liver expert with more than 100 research publications to his credit (90 first-authorships) in peer-reviewed scientific publications and industry journals, alongside 100-plus research abstracts, 15 book contributions.
Michael Ott, MD, Ph.D.: Hannover Medical School, Germany, Center of Internal Medicine
Dr. Michael Ott is leading the Cell and Gene Therapy group at the Center of Internal Medicine, Hannover Medical School, recognized as one of the world's leading centers for the treatment of liver diseases.
As an authority in experimental hepatology and highly-innovative liver cell transplantation procedures for human patients suffering from acute liver failure, Dr. Ott brings unique expertise to HepaLife in the areas of adult and embryonic stem cell research as well as gene expression in fetal liver and hepatic progenitor cells. Dr. Ott has also developed techniques for the isolation, characterization and cryopreservation of human hepatocytes for clinical use according to the guidelines of 'good manufacturing practice' and continues to pursue additional clinical research for the management of acute liver failure and the application of extracorporeal liver devices in patients.
Over a span of more than 15 years, Dr. Michael Ott's work in basic and clinical research in gastroenterology and hepatology has been extensively published in both abstract and peer-reviewed journals such as the Journal of Biological Chemistry, Hepatology, American Journal of Pathology, Journal of Hepatology, Differentiation, and the International Journal Developmental Biology.
Dr. Zorina Pitkin has over 18 years of experience in the field of biotechnology and is Regulatory Affairs Certified. Dr. Pitkin’s experience includes the development and implementation of delivery and quality system programs and regulatory strategies for cellular therapies and biologic/device combination products, including FDA-approved Phase II/III clinical trials, and Xenotransplantation.
Dr. Pitkin also serves as a Consultant for Tolerx, Inc., a biopharmaceutical company. She previously served as Senior Vice President of Regulatory Affairs and Quality Systems at RenaMed Biologics, a company developing a cell-based bioartificial kidney device. Prior to RenaMed, Dr. Pitkin co-founded Circe Biomedical, Inc., credited with pioneering the first cell-based device for acute liver failure of its time. Under her guidance as Vice President of Regulatory Affairs and Quality at Circe, Dr. Pitkin successfully obtained orphan drug designation and fast-track status for the company’s early bioartificial liver device technology from the FDA.
Dr. Zorina Pitkin is an internationally renowned expert and lecturer on the development and implementation of delivery and quality system programs, and regulatory strategies for biologic/device combination products, including bioartificial organs. In addition to her current appointment to the Board of Directors of the Regulatory Affairs Professional Society (RAPS), she previously served as an Advisor to the World Health Organization Committee on Xenotransplantation.
