The Company’s research team includes:
- Professor Garth Nicholson, Ph.D., a Nobel Prize nominee who would not only be involved in research and development but also instrumental in FDA presentations;
- Rita Ellithorpe, M.D., a physician who is board-certified in integrative medicine, has over 3,000 patients on Detoxamin® EDTA suppositories and plans to be responsible for clinical studies as well as interfacing with the FDA;
- Ernie Pfadenhauer, MS, an accomplished pharmaceutical chemist heads new formula development, manufacturing controls analytical methodology and patent preparations
- Evan Siegel, PhD, a former FDA review chemist who has extensive experience in FDA drug submissions and has worked for several large pharmaceutical companies on FDA regulatory affairs.
- Christine McLaren, Ph.D., a statistician with specialization in blood diseases and hemochromatosis, the subject of the Company’s NIH grant proposal.
- Gordon McLaren, M.D., specialist in treating hemochromatosis and principal investigator in Phase II clinical trials for another drug used to treat hemochromatosis.
- Robert Settineri, M.S., has extensive experience in research Investigational Review Board (“IRB”) clinical approvals, pharmaceutical product development, laboratory research experience and FDA New Drug Application submissions. He also has experience in writing and filing patents. He was responsible for design and coordination of all pre-clinical and clinical studies on Detoxamin® and is a co-author of a book on detoxification and chelation suppositories.
Kendal Svedeen has 15 years experience in building and running companies and is the founder and CEO of WHP, makers of Detoxamin®. Please see “Management and Research Team—Duties, Responsibilities and Experience” for more details.
MANAGEMENT AND RESEARCH TEAM
ABR’s founding team includes entrepreneurs and managers with a track record of success and a history of successfully working together. The Company’s director, officer and research team are as follows:
|Kendal “Butch” Svedeen||President, Secretary and Director|
|Robert Settineri, M.S.||Consulting Research Director|
|Del Newman||Business Consultant and Director|
|Professor Garth Nicholson, Ph.D.||Scientific Consultant|
|Rita Ellithorpe, M.D.||Medical Advisor|
|Evan Siegel, Ph.D.||FDA Consultant|
|Christine McLaren, Ph.D.||Statistician|
|Gordon McLaren, M.D||Medical Doctor, specialist in chelation therapy|
|Jerry Silver||Business Consultant|
|Ernie Pfadenhauer, MS||Research Consultant|
Duties, Responsibilities and Experience
Kendal “Butch” Svedeen has served as the Company’s Chief Executive Officer and Chief Financial Officer and as a Director of the Company since the Company’s founding. Kendal received his Bachelor Degree in Biology/Chemistry in 1984 from the University of Washington and worked in the sales industry winning many prestigious awards including placing 9th out of 1200 students for the Tom Hawkins Sales Boot Camp.
In 1996, he and a partner started Security Services Group, Inc. “SSG”, which averaged over $3,000,000 a year in sales. As the CFO and COO for the company, Kendal managed financial departments with responsibility for Budgets, Forecasting, Payroll, Accounts Payable and Receivable. He coordinated monthly payroll functions for over 200 employees within five states. In January 2001, Kendal and a partner started World Health Products, LLC where he focused on providing scientifically proven, effective, safe and affordable therapies to obtain optimal health by researching, developing, and obtaining a patent for their proprietary product “Detoxamin”. World Health Products had sales revenue averaging $2,000,000 per year with a net profit of approximately 40%. World Health Products is currently debt free. Kendal oversees all operation, administration, marketing and research for the company.
Robert Settineri, MS has served as the Company’s Consulting Director of Research since its founding. Bob has served as President and Clinical Research Director at Sierra Clinical Research since 1987. Bob is the heart and soul of research success on the suppository chelation therapy of this project as he was responsible for design and coordination of all pre-clinical and clinical studies on Detoxamin®. He began his participation in bio-medical research at the management level in 1975. He has served as Biology Research Manager and Director of Media Development in the pharmaceutical industry and published more than 35 scientific articles in viral immunology, nutritional sciences and related fields. He was responsible in preparing FDA NDA applications that also supported registration submissions in 80 countries. The products he helped developed have had revenues over $1 billion. Bob’s responsibilities include planning, coordinating and managing both preclinical and clinical research studies. He also currently serves as Senior Vice President and a Member of the Board of Directors for the American Nutraceutical Association. For the past six years, Bob planned, designed, coordinated, managed and wrote publications on six major preclinical and clinical studies on World Health Products’ chelation suppositories. He also co-wrote Detox Outside the Box, in which over 25,000 copies have been distributed to health care professionals and consumers.
