PROGRAM
FOR THE
TWENTY-NINTH ANNUAL MEETING
OF THE
AMERICAN COLLEGE OF
TOXICOLOGY
NOVEMBER 9 – 12, 2008
Hilton El Conquistador
10000 North Oracle Road
Tucson, Arizona 85737
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
GENERAL INFORMATION
2) Monday Morning – John D. Graham,
Ph.D., Dean, School of Public and
Environmental
Affairs,
Indiana
University, Bloomington, IN who will talk
on “STATE OF THE SCIENCE IN
ENVIRONMENTAL TOXIOCOLOGY”;
SOCIAL ACTIVITIES
Sunday - WELCOME BUFFET –
(Pre-registration Only)
Monday - ACT LUNCHEON
- BRIDGE LABORATORIES
RECEPTION
3) Tuesday Morning – Jack H. Dean,
Ph.D., Sc.D., DABT, Fellow ATC,
Research Professor, University of
Arizona, Tucson, AZ who will talk on;
“CHALLENGES AND OPPORTUNITIES
IN DRUG DEVELOPMENT AND
SAFETY ASSESSMENT”;
Tuesday - INFORMA HEALTHCARE
POSTER RECEPTION
Wednesday - WuXi AppTec
FAREWELL RECEPTION
4) Wednesday Morning - Richard L.
Hilderbrand, Ph.D., Science Director,
US Anti-Doping Agency who will talk on
“DETERRING
AND
DETECTING
DOPING IN THE ELITE ATHLETE”.
DISTINGUISHED SERVICE AWARD
At the Annual Luncheon of the American
College of Toxicology a plenary lecture
is presented by a distinguished member
of the toxicology community. Council
voted that the lecturer would be
designated as the recipient of the
Distinguished Service Award of the
College.
The criteria for selection
include, but are not limited to, an
individual who has made outstanding
contributions to toxicology and its
relationship to the regulation of
chemicals, and the improvement of
public health.
FURST AWARD
PLENARY LECTURE SERIES
Through a generous contribution from
Dr. Arthur Furst, the American College
of Toxicology was able to institute the
Furst Award, an award of $2000 for the
best student paper presented at each
Annual Meeting of the College. We will
be presenting our Twentieth Annual
Furst Award at the Annual Luncheon
during the Twenty-Ninth Annual Meeting
in the Hilton El Conquistador, Tucson,
AZ.
This year the College is fortunate to
have four Plenary Lecturers:
ACT STUDENT TRAVEL AWARD
1) Sunday Afternoon – David Ropeik,
B.S.J., M.S.J., Instructor, Harvard
University Extension Program, Risk
Communication Consultant, Concord,
MA who will talk on “RISK-WHY OUR
FEARS DON’T MATCH THE FACTS”;
This year the College will provide travel
awards in the amount of $1000.00 to
five students attending and presenting a
poster at the Annual Meeting.
ii
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
PROGRAM
29TH ANNUAL ACT MEETING
HILTON EL CONQUISTADOR
TUCSON, ARIZONA
SUNDAY, November 9, 2008
7:00 am – 8:00 am
Turquoise Foyer
7:30 am – 5:30 pm
Continental Breakfast
Registration
Presidio Desk
12:00 pm – 5:00 pm
Exhibit Set Up
Presidio Ballroom
12:00 pm – 5:00 pm
Poster Set up
Agave/Joshua Tree
6:00 pm – 7:00 pm
GUEST LECTURER
Turquoise I & II
7:15 pm – 9:30 pm
WELCOME BUFFET – TICKETS ONLY
Last Territory
Continuing Education Course Manuals Co-Sponsored by:
AMGEN INC, Thousand Oaks, CA
8:00 am – 11:30 am
Turquoise I
COURSE #1
STUDY DIRECTOR TRAINING
Chair: Barbara J. Mounho, Ph.D., DABT, Scientific Director, Amgen Inc., Thousand
Oaks, CA
This continuing education course is intended to provide an introduction to a study
director’s responsibilities and review both regulatory- and scientific-related aspects of
toxicology studies. The course will focus on the practicalities of study director
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AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
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responsibilities for study conduct, oversight, protocols, study monitoring, and final
reports. This course will also review the evolution and scope of the GLP regulations and
what a study director should do/not do during an FDA inspection, as well as how to
manage challenges a study director can encounter in toxicology studies and how to
appropriately communicate study deviations to a sponsor. This is an excellent course
for newer study directors, but sure to be informative for the more experienced as well.
8:00 am
WELCOME AND INTRODUCTION
Barbara J. Mounho, Ph.D., DABT, Scientific Director, Amgen Inc.,
Thousand Oaks, CA
8:10 am
STUDY CONDUCT AND OVERSIGHT – STUDY DIRECTOR
RESPONSIBILITIES
Carol S. Auletta, MBA, DABT, Director, Program Management,
Huntingdon Life Sciences, East Millstone, NJ
8:45 am
STRATEGIES FOR STUDY DIRECTORS IN CHALLENGING
SITUATIONS
Suzanne R. Wolford, Ph.D., DABT, Study Director, Covance Inc.,
Madison, WI
9:20 am
WRITING AND FINALIZING STUDY REPORTS
John Curtis Kapeghian, Ph.D., DABT, President, Preclinical Safety
Associates, Reno, NV
9:55 am
Refreshment Break
10:15 am
OVERVIEW AND HISTORY OF THE GLPs
Barbara B. Randolph, MT (ASCP), MBA, Senior Auditor, RQAP(GLP),
Biotechnical Services, Inc., Mead, WA
10:50 am
CONSIDERATIONS FOR ANIMAL MODEL SELECTION IN
TOXICOLOGY STUDIES
Mark D. Walker, D.V.M., Senior Director of Research, Charles River,
Study Direction Management, Sparks, NV
______________________________________________________________________
8:00 am – 11:30 am
Turquoise II
COURSE #2
BIO-IMAGING: NEW APPROACHES FOR SAFETY ASSESSMENT AND
TOXICOLOGY
Co-Chairs: William Slikker, Jr., Ph.D., Director, NCTR/US FDA, Jefferson, AR and
David Dorman, DVM, Ph.D., Professor, North Carolina State University, Raleigh, NC
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AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
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ISSUE: The promise of real-time and noninvasive data collection over the life-time of
an animal model is now possible with the use of bio-imaging. New technologies including
Magnetic Resonance Imaging (MRI), Magnetic Resonance Spectroscopy (MRS),
MicroPET, Optical imaging, 3D-Ultrasound and Computed Tomography (CT) are
approaches available today and have demonstrated utility for safety assessment studies.
Non-invasive imaging is the ideal medium for biomarker development because the
methods can be used similarly in humans as in animals, thus minimizing the
assumptions in data interpretation and reducing uncertainty during product development
or risk assessment. Routine use of imaging approaches for safety assessment studies
has not occurred because of the lack of guidelines for application to traditional animal
models and biomarker validation. CURRENT STATUS: Imaging technologies such as
MicroPET, MRI/MRS and CT have been developed for small animals, including
nonhuman primates, rats and mice; Imaging strategies for application to toxicology and
safety assessment have been published and presented at national meetings, symposia
and workshops; and Imaging has been listed as an emerging technology to support
Critical Path approaches. NEXT STEPS AND/OR FUTURE CONSIDERATIONS:
Human diagnosis using imaging technology is rapidly outpacing the use of bio-imaging
for safety assessment and risk assessment. Because many regulatory decisions are
based on scientific evidence of in vivo animal models, it is important for scientists to
explore the occurrence and mechanisms of toxicity in animal models using the same
techniques that are used in humans. The newly developed MicroPET provides
unprecedented resolution and allows for studies in traditional animal models including
rodents and nonhuman primates. Using these techniques data can be obtained from
serial images that will provide time course, quantitative measurements and changes in
the biodistribution directly in living systems; tumor development can be followed,
nervous system lesions can be identified early and related to behavioral outcomes in the
same animals, and drug distribution can be determined. Guidelines for the application of
imaging for purposes of safety/risk assessment need to be developed and consensus
achieved on noninvasive biomarker validation. Using this knowledge, more effective
safety assessment approaches can be developed, and improved risk assessment data
can be generated.
8:00 am
INTRODUCTION
William Slikker, Jr., Ph.D., Director, NCTR/US FDA, Jefferson, AR
8:15 am
ADVANCES IN PET IMAGING TECHNOLOGY
Michael J. Borrelli, Ph.D., Professor & Director of Research, University of
Arkansas for Medical Sciences, Little Rock, AR
9:00 am
HOW MOLECULAR IMAGING IS IMPROVING SAFETY ASSESSMENT
Tomas R. Guilarte, Ph.D., Professor, Johns Hopkins Bloomberg School of
Public Health, Baltimore, MD
9:45 am
Refreshment Break
10:00 am
TRANSLATIONAL RESEARCH: THE ROLE OF ANATOMICAL AND
FUNCTIONAL IMAGING
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AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
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Ronald L. Cowan, M.D., Ph.D., Director, Psychiatric Neuroimaging
Program, Nashville, TN
10:45 am
BIO-IMAGING IN SAFETY ASSESSMENT
David Dorman, DVM, Ph.D., Professor, North Carolina State University,
Raleigh, NC
______________________________________________________________________
8:00 am – 11:30 am
Coronado Ballroom
COURSE #3
MEDICINE – COMING SOON TO A REFRIGERATOR NEAR YOU
Co-Chairs: Claire L. Kruger, Ph.D., DABT, CEO & Director of Health Sciences, Spherix
Inc., Bethesda, MD and A. Wallace Hayes, Ph.D., DABT, FATS, Visiting Scientist,
Harvard School of Public Health, Andover, MA
Food today has more than a nutritive function. Many if not most products contain claims
alerting the user to potential health benefits. What is being said, what is the science
behind these claims and what do they convey to the consumer? This Continuing
Education Course will look at selected products and the support for the claims they
make to improve health. In addition, what tools do food manufacturers have to target
and deliver more healthful products to the market? The role for nutrigenomics to make
our food supply safer and healthier will be examined.
8:00 am
INTRODUCTION
A. Wallace Hayes, Ph.D., DABT, FATS, Visiting Scientist, Harvard School
of Public Health, Andover, MA
8:15 am
HEALTH & STRUCTURE FUNCTION CLAIMS: WHAT ARE WE
REALLY TRYING TO SAY TO THE CONSUMER?
Susan Trimbo, Ph.D., Independent Consultant, Health Science
Consulting LLC, Boca Raton, FL
8:55 am
PROBIOTICS: THE CASE FOR EFFICACY
Claire L. Kruger, Ph.D., DABT, CEO & Director of Health Sciences,
Spherix Inc., Bethesda, MD
9:35 am
OBESITY AND BLOOD GLUCOSE CONTROL: WHAT IS OUT THERE
TO HELP?
Phillip Casterton, Ph.D., DABT, Manager, Cargill Good Ingredients &
Systems, Wayzata, MN
10:15 am
Refreshment Break
10:30 am
SAFETY AND EFFECTIVENESS OF LOW CARBOHYDRATE DIETS
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AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
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Carey Mathesius, M.S., Senior Research Associate – Nutritionist,
Pioneer, DuPont Agriculture & Nutrition, Johnston, IA
11:10 am
NUTRITION: CHALLENGES AND SOLUTIONS - IS THERE A ROLE
FOR NUTRIGENOMICS
Peter Weber, M.D., Ph.D., Professor of Nutrition, Director, Corporate
Scientist, Human Nutrition & Health, Kaiseraugst, Switzerland
______________________________________________________________________
8:00 am – 11:30 am
Turquoise III
COURSE #4
ANTI-CANCER DRUG DEVELOPMENT OVERVIEW: ADVANCING OUR
UNDERSTANDING OF TARGETED APPROACHES TO ANTI-CANCER
THERAPIES
Co-Chairs: Vijayapal Reddy, DVM, Ph.D., Senior Advisor, Eli Lilly and Company,
Greenfield, IN and Elaine V. Knight, Ph.D., Research Fellow, Johnson & Johnson
Pharma R&D, LLC, Raritan, NJ
In recent years, several promising capabilities and emerging technologies have resulted
in significant increase in the understanding of targeted therapeutic approaches in the
development of new anti-cancer drugs. An International Conference on Harmonization
guideline on the requirements for the pre-clinical safety assessment of anti-cancer drugs
is being developed that will assist in harmonizing regional differences in the types of
studies needed to facilitate anti-cancer drug development to which populations or life
stages may be particularly susceptible. This course will provide an overview of the
various aspects of pre-clinical, and clinical targeted anti-cancer drug development. It will
also focus on regulatory approaches for anti-cancer drug development and pre-clinical
requirements highlighting differences between cytotoxic and targeted therapies. This
course will be of interest to government, biotechnology, pharmaceutical and consultant
toxicologists as well as general toxicologists involved with various stages of anti-cancer
drug development or regulations.
8:00 am
INTRODUCTION
Elaine V. Knight, Ph.D., Research Fellow, Johnson & Johnson Pharma
R&D, LLC, Raritan, NJ
8:05 am
THERAPEUTIC ANTIBODIES FOR CANCER THERAPY: MODALITIES
AND CONSIDERATIONS FOR PRECLINICAL DEVELOPMENT
Bahija Jallal, Ph.D., Vice President, Translational Sciences & Preclinical
Oncology, MedImmune, Gaithersburg, MD
8:55 am
EXPLORING THE POTENTIAL OF PK/PD IN EARLY PHASE
ONCOLOGY DEVELOPMENT
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AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
Dinesh De Alwis, Ph.D., Research Advisor, Group Leader PK/PD,
Europe, Eli Lilly and Company, Erl Wood, UK
9:45 am
Refreshment Break
10:00 am
SAFETY EVALUATION OF ANTI-CANCER DRUGS
Vijayapal Reddy, DVM, Ph.D., Senior Research Advisor, Eli Lilly and
Company, Greenfield, IN
10:50 am
REGULATORY
APPROACHES
FOR
ANTI-CANCER
DRUG
DEVELOPMENT – PRECLINICAL REQUIREMENTS
Elaine V. Knight, Ph.D., Research Fellow, Johnson & Johnson Pharma
R&D, LLC, Raritan, NJ
______________________________________________________________________
SUNDAY AFTERNOON – 11/9/08
1:00 pm – 4:30 pm
Turquoise I
COURSE #5
STUDY MONITORING AT CROs: KEEPING YOUR SANITY AND ACHIEVING
THE BEST PRODUCT (BEST PRACTICES, PITFALLS, AND KEYS TO
EFFICIENCY)
Co-Chairs: Paul L. Roney, Ph.D., DABT, Senior Consultant Toxicology, Kendle
International, Inc., Rockville, MD and Joseph C. Tigner, Ph.D., Toxicology Consultant,
New Milford, CT
Sponsored in part by: Charles River, Wilmington, MA
With the increased emphasis on outsourcing toxicology studies to specialty Contract
Research Organizations (CRO), toxicologists are being asked to monitor studies being
conducted outside of their organizations. In this capacity, they must ensure that the
toxicology program Is conducted properly and in a cost effective manner. This presents
a particular challenge to the toxicologist because many toxicologists have no training in
managing these types of programs. This course will provide the participants with the
tools they need to succeed in this endeavor. Specifically, this course will discuss what
factors the toxicologist needs to consider when selecting a CRO including bid solicitation
and bid analysis (cheapest is not always best); the interactions between the Study
Monitor and the CRO before, during and after the study; a CRO’s Study Director’s
perspective of what makes an effective team between the Study Monitor and the Study
Director; GLP compliance in multi-site studies; and a discussion on best practices for
building the future of our science. This course is a must for any toxicologist who is
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AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
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responsible for outsourcing toxicology studies, no matter what sort of company he/she
works for.
1:00 pm
INTRODUCTION
Paul L. Roney, Ph.D., DABT, Senior Consultant Toxicology, Kendle
International, Inc., Rockville, MD
1:05 pm
SELECTING A CRO
Joseph C. Tigner, Ph.D., Toxicology Consultant, New Midford, CT
1:35 pm
AN INDUSTRY VETERAN’S GUIDE TO EFFECTIVE STUDY
MONITORING
Steven M. Snyder, President, Outsourcing Support Services, Inc.,
Noblesville, IN
2:05 pm
STUDY MONITOR: THE CRO’s FRIEND OR FOE?
Susan McPherson, M.Sc., Scientific Program Manager, Charles River
Laboratories, Senneville, Canada
2:35 pm
Refreshment Break
2:50 pm
GLP COMPLIANCE: CHALLENGES AND ISSUES IN MANAGING
MULTI-SITE STUDIES
Kate Longman, Manager, Quality Assurance Research, MPI Research,
Inc., Mattawan, MI
3:20 pm
BUILDING THE FUTURE OF TOXICOLOGY: OUR LEGACY – OUR
RESPONSIBILITY
Stephen B. Harris, Ph.D., FATS, Consultant, Stephen B. Harris Group
Consulting, San Diego, CA
3:50 pm
Q&A
______________________________________________________________________
1:00 pm – 4:30 pm
Turquoise III
COURSE #6
BONE
MARROW
AND
HEMATOLOGY
EVALUATION
INTERPRETATION IN IMMUNO-TOXICOLOGY STUDIES
AND
Co-Chairs: Robin C. Guy, MS, DABT, Robin Guy Consulting, LLC, Lake Forest, IL and
Jerry F. Hardisty, DVM, DACVP, Fellow IATP, President/Veterinary Pathologist, EPL,
Inc., Research Triangle Park, NC
Sponsored in part by: Harlan Laboratories, Inc., Indianapolis, IN
EPL, Inc., Sterling, VA
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AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
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In order to assess immunotoxicology testing strategies as well as understanding
mechanisms of toxicity there is often a need in the investigation of bone marrow. Bone
marrow is evaluated routinely on paraffin sections in toxicity studies. However, bone
marrow differentiation is a tool that is also often requested by clients to fulfill the
requirements of several guidelines (EMEA: CPMP/SWP/-1024/99; ICH3 M3, ICH S8,
etc). A deep understanding of the cell cycle as well as the relationship of changes in the
peripheral blood and reactions by the bone marrow is a need to decide to undergo these
expensive and time-consuming investigations. The topics selected will provide the basic
knowledge on bone marrow cell cycles, relationship of results in hematology data and
bone marrow differentiation as well as evaluation of bone marrow sections vs bone
marrow differentiation.
