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), SeattleTacoma 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 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 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.
"Learning is experience. Everything else is just
information." - Albert Einstein.
AIBMR
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, 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, PhD, N.D. - Research Associate, AIBMR Life Sciences
PhD, 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 L5178Y 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
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
AIBMR
Providing A Regulatory Compliant
Science-Driven Paradigm
to the
Nutraceutical Industry
for the 21st Century
AIBMR