Delbert “Del” Newman, Co-Director of Business Relations. Following college and a tour of duty with the United States military, Del returned to his home state of California where he entered upon an entrepreneurial career which has essentially extended throughout his lifetime.
Newman was enticed to come to Nevada and manage what was then a relatively small casino which had been purchased by a friend of Newman’s for $90,000.00. The casino, now known as the Golden Nugget, Laughlin was managed by Newman who also carried out extensive remodeling and expansion of the property. Newman retained this position for five years after which the club was sold for $20,000,000.00. Following disposal of the Golden Nugget property Newman was hired as a consultant at different times for various casinos. Ultimately Newman was hired by Don Laughlin to serve as general manager of the Riverside Resort and Casino at Laughlin, Nevada where he has remained for 30 years, managing a very successful casino. He was one of the original investors and a director of WHP. His advice and direction helped solidify it’s success.
Jerry Silver has over 30 years of healthcare company building experience with particular emphasis on business strategy. Mr. Silver has been a financial and strategic consultant to emerging companies specializing in the technology and medical verticals. He has been involved in R&D in the medical field and has acquired patents for medical products. His experience includes national management and roll-out of medical facilities in cardiac and pulmonary rehabilitation. His medical marketing expertise includes the pioneering of cardiac rehabilitation and diagnostic imaging facilities throughout the US. Mr. Silver is a Phi Beta Kappa graduate of the University of Richmond, Virginia and a graduate of the Dickinson School of Law, now Penn State University. He is a former member of the Advisory Board of the Orange County California Inventors Forum and former member of the Orange County California Venture Forum. Mr. Silver maintains membership currently in the Pennsylvania Bar Association.
Professor Garth Nicolson, Ph.D. is a key Scientific Consultant. Early in his career, he co-authored “The Fluid Mosaic Model of the Structure of Cell Membranes,” which then and now is considered one of science’s great breakthroughs. Dr. Nicolson has over 580 scientific and medical publications, several of which are citation classics. He holds nine U.S. patents. Dr. Nicholson’s previous positions include Professor and Chairman, Department of Tumor Biology at the University of Texas MD Anderson Cancer Center, Professor of Internal Medicine and Professor of Pathology and Laboratory Medicine at the University of Texas Medical School at Houston and Professor of Comparative Pathology at Texas A & M University. He is a Colonel (Honorary) of the U.S. Army Special Forces and a U.S. Navy SEAL (Honorary) for his work on Armed Forces and veterans’ illnesses. He is also engaged in research on the role of chronic infections in a variety of chronic illnesses, such as Chronic Fatigue Syndrome, Fibromyalgia Syndrome, Rheumatoid Arthritis, Gulf War Illness and various autoimmune diseases. Dr. Nicolson was also a Nobel Prize Nominee.
Rita Ellithorpe, M.D., the Company’s Medical Advisor, has given talks and published research on chelation therapy suppositories and is an expert on fatigue and cellular medicine. In May 2003, she founded TLC in Tustin, California, where more than 3,000 patients have been using chelation suppositories, and is also TLC’s Medical Director. She received her medical degree from Chicago Medical School at the University of Health Science in North Chicago, Illinois. She holds a second doctorate in Integrative Medicine focusing on health at the cellular level. Dr. Ellithorpe is Board Certified by the American Academy of Anti-aging Medicine, and also Board-certified in Integrative Medicine. Dr. Ellithorpe has participated in several clinical studies and has served as a principal investigator. Dr. Ellithorpe is the principle author of the book Detox Outside the Box.
Evan Siegel, Ph.D. is the President and CEO of Ground Zero Pharmaceuticals, Inc. Prior to GZP Evan served as Consultant and CEO to OXO Chemie Inc., Vice President, Regulatory Affairs and Bioethics for Medical Science Systems, Inc. (now Interleukin Genetics), and Director of Regulatory Consulting Services and Principal Regulatory Scientist for Quintiles, Inc., North Carolina. Dr. Siegel has also held regulatory affairs and executive positions at Astra and Syntex, and was a Toxicology Reviewer at the US Food and Drug Administration, as well as Supervising Toxicologist and Chief of Special Services at the State of California’s Food and Drug Branch, Department of Health Services. He is the author of a number of published articles in peer-reviewed journals, the editor of books on drug development and author of chapters on nonclinical development, vaccine biotechnology, and quality assurance. He has Master and Doctor of Philosophy degrees in Virology and Molecular Biology and is an Adjunct Professor in the School of Pharmacy and Centre for Integrated Preclinical Drug Development, University of Queensland, Australia. He is a member of the Lt. Governor’s Biotechnology Advisory Committee to the California Economic Development Commission.