1:00 pm
INTRODUCTION
Robin C. Guy, M.S., DABT, Toxicology & GLP Consultant, Robin Guy
Consulting, LLC, Lake Forest, IL
1:05 pm
HEMATOPOIESIS: CELL LINEAGES, CYTOKINES AND COLONY
STIMULATING FACTORS
Denise Bounous, DVM, Ph.D., DACVP, Group Director, Clinical
Pathology-Drug Safety Evaluation, Bristol-Myers Squibb, Princeton, NJ
1:45 pm
HISTOPATHOLOGIC EXAMINATION OF THE HEMATOPOIECTIC
SYSTEM IN TISSUE SECTIONS
Susan A. Elmore, MS, DVM, DACVP, NTP Pathologist & Staff Scientist,
NIEHS, Research Triangle Park, NC
2:25 pm
Refreshment Break
2:40 pm
COLLECTION TECHNIQUES, EVALUATION AND INTERPRETATION
OF BONE MARROW SMEARS
Klaus Weber, Ph.D., Dr.rer.nat., Dipl.Biol., Vet.-Ing., Head of Pathology/
Diagnostics, Chief Scientific Officer, RCC Ltd., Harlan Inc., Itingen,
Switzerland
3:20 pm
RELATIONSHIP OF HEMATOLOGY PARAMETERS AND BONE
MARROW. SENSE & NON-SENSE
Klaus Weber, Ph.D., Dr.rer.nat., Dipl.Biol., Vet.-Ing., Head of Pathology/
Diagnostics, Chief Scientific Officer, RCC Ltd., Harlan Inc., Itingen,
Switzerland
4:00 pm
Q&A
______________________________________________________________________
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AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
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1:00 pm – 4:30 pm
Turquoise II
COURSE #7
BIOLOGICS 101 – PRECLINICAL TO CLINICAL TRANSITION
Co-Chairs: Hanan Ghantous, Ph.D., DABT, Pharmacology/Toxicology Supervisor, US
FDA, CDER, Silver Spring, MD and Melanie Hartsough, Ph.D., Senior Consultant,
Biologics Consulting Group, Inc., Germantown, MD
The development of biological therapeutic products (Biologics) for the diagnosis and
treatment of human diseases is a cooperative effort between biopharmaceutical
companies and regulatory agencies. Biologics used as therapeutic products include
monoclonal antibodies for human use, cytokines, enzymes, growth factors,
thrombolytics, and extracted proteins. Due to the relatively unique properties of Biologics
(e.g. large molecular size, target specificity, and immunogenicity), their safety
assessment differs from that of small molecular-sized drugs. This course will present an
introduction to Biologics (manufacturing, immunogenicity and comparability) and will
cover the types and the design of pharmacology and toxicology studies considered
scientifically appropriate to support the safe development and, ultimately, the approval of
Biologics. In addition, ICH and FDA guidance documents which define the relevance of
specific types of studies and the scientifically sound path for the development of
Biologics will be discussed.
1:00 pm
INTRODUCTION TO BIOLOGICS
Melanie Hartsough, Ph.D., Senior Consultant, Biologics Consulting
Group, Inc., Germantown, MD
1:20 pm
THE NON-CLINICAL TOXICOLOGY STRATEGY FOR BIOLOGICS:
PRINCIPLES AND PRACTICES
Marque Todd, DVM, MS, DABT, Regulatory Strategy Lead, Pfizer Inc.,
San Diego, CA
2:05 pm
APPLICATION OF SPECIALIZED TOXICITY STUDIES IN BIOLOGICS
PRODUCT DEVELOPMENT
Patricia Ryan, Ph.D., Principal Toxicologist, MedImmune, Inc.,
Gaithersburg, MD
2:50 pm
Refreshment Break
3:00 pm
A REGULATORY PERSPECTIVE ON BIOLOGICAL PRODUCTS
Hanan Ghantous, Ph.D., DABT, Pharmacology/ Toxicology Supervisor,
US FDA, CDER, DAVP, Silver Spring, MD
3:30 pm
Q&A
______________________________________________________________________
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AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
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1:00 pm – 4:30 pm
Coronado Ballroom
COURSE #8
FROM BENCH TO BEDSIDE: THE ABSOLUTE ESSENTIALS OF VACCINE
DEVELOPMENT
Chair: Robert V. House, Ph.D., President, DynPort Vaccine Company LLC, Frederick,
Maryland
This course will focus on the product development lifecycle of vaccines from
discovery/proof of concept through conduct of clinical trials. Emphasis will be placed on
the crucial regulatory considerations, the extensive safety testing required (both
preclinical and clinical), manufacturing and testing considerations specific to vaccines,
and clinical testing designs including direct demonstration of efficacy as well as
demonstrating efficacy when humans exposure is contraindicated. Common themes of
risk management and integrated regulatory strategy will be emphasized.
1:00 pm
INTRODUCTION
Robert V. House, Ph.D., President, DynPort Vaccine Company LLC,
Frederick, MD
1:10 pm
REGULATORY ASPECTS OF PRELICENSURE DEVELOPMENT OF
PREVENTIVE VACCINES
Marion F. Gruber, Ph.D., Associate Director for Regulatory Policy, US
FDA, CBER, Rockville, MD
1:55 pm
ADJUVANTS IN VACCINE DEVELOPMENT: REGULATORY
CONSIDERATIONS
Steven Kunder, Ph.D., DABT, Senior Consultant, Biologics Consulting
Group, Alexandria, VA
2:40 pm
Refreshment Break
3:00 pm
EXAMPLES OF NON-CLINICAL PROGRAMS ILLUSTRATING CASEBY-CASE APPROACHES TO THE DEVELOPMENT OF PREVENTIVE
VACCINES
Deborah L. Novicki, Ph.D., DABT, Global Head, Toxicology, Novartis
Vaccines, Cambridge, MA
3:40 pm
HOW CLINICAL TRIALS FOR VACCINES SHOULD BE CONDUCTED
Richard N. Greenberg, M.D., Professor of Medicine, University of
Kentucky School of Medicine, Lexington, KY
______________________________________________________________________
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AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
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6:00 pm GUEST SPEAKER
Turquoise I & II
Sponsored in part by: BioReliance, Rockville, MD
DAVID ROPEIK, BSJ, MSJ
Instructor, Harvard University Extension Program, Risk Communication
Consultant, Concord, MA
“RISK – WHY OUR FEARS DON’T MATCH THE FACTS”
______________________________________________________________________
7:15 PM
WELCOME BUFFET -
(Pre-Registered Only)
Last Territory
________________________________________________________________
MONDAY MORNING, 11/10/08
7:00 am – 8:00 am
Presidio Ballroom
7:30 am – 5:30 pm
Continental Breakfast
Registration
Presidio Desk
12:00 pm – 5:00 pm
ACT EXHIBITORS
Presidio Ballroom
12:00 pm – 5:00 pm
Posters
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AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
8:00 am – 8:45 am
Turquoise I & II
PLENARY LECTURE
Sponsored in part by: ExxonMobil Biomedical Sciences Inc., Annandale, NJ
JOHN D. GRAHAM, Ph.D.
Dean, School of Public and Environmental Affairs
Indiana University, Bloomington, IN
“STATE OF THE SCIENCE IN ENVIRONMENTAL
TOXICOLOGY”
______________________________________________________________________
9:00 – 12:00 -
SYMPOSIUM I
Canyon Suites I & II
ADVANCEMENT & CURRENT TRENDS IN ENVIRONMENTAL CHEMICAL
SAFETY ASSESSMENT
Co-Chairs: Richard A. Becker, Ph.D., DABT, American Chemistry Council, Arlington, VA
and Richard D. Phillips, Ph.D., DABT, Senior Science Advisor, ExxonMobil Petroleum &
Chemical, Machelen, Belgium
Sponsored in part by: American Chemistry Council, Arlington, VA
In 2007, the National Research Council issued a report “Toxicity Testing in the 21st
Century: A Vision and a Strategy”. The report describes how advances in molecular
biology, biotechnology, and related fields are paving the way for major improvements in
how health risks are evaluated for potentially toxic chemicals. These advances could
make toxicity testing quicker, less expensive, and more directly relevant to “real world”
human exposures. They could also reduce the need for animal testing by substituting
more laboratory tests based on human cells rather than laboratory animal models. The
vision is about how systems biology, bioinformatics, and rapid assay technologies can
change the way decisions are made about chemical safety by providing a better
understanding of how cellular networks or pathways in humans carry out normal
functions that are key to maintaining health.
The EPA’s National Center for
Computational Toxicology has initiated a research program called ToxCast with the
intent of improving EPA’s chemical toxicity evaluations by developing methods to
evaluate a large number of chemicals for potential toxicity and using the information to
12
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
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help prioritize testing of those chemicals for further evaluation. The National Toxicology
Program and the National Institutes of Health (NIH) Chemical Genomics Center (NCGC)
have complementary research programs designed to improve chemical toxicity
evaluations by developing high throughput screening (HTS) methods that evaluate the
impact of environmental chemicals on key toxicity pathways. These programs are
coordinating in order to leverage the capacity from these programs in realizing the NRC
vision. In addition, The American Chemistry Council through their Long-range Research
Initiative is engaged in research that is supportive of these efforts. This symposium will
review the various programs, highlight progress and discuss the practicalities that are
ahead in order to achieve real progress towards the vision.
9:00 am
INTRODUCTION
Richard A. Becker, Ph.D., DABT, American Chemistry Council,
Arlington, VA
9:15 am
TRANSFORMING TOXICITY TESTING OF ENVIRONMENTAL
CHEMICALS
David J. Dix, Ph.D., Research Biologist, US EPA, Research Triangle
Park, NC
9:40 am
EPA’s TOXCAST PROGRAM FOR PREDICTING TOXICITY AND
PRIORITIZING CHEMICALS FOR FURTHER SCREENING AND
TESTING
Keith Houck, Ph.D., Toxicologist, US EPA, Research Triangle Park, NC
10:05 am
Refreshment Break
10:20 am
ASSESSING THE EXPOSURE-DOSE-TOXICITY RELATIONSHIP
WITHIN THE EPA’s TOXCAST PROGRAM
Russell S. Thomas, Ph.D., Director of Functional Genomics, The Hamner
Institutes for Health Sciences, Research Triangle Park, NC
10:45 am
NTP’s HIGH THROUGH-PUT SCREENING INITIATIVE: MEETING THE
CHALLENGE OF 21ST CENTURY TOXICOLOGY
Raymond R. Tice, Ph.D., Acting Branch Chief, NTP Biomolecular
Screening Branch, NIEHS/NTP, Research Triangle Park, NC
11:15 am
APPLICATION OF NEW TECHNOLOGIES AND THE FUTURE OF
TOXICITY ASSESSMENT FOR THE 21ST CENTURY
James S. Bus, Ph.D., DABT, ATS, Director of External Technology, The
Dow Chemical Company, Midland, MI
11:40 am
PANEL DISCUSSION
______________________________________________________________________
13
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
9:00 – 12:00 Turquoise III
SYMPOSIUM II
NONCLINICAL SAFETY
THERAPEUTICS
ASSESSMENT
OF
RNA
–
TARGETING
Co-Chairs: Melissa Rhodes, Ph.D., DABT, Safety Assessment Project Manager,
GlaxoSmithKline, Research Triangle Park, NC and Angelique Braen, Ph.D., DABT,
Toxicologist, Hoffmann-La Roche, Inc., Nutley, NJ
As the carrier for genetic information from the nucleus to the cytoplasm, RNA is a prime
target for therapeutic intervention. Over the last two decades major advancements have
been made in harnessing the full potential of RNA- targeted therapeutics heralding an
exciting new era of gene-specific treatments. Preclinical toxicology studies have
revealed that RNA-targeting agents have a unique toxicity profile when compared to
classical small molecules and biologics and these class effects are mainly attributed to
modifications of the oligonucleotide backbone. This symposium will provide an overview
of safety profiles of the various types of RNA-targeting therapeutics [antisense
oligonucleotides (ASOs) versus siRNA] as well as highlight the challenges associated
with targeting microRNAs. ASOs and siRNAs are single and double stranded RNA
products, respectively, and by design these fundamental differences have given rise to
specific safety assessment challenges of developing each type. Targeting endogenous
microRNAs, which play a vital role in regulating gene expression, is one of the latest
RNA-based strategies to enter into development. Issues involving toxicity,
pharmacokinetics, pharmacodynamics, therapeutic delivery, and specificity will be
discussed. Finally, regulatory considerations of RNA-targeting therapeutics will be
reviewed.
9:00 am
OVERVIEW OF RNA-BASED THERAPEUTICS
Jan Losos, Ph.D., Safety Assessment Project Manager, GlaxoSmithKline,
Research Triangle Park, NC
9:40 am
INFLUENCE OF PK ON THE ACTIVITY AND TOXICITY OF
OLIGONUCLEOTIDES (FOCUS ON ANTISENSE PRODUCTS)
Richard Geary, Ph.D., Vice President, Pharmacokinetics/ Metabolism,
ISIS Pharmaceuticals, Carlsbad, CA
10:20 am
Refreshment Break
10:40 am
RNA-TARGETED THERAPIES: ISSUES IN SAFETY ASSESSMENT
Arthur A. Levin, Ph.D., DABT, Senior Consultant, Levin BioScience,
Rancho Santa Fe, CA
NON-CLINICAL REGULATORY CONSIDERATIONS OF
THERAPEUTIC OLIGONUCLEOTIDE-BASED AGENTS
Shwu-Luan Lee, Ph.D., Pharmacology Reviewer, US FDA, CDER, Silver
Spring, MD
______________________________________________________________________
11:20 am
14
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
9:00 – 12:00 -
SYMPOSIUM III
Coronado Ballroom
REGULATORY IMPLICATIONS OF DISCOVERY TOXICOLOGY
Co-Chairs: Drew Badger, Ph.D., DABT, Senior Director, Toxicology & Regulatory
Affairs, Amira Pharmaceuticals, San Diego, CA and Greg Stevens, Ph.D., Senior
Director, Pfizer Global R&D, San Diego, CA
Drug discovery and drug development have evolved into distinct entities within the
pharmaceutical industry. Drug discovery focuses on nominating new molecules that
meet pharmacology, pharmacokinetic, and early safety requirements prior to further
testing. Development is focused on further characterization of initial findings while
satisfying regulatory requirements for testing in humans and ultimately registration.
Such distinctions between discovery and development create artificial "hand-offs" from
one phase to another and in some organizations, there are even additional hand-offs
within discovery. This can have significant deleterious consequences such as loss of
institutional memory, slowing of project timelines due to team representative transitions,
lack of feedback from later phases into discovery, duplication of effort, and unrecognized
regulatory implications of discovery and investigative studies. As a discipline, toxicology
has the greatest potential for bridging discovery and development and avoiding some of
these pitfalls. The purpose of this session will be to describe the interdependencies of
toxicology applied within discovery and development, examples of where these
connections have the greatest impact, and when broken what the impacts can be. The
session will include discussions on toxicology species selection, impact of investigative
toxicology studies, submitting early safety data and investigative studies to regulatory
agencies, and a proposed paradigm for building a bridge between discovery and
development.
9:00 am
NOVEL APPROACHES TO ASSESS THE SAFETY OF MODULATING
UNPRECEDENTED TARGETS
Husam Younis, PharmD, Ph.D., Associate Director, Drug Safety R&D,
Pfizer Inc., La Jolla Laboratories, San Diego, CA
9:30 am
A PARADIGM FOR DISCOVERY AND REGULATORY TOXICOLOGY
CO-EXISTENCE
Drew Badger, Ph.D., DABT, Senior Director, Toxicology & Regulatory
Affairs, Amira Pharmaceuticals, San Diego, CA
10:00 am
Refreshment Break
10:20 am
USING EARLY METABOLISM AND PHARMACOKINETIC DATA TO
HELP DEFINE THE NONCLINICAL SAFETY DEVELOPMENT PLAN
John-Michael Sauer, Ph.D., Vice President, Head of Lead Discovery &
Optimization, Elan Pharmaceuticals, So San Francisco, CA
10:50 am
PHARMACOLOGICAL MECHANISM-BASED TOXICITY AND ANIMAL
MODELS OF HUMAN DISEASE FOR SAFETY ASSESSMENT
15
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
Greg Stevens, Ph.D., Senior Director, Pfizer Global R&D, San Diego, CA
11:20 am
INTEGRATION OF DISCOVERY PHARMACOLOGY AND
TOXICOLOGY: DO WE BRIDGE THE GAP EARLY ENOUGH
Kenneth L. Hastings, Dr.P.H., Associate Vice President, Regulatory
Policy, sanofi-aventis, Bethesda, MD
_____________________________________________________________________
12:00 pm – 2:00 pm
Turquoise I & II
ACT LUNCHEON
Sponsored in Part By:
WIL RESEARCH LABORATORIES, LLC, Ashland, OH
Welcome and Award Ceremony
A. Wallace Hayes, Ph.D., DABT, FATS, President
Lifetime Contribution Award
SHAYNE C. GAD, Ph.D., DABT, ATS
Gad Consulting Services, Cary, NC
ACT President’s Award
FURST Award
KEYNOTE SPEAKER & DISTINGUISHED SERVICE AWARDEE
RONALD W. ESTABROOK, Ph.D.
University of Texas System Ashbel Smith Emeritus Professor
The University of Texas Southwestern Medical Center, Dallas, TX
16
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
“A NAIVE BIOCHEMIST WANDERS INTO THE DEN
OF TOXICOLOGY – FROM DIOXIN TO TOBACCO”
________________________________________________________________
MONDAY AFTERNOON, 11/10/08
2:00 – 5:00 -
SYMPOSIUM IV
Coronado Suite I & II
CASE STUDIES IN BIOMARKER QUALIFICATION AND THEIR IMPACT ON
THE PHARMACEUTICAL INDUSTRY AND REGULATORY AGENCIES
Co-Chairs: William B. Mattes, Ph.D., DABT, The Critical Path Institute, Rockville, MD
and I.Y. Rosenblum, Ph.D., FATS, Rosenblum Consulting LLC, Newton, NJ
Recent progress in the qualification and application of new safety biomarkers has been
evidenced by collaborative research efforts involving the pharmaceutical industry,
universities, regulatory agencies and the Critical Path Institute. The mission to qualify
and apply new biomarkers requires a consensus process among all stakeholders.
Consortia involved in the current biomarker qualification process are focused on
accelerating the application of new biomarkers in the drug development process,
including consensus regarding the relevance of novel biomarkers for investigative
clinical application and regulatory decision-making. This new process has both shortand long-term effects on the pharmaceutical industry and regulatory agencies. This
session will examine case studies in biomarker qualification and their impact on selected
pharmaceutical companies, the FDA and the EMEA. The outcomes of these biomarker
qualifications represent not only the first steps in a transformation of how new drugs are
developed, but also in how regulatory agencies communicate with the pharmaceutical
industry for successful expansion of novel therapies.
