AIBMR

AIBMR Life Sciences, Inc

Alexander G. Schauss, PhD, 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

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 co-authored by staff, along with hundreds of papers published in a wide range of peer-review journals, trade publications, and consumer magazines.

AIBMR

Library Services Division

Currently, the library’s

collection contains

over 17,000 books

and thousands of issues

among hundreds of

journals, dating back to 1962.

AIBMR

Literature Collection

Over 100,000 reference

papers are maintained

and compiled in

an electronic database,

accessible to all staff Secure files

managed by a full-time

professional library

support team.

AIBMR

Reference Natural Medicines Section

Part of the display collection of late 19th and early 20th century natural medicinal and botanical products.

1911 “Modern Materia Medica”

AIBMR

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.

AIBMR

"Learning is experience. Everything else is just

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., PhD - Senior Research Scientist, AIBMR Life Sciences

PhD, Laval University, CanadaM.S., Bordeaux University, FranceM.S., Agriculture Academy, PolandPost-Doctoral Fellowships:

(United States [UC-Davis], Canada [Nat’l Research Council], Norway [Norwegian Research Council], Costa Rica)

Grant recipient, National Science FoundationAdjunct Research Faculty, California State University-Fullerton,

Dept. Biological Sciences

Research Interests:Bioactive compounds in plants and molecular

mechanisms and health effects;Immunomodulation and natural antioxidantsDigestive physiologyStructure and function of the digestive systemOntogenetic, dietary, and phylogenetic effects on activity

and gene expression of digestive enzymes

AIBMR

Donna Kachinskas, PhD, N.D. - Research Associate, AIBMR Life Sciences

PhD, Pharmacology and Toxicology, University of California at DavisM.A., Zoology, University of California at DavisB.S., Biochemistry, University of California at DavisPost-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-DavisStaff Research Associate, California Primate Research Center, School of Medicine, Department of Internal Medicine, UC-DavisLicensed Naturopathic Physician, State of Washington

Research Interests:OncologyGeriatricsWomen’s HealthDrug and Herb Pharmacology

AIBMR

Sample of AIBMR CommissionedGLP/GCP, OECD, EC, FDA Compliant

Oral/Topical Toxicity/Safety Studies1. Analytical chemistry, characterization, method validation2. Microbiological assays3. In vitro Bioassays, antioxidant assays (TAO, ORAC, NORAC, SOD, HORAC)4. Pesticide assays (FDA/USP panels)5. Stability (inoculated/non-inoculated) and Shelf-Life studies6. In vitro Mode of Action studies7. Mitogenicity assays8. Acute 14-Day Oral Toxicity study (Limit Test)9. Subchronic 90-Day Oral Toxicity study with histopathologies10. Chronic 1-year Oral Toxicity study with histopathologies11. Bacterial Reverse Mutagenicity Test (AMES) 12. Mouse Lymphoma L5178Y Cell Mutagenicity assay13. In vitro Immortalized Human Hepatocyte assay14. Non-clinical animals efficacy studies15. Open-Label, Single or Multiple-Dose study with safety panels16. Non-clinical radiopharmacokinetic studies17. Human pharmacokinetic studies18. Controlled (single-, double-blind) phase 2 and phase 3 clinical trials

AIBMR

Research on Natural Products

PART II

ANTIOXIDANT ACTIVITY

PART I

COMPOSITION

PART IV

IMMUNEMODULATION

PART III

TOXICITY/SAFETY

Product

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).

AIBMRAIBMR’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.

AIBMR

Satisfied Clients World-Wide

“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.”

AIBMRSatisfied 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

AIBMRAIBMR Life Sciences

Providing A Regulatory Compliant

Science-Driven Paradigm

to the

Nutraceutical Industry

for the 21st Century

AIBMR