AIBMR Life Sciences Inc Alexander G Schauss Ph

AIBMR Life Sciences, Inc Alexander G. Schauss, Ph. D, FACN President and CEO, Director, Natural and Medicinal Products Research, Puyallup, WA

AIBMR • • AIBMR Life Sciences, Inc. , is located in Puyallup, Washington, at the foothills of Mt. Rainier (14, 410 ft), yet minutes from the Port of Tacoma (sea level), Seattle. Tacoma International Airport, I-5 and I-90, and within easy access to Pacific/Asian, European and Latin American markets. In the years, 2003 -2005, AIBMR worked on projects in 42 countries, from Indonesia to China, Iceland to South Africa, Brazil to Canada.

AIBMR was founded as a research institute in the Graduate School, City University-Seattle, in the 1970’s. In 1980, AIBMR became a private institution. Through the end of 2005, AIBMR has served over 500 companies world wide. AIBMR Life Sciences headquarters in Puyallup, Washington.

AIBMR The Entrance to one of AIBMR’s Extensive Climate-controlled Libraries Near the entrance to AIBMR’s main library are found framed examples of the many books authored or coauthored by staff, along with hundreds of papers published in a wide range of peerreview journals, trade publications, and consumer magazines.

Library Services Division AIBMR Currently, the library’s collection contains over 17, 000 books and thousands of issues among hundreds of journals, dating back to 1962.

Literature Collection AIBMR Over 100, 000 reference papers are maintained and compiled in an electronic database, accessible to all staff managed by a full-time professional library support team. Secure files

Reference Natural Medicines Section AIBMR Part of the display collection of late 19 th and early 20 th century natural medicinal and botanical products. 1911 “Modern Materia Medica”

AIBMR’s library collection enables staff to: – – – – – Conduct timely cost-effective scientific literature reviews; Provide copies of literature electronically to clients; Prepare NDI submissions to FDA; Provide patent assistance to inventors, companies, and law firms (i. e. , prior art, literature); Support GRAS self-determination efforts; Assist companies in product formulation development; Prepare manuscripts and articles for publications; Assist in nonclinical and clinical trial protocol development; Prepare expert opinions.

"Learning is experience. Everything else is just AIBMR information. " - Albert Einstein. AIBMR staff brings years of experience and academic training to serve the needs of clients in disciplines and skills as diverse as: nutritional sciences allopathic/naturopathic medicine analytical chemistry psychology/sociology genetics biostatistics/epidemiology biochemistry library sciences botanical medicine translation services dietetics technical editing zoology marine sciences/oceanography Comparative and general physiology

AIBMR Anna Gawlicka, M. S. , Ph. D - Senior Research Scientist, AIBMR Life Sciences Ph. D, Laval University, Canada M. S. , Bordeaux University, France M. S. , Agriculture Academy, Poland Post-Doctoral Fellowships: (United States [UC-Davis], Canada [Nat’l Research Council], Norway [Norwegian Research Council], Costa Rica) Grant recipient, National Science Foundation Adjunct Research Faculty, California State University-Fullerton, Dept. Biological Sciences Research Interests: Bioactive compounds in plants and molecular mechanisms and health effects; Immunomodulation and natural antioxidants Digestive physiology Structure and function of the digestive system Ontogenetic, dietary, and phylogenetic effects on activity and gene expression of digestive enzymes

AIBMR Donna Kachinskas, Ph. D, N. D. - Research Associate, AIBMR Life Sciences Ph. D, Pharmacology and Toxicology, University of California at Davis M. A. , Zoology, University of California at Davis B. S. , Biochemistry, University of California at Davis Post-Doctoral Fellowships: Rowe Genetics Program, UC-Davis School of Medicine Nutritional Sciences, Department of Nutrition Sciences, UC-Berkeley Staff Research Associate, Division of Endocrinology, UC-Davis Staff Research Associate, California Primate Research Center, School of Medicine, Department of Internal Medicine, UC-Davis Licensed Naturopathic Physician, State of Washington Research Interests: Oncology Geriatrics Women’s Health Drug and Herb Pharmacology