2:00 pm
INTRODUCTION
William B. Mattes, Ph.D., DABT, The Critical Path Institute, Rockville, MD
2:05 pm
KEYNOTE ADDRESS – FILLING “POTHOLES” IN THE ROAD TO
QUALIFICATION OF BIOMARKERS
Raymond L. Woosley, M.D., Ph.D., President and CEO, The Critical Path
Institute, Tucson, AZ
2:30 pm
QUALIFICATION OF BIOMARKERS OF NEPHROTOXICITY: IMPACT
ON NOVARTIS AND MERCK
17
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
Frank Dieterle, Ph.D., Head External Affairs & Safety Biomarkers iTox,
Novartis Pharma AG, Basel, Switzerland
2:55 pm
QUALIFICATION OF BIOMARKERS OF NEPHROTOXICITY: IMPACT
ON THE US FDA
Elizabeth A. Hausner, DVM, DABT, DABVT, Senior Pharmacologist, US
FDA – CDER, Division of Cardiovascular & Renal Drug Products,
Beltsville, MD
3:20 pm
QUALIFICATION OF BIOMARKERS OF NEPHROTOXICITY: IMPACT
ON THE EMEA
Jean-Marc Vidal, M.D., Scientific Administrator, European Medicines
Agency, London, UK
3:45 pm
Refreshment Break
3:55 pm
QUALIFICATION OF BIOMARKERS OF HEPATOTOXICITY:
IMPACT ON PFIZER
Shelli Schomaker, B.A., Safety Biomarkers, Pfizer, Groton, CT
4:20 pm
REALIZING THE GENOMIC POTENTIAL THROUGH
COLLABORATION TO IMPROVE CARCINOGENICITY TESTING AND
RISK ASSESSMENT
Mark Fielden, Ph.D., DABT, Senior Scientist, Roche Palo Alto LLC, Palo
Alto, CA
4:45 pm
THE SECOND STEP IN BIOMARKER QUALIFICATION: NEW
BIOMARKERS IN THE QUALIFICATION PIPELINE
William B. Mattes, Ph.D., DABT, Director of Toxicology, The Critical Path
Institute, Rockville, MD
______________________________________________________________________
2:00 – 5:00 -
SYMPOSIUM V
Canyon Suites I & II
DRUG ABUSE LIABILITY ASSESSMENT – NONCLINICAL AND CLINICAL
METHODS
Co-Chairs: David R. Compton, Ph.D., DABT, Principal Research Investigator Toxicology, sanofi-aventis, Bridgewater, NJ and Mary-Jeanne Kallman, Ph.D., Research
Advisor, Eli Lilly & Company, Greenfield, IN
Content will include overviews of the following on drug abuse liability assessment
(DALA): a) Preclinical DALA models - strengths, utility & issues related to drug
development ; b) Update on the initial and subsequent activities related to a
18
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
proposal on DALA -related topics for potential selection as an Emerging Issue during
the annual ILSI-HESI meeting in January, 2008; c) An overview of the PhRMA/FDA
Dialogue
Session
of
Feb
20,
2008
held between
FDA
and various pharmaceutical industry representatives, including four specific case
studies presented for an open question & answer discussion session; and d) Current
FDA perspective on the Dialog Session, and an overview of the current regulatory
environment and guidances (especially relating to the tentative 2008 release of FDA
Guidance). The significance and timeliness of the issue is demonstrated by the number
of continuing education courses and scientific presentations held during 2006-2008,
the PhRMA/FDA Dialogue and HESI proposal of 2008, plus the relatively recent EU
regulations and FDA plan to tentatively release a US guidance in 2008. The issue is of
interest to all pharmaceutical companies (not just those developing CNS-targeted
therapies) and consumer healthcare, as well as academics and regulatory agencies.
2:00 pm
INTRODUCTION AND OVERVIEW OF DRUG ABUSE LIABILITY
ASSESSMENT
David R. Compton, Ph.D., DABT, Principal Research Investigator –
Toxicology, sanofi-aventis, Bridgewater, NJ
2:30 pm
PRECLINICAL DRUG ABUSE LIABILITY ASSESSMENT MODELS
S. Stevens Negus, Ph.D., Professor, Pharmacology & Toxicology,
Virginia Commonwealth University, Richmond, VA
3:00 pm
Refreshment Break
3:15 pm
UPDATE ON 2008 PRE-CLINICAL ABUSE LIABILITY ASSESSMENT
PROPOSAL TO HESI AS AN EMERGING ISSUE
Mary-Jeanne Kallman, Ph.D., Research Advisor, Eli Lilly & Company,
Greenfield, IL
3:45 pm
OVERVIEW OF 2008 PhRMA/FDA DIALOGUE SESSION ON DRUG
ABUSE ASSESSMENT
Mark Ammann, Pharm.D., Vice President Regulatory Affairs, United
BioSource Corporation, Ann Arbor, MI
4:15 pm
OVERVIEW OF THE REGULATORY ENVIRONMENT AND
GUIDANCES
Michael Klein, Ph.D., Director, Controlled Substance Staff, US FDA,
Center for Drug Evaluation and Research, Silver Spring, MD
4:45 pm
WRAP UP
______________________________________________________________________
19
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
2:00 – 5:00 -
SYMPOSIUM VI
Turquoise III
RISK ASSESSMENT OF GENOTOXIC IMPURITIES
Co-Chairs: Angélique Braen, Ph.D., DABT., Toxicologist, Hoffmann-La Roche, Inc.,
Nutley, NJ and Elmar Gocke, Ph.D., Genotoxicity Group Leader, Hoffmann-La Roche,
Inc., Basel, Switzerland
Genotoxic impurities during the drug development process have received an increase in
attention over the last few years. Although genotoxic properties can be acceptable for
some drugs depending on the clinical indication, impurities in drug substances and
products do not have beneficial effects and thus may impose a risk without benefit. This
symposium will provide an insight on the technical challenges and its impact on drug
development that come with recent regulatory requirements. In addition, case scenarios
will be presented with genotoxic impurities during drug development. Potential solutions
from an industry perspective will be presented, putting the genotoxic impurities in
perspective with the threshold of toxicological concern (TTC) concept for
pharmaceuticals. Furthermore, the staged TTC concept will be presented that proposes
an increase in the allowable daily intake at early stages of drug development without
compromising safety as shorter durations of exposure justify higher limits according to
the cumulative dose concept. Finally, an update on regulatory views with recommended
approaches as well as proposed revisions to guidances (ICH) will be presented.
2:00 pm
OVERVIEW OF GENOTOXIC IMPURITIES
Krista Dobo, Ph.D., Associate Director, Genetic Toxicology, Pfizer,
Groton, CT
2:30 pm
GENOTOXIC IMPURITIES: CASE SCENARIOS AND AN INDUSTRY
PERSPECTIVE
Elmar Gocke, Ph.D., Genotoxicity Group Leader, Hoffmann-La Roche,
Inc., Basel, Switzerland
3:00 pm
Refreshment Break
3:15 pm
RISK ASSESSMENT OF GENOTOXIC AND CARCINOGENIC
IMPURITIES: CURRENT ISSUES AND CASE STUDIES
Joel Bercu, M.P.H., Risk Assessment Toxicology, Eli Lilly and Company,
Greenfield, IN
3:45 pm
GENOTOXIC IMPURITIES: US AND EU REGULATORY
PERSPECTIVES
Timothy J. McGovern, Ph.D., Consultant, SciLucent, LLC, Herndon, VA
4:15 pm
PANEL DISCUSSION
______________________________________________________________________
20
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
5:30 pm
MEMBERS’ MEETING (Members Only)
Turquoise III
Call to Order - President, A. Wally Hayes, PhD, DABT, FATS, Harvard School of
Public Health, Boston, MA
Minutes from 2007 Annual Meeting - Secretary, Tracey Zoetis, M.S., SciLucent
LLC, Herndon, VA
Officers Reports
President - President, A. Wally Hayes, PhD, DABT, FATS, Harvard School of
Public Health, Boston, MA
President Elect - Kenneth L. Hastings, Dr.P.H., sanofi-aventis, Bethesda MD
Treasurer - Mary Ellen Cosenza, Ph.D., DABT, Amgen Inc., Thousand Oaks, CA
Committee Reports
Membership Committee – Norman N. Kim, M.S., DABT, Inotek Pharmaceuticals
Corporation, Beverly MA
Nominating Committee - Past President, Stephen B. Harris, Ph.D., FATS, Stephen
B Harris Group, San Diego, CA
Publications Committee - Editor-in-Chief, Harihara M. Mehendale, Ph.D., DABT,
FATS, The University of Louisiana at Monroe, Monroe, LA
7:00 pm - 9:00 pm -
Turquoise I & II
BRIDGE LABORATORIES RECEPTION
_______________________________________________________
TUESDAY MORNING, 11/11/08
7:00 am – 8:00 am
Presidio Ballroom
Continental Breakfast
21
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
7:30 am – 5:30 pm
Registration
Presidio Desk
12:00 pm – 5:00 pm
ACT EXHIBITORS
Presidio Ballroom
12:00 pm – 5:00 pm
Posters
8:00 am – 8:45 am
Turquoise II & III
PLENARY LECTURE
Sponsored in part by: Calvert Laboratories, Olyphant, PA
JACK H. DEAN,
Ph.D., SC.D., DABT, FELLOW ATS
Research Professor, Depts. Of Pharmacology & Pharmacology/Toxicology,
University of Arizona, Tucson, AZ and Drug Development Advisors, LLC.
Tucson, AZ
“CHALLENGES AND OPPORTUNITIES IN DRUG
DEVELOPMENT AND SAFETY ASSESSMENT”
________________________________________________________________
9:00 – 12:00 Turquoise I
SYMPOSIUM VII
THE STRAIN A MOUSE AS A MODEL FOR PULMONARY
CARCINOGENESIS AND NON-NEOPLASTIC PULMONARY DISEASE
Chair: Hans-Juergen Haussmann, Ph.D., Toxicology Consultant, Roesrath, Germany;
Co-Chair: William C. Hall, V.M.D., Ph.D., DACVP, Consulting Pathologist, Hall
Consulting, Inc., Mount Airy, MD
22
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
Sponsored in part by: Philip Morris International, Lausanne, Switzerland
Lung cancer and chronic-obstructive pulmonary disease are increasing in prevalence on
a world-wide basis, require improved prevention and treatment strategies, and are
strongly related to the inhalation of complex aerosol mixtures, such as cigarette smoke
and other environmental aerosols. Therefore, non-clinical models of human diseases are
needed to unravel the mechanisms of disease pathogenesis, and to assess the safety
and efficacy for various therapeutic modalities. The Strain A mouse has been
considered susceptible for lung cancer development, which has been linked to the
presence of ‘pulmonary adenoma susceptibility’ loci and high mutation and expression
rates for the K-ras proto-oncogene. Gene expression patterns in chemically induced lung
tumors showed parallels to those in human lung tumors. Depending on the daily dose
and exposure/post-exposure scenarios, the Strain A mouse has been shown to respond
to cigarette smoke inhalation with enhanced lung tumorigenicity and also emphysema
formation, both end points potentially being related to observed pulmonary inflammatory
effects. Lung tumorigenicity in this model can be accelerated or delayed by genetic
modulation, such as p53 mutation, or intervention with chemopreventive compounds,
such as glucocorticoids, respectively. The strengths and weaknesses of these disease
models for extrapolation to human diseases and their utility for basic research and nonclinical testing will be reviewed in this symposium.
9:00 am
INTRODUCTION TO THE SYMPOSIUM
Hans-Juergen Haussmann, Ph.D., Toxicology Consultant, Roesrath,
Germany
9:10 am
ACTIVATION STATES OF MACROPHAGES IN A/J MICE DURING
PULMONARY CARCINOGENESIS AND CHRONIC PULMONARY
INFLAMMATION
Alvin Malkinson, Ph.D., Professor, Department of Pharmaceutical
Sciences, School of Pharmacy, University of Colorado, Denver, CO
9:40 am
CHEMICALLY INDUCED MOUSE SQUAMOUS CELL CARCINOMAS
IN THE A/J MOUSE MODEL
Ming You, M.D., Ph.D., Professor, Head, Chemoprevention Program
Siteman Cancer Center, Washington University School of Medicine,
St. Louis, MO
10:10 am
Refreshment Break
10:25 am
USE OF THE STRAIN A MOUSE MODEL IN THE DEVELOPMENT OF
CHEMOPREVENTIVE AGENTS
Michael Pereira, Ph.D., Emeritus Professor, Ohio State University College
of Medicine, Columbus, OH
10:55 am
PULMONARY NEOPLASIA IN STRAIN A MICE FOLLOWING LONGTERM TOBACCO SMOKE INHALATION
Rosemarie Lichtner, Ph.D., PMI Research & Development, Philip Morris
Research Laboratories GmbH, Cologne, Germany
23
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
11:25 am
NON-NEOPLASTIC DISEASE MODELLING IN THE STRAIN A MOUSE
Terry Gordon, Ph.D., Professor of Environmental Medicine, New York
University School of Medicine, Tuxedo, NY
______________________________________________________________________
9:00 – 12:00 SYMPOSIUM VIII
Coronado Ballroom
COLLABORATIVE HESI PROGRAMS IN TOXICOGENOMICS
BIOMARKERS: RESEARCH, RESULTS AND RECOMMENDATIONS
AND
Co-Chairs: Jack H. Dean, Ph.D., SC.D., DABT, FELLOW ATS, Research Professor,
University of Arizona, Tucson, AZ and Syril Pettit, M.E.M., HESI Associate Director,
Scientific Outreach, HESI, Washington, DC
Sponsored in part by: HESI, Washington, DC
This session will feature outcomes of recent HESI activities in the fields of
toxicogenomics and biomarkers. Both toxicogenomics and biomarkers are recognized
as research areas of critical importance for chemical, pharmaceutical, and consumer
products scientists as they strive to better characterize mechanisms and markers of
toxicity. Specifically, the session will include data on renal and cardiac biomarkers,
characterization of ‘normal/baseline’ fluctuations in gene expression in experimental
animals, and outcomes of a rodent study that combined serum measures,
histopathology, and microarray data to characterize mechanisms of preclinical cardiac
toxicity. The session will also feature an overview of how HESI’s approach to
collaborative science – involving academic, industrial, and government scientists – can
bring unique perspectives and resources to addressing and reaching resolution on
complex toxicological issues.
9:00 am
INTRODUCTION
Jack H. Dean, Ph.D., SC.D., DABT, FELLOW ATS, Research Professor,
University of Arizona, Tucson, AZ
9:10 am
OVERVIEW OF HESI STRUCTURE AND COLLABORATIVE
APPROACHES
Syril Pettit, M.E.M., HESI Senior Scientific Program Manager, HESI,
Washington DC
9:40 am
A DATABASE OF CONTROL RODENT GENE EXPRESSION
Karol Thompson, Ph.D., Pharmacologist, US FDA, Silver Spring, MD
10:10 am
Refreshment Break
10:25 am
EXPLORATION OF MECHANISMS OF DOXOROBUCIN TOXICITY: A
MULTI-ENDPOINT RODENT STUDY
Hisham Hamaden, Ph.D., Amgen Inc., Thousand Oaks, CA
24
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
10:55 am
TROPONINS AS A MARKER OF CARDIAC TOXICITY
Eugene H. Herman, Ph.D., Pharmacologist, US FDA, Silver Spring, MD
11:25 am
MULTI-LAB STUDY ON SITE-SPECIFIC MARKERS OR RENAL
TOXICITY
Ernie Harpur, Ph.D., Global Associate Director, Drug Safety Evaluation,
sanofi-aventis, Northumberland, UK
______________________________________________________________________
9:00 – 12:00 Turquoise III
SYMPOSIUM IX
A PRACTICAL GUIDE TO DEVELOPING NANO-PARTICULATE PRODUCTS
Co-Chairs: David W. Hobson, Ph.D., DABT, President, LoneStar PharmTox LLC,
Boerne, TX and Patricia Frank, Ph.D., President, Patricia Frank & Associates, Inc.,
Evanston, IL
Sponsored in part by: nanoTox Inc., Austin, TX
This Symposium will focus on the practical aspects of developing products in the
nanoparticle space, including results of actual development programs, occupational
safety lessons learned and practical environmental release issues. While many
symposia have presented the potential toxicity of nanomaterials and have provided
results from toxicologic investigations directed toward theoretical aspects of
nanotechnology applications including both pharmaceutical and consumer products,
there are now approved nanopharmaceuticals from which we can derive knowledge. An
overview and summary of the state of nanoproduct development to date to include a
current and practical perspective on safety and risk management for nanoproducts will
be presented along with examples of products that have completed or are in
development.
9:00 am
PRACTICAL APPROACHES TO DEVELOPING NANOPRODUCTS
David W. Hobson, Ph.D., DABT, President, LoneStar PharmTox LLC,
Boerne, TX
9:35 am
THE CHALLENGES OF DEVELOPING INTRAVENOUSLY
ADMINISTERED MUTLI-COMPONENT NANOPHARMACEUTICALS
Mark N. Milton, Ph.D., Vice President, Nonclinical Development, Tempo
Pharmaceuticals Inc., Cambridge, MA
10:00 am
Refreshment Break
10:15 am
NANOTECHNOLOGY: PRACTICAL SAFETY AND RISK
MANAGEMENT
Lawrence M. Gibbs, MPH, CIH, Associate Vice Provost for Environmental
Health & Safety, Stanford University, Stanford, CA
25
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
10:45 am
CYT-6091: A MODEL CANCER NANOMEDICINE
Larry Tamarkin, Ph.D., President and CEO, CytImmune, Rockville, MD
11:15 am
DEVELOPMENT OF A TOPICAL NANOPARTICULATE
PHARMACEUTICAL
Patricia Frank, Ph.D., President, Patricia Frank & Associates, Inc.,
Evanston, IL
TUESDAY AFTERNOON, 11/11/08
12:00 noon – 1:15 pm
AD HOC 2009 PROGRAM PLANNING MEETING
White Dove
Open to all – sign up, in advance, at registration desk
1:30 – 5:00 Turquoise I
SYMPOSIUM X
CONSIDERATIONS
FOR
NON-CLINICAL
DEVELOPMENT IN EUROPE
DRUG
AND
BIOLOGIC
Co-Chairs: Hilary Sheevers, Ph.D., President & CEO, Aclairo PDG, Inc., Vienna, VA
and Paul L. Roney, Ph.D., DABT, Senior Consultant, Toxicology, Kendle International
Inc., Rockville MD
Sponsored in part by: Aclairo PDG., Inc., Vienna, VA
The ICH guidelines have been significant in harmonizing drug and biologic development
across the US and Europe, as well as much of the world. This session will focus on
regional differences that still exist between the US and Europe in nonclinical
development.
These differences should be considered in strategic planning,
interactions, interpretation, and in presentation to the regional regulator, FDA or EMEA.
Further complicating development plans is that as the EU has grown, greater regional
differences exist between member states in the EMEA. This session includes
experienced regulators from EMEA, as well as representatives from industry that
implement development plans and activities that succeed on both sides of the ocean.
1:30 pm
INTRODUCTION
Hilary Sheevers, Ph.D., President & CEO, Aclairo PDG, Inc., Vienna, VA
1:35 pm
THE EMEA REGULATORY PROCESS: OVERVIEW OF EUROPEAN
NON-CLINICAL DEVELOPMENT
26
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
Per Sjoberg, Ph.D., Toxicology and Regulatory Consultant, EUreda AB,
Uppsala, Sweden
2:20 pm
UNWANTED IMMUNE RESPONSES OF BIOLOGICS: FROM ADAs
TO IRRs
Harald Kropshofer, Global Coordinator Immunosafety, F. Hoffmann La
Roche Ltd., Basel, Switzerland
3:05 pm
Refreshment Break
3:25 pm
ENVIRONMENTAL ASSESSMENTS IN THE EU
Katie Barrett, Programme Director, Huntingdon Life Sciences,
Huntingdon, UK
4:05 pm
THE EMEA REGULATORY PROCESS: CURRENT FOCUS,
UPCOMING CONCERNS, AND GUIDACNE
Jean-Marc Vidal, M.D., Scientific Administrator, European Medicines
Agency, London, UK
4:45 pm
QUESTIONS & ANSWERS
______________________________________________________________________
1:30 – 5:00 SYMPOSIUM XI
Coronado Ballroom
HOST RESISTANCE ASSAYS IN IMMUNOTOXICITY TESTING
Chair:
Gary R. Burleson, Ph.D., President & CEO, BRT-Burleson Research
Technologies, Inc., Morrisville, NC
Clearance of an infectious microorganism requires all aspects of the immune system to
work together and is the ultimate measure of the health of the immune system.
Mechanistic immune functions may be included while measuring clearance and include:
cytokines, macrophage activity, natural killer (NK) cell activity, cytotoxic T lymphocyte
(CTL) activity, and specific IgM and IgG. Measurement of these immunological functions
provides an evaluation of innate immunity by measuring macrophage or NK activity, an
evaluation of cell-mediated immunity by measuring CTL activity, and an evaluation of
humoral-mediated immunity (HMI) by measuring specific IgM or IgG. Measurement of
influenza-specific IgM or IgG also provides a measurement of T-dependent antibody
response (TDAR) since influenza is a T-dependent antigen. This symposium will
provide information on strategies for host resistance testing for pharmaceuticals and
chemicals. The following host resistance models will be discussed: (1) influenza virus
host resistance model for evaluating the overall health of the immune system and its use
in developmental immunotoxicity testing (DIT), (2) S. pneumoniae pulmonary host
resistance model to evaluate innate immunity and to rank-order anti-inflammatory
therapeutic agents, (3) a systemic S. pneumoniae host resistance model to evaluate
27
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
therapeutics that affect marginal zone B (MZB) cells, and (4) MCMV host resistance
model to determine if treatment results in reactivation of latent viral infections.