Christine McLaren, Ph.D., is the Professor and Vice Chair, Department of Epidemiology, University of California, Irvine. She has 25 years of experience in the design, conduct, and statistical analysis of clinical research. In 1993, she was elected a Fellow of the American Statistical Association, in part for “innovative research in biology and medicine”. She has over 130 publications, including 46 papers related to hemochromotosis, iron overload, and measures of iron status. As P.I. of a Field Center for the Hemochromatosis and Iron Overload Screening (HEIRS) Study, she supervised enrollment of 20,400 participants at the University of California, Irvine. Currently, as P.I. of the NIH R01 grant, “Iron Status: A Pathway Analysis in Multiple Ethnicities”, she leads the investigation of genetic studies of iron-related measures in African-American, Asian, Caucasian, and Hispanic participants of the HEIRS study. She has a strong track record of collaboration and publication of research findings from prior studies. From 1998 through September of 2010, she served as Director of the Biostatistics Shared Resource, Chao Family Comprehensive Cancer Center when she accepted the position of co-Leader of the Program in Cancer Prevention and Prognosis.
Gordon McLaren, M.D., is a hematologist and professor at the University of California, Irvine and the Veterans Affairs Long Beach Healthcare System, Long Beach, CA. He has been involved with research on iron metabolism for over 30 years, including investigations of iron absorption in animals, the normal regulation of intestinal iron absorption in humans, and the altered regulation in patients with hemochromatosis. He is Vice-Chair for 2011 and Chair for 2012 of the Scientific Committee on Iron and Heme for the American Society Hematology. He served as the Medical Director for the UC Irvine Field Center of the NIH-funded Hemochromatosis and Iron Overload Screening (HEIRS) Study that enrolled 20,400 participants at the University of California, Irvine. His experience with iron chelation therapies includes participation in the phase I/2, dose-escalation trial of deferasirox (Exjade) that was conducted for the treatment of iron overload in HFE-related hereditary hemochromatosis. For this research, he will assist with design of the animal studies and will serve as Medical Director for the proposed clinical trial to enroll patients, supervise clinical data monitoring, review laboratory test evaluation, conduct safety and efficacy assessment, and interpret results.
Ernest H. Pfadenhauer, MS., Ernest H. Pfadenhauer, was most recently (2010-2012) a founder and the Chief Operations Officer of Epiomed, Inc., a company developing new chemical entity treatments for diseases of the central nervous system. From 2007-2009, he held the position of VP, Pharmaceutical Development at Cenomed BioSciences, LLC, a joint venture between Abraxis Bioscience and Cenomed Inc. In this position he was responsible for new compound chemistry research, discovery and IND enabling ADME and CMC development. Prior to that, he was a consultant to the pharmaceutical industry, assisting principally in the manufacturing and controls area of new drug development, assisting in the successful approval process of several INDs and NDAs. From 1996 to 2002, Ernie was Director, Chemistry Research at NeoTherapeutics, Inc. He was responsible for GMP synthesis and formulation of CNS and oncology drugs, compilation of the Chemistry, Manufacturing and Controls sections of regulatory submissions, management of new drug pharmacokinetics, metabolism, and bioanalytical development, and had primary responsibility for biopharmaceutical areas of drug discovery. From 1987 to 1996, Mr. Pfadenhauer was employed in various positions as a research and project scientist at Baxter Healthcare Corporation, working in the clinical chemistry diagnostic, instrument design, and bioprosthetic heart valve development areas. While at Baxter, he was directly responsible for the design, manufacturing, and post-launch support of several successful commercial products. From 1970 until 1987, Mr. Pfadenhauer was employed at Newport Pharmaceuticals, where he was the Supervisor of Quality Control, and later a Senior Research Scientist. During that period, he was involved in the analytical, pharmacokinetic, and metabolism areas of new drug development. Mr. Pfadenhauer holds a B.S. and M.A. degree in Physical Chemistry from the University of California, Santa Barbara, where he graduated Cum Laude and was awarded the highest honor in the Chemistry Department.