AIBMR 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. Sample of AIBMR Commissioned GLP/GCP, OECD, EC, FDA Compliant Oral/Topical Toxicity/Safety Studies Analytical chemistry, characterization, method validation Microbiological assays In vitro Bioassays, antioxidant assays (TAO, ORAC, NORAC, SOD, HORAC) Pesticide assays (FDA/USP panels) Stability (inoculated/non-inoculated) and Shelf-Life studies In vitro Mode of Action studies Mitogenicity assays Acute 14 -Day Oral Toxicity study (Limit Test) Subchronic 90 -Day Oral Toxicity study with histopathologies Chronic 1 -year Oral Toxicity study with histopathologies Bacterial Reverse Mutagenicity Test (AMES) Mouse Lymphoma L 5178 Y Cell Mutagenicity assay In vitro Immortalized Human Hepatocyte assay Non-clinical animals efficacy studies Open-Label, Single or Multiple-Dose study with safety panels Non-clinical radiopharmacokinetic studies Human pharmacokinetic studies Controlled (single-, double-blind) phase 2 and phase 3 clinical trials

Research on Natural Products AIBMR PART IV IMMUNE MODULATION PART III TOXICITY/ SAFETY PART I Product PART II ANTIOXIDANT ACTIVITY COMPOSITION

AIBMR Domestic and Foreign Regulatory Guidance • Product registration guidance in over 25 countries • DSHEA regulatory guidance Structure/function claims (1, 000’s developed) Label/packaging compliance (first industry manual) • FTC regulatory guidance • State regulatory guidance (e. g, CA-Prop. 65) • Foreign regulatory guidance (over 45 countries)

AIBMR Recognition by Industry and the Scientific Community AIBMR Life Sciences earns Nutrition Business Journal’s 2005 “Efforts on Behalf of Industry”Award: “AIBMR has supported scientific integrity in the industry through its involvement with numerous health organizations, including the National Institutes of Health Office of Alternative Medicine Advisory Council (AMPAC); the NIH Office of Dietary Supplements (ODS); and the U. S. Pharmacopoeia Convention (USP) … for garnering high-level legislative visibility for the industry … AIBMR provides research and regulatory guidance to the nutrition industry. ” AIBMR’s Director of Natural and Medicinal Products Research, received the 2005 Linus Pauling Lecture Award from the American College for the Advancement of Medicine. AIBMR’s Director of Research receives 2003 Post-doctoral Fellowship at the National Cancer Institute (NCI), National Institutes of Health (NIH).

AIBMR’s Foundation in DSHEA Executive Staff are founders of CFH and APMA (1991; 1992) Three years of lobbying in Congress, 1992 -1994, working directly with the Congressional sponsors of DSHEA in the Senate and House.

Satisfied Clients World-Wide AIBMR “Highly recommend AIBMR Life Sciences to any company that seeks a skilled full-service nutraceutical consulting company that has consistently demonstrated a high degree of ethics combined with a remarkable range of resources and in-house expertise. ” “…. extremely ethical, very professional and superb customer service. ” “ No one in this industry has the depth and breadth of knowledge of AIBMR and it’s staff. ” “Since utilizing AIBMR’s services, our sales have gone up 40% [in 5 months]. ” “…. AIBMR has been invaluable to our growth. ” “…. AIBMR has consistently brought unique insight to help us move forward when we’ve encountered obstacles. ” “…. provided service beyond our expectation. ” “…. . helping the entire industry towards growing with dignity and professionalism. ”

AIBMR Satisfied clients … “In partnership with a major, global direct-to-consumer organization, AIBMR developed over 300 formulas, claims and warnings for dietary supplements in the US, Latin America, Europe and Asia/Pacific sometimes against almost unrealistic timelines. The adage that ‘we couldn’t have done it without you’ certainly holds true. ” Roche Consumer Health

AIBMR Life Sciences Providing A Regulatory Compliant Science-Driven Paradigm to the Nutraceutical Industry for the 21 st Century

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