1:30 pm
INTRODUCTION
Gary R. Burleson, Ph.D., President & CEO, BRT-Burleson Research
Technologies, Inc., Morrisville, NC
1:40 pm
INFLUENZA HOST RESISTANCE ASSAY TO ASSESS
DEVELOPMENT IMMUNOTOXICITY (DIT)
Rodney R. Dietert, Ph.D., Professor, Cornell University, Ithaca, NY
2:20 pm
STREPTOCOCCUS PNEUMONIAE HOST RESISTANCE MODEL TO
EVALUATE INNATE IMMUNITY
Daniel Wierda, Ph.D., Eli Lilly & Company, Greenfield, IN
3:00 pm
Refreshment Break
3:15 pm
SYSTEMIC STREPTOCOCCUS PNEUMONIAE HOST RESISTANCE
MODEL TO EVALUATE MARGINAL ZONE B (MZB) CELL
IMMUNOTOXICITY
Florence G. Burleson, Ph.D., Executive Vice President & Director
Laboratory Operations, BRT-Burleson Research Technologies, Inc.,
Morrisville, NC
3:55 pm
MCMV HOST RESISTANCE MODEL TO DETECT LATENT VIRAL
REACTIVATION IMMUNOTOXICITY
Gary R. Burleson, Ph.D., President & CEO, BRT-Burleson Research
Technologies, Inc., Morrisville, NC
4:35 pm
QUESTIONS & ANSWERS
______________________________________________________________________
1:30 – 5:00 -
SYMPOSIUM XII
Turquoise III
CLINICAL AND PATHOLOGIC CONSIDERATIONS IN OCULAR TOXICITY
STUDIES
Co-Chairs:
Jerry F. Hardisty, DVM, DACVP, Fellow IATP, President/Veterinary
Pathologist, EPL, Inc., Research Triangle Park, NC and David L. Hopper, DVM, Ph.D.,
DABT, Bioanalytical Systems, Mount Vernon, IN
Sponsored in part by: BASi, West Lafayette, IN
EPL, Inc., Sterling, VA
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AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
The eye is a special structure for which irritation or toxicity must be evaluated for
industrial chemicals, as well as any human health products that will be used in or near it.
In addition, important diseases such as glaucoma and macular degeneration are targets
for companies developing more efficacious therapies with fewer side effects. This
symposium will review the normal anatomy and variations of the eye for the most
commonly used laboratory animal species, and the clinical examination of the eye and
interpretation of the collected data. The design and execution of ocular toxicity studies
will be discussed with a final presentation on spontaneous or environmentally induced
lesions. These presentations will be of interest to attendees involved in any aspects of
testing chemicals for possible ocular irritation or toxicity, or in developing new ocular
therapeutics.
1:30 pm
OCULAR ANATOMY AND VARIATIONS IN LABORATORY ANIMALS
Richard R. Dubielzig, DVM, DACVP, Veterinary Pathologist, University of
Wisconsin, School of Veterinary Medicine, Madison, WI
2:15 pm
CLINICAL EXAMINATION OF THE EYE IN LABORATORY ANIMALS
Michael H. Brown, DVM, MS, DACVO, Veterinary Ophthalmologist,
Independent Consultant, Veterinary Referral Centre, Veterinary
Ophthalmology Services, Inc., Little Falls, NJ
3:00 pm
Refreshment Break
3:15 pm
OCULAR TOXICITY STUDIES – DOSING AND EVALUATIONS
James Wheeler, Ph.D., DABT, Toxicologist, Alcon Research Ltd., Fort
Worth, TX
4:00 pm
OCULAR PATHOLOGIC CONDITIONS AND ISSUES
James Render, DVM, Ph.D., DACVP, Research Fellow, Veterinary
Pathologist, Toxicologic Pathology, DSRD, Pfizer Global R&D,
Groton, CT
4:45 pm
WRAP UP
______________________________________________________________________
5:30 pm - 7:00 pm
Agave/Joshua Tree/Turquoise Foyer
POSTER SESSION & RECEPTION
Sponsored by: INFORMA HEALTHCARE, NY
29
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
WEDNESDAY MORNING, 11/12/08
7:00 am – 8:00 am
Presidio Ballroom
7:30 am – 3:30 pm
Continental Breakfast
Registration
Presidio Desk
8:00 am – 8:45 am
Turquoise III
PLENARY LECTURE
Sponsored in part by: MPI Research, Mattawan, MI
RICHARD L. HILDERBRAND, Ph.D.
Science Director, US Anti-Doping Agency, Colorado Springs, CO
“DETERRING AND DETECTING DOPING IN THE
ELITE ATHLETE”
______________________________________________________________________
9:00 – 12:00 Turquoise I
SYMPOSIUM XIII
FORENSIC TOXICOLOGY: RECENT ADVANCES AND CURRENT ISSUES
Co-Chairs: Mary Ellen Cosenza, Ph.D., DABT, Executive Director, Regulatory Affairs &
Safety, Amgen Inc., Thousand Oaks, CA and David Hobson, Ph.D., DABT, President,
LoneStar PharmTox LLC, Boerne, TX
Sponsored in part by: Amgen Inc., Thousand Oaks, CA
Modern forensic toxicology includes three general aspects: (1) post-mortem toxicology,
which determines the absence or presence of drugs and their metabolites in human
fluids and tissues, and evaluates their role as a determinant or contributory factor in the
30
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
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cause and manner of death; (2) human-performance toxicology, which determines the
absence or presence of drugs and chemicals in blood, breath or other appropriate
specimen(s), and evaluates their role in modifying human performance or behavior; and
(3) forensic drug testing, which determines the absence or presence of drugs and their
metabolites in specimens such as urine to demonstrate prior use or abuse. Since
toxicologists in general are becoming increasingly required to testify before regulatory
agencies or in civil matters, a basic understanding and appreciation of forensic
toxicology is valuable for most toxicologists. This session will provide an overview of
different facets of modern forensic toxicology of value and interest to experienced
toxicologists as well as those interested in the field.
9:00 am
EPO IN SPORTS, THE INS AND OUTS OF DOPING
Don Catlin, M.D., President & CEO, Anti-Doping Research Los Angeles,
CA
9:40 am
HEALTH EFFECTS OF CLANDESTINE METHAMPHETAMINE
LABORATORY EXPOSURE
Jeff L. Burgess, M.D., MPH, Director, Division of Community,
Environment & Policy, Mel & Enid Zuckerman College of Public Health,
University of Arizona, Tucson, AZ
10:20 am
Refreshment Break
10:35 am
GHB, AFTER THE RAVE
Christine Haller, M.D., Director, Clinical Safety, Amgen Inc., San
Francisco, CA
11:15 am
YOU ARE MORE THAN JUST A TOXICOLOGIST IN THE FIELD OF
POSTMORTEM TOXICOLOGY
Dan Anderson, M.S., DABC, FTS-ABFT, Supervising Criminalist II, Los
Angeles County Department of Coroner, Los Angeles, CA
______________________________________________________________________
9:00 – 12:00 SYMPOSIUM XIV
Coronado Ballroom
THE ROLE OF TOXICOLOGY IN LATE STAGE DRUG DEVELOPMENT AND
COMMERCIALIZATION
Co-Chairs: Lorrene A. Buckley, Ph.D., Senior Research Advisor, Eli Lilly and Company,
Greenfield, IN and Greg L. Finch, Ph.D., DABT. Pfizer Global R&D, Groton, CT
In the latter stages of drug development, focus is primarily on the pivotal clinical trials
which will be submitted to regulatory agencies to demonstrate the safety and efficacy of
31
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
a drug candidate. However, the toxicologist will be heavily engaged in a variety of latestage development activities including completion of the final definitive toxicology studies
(e.g., chronic non-rodent toxicity studies, rodent carcinogenicity bioassays, reproductive
and toxicology studies, and environmental assessments) and development of an
integrated assessment relating nonclinical and clinical safety. As CMC finalizes new
drug substance and especially new drug product specifications, the toxicologist must
ensure the safety of impurities and solvents, and additional qualification studies may
even be necessary. Nonclinical sections of the submission dossiers and global
language must also be written and finalized, in conjunction with Medical, CMC, and
Regulatory Team members. In the last several years, interest in patient safety in the
postmarket setting has risen to the fore, and there is concern how the industry
monitors, manages, and communicates adverse events that are captured after a drug
has gone to market. The toxicologist contributes materially to risk management plans
which are formulated prior to submission and marketing and which are developed in
partnership with global patient safety physicians. This symposium is specifically
designed for pharmaceutical toxicologists and regulatory scientists who review
nonclinical safety assessment packages for human pharmaceutical marketing
applications. The topic of how toxicology might contribute to understanding adverse
events captured postmarketing is especially timely.
9:00 am
INTRODUCTION
Lorrene A. Buckley, Ph.D., Senior Research Advisor, Eli Lilly and
Company, Greenfield, IN
9:15 am
ROLE OF THE TOXICOLOGIST IN PREPARATION OF THE
REGISTRATION DOSSIER AND REGULATORY REVIEW
Gregory L. Finch, Ph.D., DABT, Pfizer Global R&D, Groton, CT
9:45 am
NONCLINICAL TOXICOLOGY SUPPORT FOR CMC IN LATE-PHASE
DRUG DEVELOPMENT
Neil Johnson, Ph.D., FRCPath, Senior Fellow, Schering-Plough Research
Institute, Lafayette, NJ
10:15 am
Refreshment Break
10:30 am
THE ROLE OF TOXICOLOGY IN POST-MARKET SAFETY
Lorrene A. Buckley, Ph.D., Senior Research Advisor, Eli Lilly and
Company, Greenfield, IN
11:00 am
POST-MARKET SAFETY ISSUES: DEVELOPMENT OF
NONCLINICAL MODELS
Jack Uetrecht, Ph.D., M.D., Professor of Pharmacy & Medicine, Canada
Research Chair in Adverse Drug Reactions, University of Toronto, Leslie
Dan Faculty of Pharmacy, Toronto, Canada
11:30 am
Q&A
______________________________________________________________________
32
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
9:00 – 12:00 Turquoise III
SYMPOSIUM XV
TOXICOLOGIC PATHOLOGY
CENTRAL NERVOUS SYSTEM
LESIONS
OF
THE
PERIPHERAL
AND
Co-Chairs: Robin C. Guy, MS, DABT, Robin Guy Consulting, LLC, Lake Forest, IL and
Jerry F. Hardisty, DVM, DACVP, Fellow IATP, President/Veterinary Pathologist, EPL,
Inc., Research Triangle Park, NC
Sponsored in part by: EPL, Inc., Sterling, V A
Harlan Laboratories, Inc., Indianapolis, IN
In order to assess neurotoxicity in the peripheral and central nervous system, a number
of testing strategies have been developed as in-life observations in functional
observation batteries, which include a variety of clinical tests, and observations. The
understanding of the functional anatomy of the different structures and the rate and type
of spontaneous lesions is deemed to be the basis for understanding neurotoxicity. The
topics selected will provide an overview on spontaneous and induced lesions in the
peripheral and central nervous system including degenerative, inflammatory and
proliferative lesions. Additionally, an overview on adequate techniques in
neuropathology and related artifacts will be presented.
9:00 am
PERIPHERAL NERVOUS SYSTEM: NON-NEOPLASTIC
SPONTANEOUS AND INDUCED LESIONS
Georg Krinke, DVM, Ph.D., Veterinary Pathologist, Professor, Toxicologic
Pathologist, AnaPath GmbH, Oberbuchsiten, Switzerland
9:40 am
CENTRAL NERVOUS SYSTEM: NON-PROLIFERATIVE
SPONTANEOUS AND INDUCED LESIONS
Robert Sills, D.V.M., Ph.D., Group Leader, Molecular Pathology Group,
NIEHS, Research Triangle Park, NC
10:20 am
Refreshment Break
10:35 am
PROLIFERATIVE LESIONS OF THE NERVOUS SYSTEM IN
LABORATORY ANIMALS
Klaus Weber, Ph.D., Dr.rer.nat., Dipl.Biol., Vet.-Ing., Head of Pathology/
Diagnostics, Chief Scientific Officer, RCC Ltd., Harlan Inc., Itingen,
Switzerland
11:15 am
TECHNIQUES AND ARTIFACTS
Robert Garman, DVM, DACVP, Veterinary Pathologist, Consultants in
Veterinary Pathology, Inc., Murrysville, PA
______________________________________________________________________
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AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
WEDNESDAY AFTERNOON, 11/12/08
1:30 – 5:00 Turquoise I
SYMPOSIUM XVI
HOT TOPICS
Co-Chairs: Drew A. Badger, Ph.D., DABT, Senior Director, Toxicology & Regulatory
Affairs, Amira Pharmaceuticals, San Diego, CA and Alan P. Brown, Ph.D., DABT, Senior
Toxicologist, NAMSA, Northwood, OH
Sponsored in part by: SciLucent, LLC, Herndon, VA
The Hot Topics session will provide 3 distinct presentations that should have broad
interest amongst attendees at the 2008 ACT meeting. The first presentation will be given
from a clinician’s perspective describing the fascinating story behind the development of
Botox, a highly potent naturally occurring toxin. This presentation will describe how a
potent toxin has been used for a diverse array of therapeutic indications that represent
approximately half of its clinical use. The second presentation will describe the threat
that various activist and extremist organizations pose to biomedical and scientific
research, including the threat of violence and terrorism. The last presentation will be an
update on current/proposed changes to the ICH (International Conference on
Harmonization) Guidelines including S2, S6, S9, and M3.
1:30 pm
INTRODUCTION
Alan P. Brown, Ph.D., DABT, Senior Toxicologist, NAMSA,
Northwood, OH
1:40 pm
DEVELOPMENT OF BOTOX
Mitchell Brin, MD, Senior Vice-President, Global Development, Allergan,
Inc., Irvine, CA
2:25 pm
THE THREAT OF EXTREMIST GROUPS TO BIOMEDICAL
RESEARCH
John Sancenito, Vice President, Information Network Associates, Inc.
(INA, Inc.), Harrisburg, PA
3:05 pm
Refreshment Break
3:25 pm
UPDATE ON CHANGES TO THE ICH GUIDELINES
Mary Ellen Cosenza, Ph.D., DABT, Executive Director, Regulatory Affairs,
Amgen Inc., Thousand Oaks, CA
4:10 pm
Q&A
______________________________________________________________________
34
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
1:30 – 5:00 -
SYMPOSIUM XVII
Coronado Ballroom
REGIONAL ISSUES IN ENVIRONMENTAL TOXICOLOGY
Chair: A. Jay Gandolfi, Ph.D., Associate Dean, Research and Graduate Studies,
College of Pharmacy, University of Arizona, Tucson, AZ
In the arid Southwest, arsenic is an environmental concern due to its presence in
drinking water and potential exposure from dusts coming off mine tailings that are laced
with numerous metals, including arsenic. The multitude of toxic effects associated with
arsenic are being examined by University of Arizona investigators. Prenatal exposure to
arsenic has been shown to affect the development of both the heart and lungs, resulting
in physiological and pathological effects later in life. The mechanisms of these
alterations and possible therapeutics are being examined. Arsenic exposure produces
reactive oxygen species causing tissues to mount an oxidative stress response. The
regulation of this response is critical to controlling arsenic toxicity and is a focus of
investigation. Arsenic has effects on the vascular system and with the preponderance of
diabetes in the Southwest, arsenic’s role in this disease is being explored. The
carcinogenic effects of arsenic on numerous tissues is well recognized and studies are
underway to determine if epigenetic mechanisms are involved and if arsenic metabolites
are the culprit. Lastly, the susceptibility of individuals to arsenic may be related to their
genetic profile and this is being evaluated in population studies.
1: 30 pm
ARSENIC – A CENTERPIECE OF TOXICITY STUDIES AT THE
UNIVERSITY OF ARIZONA
A. Jay Gandolfi, Ph.D., Associate Dean, Research and Graduate Studies,
University of Arizona College of Pharmacy, Tucson, AZ
1:40 pm
PULMONARY TOXICITY OF ARSENIC FOLLOWING IN UTERO AND
EARLY POSTNATAL EXPOSURES
R. Clark Lantz, Ph.D., Associate Head, Department of Cell Biology &
Anatomy, University of Arizona, Tucson, AZ
2:10 pm
EFFECT OF ARSENIC ON CARDIOVASCULAR DEVELOPMENT
Todd D. Camenisch, Ph.D., Associate Professor, Department
Pharmacology & Toxicology, University of Arizona College of Pharmacy,
Tucson, AZ
2:40 pm
THE Nrf2-DEPENDENT CELLULAR DEFENSE MECHANISM IN
ARSENIC TOXICITY
Donna D. Zhang, Ph.D., Assistant Professor, Department
Pharmacology/Toxicology, University of Arizona College of Pharmacy,
Tucson, AZ
3:10 pm
Refreshment Break
3:30 pm
MODULATION OF INSULIN SIGNALING BY ARSENIC
35
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
Richard R. Vaillancourt, Ph.D., Associate Professor, Department
Pharmacology & Toxicology, University of Tucson College of Pharmacy,
Tucson, AZ
4:00 pm
EPIGENETIC REMODELING DURING ARSENICAL-INDUCED
MALIGNANT TRANSFORMATION
Bernard W. Futscher, Ph.D., Professor, Department
Pharmacology/Toxicology, University of Arizona, Tucson, AZ
4:30 pm
MODELS OF HUMAN VARIATION IN ARSENIC ENVIRONMENTAL
TOXICOLOGY: “TOWNS IN A TUBE”
Walter T. Klimecki, DVM, Ph.D., Assistant Professor, Department
Pharmacology and Toxicology, University of Arizona College of
Pharmacy, Tucson, AZ
______________________________________________________________________
1:30 – 5:00 Turquoise III
SYMPOSIUM XVIII
STEM CELLS AND MEDICINE DEVELOPMENT
Co-Chairs: Kenneth J. Olivier, Jr., Ph.D., Associate Director of Toxicology, Merrimack
Pharmaceuticals, Cambridge, MA and Kyle L. Kolaja, Ph.D., DABT, Director, Roche,
Palo Alto, CA
Pluripotent stem cells are the basic building blocks that form all the tissues in the human
body and can give rise to any fetal or adult cell type. Recent advances in the
understanding of how these cells function, and how to control the differentiation process
to produce various cell types, has made possible great strides in utilization of these cells
in drug development, both as a therapeutic product and a research tool. In terms of
potential for new therapies and treatments in previously difficult or unmanageable
diseases, great opportunities for stem cell therapy exist in situations such as organ
transplant, organ/tissue replacement and insulin dependent diabetes mellitus. In
addition to therapeutic applications of stems cells, models that leverage adult
tissues/organs from stem cell derived sources are a promising area for preclinical
screening and safety assessment. This symposium will review current knowledge of
stem cells, their current and potential clinical applications, use in predicting safety of
future medicines and the current legal and regulatory ramifications.
1: 30 pm
IDENTIFICATION OF SMALL MOLECULES AND CANDIDATE
BIOMARKERS OF TOXICITY IN HUMAN EMBRYONIC STEM CELLS
Gabriela Cezar, D.V.M., Ph.D., Assistant Professor, University of
Wisconsin, Dept Animal Sciences, Madison, WI
36
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
2:10 pm
UPDATE ON DIFFERENTIATION AND CHARACTERIZATION OF Hes
AND Ips DERIVED CARDIOMYOCYTES AND THEIR UTILITY FOR
CARDIOTOXICITY TESTING
Chris Kendrick-Parker, Ph.D., Chief Technical Officer, Cellular Dynamics
Intl., Inc., Madison, WI
2:50 pm
Refreshment Break
3:00 pm
PRECLINICAL SAFETY EVALUATION OF STEM CELL THERAPIES;
KEY CONSIDERATIONS FOR FACILITATING CLINICAL TRIALS
Joy Cavagnaro, Ph.D., DABT, RAC, President, Access BIO, LC,
Boyce, VA
3:40 pm
CURRENT LEGAL AND REGULATORY REQUIREMENTS THAT MAY
AFFECT HUMAN EMBRYONIC STEM CELL RESEARCH
Michael Malinowski, J.D., Ernest R. and Iris M. Eldred Endowed
Professor of Law, Patent Attorney for Stem Cells, Baton Rouge, LA
4:20 pm
HUMAN EMBRYONIC STEM CELL-BASED THERAPIES: US FDA
PRODUCT AND PRECLINICAL REGULATORY CONSIDERATIONS
Donald W. Fink, Jr., Ph.D., Expert Biologist: Human Embryonic Stem
Cells, Center for Biologics Evaluation & Research, US FDA,
Rockville, MD
_____________________________________________________________________________
6:00 pm - 8:00 pm
Sundance Cafe
WuXi AppTec FAREWELL RECEPTION
37
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
INSTRUCTIONS FOR PREPARING POSTERS
FOR THE ANNUAL MEETING OF THE
AMERICAN COLLEGE OF TOXICOLOGY
The Poster Session has been scheduled for Tuesday, November
11, 2008 from 5:30 pm until 7:00 pm. You will be assigned a
number for the exact location of your poster.
Each presentation is assigned a 4’ x 6’ cork board that includes 2.2.
square meters (24 square feet) on which to display data. Please
identify your poster with a title and the names of the investigators in
1” (2.5 cm) lettering at the top of the display. It is very helpful to
post a copy of your abstract.
Micrographs, photomicrographs, charts, and graphs should be
mounted on firm mounting board. Matte finish on photographs
gives the best visibility. Matte surface paper may be used, or you
can simply dry glossy prints with the emulsion side of the paper
facing away from the drying drum surface.
Presenters should provide their own push pins (5/8” long) for
attaching posters to the display unit.
The Poster Boards will be available Sunday evening, November 9,
2008. Posters should be set up by Monday morning to be available
for as long as possible to attendees.
You are expected to be present at your poster for discussion and to
answer questions during the 5:30 pm to 7:00 pm Poster Session,
Tuesday, November 11, 2008.
Please remove your posters at the end of the session (7:00 pm) on
Tuesday evening. ACT is not responsible for removing or
storing posters.
38
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
SYMPOSIA AND CONTINUING EDUCATION COURSE CHAIRS
AND SPEAKERS
Mark A. Ammann, Pharm.D.
Vice President Regulatory Affairs
United BioSource Corporation
2200 Commonwealth Blvd., Suite 100
Ann Arbor, MI 48105
T: 734-994-8940 x1675
F: 734-994-8927
Email: mark.ammann@unitedbiosource.com
Richard A. Becker, Ph.D., DABT
American Chemistry Council
1300 Wilson Boulevard
Arlington, VA 22209
T: 703-741-5210
F: 703-741-6210
Email:
rick_becker@americanchemistry.com
Dan Anderson, MS, DABC, FTS-ABFT
Supervising Criminalist II
Los Angeles County Department of Coroner
1104 N. Mission Road
Los Angeles, CA 90033
T: 323-343-0660
F: 323-222-5171
Email: danderson@coroner.lacounty.gov
Joel Bercu, M.P.H.
Risk Assessment Toxicology
Eli Lilly and Company
2001 West Main Street
P. O. Box
Greenfield, In 46140
T: 317-277-4749
F: 317-276-1268
Email: jpbercu@lilly.com
Carol S. Auletta, MBA, DABT
Director, Program Management
Huntingdon Life Sciences
P. O. Box 2360
Mettlers Road
East Millstone, NJ 08875-2360
T: 732-873-2550 x2960
F: 732-873-3992
Email: aulettac@princeton.huntingdon.com
Michael J. Borrellie, Ph.D.
Professor & Director of Research
University of Arkansas for Medical Sciences
Department of Radiology
4301 West Markham Street, #556
Little Rock, AR 72205
T: 501-526-5897
F: 501-526-6147
Email: mjborrellie@uams.edu
Drew A. Badger, Ph.D. DABT
Senior Director, Toxicology & Reg. Affairs
Amira Pharmaceuticals
9535 Waples Street, Ste. 100
San Diego, CA 92121
T: 858-228-4688
F: 858-228-4788
Email: drew.badger@amirapharm.com
Denise Bounous, DVM, Ph.D., DACVP
Group Director, Clinical Path-Drug Sfty Eval
Bristol-Myers Squibb
F14-03
P. O. Box 4000
Princeton, NJ 08543-4000
T: 609-252-3247
F: 609-252-6896
Email: denise.bounous@bms.com
Katie Barrett
Programme Director
Huntingdon Life Sciences
Woolley Road
Alconbury
Huntingdon, Cambs.
PE28 4HS, UNITED KINGDOM
T: 44 1480 892101
F: 44 1480 892165
Email: barrettk@ukorg.huntingdon.com
Angelique Braen, Ph.D., DABT
Toxicologist
Hoffmann-La Roche, Inc.
Non-Clinical Safety
340 Kingsland Street
Nutley, NJ 07110
T: 973-235-3860
F: 973-235-4710
Email: angelique.braen@roche.com
39
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
Mitchell Brin, M.D.
Senior Vice-President, Global Development
Allergan, Inc.
2525 Dupont Drive
Irvine, CA 92612
T: 714-246-4429
F: 714-246-4696
Email: brin_mitchell@allergan.com
Florence G. Burleson, Ph.D.
Executive VP & Dir Laboratory Operations
BRT-Burleson Research Technologies, Inc.
120 First Flight Lane
Morrisville, NC 27560
T: 919-719-2500
F: 919-719-2505
Email: fburleson@brt-labs.com
Alan P. Brown, Ph.D., DABT
Senior Toxicologist
NAMSA
6750 Wales Road
Northwood, OH 43619
T: 419-662-8509
F: 419-666-2954
Email: abrown@namsa.com
Gary R. Burleson, Ph.D.
President & CEO
BRT-Burleson Research Technologies, Inc.
120 First Flight Lane
Morrisville, NC 27560
T: 919-719-2500
F: 919-719-2505
Email: gburleson@brt-labs.com
Michael H. Brown, DVM, MS, DACVO
Veterinary Ophthalmologist
Independent Consultant
Veterinary Referral Centre
Veterinary Ophthalmology Services, Inc.
48 Notch Road
Little Falls, NJ 07424
T: 973-890-4430
F: 973-723-3365
Email: muro127@aol.com
James S. Bus, Ph.D., DABT, ATS
Director of External Technology
The Dow Chemical Company
Toxicology & Environ. Res & Consulting
1803 Building, Washington Street
Midland, MI 48674
T: 989-635-4557
F: 989-638-9863
Email: jbus@dow.com
Lorrene A. Buckley, Ph.D.
Senior Research Advisor
Eli Lilly and Company
Toxicology
2001 West Main Street
P. O. Box 708
Greenfield, IN 46140
T: 317-277-7324
F: 317-277-5002
Email: buckley_lorrene_a@lilly.com
Todd D. Camenisch, Ph.D.
Associate Professor
University of Arizona College of Pharmacy
Department of Pharmacology & Toxicology
Skaggs Building, Room 234
1703 E. Mabel Street
P. O. Box 210207
Tucson, AZ 85721-0207
T: 520-626-0240
F: 520-626-2466
Email: camenisch@pharmacy.arizona.edu
Jeff L. Burgess, M.D., MPH
Director, Div Community, Environ & Policy
Mel & Enid Zuckerman College Public Hlth
University of Arizona
1295 N. Martin Avenue
P. O. Box 245210
Tucson, AZ 85724-5210
T: 520-626-4918
F: 520-626-8009
Email: jburgess@u.arizona.edu
Phillip Casterton, Ph.D., DABT
Manager
Cargill Food Ingredients & Systems
Regulatory & Scientific Affairs
15407 McGinty Road
W MS 163
Wayzata, MN 55391
T: 952-742-4497
F: 952-742-7573
Email: casterton@cargill.com
40
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
Don Catlin, M.D.
President & CEO
Anti-Doping Research, Inc.
3873 Grand View Blvd.
Los Angeles, CA 90066
T: 310-482-6925
F: 310-482-6929
Email: dcatlin@antidopingresearch.org
Ronald L. Cowan, M.D., Ph.D.
Director, Psychiatric Neuroimaging Program
Assistant Professor, Departments of
Psychiatry/Radiology
1601 23rd Avenue South
Suite #3057
Nashville, TN 37212
T: 615-322-2303
F: 615-936-3563
Email: ronald.l.cowan@vanderbilt.edu
Joy Cavagnaro, Ph.D., DABT, RAC
President
Access BIO, LC
P. O. Box 240
Boyce, VA 22520-0240
T: 540-837-9002
F: 540-837-9003
Email: jcavagnaro@accessbio.com
Dinesh De Alwis, Ph.D.
Research Advisor
Group Leader PK/PD, Europe
Eli Lilly and Company
Erl Wood
United Kingdom
T: 44-44-1276-483509
F: 44-44-1276-483565
Email: dda@lilly.com
Gabriela Cezar, DVM, Ph.D.
Assistant Professor
University of Wisconsin
Department of Animal Sciences
1675 Observatory Drive
Madison, WI 53705
T: 608-263-4307
Email: ggcezar@wisc.edu
Jack H. Dean, Ph.D., Sc.D., DABT, FATS
Research Professor
University of Arizona
Dept Pharma & Toxicology
10331 N. Wild Creek Drive
Tucson, AZ 85742
T: 520-544-3842
F: 520-544-3842
Email: jackhd1@msn.com
David R. Compton, Ph.D., DABT
Principal Research Investigator - Toxicology
sanofi-aventis
Drug Safety Evaluation
1041 Route 202-206 - MC: JR2-103A
PO Box 6800
Bridgewater, NJ 08807-0800
T: 908-541-5328
F: 908-231-2629
Email: david.compton@sanofi-aventis.com
Frank Dieterle, Ph.D.
Head External Affairs and Safety
Biomarkers iTox
Novartis Pharma AG
CHBS, WKL-136.2.86
Klybeckstrasse 141
CH-4057, Basel
Switzerland
T: 41 61 6961980
F: 41 61 6966992
Email: frank.dieterle@novartis.com
Mary Ellen Cosenza, Ph.D., DABT
Executive Director, Regulatory Affairs
Amgen Inc.
1 Amgen Center Drive
Mail Stop 38-4-C
Thousand Oaks, CA 91320-1789
T: 805-447-6318
F: 805-499-9228
Email: mcosenza@amgen.com
Rodney R. Dietert, Ph.D.
Professor
Cornell University
Department Microbiology/Immunotoxicology
C5 135 VMC
College of Veterinary Medicine
Ithaca, NY 14853
T: 607-253-4015
F: 607-253-3384
Email: rrd1@cornell.edu
41
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
David J. Dix, Ph.D.
Research Biologist
US EPA
Mail Drop D343-03
Research Triangle Park, NC 27711
T: 919-541-2701
F: 919-541-3513
Email: dix.david@epa.gov
Ronald W. Estabrook, Ph.D.
Univ Texas System Ashbel Smith Emeritus
Professor,
The Univ Texas Southwestern Med Center
10660 Park Village Place, Apt. #B
Dallas, TX 75230
T: 214-648-3456
Email: estabrook@utsw.swmed.edu
Krista I. Dobo, Ph.D.
Associate Director, Genetic Toxicology
Pfizer Global R& D
Eastern Point Road
Bldg. 274/1240
Groton, CT 06340
T: 860-715-5292
F: 860-715-1251
Email: krista.I.dobo@pfizer.com
Mark Fielden, Ph.D., DABT
Senior Scientist
Discovery and Investigative Safety
Non-Clinical Drug Safety
Roche Palo Alto LLC
3431 Hillview Avenue
Palo Alto, CA 94303
T: 650-855-5136
F: 650-855-5588
Email: mark.fielden@roche.com
David Dorman, DVM, Ph.D.
Professor
North Carolina State University
4700 Hillsborough
Raleigh, NC 27606
T: 919-513-6413
F: 919-513-6452
Email: david_dorman@ncsu.edu
Gregory L. Finch, Ph.D., DABT
Pfizer Global R&D
Drug Safety Research & Development
MS8274-1238
Eastern Point Road
Groton, CT 06340
T: 860-686-0273
F: 860-441-5499
Email: gregory.l.finch@pfizer.com
Richard R. Dubielzig, DVM, DACVP,
Veterinary Pathologist
Univ Wisconsin School of Vet Medicine
Dept of PBS
2015 Linden Drive
Madison, WI 53706
Tel: (608) 263-9805
Fax: (608) 262-9150
Email: dubielzr@svm.vetmed.wisc.edu
Donald W. Fink, Jr., Ph.D.
Center for Biologics Evaluation & Research
US FDA
Office of Cellular, Tissue & Gene Therapies
Division of Cellular & Gene Therapies
1401 Rockville Pike
Suite 200N – HFM-720
Rockville, MD 20852-1448
T: 301-827-5153
F: 301-827-9796
Email: donald.fink@fda.hhs.gov
Susan A. Elmore, MS, DVM, DACVP
NTP Pathologist & Staff Scientist
Natl Institute of Environmental Hlth Sciences
Cellular & Molecular Branch
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
T: 919-541-3474
F: 919-541-7666
Email: elmore@niehs.nih.gov
Patricia Frank, Ph.D.
President
Patricia Frank & Associates, Inc.
417 Dewey
Evanston, IL 60202
T: 847-864-6535
F: 847-864-6580
Email: patfrank@att.net
42
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
Bernard W. Futscher, Ph.D.
Professor
University of Arizona
Department of Pharmacology & Toxicology
1703 E. Mabel Street
Tucson, AZ 85721-0207
T: 520-626-4646
F: 520-626-2466
Email: bfutscher@azcc.arizona.edu
Lawrence M. Gibbs, MPH, CIH
Associate Vice Provost for Environmental
Health and Safety
Stanford University
ESF – 480 Oak Road
Stanford, CA 94305
T: 650-723-7403
Email: llgibbs@stanford.edu
Elmar Gocke, Ph.D.
Genotoxicity Group Leader
Hoffmann-La Roche, Inc.
PRNOBTRN
Building 73 215B
Basel, 4070, Switzerland
T: 41 616 884797
Email: elmar.gocke@roche.com
A. Jay Gandolfi, Ph.D.
Associate Dean, Research and Graduate
Studies
University of Arizona College of Pharmacy
P. O. Box 210207
1703 E. Mabel Street
Tucson, AZ 85721-0207
T: 520-626-6696
F: 520-626-2466
Email: gandolfi@pharmacy.arizona.edu
Terry Gordon, Ph.D.
Professor of Environmental Medicine
New York University School of Medicine
57 Old Forge Road
Tuxedo, NY 10987
T: 845-731-3536
F: 845-351-5472
Email: gordont@env.med.nyu.edu
Robert Garman, DVM, DACVP
President
Consultants in Veterinary Pathology, Inc.
P. O. Box 68
Murrysville, PA 15668
T: 724-733-5154
F: 724-733-3032
Email: vetpathol@cs.com
John D. Graham, Ph.D.
Dean, School of Public and Environmental
Affairs
Indiana University
1315 E. Tenth Street
Bloomington, IN 47405
T: 812-855-1432
F: 812-855-6234
Email: grahamjd@indiana.edu
Richard Geary, Ph.D.
Vice President, Pharma/Metabolism
ISIS Pharmaceuticals
1890 Rutherford Avenue
Carlsbad, CA 92008
T: 760-603-2501
F: 760-603-4650
Email: rgeary@isisph.com
Richard N. Greenberg. M.D.
VA Staff Physician, Lexington VA Med Ctr
The Belinda Mason Carden & Paul Mason
Professor of HIV/AIDS Res. & Education
Professor of Medicine
University of Kentucky School of Medicine
Department of Medicine, Room MN-672
800 Rose Street
Lexington, KY 40536-0084
T: 859-323-6327
F: 859-323-1631
Email: rngree01@email.uky.edu
Hanan Ghantous, Ph.D., DABT
Pharmacology/Toxicology Supervisor
US FDA, CDER
Division of Antiviral Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
T: 301-796-0717
F: 301-796-9883
Email: hanan.ghantous@fda.hhs.gov
43
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
Marion F. Gruber, Ph.D.
Associate Director for Regulatory Policy
US FDA
CBER
1401 Rockville Pike
Rockville, MD 20852
T: 301-827-5117
F: 301-827-3532
Email: gruber@cber.fda.gov
Hisham Hamadeh, Ph.D.
Amgen Inc.
1 Amgen Center Drive
Mail Stop 5-1-A
Thousand Oaks CA 91320
T: 805-447-4818
F: 805-499-4686
Email: hhamadeh@amgen.com
Jerry F. Hardisty, D.V.M.
President & CEO
EPL, Inc.
P. O. Box 12766
Res Triangle Park, NC 27709
T: 919-998-9407 x600
F: 919-998-9607
Email: jhardisty@epl-inc.com
Tomas R. Guilarte, Ph.D.
Professor, Molecular Neurotoxicology
Johns Hopkins Bloomberg Sch Public Hlth
615 N. Wolfe Street
Baltimore, MD 21205
T: 410-955-2485
F: 410-502-2470
Email: tguilart@jhsph.edu
Ernie Harpur, Ph.D.
Global Associate Director
Drug Safety Evaluation
sanofi-aventis
Alnwick Research Centre
Willoburn Avenue
Alnwick, Northumberland NE66 2Jh
United Kingdom
T: 44-1665-60-8502
F: 44-1665-60-8503
Email: ernie.harpur@sanofi-aventis.com
Robin C. Guy, M.S., DABT
Toxicology and GLP Consultant
Robin Guy Consulting, LLC
P. O. Box 830
Preclinical Toxicology & GLP Training
Lake Forest, IL 60045-0830
T: 847-295-9250
F: 847-295-9251
Email: rcg@robinguy.com
William C. Hall, V.M.D., Ph.D., DACVP
Consulting Pathologist
Hall Consulting, Inc.
12337 Sherwood Forest Drive, C26
Mount Airy, MD 21771
T: 301-865-8114
F: 301-865-8118
Email: hallconsulting@earthlink.net
Stephen B. Harris, Ph.D., FATS
Consultant
Stephen B. Harris Group Consulting
6109 Madra Avenue
San Diego, CA 92120
T: 619-469-7886
F: 619-469-6852
Email: steve@sbhgrp.com
Christine Haller, M.D.
Director, Clinical Safety
Amgen Inc.
1120 Veterans Blvd.
South San Francisco, CA 94080
T: 650-244-2484
F: 650-292-9325
Email: challer@amgen.com
Melanie Hartsough, Ph.D.
Senior Consultant
Biologics Consulting Group, Inc.
12526 Timber Hollow Place
Germantown, MD 20874
T: 301-742-3665
Email: mhartsough@bcg-usa.com
44
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
Kenneth L. Hastings, Dr.P.H.
Associate VP, Regulatory Policy
sanofi-aventis
Corporate Reg Affairs Office
4520 East West Highway, #210
Bethesda, MD 20814
T: 301-771-4267
F: 301-771-4287
Email:kenneth.hastings@sanofi-aventis.com
Richard L. Hilderbrand, Ph.D
Science Director
US Anti-Doping Agency
1330 Quail Lake Loop, Suite 260
Colorado Springs, CO 80906-7346
T: 719-785-2030
F: 719-785-2029
Email: rhilderbrand@usada.org
David W. Hobson, Ph.D., DABT
President
LoneStar PharmTox LLC
613 Pleasant Valley Drive
Boerne, TX 78006
T: 210-269-6169
F: 830-229-5782
Email: dave@lonestarpharmtox.com
Elizabeth Hausner, DVM, DABT, DABVT
Senior Pharmacologist
US FDA/CDER
Div Cardiovascular & Renal Drug Products
5901-B Ammendale Road
Beltsville, MD 20705-1266
T: 301-796-1084
Email: elizabeth.hausner@fda.hhs.gov
David L. Hopper, DVM, PhD, DABT
Director of Toxicology
BASi
10424 Middle Mt. Vernon
Mt. Vernon, IN 47620
T: 812-985-3400
Email: dhopper@bioanalytical.com
Hans-Juergen Haussmann, Ph.D.
Toxicology Consultant
Ueberhoefer Feld 36a 51503
Roesrath, Germany
T: 49-2205-894-0384
F: 49-2205-894-0385
Email: hansj.haussmann@t-online.de
Keith Houck, Ph.D.
Toxicologist
US EPA
Mail Drop D343-03
Research Triangle Park, NC 27711
T: 919-541-5519
F: 919-541-3513
Email: houck.keith@epa.gov
A. Wallace Hayes, PhD, DABT, FATS
Visiting Scientist
Harvard School of Public Health
298 S. Main Street
Andover, MA 01810
T: 978-409-1153
F: 978-409-1154
Email: awallacehayes@comcast.net
Robert V. House, Ph.D.
President
DynPort Vaccine Company LLC
64 Thomas Johnson Drive
Frederick, MD 21702
T: 301-607-5028
F: 301-607-5099
Email: rhouse2@csc.com
Eugene H. Herman, Ph.D.
Pharmacologist
US FDA
Center for Drug Evaluation & Research
Division of Applied Pharmacology Research
White Oak Life Sciences Bldg 64, Rm. 2011
10903 New Hampshire Avenue
Mail Stop HFD-910
Silver Spring, MD 20993
T: 301-796-0081
F: 301-796-9818
Email: eugene.herman@fda.hhs.gov
Bahija Jallal, Ph.D.
Vice President
MedImmune
Translational Sciences/Preclin Oncology
One MedImmune Way
Gaithersburg, MD 20878
T: 301-398-5268
F: 301-398-8268
Email: jallalb@medimmune.com
45
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
Neil Johnson, Ph.D., FRCPath
Senior Fellow
Schering-Plough Research Institute
144 Route 94
Box 32
Lafayette, NJ 07848
T: 973-940-4199
F: 973-940-4183
Email: neil.johnson@spcorp.com
Walter T. Klimecki, DVM, Ph.D.
Assistant Professor
University of Arizona College of Pharmacy
Department of Pharmacology & Toxicology
P. O. Box 210207
Tucson, AZ 85721-0207
T: 520-626-7470
F: 520-626-2466
Email: klimecki@pharmacy.arizona.edu
Mary Jeanne Kallman, Ph.D.
Research Advisor
Eli Lilly & Company
2001 West Main Street
Investigative Toxicology
Greenfield, IN 46140
T: 317-277-4862
F: 317-277-6770
Email: kallman_mary_jeanne@lilly.com
Elaine V. Knight, Ph.D.
Research Fellow
Johnson & Johnson Pharma R&D, LLC
1000 Route 202
OMP Admin. Bldg. 2360
Raritan, NJ 08869
T: 908-704-4344
F: 908-218-0668
Email: eknight@prdus.jnj.com
John Curtis Kapeghian, Ph.D., DABT
President
Preclinical Safety Associates
14240 Via Contento Court
Reno, NV 89511
T: 775-853-2315
F: 775-853-5401
Email: johnkap@charter.net
Kyle L. Kolaja, Ph.D., DABT
Director
Roche
3431 Hillview Avenue
Palo Alto, CA 94304
T: 650-354-7587
F: 650-855-5588
Email: kyle.kolaja@roche.com
Chris Kendrick-Parker, Ph.D.
Chief Commercial Officer
Cellular Dynamics International Inc.
525 Science Drive
Madison, WI 53711
T: 608-310-5109
F: 608-310-5101
Email: cparker@cellular-dynamics.com
Georg Krinke, DVM, Ph.D.
Veterinary Pathologist & Professor,
Toxicologic Pathologist
AnaPath GmbH
Buchsweg 56
4625 Oberbuchsiten, Switzerland
T: 41 619016484
Email: krinke@bluewin.ch
Michael Klein, Ph.D.
Director, Controlled Substance Staff
US FDA
Center for Drug Evaluation & Research
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
T: 301-796-5402
F: 301-847-8736
Email: michael.klein@fda.hhs.gov
Harald Kropshofer
Global Coordinator Immunosafety
F. Hoffmann La Roche Ltd.
Trenzacherstrasse 124
CH-4070, Basel
Switzerland
T: 41 61 68 83569
F: 41 61 68 83678
Email: harald.kropshofer@roche.com
46
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
Claire L. Kruger, Ph.D., DABT
CEO & Director of Health Sciences
Spherix Inc.
6430 Rockledge Drive
Bethesda, MD 20817
T: 301-419-7837
F: 301-210-4908
Email: ckruger@spherix.com
Kate Longman
Manager, Quality Assurance Research
MPI Research, Inc.
54943 North Main Street
Mattawan, MI 49071-9399
T: 269-668-3336 x1340
F: 269-668-4151
Email: kate.longman@mpireserch.com
Steven C. Kunder, Ph.D., DABT
Senior Consultant
Biologics Consulting Group
1317 King Street
Alexandria, VA 22314
T: 240-750-5035
Email: skunder@bcg-usa.com
Jan K. Losos, Ph.D.
Safety Assessment Project Manager
GlaxoSmithKline
P. O. Box 13398
5 Moore Drive
Research Triangle Park, NC 27709
T: 919-483-9985
F: 919-483-0131
Email: jan.k.losos@gsk.com
R. Clark Lantz, Ph.D.
Associate Head
University of Arizona
Department of Cell Biology & Anatomy
1703 E. Mabel Street
Tucson, AZ 85721-0207
T: 520-626-6716
F: 520-626-2097
Email: lantz@email.arizona.edu
Michael Malinowski, J.D.
Ernest R. & Iris M. Eldred Endowed
Professor of Law
Patent Attorney for Stem Cells
1 East Campus Drive, #336
Baton Rouge, LA 70803
T: 225-578-8716
Email: michael.malinowski@law.lsu.edu
Shwu-Luan Lee, Ph.D.
Pharmacology Reviewer
DDOP, OODP, OND, CDER
10903 New Hampshire Avenue
Silver Spring, MD 20993
T: 301-796-1395
F: 301-796-9845
Email: shwuluan.lee@fda.hhs.gov
Alvin Malkinson, Ph.D.
Professor, Dept Pharmaceutical Sciences
School of Pharmacy
University of Colorado
4200 East 9th Avenue
Box C238
Denver, CO 80262
T: 303-315-4579
F: 303-315-6281
Email: al.malkinson@uchsc.edu
Arthur A. Levin, Ph.D., DABT
Senior Consultant
Levin Bioscience
15951 Avenida Calma
Rancho Santa Fe, CA 92091
T: 858-449-7779
Email: art.levin@gmail.com
Carey Mathesius, M.S.
Senior Research Associate- Nutritionist
Pioneer, DuPont Agriculture & Nutrition
P. O. Box 552
7250 NW 62nd Avenue
Johnston, IA 50131-0552
T: 515-270-4239
F: 515-334-4478
Email: carey.mathesius@pioneer.com
Rosemarie Lichtner, Ph.D.
PMI Research & Development
Philip Morris Research Laboratories GmbH
Fuggerstrasse 3
51149 Cologne
Germany
T: 49-2203-303375
F: 49-2203-303362
Email: rosemarie.lichtner@pmintl.com
47
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
William B. Mattes, Ph.D., DABT
Director of Toxicology
The Critical Path Institute
Fallsgrove Village Office Center
14955 Shady Grove Rd., #370
Rockville, MD 20850
T: 301-762-7650
F: 301-762-7722
Email: wmattes@c-path.org
S. Stevens Negus, Ph.D.
Professor, Pharmacology & Toxicology
Virginia Commonwealth University
410 North 12th Street
Robert Blackwell Smith Building
Richmond, VA 23298-0613
T: 804-828-3158
F: 804-828-2117
Email: ssnegus@vcu.edu
Timothy J. McGovern, Ph.D.
Consultant
SciLucent, LLC
585 Grove Street
Suite #300
Herndon, VA 20170
T: 703-435-0033 x242
F: 703-435-0440
Email: t.mcgovern@scilucent.com
Deborah L. Novicki, Ph.D.
Global Head, Toxicology
Novartis Vaccines
350 Massachusetts Avenue
Cambridge, MA 02139
T: 617-871-8206
Email: deborah.novicki@novartis.com
Kenneth J. Olivier, Jr., Ph.D
Associate Director of Toxicology
Merrimack Pharmaceuticals
One Kendall Square
Building 700, 2nd Floor
Cambridge, MA 02139
T: 617-441-7416
F: 617-441-7761
Email: kolivier@merrimackpharma.com
Susan McPherson, M.Sc.
Scientific Program Manager
Charles River Laboratories
22022 TransCanadian
Senneville, Quebec H9X 3R3
Canada
T: 514-630-8200 x8703
F: 514-630-8230
Email: sue.mcpherson@crl.com
Michael A. Pereira, Ph.D.
Emeritus Professor
Ohio State University College of Medicine
Division of Hematology and Oncology
Wiseman Hall, Room 320
410 W. 12th Avenue
Columbus, OH 43210
T: 614-222-0405
Email: michael.pereira@osumc.edu
Mark N. Milton, Ph.D.
Vice President, Nonclinical Development
Tempo Pharmaceuticals Inc.
161 First Street, Suite 2A
Cambridge, MA 02142
T: 617-551-9604
F: 617-494-1544
Email:
mmilton@tempopharmaceuticals.com
Syril Pettit, M.E.M.
Senior Scientific Program Manager
HESI
One Thomas Circle, NW
Washington, DC 20005
T: 202-659-3306
F: 202-296-3617
Email: spettit@ilsi.org
Barbara J. Mounho, Ph.D., DABT
Scientific Director
Amgen Inc.
One Amgen Center Drive
MS 29-2-A
Thousand Oaks, CA 91320-1799
T: 805-447-5619
F: 805-499-2936
Email: bmounho@amgen.com
48
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
Richard D. Phillips, Ph.D., DABT
Senior Science Advisor
ExxonMobil Petroleum & Chemical
Hermeslaan 2
1831, Machelen, Belgium
T: 322-722-2550
F: 322-722-4209
Email: richard.d.phillips@exxonmobil.com
Paul L. Roney, Ph.D., DABT
Senior Consultant, Toxicology
Kendle International Inc.
Regulatory Affairs
7361 Calhoun Place, Suite 500
Rockville, MD 20855
T: 301-838-3120 ex1363
F: 301-838-3182
Email: roney.paull@kendle.com
Barbara B. Randolph, MT (ASCP), MBA
Senior Auditor, RQAP (GLP)
Biotechnical Services, Inc.
4510 E. Pineglen Lane
Mead, WA 99021
T: 509-468-4676
F: 509-468-4384
Email: brando@biotechnicalservices.com
I.Y. Rosenblum, Ph.D., ATS
Rosenblum Consulting LLC
5 Brook Valley Way
Newton, NJ 07860
T: 973-383-6744
F: 973-383-6744
Email: iyconsulting@embarqmail.com
Vijayapal Reddy, DVM, Ph.D.
Senior Advisor
Eli Lilly and Company
2001 W. Main Street
Greenfield, IN 46140
T: 317-277-7325
F: 317-277-5002
Email: reddy_vijayapal_r@lilly.com
David Ropeik, BSJ, MSJ
Instructor
Harvard University Extension Program
Risk Communication Consultant
21 Baker Avenue
Concord, MA 01742
T: 978-369-5675
F: 978-369-0007
Email: dpr@dropeik.com
James Render, DVM, Ph.D., DACVP
Research Fellow, Veterinary Pathologist
Pfizer Global R&D
Toxicologic Pathology, DSRD
1 Eastern Point Rd., 8274 – 2722B
Groton, CT 06340
T: 860-686-9446
F: 860-686-0557
Email: james.render@pfizer.com
Patricia Ryan, Ph.D.
Principal Toxicologist
MedImmune, Inc.
One MedImmune Way
Gaithersburg, MD 20878
T: 301-398-4387
F: 301-398-9387
Email: ryanp@medimmune.com
Melissa Rhodes, Ph.D., DABT
Safety Assessment Project Manager
GlaxoSmithKline
P. O. Box 13398
5 Moore Drive
Research Triangle Park, NC 27709
T: 919-483-6908
F: 919-483-0131
Email: Melissa.c.rhodes@gsk.com
Mr. John Sancenito
Vice President
Information Network Associates, Inc.
(INA, Inc.)
5235 North Front Street
Harrisburg, PA 17110
T: 717-599-5505
F: 717-599-5507
Email: jsancenito@ina-inc.com
49
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
John-Michael Sauer, Ph.D.
Vice President
Head Lead Discovery and Optimization
Elan Pharmaceuticals
800 Gateway Boulevard
So San Francisco, CA 94080
T: 650-877-7644
F: 650-877-7486
Email: john.sauer@elan.com
William Slikker, Jr., Ph.D.
Director
NCTR/US FDA
3900 NCTR Road
Jefferson, AK 72079
T: 870-543-7517
F: 870-543-7576
Email: william.slikker@fda.hhs.gov
Mr. Steven M. Snyder
President
Outsourcing Support Services, Inc.
6569 Braemar Avenue
Noblesville, IN 46062
T: 317-408-0286
F: 317-770-7750
Email: omfp@pitspirce-support.com
Shelli Schomaker, B.A.
Safety Biomarkers
Drug Safety Research & Development
Pfizer, Inc.
MS 8274-1227
Groton, CT 06340
T: 860-441-5172
F: 860-715-7483
Email: shelli.j.schomaker@pfizer.com
Greg Stevens, Ph.D.
Senior Director
Pfizer Inc.
10777 Science Center Drive
San Diego, CA 92121
T: 858-622-5901
F: 858-678-8290
Email: greg.j.stevens@pfizer.com
Hilary Sheevers, Ph.D.
President & CEO
Aclairo PDG, Inc.
1950 Old Gallows Road
Suite #300
Vienna, VA 22182
T: 703-506-6760 x307
F: 703-506-0142
Email: hsheevers@aclairo.com
Larry Tamarkin, Ph.D.
President and CEO
CytImmune
9640 Medical Center Drive
Rockville, MD 20850
T: 240-864-2796
F: 301-315-2438
Email: itamarkin@cytimmune.com
Robert Sills, DVM, Ph.D.
Group Leader
Molecular Pathology Group
NIEHS
P.O. Box 12233
Mail Drop B3-06
Research Triangle Park, NC 27709
T: 919-541-0180
F: 919-541-7666
Email: sills@niehs.nih.gov
Russell S. Thomas, Ph.D.
Director
Center For Genomic Biology &
Bioinformatics
The Hamner Institutes for Health Sciences
6 Davis Drive
P. O. Box 12137
Research Triangle Park, NC 27709-2137
T: 919-558-1311
F: 919-558-1300
Email: rthomas@thehamner.org
Per Sjoberg, Ph.D.
Toxicology & Regulatory Consultant
Eureda AB
Dag Hammarskolds vag 10c
SE-751-83
Uppsala
Sweden
T: 46 (0)18-591633
F: 46 (0)18-591634
Email: per.sjoberg@eureda.com
50
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
Karol Thompson, Ph.D.
Molecular Toxicology Team Leader
Division of Applied Pharmacology Res
US FDA/CDER
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
T: 301-796-0126
F: 301-796-9818
Email: karol.thompson@fda.hhs.gov
Jack Uetrecht, Ph.D., M.D.
Professor of Pharmacy & Medicine
Canada Res Chair Adverse Drug Reactions
University of Toronto
Leslie Dan Faculty of Pharmacy
144 College Street
Toronto, M5S 3M2
CANADA
T: (419) 978-8939
Email: jack.uetrecht@utoronto.ca
Raymond R. Tice, Ph.D.
Acting Branch Chief
NTP Biomolecular Screening Branch
NIEHS/NTP
Mail Code EC-17
P. O. Box 12233
Research Triangle Park, NC 27709
T: 919-541-4482
F: 919-541-0947
Email: tice@niehs.nih.gov
Richard R. Vaillancourt, Ph.D.
Assistant Professor
University of Arizona College of Pharmacy
Department of Pharmacology & Toxicology
1703 E. Mabel Street
Tucson, AZ 85721-0207
T: 520-626-4374
F: 520-626-2466
Email: vaillancourt@pharmacy.arizona.edu
Joseph C. Tigner, Ph.D.
Toxicology Consultant
1 Santa Lane
New Milford, CT 06776-2363
T: 203-417-9203
Email: jtigner1523@earthlink.net
Jean-Marc Vidal, M.D.
Scientific Administrator
European Medicines Agency
Pre-authorization Human Medicines Unit
Safety and Efficacy Sector
7 Westferry Circus
Canary Wharf
London, E14 4HB
United Kingdom
T: 44 (20) 75237156
F: 44 (20) 74188613
Email: jean-marc.vidal@emea.europa.eu
Marque Todd, DVM, MS, DABT
Regulatory Strategy Lead
Pfizer Inc.
Drug Safety Research & Development
10646 Science Center Drive
San Diego, CA 92121
T: 858-526-4700
F: 858-952-4467
Email: marque.todd@pfizer.com
Mark D. Walker, D.V.M.
Senior Director of Research
Charles River
Study Direction Management
587 Dunn Circle
Sparks, NV 89431
T: 775-352-7982
F: 775-331-2289
Email: mark.walker@crl.com
Susan Trimbo, Ph.D.
Independent Consultant
Health Science Consulting LLC
23 Royal Palm Way #5
Boca Raton, FL 33432
T: 516-391-1871
F: 516-391-1871
Email: strimbo@bellsouth.net
Klaus Weber, Ph.D., Dr.rer.nat., Dipl.Biol.,
Vet.-Ing.
Head of Pathology/Diagnostics, Chief
Scientific Officer
RCC Ltd.
Harlan Inc.
Itingen, Switzerland
T: 41 61 975 1268
F: 41 61 971 7725
Email: weber.klaus@rcc.ch
51
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
Peter Weber, M.D., Ph.D.
Professor of Nutrition
Director, Corporate Scientist
Human Nutrition & Health
P. O. Box 2676, Bldg. 203-035
Wurmisweg 576
CH-4303 Kaiseraugst, Switzerland
T: 41 61-8158135
Email: peter.weber@dsm.com
Raymond L. Woosley, M.D., Ph.D.
President and CEO
The Critical Path Institute
4280 N. Campbell Ae., #214
Tucson, AZ 85718
T: 520-547-3440
Email: rwoosley@c-path.org
Ming You, M.D., Ph.D.
Professor,
Head, Chemopreventive Program
Siteman Cancer Center
Washington University School of Medicine
660 South Euclid
Campus Box 8109
St. Louis, MO 63110
T: 314-362-9379
F: 314-362-9366
Email: youm@wustl.edu
James Wheeler, Ph.D.
Sr. Toxicologist
Alcon Laboratories, Inc.
6201 South Freeway, R9-7
Fort Worth TX 76134
T: 817-615-2821
F: 817-615-4661
Email: james.wheeler@alconlabs.com
Daniel Wierda, Ph.D.
Eli Lilly & Company
Immunotoxicology
2636 South Hillview Drive
New Palestine, IN 46163
T: 317-277-4227
F: 317-277-4436
Email: dwierda@lilly.com
Husam Younis, PharmD, Ph.D.
Associate Director, Drug Safety R&D
Pfizer Inc., La Jolla Laboratories
10777 Science Center Drive
San Diego CA 92121
T: 858-622-7661
F: 858-678-8290
Email: husam.younis@pfizer.com
Suzanne R. Wolford, Ph.D., DABT
Covance Inc.
3301 Kinsman Blvd.
Madison, WI 53704
T: 608-242-2721
F: 608-242-2736
Email: suzanne.wolford@covance.com
Donna D. Zhang, Ph.D.
Assistant Professor
University of Arizona College of Pharmacy
Department of Pharmacology & Toxicology
1703 E. Mabel Street
Tucson, AZ 85721-0207
T: 520-626-9918
F: 520-626-2466
Email: dzhang@pharmacy.arizona.edu
52
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
SYMPOSIA ABSTRACTS
53
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
POSTER ABSTRACTS
69
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
ABSTRACT AUTHORS
Addepalli, V.. – P57
Alfredson, T. – P46
Ambroso, J. – P50
Ammann, M. – V
Anderson, D. – XIII
Api, A.M. – P3
Arens, J.R. – P27
Authier, S. – P25
Badger, D. – III
Baird, T. – P17
Ball, J. – P5
Banerjee, A. – P13
Baranowski, T. – P4
Barber, G. – P42
Barrett, K. – X
Baskin, P. – P47
Bauer, R. – P43
Baxter, T. – P11
Bechtel, C. – P43
Behl, M. – P53
Bercu, J. – VI
Berridge, B. – P36, P50
Betton, G. – VIII
Beushausen, S. – VIII
Bhatia, S.P. – P3
Bockoven, L. – P30
Bolden-Tiller, O. – P11
Bolt, A. – XVII
Borad, M. – P42
Borrelli, K.M. – P44
Bouchard, G.F. – P1, P2, P52
Bounous, D. – VIII
Boyer, J.M. – P44
Boyer, M. – P8
Bozigian, H. – P48
Brain, K.R. – P3
Brin, M.F. - XVI
Broka, D. – XVII
Brown, L. – P1, P2, P52
Brown, M.H. – XII
Buckley, L.A. – XIV
Buettner, A. – VII, P33
Bui, Q. – P34
Burgess, J.L. – XIII
Burkhardt, B. – P40
Burleson, F.G. – XI
Burleson, G.R. – XI
Bus, J.S. - I
Butt, M.T. – P48
Caissie, J.A. – P44
Caitlin, D. - XIII
Camenisch, T.D. – XVII
Cao, L. – P43
Carathers, M. – P26
Cariello, N.F. – P36
Castro, D.J. – P37
Cavagnaro, J. – XVIII
Cerven, D. – P26
Cezar, G.G. – XVIII
Chanda, S. – P46
Chaurand, F. – P25
Collins, A. – P9, P22
Collison, K. – P23
Compton, D.R. – V
Cooper, G. – P46
Cooper, M. – P21
Cosenza, M.E. – XVI
Cox, M.B. – P6
Cracknell, S. – P16
Craig, L. – P51
Cummings, C. – P50
Cunningham, M.J. – P29, P30
D’Amico, L.J. – P59
Dalton, J. – P17
Datiri, T. – P11
Day-Lollini, P. – P46
DeGeorge, G.L. – P18, P19
Demonakou, M.D. – P12, P38
Der, K. – P43
Desbiens, S. – P41
Dieterle, F. – IV
Dietert, R.R. – XI
Dix, D.J. – I
Dobo, K. – VI
Dodd, A. – P5
Donovan, A. – P26
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AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
Druwe, I.J. – XVII
Du, Y. – XVII
Dubielzig, R.R. – XII
Dubois, J. – P41
Dumitriu, A. – P29
Dumont, S. – P7
Dybdal, N. – P49
Eblin, K.E. – XVII
Edwards, C.N. – P34
Eimon, P.M. - P4
Ennulat, D. – VIII
Espinoza, Y. – P43
Evert, S. – P34
Falvo, R. – P41
Faqi, A.S. – P23
Federspiel, M. – P42
Fielden, M.R. – IV
Finch, G.L. – XIV
Fink, Jr., D.W. – XVIII
Flagella, K. – P49
Flora, F. – P35
Foley, C.M. – P27
Forsberg, E.M. – P44
Foster, W. – P14
Fournier, S. – P25
Frank, P. – IX
Friedrichs, B. – P32, P33
Futscher, B.W. – XVII
Gandolfi, A.J. – XVII
Garman, R. – XV
Gasper, C. – P43
Gautier, J-C. – VIII
Gauvin, D. – P17
Geary, R. – II
Gebel, S. – VII, P33
Gendron, R.M. – P7
Gibbs, L.M. – IX
Gocke, E. – VI
Godsey, J. – P10
Goldstein, D. – P46
Gordon, T. – VII
Gorham, S. – P11
Gosselin, S.J. – P16
Graham, E. – P11, P47
Graham, T. – P11
Green, D.M. – P3
Greenslade, A. – P42
Greiner, S. – P42
Gruebbel, M.M. – P24
Hale, S. – XV
Haller, C. – XIII
Hamaden, H. - VIII
Hamilton, B.F. – P36
Hammond, D. – P30
Harpur, E. – VIII
Harter, M. – P17
Hastings, K.L. – III
Hausner, E. - IV
Haussmann, H-J. – VII, P33
Hayes, A.W. – P35
Hays, A. – XVII
Henwood, S. – P49
Herman, E.H. - VIII
Hill, A. – P5
Hill, R. – P46
Hobson, D.W. – IX
Hoffman, D. – VIII
Holdsworth, D. – P17
Hoover, A. – P21
Houck, K. – I
Jabbour, A.J. – P48
Jeevarajan, A. – P30
Jenks, N. – P42
Jensen, T.J. – XVII
Jochumsen, M. – P34
Johnson, N. – XIV
Jones, K.L. – P44
Jones, M. – P5
Jordan, H. – P36
Joshi, P.V. – P56
Kallman, M-J. – V
Kaplowitz, N. – P36
Karalius, B.J. – P44
Karantabias, G.C. – P16
Kelly, C. – P16
Kendrick-Parker, C. – XVIII
Killeen, K.P. – P44
Kim, D. – P2
Klein, M. – V
Klimecki, W. – XVII
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AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
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Kochi, S.K. – P44
Kolaja, K. – P46
Komocsar, W.J. – XI
Kone-Coulibaly, S. – P11
Kramer, S. – P51
Krautter, G.R. – P31
Krinke, G.J. – XV
Kropshofer, H. – X
Kruger, C.L. – P35
Kulkarni, Y.A. – P55
Lalko, J. – P3
Lane, M.R. – P23
Lantz, R.C. – XVII
Lavallée, S. – P41
Lawson, C. – P52
Lee Grotz, V. – P35
Lee, J-H. – P13
Lee, S-L. – II
Lee, W-Y. – P6
Leigh, H. – P52
Lema, C. – P30
Lemire, I. – P7
Leone, A. – P22
LeSauteur, L. – P41
Levin, A.A. – II
Li, C. – P58
Li, F. – P46
Lichtner, R.B. – VII, P33
Lin, W.S. – P58
Liu, J. – P1, P2, P52
Liu, Z-X. – P36
Lollini, L. – P46
Lorenz, M. – P46
Losos, J. – II
Lum, R.C. – P48
Ma, J. – P43
MacElrevey, C.M. – P10
MacKillop, E.A. – P45
Mader, E. – P42
Madsen, T. – P1, P2
Magowan, J.A. – P48
Maheshwari, V.L. – P56
Malinowski, M. – XVIII
Malkinson, A.M. – VII
Mangum, J.B. – P36
Mattes, W. – IV, P21
Mazak, V. – P29
McDorman, K. – P49
McGovern, T.J. – VI
McGrath, P. – P58, P59
McKeon, M. – P49
McMillian, M. – P9, P22
Metzler, M. – P40
Meyer, K. – P43
Miller, R.T. – P36
Milton, M.N. – IX
Miyamoto, M. – P16
Morinello, E. – P49
Mould, A.P. – P31
Myers, R. – P42
Mykoniatis, M.G. – P12, P38
Mylecraine, L. – VIII
Negus, S.S. – V
Novak, P. – XVII
Ogden, L. – P11
Panoutsopoulos, G.I. – P12, P38, P39
Papadimas, G.K. – P12, P38, P39
Pathak, G. – P57
Peck, M. – P32
Peng, K.W. – P42
Pereira, M.A. – VII
Peterson, R.A. – P36
Pettit, S. – VIII
Pfeiffer, E. – P40
Piccirillo, V.J. – P10
Piehl, M. – P26
Platz, S. – P46
Potts, R.J. – P31
Potts, S.J. – P20
Powers, C.M. – P45
Pratt, L. – P19
Prescott, J. – P36, P50
Pype, J. – P32
Rakela, J. – P42
Ramaiah, S.K. – P13
Ramani, T. – P16
Redente, E.F. – VII
Regan, S. – XVII
Reifke, B. – VIII
Render, J. – XII
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Reno, F. – P47
Robertson, D. – P14
Roland, K.L. – P44
Rossi, P. – P21
Rowe, C. – P16
Ruepp, S. – P14
Russell, S.J. – P42
Ryde, I. – P45
Sacaan, A.I. – P48
Sampath, S. – P9
Sateesh, B. – P54
Sauer, J-M. – III
Schomaker, S. – IV
Schuetz, C. – P49
Schuster, K. – VIII
Seidler, F.J. – P45
Seng, W.L. – P59
Shorey, L.E. – P28
Singh, B.P. – P24
Sistare, F. – IV
Sjoberg, P. – X
Skaltsas, S.D. – P12, P38
Slotkin, T.A. – P45
Smith, A.M. – P45
Smith, S.Y. – P7
Snead, J. – P11
Soda, R. – P26
Sollome, J. – XVII
Sonee, M. – P9
Stevens, G. – III
Steward, K. – P11
Stinn, W. – VII, P53
Stokes, A. – P50
Stryker, S. – P14
Sun, Z. – XVII
Tamarkin, L. – IX
Tao, J. – P18
Taylor, E. – P9, P22
Thomas, J. – P10
Thomas, L.J. – P44
Thomas, R.S. – I
Thompson, J. – P42
Thompson, K. – VIII
Thygesen, H.V. – P34
Tice, R.R. – I
Tichenor, S. – P43
Tinge, S.A. – P44
Toms, S. – P29
Troncy, E. – P25
Tzirogiannis, K.N. – P12, P38, P39
Uetrecht, J. – XIV
Vaillancourt, R.R. – XVII
Van Miert, E. – P32
Vanscheeuwijck, P. – P32
Veeranjaneyulu, A. – P54, P55
Vessie, S. – P16
Viau, A. – P8
Vidal, J-M. – IV, X
Vile, R. – P42
Villeneuve, N.F. – XVII
Walisser, J.A. – P27
Walker, E. – P21
Wallace, W. – P30
Wang, H. – P49
Wang, X-J. – XVII
Washer, G. – P25
Weber, K. – XV
Weigele, M.S. – P48
Weiler, H. – P32
Weinbauer, G.F. – P15
Weller, P. – P46
Wheeler, J. – XII
Wierda, D. – XI
Williams, D.E. – P28, P37
Wong, B. – P46
Woosley, R.L. – IV
Wrench, N. – P45
You, M. – VII
Younis, H. – III
Zabka, T. – P46
Zhang, D.D. – XVII
Zhang, Y.S. – P53
Zheng, W. – P53
Ziegelhofer, T. – P16
Zühlke, U. – P15
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AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
THANK YOU TO OUR EXHIBITORS
Affymetrix, Inc.
Santa Clara, CA
Eurofins Product Safety
Laboratories
Dayton, NJ
BASi
West Lafayette, IN
Experimur
Chicago, IL
Battelle
Columbus, OH
Harlan Laboratories, Inc.
Indianapolis, IN
Bench International
Beverly Hills, CA
HistoTox Labs., Inc.
Boulder, CO
BioDuro, LLC
Beijing, China
Histo-Scientific Research Labs
Mount Jackson, VA
BioReliance
Rockville, MD
Huntingdon Life Sciences Inc.
East Millstone, NJ
Bridge Laboratories
Gaithersburg, MD
IIT Research Institute (IITRI)
Chicago, IL
Calvert Laboratories
Olyphant, PA
Informa Healthcare
New York, NY
CeeTox, Inc.
Kalamazoo, MI
LAB Research Inc.
Laval, Canada
Charles River
Wilmington, MA
Leadscope, Inc.
Columbus, OH
CIT
Evreux, France
Lovelace Respiratory Research Institute
Albuquerque, NM
CorDynamics, Inc.
Chicago, IL
Maccine Pte Ltd
Singapore
Data Sciences International
St. Paul, MN
Marshall BioResources
North Rose, NY
EPL, Inc.
Sterling, VA
MB Research Laboratories
Spinnerstown, PA
89
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
MPI Research
Mattawan, MI
SciTech Recruiters, Inc.
San Diego, CA
National Library of Medicine
Bethesda, MD
Seventh Wave
Chesterfield, MO
Numira Biosciences
Irvine, CA
Sinclair Research Center, Inc.
Columbia, MO
Pacific BioLabs
Hercules, CA
SNBL USA, Ltd.
Everett, WA
PDS Preclinical Data Systems, Inc.
Mount Arlington, NJ
Southern Research Institute
Birmingham, AL
Ricerca Biosciences, LLC
Concord, Oh
SRI International
Menlo Park, CA
RTI International
Research Triangle Park, NC
Summit plc
Abbingdon, United Kingdom
SAGE
Thousand Oaks, CA
WIL Research Laboratories, LLC
Ashland, OH
WuXi AppTec
St. Paul, MN
90
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
AMERICAN COLLEGE OF TOXICOLOGY - 2008
PRESIDENT
PRESIDENT ELECT
VICE PRESIDENT
A.Wallace Hayes, Ph.D., DABT, FATS, FIBiol, FACFE
Science Advisor
Harvard School of Public Health
Dept of Environmental Health
298 South Main Street
Andover, MA 01801
T: 978-749-3085 F: 978-409-1154
Email: awallacehayes@comcast.net
Kenneth L. Hastings, Dr.P.H.
Associate VP, Reg Policy
sanofi-aventis
Corp Reg Affairs Office
4520 East West Highway
Suite 210
Bethesda, MD 20814
T: 301-771-4267 F: 301-771-4287
Email:kenneth.hastings@sanofi-aventis.com
Carol S. Auletta, MBA, DABT
Director, Program Management
Huntingdon Life Sciences
P. O. Box 2360
Mettlers Road
East Millstone, NJ 08875-2360
T: 732-873-2550 x2960 F: 732-873-3992
Email: aulettac@princeton.huntingdon.com
SECRETARY
TREASURER
PAST PRESIDENT
Tracey Zoetis, M.S.
Managing Consultant
SciLucent LLC
585 Grove Street, Suite #300
Herndon, VA 20170
T: 703-435-0033 x230 F: 703-435-0440
Email: tzoetis@scilucent.com
Mary Ellen Cosenza, Ph.D., DABT
Exec. Director, Regulatory Affairs
Amgen Inc.
1 Amgen Ct. Drive, MS 38-4-C
Thousand Oaks, CA 91320-1789
T: 805-447-6318 F: 805-499-9228
Email: mcosenza@amgen.com
Stephen B. Harris, Ph.D., FATS
Stephen B. Harris Group
6109 Madra Avenue
San Diego, CA 92120
T: (619) 469-7886 F: (619) 469-6852
Email: steve@sbhgrp.com
COUNCILORS - 2008 Only
Elaine V. Knight, Ph.D.
Research Fellow
Johnson & Johnson Pharma R&D, L.L.C.
Global Preclinical Development
P. O. Box 300, 1000 Route 202
Raritan, NJ 08869
T: 908-704-4344 F: 908-218-0668
Email: eknight@its.jnj.com
Barbara J. Mounho, Ph.D., DABT
Scientific Director
Amgen Inc.
1 Amgen Center Drive
MS 5-1-A
Thousand Oaks, CA 91320-1789
T: 805-447-5619 F: 805-499-2936
Email: bmounho@amgen.com
Richard D. Phillips, Ph.D., DABT
Senior Science Advisor
ExxonMobil Petroleum & Chemical
Hermeslaan 2
1831 Machelen
Belgium
T: 32 2 722 2550 F: 32 2 722 4209
Email: richard.d.phillips@exxonmobil.com
COUNCILORS - 2007- 2009
Norman N. Kim, M.S., DABT
Senior Director, Toxicology
Inotek Pharmaceuticals Corp.
100 Cummings Center
Beverly, MA 01915
T: 978-232-9660 F:
Email: nkim@inotekcorp.com
David G. Serota, Ph.D.
VP, Tox & Path/Sr Princ.Study Director
MPI Research
54943 N. Main Street
Mattawan, MI 49071
T: 269-668-3336 F: 269-668-4151
Email: dave.serota@mpiresearch.com
Abraham J. Tobia, Ph.D.
Regulatory & Toxicology Consultant
105 Clubstone Lane
Cary, NC 27518
T: 919-387-1167
Email: tobiaa@earthlink.net
COUNCILORS - 2008- 2010
Nancy Holmes, Ph.D., DABT
Senior Toxicologist
Alcon
6201 South Freeway
Ft. Worth, TX 76134-2099
T: 817- 615-5340 F: 817- 302-4533
Email: nancy.holmes@alconlabs.com
Tracey L. Spriggs, DABT, Ph.D.
Director, Toxicology, Worldwide R&D
GlaxoSmithKline
1500 Littleton Road
Parsippanny, NJ 07054-3884
T: 973-889-2503 F: 973- 889-2469
Email: tracey.l.spriggs@gsk.com
Joseph C. Tigner, Ph.D.
Toxicology Consultant
1 Santa Lane
New Milford, CT 06776-2363
T: 203-417-9203(c) H: 860-354-8322
Email: jtigner1523@earthlink.net
EDITOR-IN-CHIEF
Harihara M. Mehendale, Ph.D., DABT, FATS
Prof. & Kitty DeGree Endowed Chair
The University of Louisiana at Monroe
School of Pharmacy/Coll Health Sciences
700 University Drive
Monroe, LA 71209-0495
T: 318-342-1691 F: 318-342-1686
Email: mehendale@ulm.edu
Secretariat Phone Number:
301-634-7840 -
FAX Number
301-634-7852 - Email: ekagan@actox.org/clemire@actox.org
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ACT COMMITTEES – 2008
AWARDS COMMITTEE
Carol S. Auletta, MBA, DABT - Chair
2006-2008
Robert E. Osterberg, Ph.D., ATS
Aclairo PDG Inc.
8230 Leesburg Pike
Suite #620
Vienna, VA 22182
T: 703-506-6760 F: 703-506-0142
Email: pharmadrugs@comcast.net
2007-2009
Alan C. Katz, M.S.,DABT
President
toXcel LLC
7140 Heritage Village Plaza
Suite 101
Gainesville VA 20155
T: 703-335-5670 F: 703-310-6950
Email: akatz@toxcel.com
2008 - 2010
William P. Beierschmitt, PhD, DABT
Research Advisor
Pfizer Global Res & Development
Safety Sciences
Eastern Pt. Rd., Bldg. 274
Groton, CT06340
T: 860-441-5245 F: 860-441-5499
Email: william.p.beierschmitt@pfizer.com
EDUCATION COMMITTEE
Elaine V. Knight, Ph.D., David G. Serota, Ph.D., Nancy Holmes, Ph.D., Joseph C. TIgner, Ph.D., Co-Chairs
2007-2008
Daniel Christopher Kemp, Ph.D.
Senior Toxicologist
GlaxoSmithKline
Safety Assessment
P O Box 13398 - Five Moore Park
Res Triangle Pk NC 27709-3398
T: 919-483-1675
Email: daniel.c.kemp@gsk.com
2008 -2009
Hanan N. Ghantous, Ph.D., DABT
Pharmacologist/Toxicologist
US FDA
CDER/OAP/DAVP
10903 New Hampshire Avenue
Silver Spring, MD 20993
T: 301-796-0717 F: 301-796-9883
Email: hanan.ghantous@fda.hhs.gov
Patricia C. Ryan, Ph.D.
Toxicologist
MedImmune, Inc.
One MedImmune Way
Gaithersburg MD 20878
T: 301-398-4387 F: 301- 398-9387
Email: ryanp@medimmune.com
Marque D. Todd, D.V.M., DABT
Associate Research Fellow
Pfizer Inc.
Drug Safety R&D
10646 Science Center Drive (CB4)
San Diego, CA 92121
T: 858-526-4700 F: 858-678-8290
Email: marquee.todd@pfizer.com
FINANCE COMMITTEE
Mary Ellen Cosenza, Ph.D., DABT, Chair
2006-2008
Suzanne R. Wolford, Ph.D.
Senior Program Manager
Covance Laboratories, Inc.
3301 Kinsman Blvd. - 34
Madison, WI 53704
T: 608-242-2721 F: 608-242-2736
Email: suzanne.wolford@covance.com
2007-2009
Anthony L. Kiorpes, Ph.D., DVM
Consultant
2470 Skyline Drive
Bloomington, MN 55425
T: 952-854-9060
Email: a.kiorpes@att.net
92
2008 - 2010
Arpad J. Madarasz, DVM. DABT
Vice President, Bus. Development
Huntingdon Life Sciences
P. O. Box 2360
Mettlers Road
East Millstone, NJ 08875-2360
T: 732-873-2550 F: 732- 873-8899
Email:madarasa@princeton
.huntingdon.com
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
MEMBERSHIP COMMITTEE
Norman N. Kim, M.S., DABT, Chair
2006-2008
Jos. J.W.M. Mertens, Ph.D.,DABT
Assistant Director of Toxicology
WIL Research Laboratories, LLC
1407 George Road
Ashland, OH 44805-9281
T: 419-289-8700 F:419-289-3650
Email: jmertens@wilresearch.com
2007-2009
Shelley V. Ching, DVM, Ph.D.
President
SVC Associates, Inc.
2008 Sterling Silver Drive
Apex, NC 27502
T:919-387-8483 F:919-363-6665
Email: svching@worldnet.att.net
2008 - 2010
Gary Bruce Kolesar, MPH, ABT
Product Toxicologist
Dow Corning Corporation
2200 W. Salzburg Rd.
Midland, MI 48640
T:989-496-4190 F:989-96-5595
Email:gary.kolesar@dowcornin
NOMINATING COMMITTEE
Stephen B. Harris, Ph.D., FATS, Chair
2008
David R. Compton, Ph.D.
Principal Res Investigator - Tox
sanofi-aventis
Drug Safety Evaluation
1041 Route 202-206 - MC: JR2-103A
PO Box 6800
Bridgewater, NJ 08807-0800
T: 908-541-5328 F: 908-730-7132
Email: david.compton@sanofi-aventis.com
2008
Grace M. Furman, Ph.D., DABT
Principal
Paracelsus, Inc.
128 Daphne Street
Leucadia, CA 92024
T: 760-271-2858
Email: paracelsus.inc@cox.net
OUTREACH COMMITTEE
Stephen B. Harris, Ph.D., FATS, Chair
2006-2008
Maria J. Tort, Ph.D., DABT
4235 Law Street
Houston, TX 77085
T: (713) 660-6393
Email: mjtort@yahoo.com
2007-2009
Michael J Santostefano, PhD,DABT
Principal Scientist
Amgen Inc.
Comparative Biology/Sfty Sci- Tox
1201 Amgen Court West
Mail Stop - AW1/J4144
Seattle WA 98119-3105
T: 206-265-7644 F: 206-216-5932
Email: msantost@amgen.com
93
2008 -2010
Nadia Ernst, M.A.
Scientist
Amgen Inc.
One Amgen Center Dr
MS 29-2-A
Thousand Oaks, CA 91320
T: 805-447-2932 F:805-99-2936
Email: nernst@amgen.com
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
PROGRAM PLANNING (LONG RANGE) COMMITTEE
Carol S. Auletta, MBA, DABT, Chair
2006-2008
Robin C. Guy, M.S., DABT
Toxicology Consultant
Robin Guy Consulting, LLC
P. O. Box 830
Preclinical, Tox/& GLP Training
Lake Forest, IL 60045-0830
T: 847-295-9250 F: 847-295-9251
Email: rcg@robinguy.com
2007-2009
George E. Dearlove, Ph.D., DABT
Assoc Director, Reg. Affairs
Eissai Medical Research, Inc
55 Challenger Road
Ridgefield Park, NJ 07660
T: 610-274-2321
Email: gedearlove@aol.com
2008-2010
Rochelle W. Tyl, Ph.D.
Senior Fellow
RTI International
HLB-124-3040 Cornwallis Rd
P. O. Box 12194
Res Triangle Pk NC 27709
T:919-541-5972 F:919-541-6906
Email: rwt@rti.org
PUBLICATIONS COMMITTEE
Harihara M. Mehendale, Ph.D., Chair
Mary Ellen Cosenza, Ph.D., DABT
Sr. Director of Toxicology
Amgen Inc.
1 Amgen Ct. Drive, MS 38-4-C
Thousand Oaks CA 91320-1789
T: 805-447-6318 F: 805-499-2936
Email: mcosenza@amgen.com
Robert Snyder, Ph.D., ATS
Associate Dean, Research
Rutgers State Univ of NJ
Ernest Mario School of Pharmacy
160 Frelinghuysen Road, Rm. 104
Piscataway, NJ 08854-8020
T:732-445-2675 x615 F:732-445-5767
Email: rsnyder@eohsi.rutgers.edu
Shayne C. Gad, Ph.D., DABT
Gad Consulting Services
102 Woodtrail Lane
Cary, NC 27511
T:919-233-2926 F: 919-233-2927
Email: scgad@ix.netcom.com
David Hobson, Ph.D., DABT
H&H Scientific Services, LLP
613 Pleasant Valley Drive
Boerne, TX 78006
T:210-269-6169 F:830-229-5782
Email: dave@hh-llp.net
Tracey Zoetis, M.S.
Managing Consultant
SciLucent LLC
585 Grove Street
Suite #300
Herndon, VA 20170
T: 703-435-0033 x230 F: 703-435-0440
Email: tzoetis@scilucent.com
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AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
PROGRAM COMMITTEE
Kenneth L. Hastings, Dr.P.H., Program Chair
Carol S. Auletta, MBA, DABT, Huntingdon Life Sciences, East Millstone, NJ
Drew A. Badger, Ph.D., DABT, Amira Pharmaceuticals, San Diego, CA
Angelique Braen, Ph.D., DABT, Hoffman-La Roche, Inc., Nutley, NJ
Alan P. Brown, Ph.D., NAMSA, Northwood, OH
Lorrene A. Buckley, Ph.D., Eli Lilly and Company, Greenfield, IN
Mary Ellen Cosenza, Ph.D., DABT, Amgen Inc., Thousand Oaks, CA
Stephen B. Harris, Ph.D., FATS, Stephen B Harris Group, San Diego, CA
A. Wallace Hayes, Ph.D., DABT, FATS, FIBiol., FACFE, Harvard School of
Public Health, Andover, MA
David W. Hobson, Ph.D., DABT, LoneStar PharmTox, LLC, Boerne, TX
Kenneth J. Olivier, Jr., Ph.D., Merrimack Pharmaceuticals, Cambridge, MA
Melissa Rhodes, Ph.D., DABT, GlaxoSmithKline, Research Triangle Park, NC
I Y Rosenblum, Ph.D., FATS, Rosenblum Consulting, LLC, Newton, NJ
Hilary V. Sheevers, Ph.D., Aclairo PDG., Inc., Vienna, VA
95
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
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AMERICAN COLLEGE OF TOXICOLOGY
PAST PRESIDENTS
1979-1980
M. Selikoff (Deceased)
1980-1981
Myron Mehlman, Ph.D.
1981-1982
Yula Bingham, Ph.D.
1982-1983
Arthur Furst, Ph.D., Sc.D. (Deceased)
1983-1984
Gary Flamm, Ph.D.
1984-1985
Ronald W. Hart, Ph.D.
1985-1986
Marshall Steinberg, Ph.D. (Deceased)
1986-1987
Gordon W. Newell, Ph.D.
1987-1988
Robert M. Diener, D.V.M.
1988-1989
Richard M. Hoar, Ph.D.
1989-1990
Carol M. Henry, Ph.D., DABT
1990-1991
Shayne C. Gad, Ph.D., DABT
1991-1992
Mildred S. Christian, Ph.D., ATS
1992-1993
Karen M. MacKenzie, Ph.D., DABT
1993-1994
Richard D. Thomas, Ph.D., DABT
1994-1995
Sharon J. Northup, Ph.D.
1995-1996
Sidney Green, Ph.D.
1996-1997
John A. Thomas, Ph.D.
1997-1998
Christopher P. Chengelis, Ph.D.
1998-1999
David W. Hobson, Ph.D., DABT
1999-2000
Merrill R. Osheroff, Ph.D., DABT
2000-2001
Suzanne C. Fitzpatrick, Ph.D., DABT
2001-2002
Robert E. Osterberg, Ph.D.
2002-2003
John E. Atkinson, Ph.D., DABT
2003-2004
Robert Snyder, Ph.D., ATS
2004-2005
Patricia Frank, Ph.D.
2005-2006
Leigh Ann Burns Naas, Ph.D., DABT
2006-2007
Stephen B. Harris, Ph.D., FATS
2007-2008
A.Wallace Hayes, Ph.D., DABT, FATS
96
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
29th ANNUAL MEETING SPONSORS – 2008
Aclairo PDG., Inc.
Bridge Laboratories
Vienna, VA
www.aclairo.com
Gaithersburg, MD
www.bridgecro.com
Affymetrix Inc.
Bristol-Myers Squibb Company
Santa Clara, CA
www.affymetrix.com
Princeton, NJ
www.bms.com
Alcon Research, Inc.
Calvert Laboratories
Fort Worth, TX
www.alconlabs.com
Olyphant, PA
www.calvertlabs.com
Allergan
Charles River
Irvine, CA
www.allergan.com
Wilmington, MA
www.criver.com
American Chemistry Council
Charles River Labs Preclinical
Services Montreal
Arlington, VA
www.americanchemistry.com
Senneville, Canada
www.criver.com
Amgen Inc.
Thousand Oaks, CA
www.amgen.com
Covance Laboratories, Inc.
Madison, WI
www.covance.com
BASi
West Lafayette, IN
www.bastox.com
Eli Lilly and Company
Indianapolis IN
www.lilly.com
Battelle
Columbus, OH
www.battelle.org/hhs/toxicology
EPL, Inc.
Sterling, VA
www.epl-inc.com
Biogen Idec MA Inc.
Cambridge, MA
www.biogen.com
Experimur
Chicago, IL
www.experimur.com
BioReliance
Rockville, MD
www.bioreliance.com
97
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
ExxonMobil Biomedical Sciences,
Inc.
MPI Research
Mattawan, MI
www.mpiresearch.com
Annandale, NJ
www.exxonmobil.com
nanoTox Inc.
Austin, TX
www.nanotox.com
Frito-Lay, Inc.
Plano, TX
www.fritolay.com
Novartis Pharmaceutical
Corporation
Genentech, Inc.
South San Francisco, CA
www.gene.com
East Hanover, NJ
www.novartis.com
GlaxoSmithKline
Pfizer Inc.
Research Triangle Park, NC
www.gsk.com
Groton, CT
www.pfizer.com
Harlan Laboratories, Inc.
Philip Morris International
Indianapolis, IN
www.harlan.com
Lausanne, Switzerland
www.philipmorrisinternational.com
Health and Environmental
Sciences Institute (HESI)
Purdue Pharma LP
Cranberry, NJ
www.pharma.com
Washington, DC
www.ilsi.org
Ricerca Biosciences, LLC
Hoffmann-La Roche, Inc.
Concord, OH
www.ricerca.com
Nutley, NJ
www.rocheusa.com
sanofi-aventis
Huntingdon Life Sciences
Bridgewater, NJ
www.sanofi-aventis.com
East Millstone, NJ
www.huntingdon.com
Southern Research Institute
Birmingham, AL
www.southernresearch.org
Informa Healthcare
New York, NY
www.informahealthcare.com
SciLucent, LLC
LAB Research Inc.
Herndon, VA
www.scilucent.com
Laval, Canada
www.labresearch.com
Stiefel Research Institute, Inc.
Merck and Company
Coral Gables FL
www.stiefel.com
West Point, PA
www.merck.com
98
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
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Summit Drug Development
Services, LLC
Rockville, MD
www.summitdrug.com
WIL Research Laboratories, LLC
Ashland, OH
www.wilresearch.com
WuXi AppTec
St. Paul, MN
www.wuxiapptec.com
Wyeth Research
Chazy, NJ
www.wyeth.com
99
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
________________________________________________________________________
29TH ANNUAL MEETING CONSULTANT
SPONSORSHIP
Hugh E. Black, DVM, Ph.D.
Hugh E Black & Associates, Inc., Sparta, NJ
hugh.black@h-black.com
William J. Brock, Ph.D.
Brock Scientific Consulting, LLC, Montgomery Village, MD
billbrock@comcast.net
Shelley V. Ching, D.V.M., Ph.D.
SVC Associates Inc., Apex, NC
svching@worldnet.att.net
Chris R. Coggins, Ph.D.
Carson Watts Consulting, LLC, King NC
chris@carsonwattsconsulting.com
Patricia Frank, Ph.D.
Patricia Frank & Associates, Inc., Evanston, IL
patfrank@att.net
Shayne C. Gad, Ph.D., DABT
Gad Consulting Services, Cary, NC
scgad@ix.netcom.com
Robin C. Guy, M.S., DABT
Robin Guy Consulting, LLC, Lake Forest, IL
rcg@robinguy.com
William C. Hall, VMD, Ph.D., DACVP
Hall Consulting, Inc., Mount Airy, MD
hallconsulting@earthlink.net
100
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
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Stephen B. Harris, Ph.D.
Stephen B. Harris Group, San Diego, CA
steve@sbjgrp.com
Robert W. Kapp, Jr., Ph.D.
BioTox, Lutherville, MD
rwkapp@gmail.com
Alan C. Katz, M.S., DABT
toXcel LLC, Gainesville, VA
akatz@toxcel.com
Dennis J. Naas, B.S., PMP®
ProDev Consulting Services, Ltd., Poway, CA
dennisnaas@cox.net
Sharon J. Northup, Ph.D., DABT
Northup RTS, Highland Park, IL
northuprts@aol.com
Richard A. Parent, Ph.D., DABT, FATS, RAC
Consultox, Ltd., Damariscotta, ME
rparent@consultox.com
Karen S. Regan, D.V.M., DABT
Regan Path./Tox. Services Inc., Ashland, OH
kregan@zoominternet.net
George M. Shopp, Ph.D., DABT
Shopp Nonclinical Consulting LLC, Boulder CO
george@shoppnonlcin.com
Steven M. Snyder, M.S.
Outsourcing Support Services, Inc., Noblesville IN
info@outsource-support.com
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AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
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ACT CORPORATE MEMBERSHIP - 2008
Abbott Laboratories, Abbott Park, IL
Alcon Research, Inc., Fort Worth, TX
Allergan, Irvine, CA
American Chemistry Council, Arlington, VA
American Petroleum Institute, Washington, DC
Amgen Inc., Thousand Oaks, CA
AstraZeneca LP, Wilmington, DE
BASi, West Lafayette, IN
Battelle, Columbus, OH
Baxter Healthcare Corporation, Round Lake, IL
Bayer Healthcare Pharmaceuticals, Pine Brook, NJ
Biogen Idec MA, Inc., Cambridge, MA
Boehringer Ingelheim, Ridgefield, CT
Bristol-Myers Squibb, PRI, Princeton, NJ
Cantox Health Sciences International, Mississauga, Ontario, Canada
Centocor, Inc., (Johnson & Johnson) Radnor, PA
Charles River, Wilmington, MA
Covance Laboratories Inc., Madison, WI
Data Sciences International, Saint Paul, MN
Eli Lilly and Company, Indianapolis, IN
EPL, Inc., Sterling, VA
Experimur, Chicago, IL
ExxonMobil Biomedical Sciences, Inc., Annandale, NJ
Frito-Lay, Inc., Plano, TX
Genentech, Inc., South San Francisco, CA
GlaxoSmithKline, Research Triangle Park, NC
Halozyme Therapeutics, Inc., San Diego, CA
Hoffmann-La Roche, Inc., Nutley, NJ
Huntingdon Life Sciences, PRC, East Millstone, NJ
Integrated Laboratory Systems, Research Triangle Park, NC
L’Oreal USA, Inc., Clark, NJ
MannKind Corporation, Valencia, CA
MPI Research, Mattawan, MI
Novartis Pharmaceutical Corporation, East Hanover, NJ
P&G Pharmaceuticals Inc., Mason, OH
Pfizer Inc., Groton, CT
Philip Morris USA, Richmond, VA
Purdue Pharma, LP, Cranbury, NJ
sanofi-aventis, Bridgewater, NJ
Schering-Plough Research Institute, Lafayette, NJ
Sequani Limited, Ledbury, United Kingdom
TAP Pharmaceutical Products Inc., Lake Forest, IL
WIL Research Laboratories, LLC, Ashland, OH
Wyeth Research, Chazy, NY
102
AMERICAN COLLEGE OF TOXICOLOGY 29TH ANNUAL MEETING
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ACT 30TH ANNUAL MEETING
NOVEMBER 1 - 4, 2009
WYNDHAM PALM SPRING
PALM SPRINGS, CA
**************************************
ACT 31ST ANNUAL MEETING
NOVEMBER 7 - 10, 2010
BALTIMORE MARRIOTT WATERFRONT HOTEL
BALTIMORE, MD
**************************************
ACT 32nd ANNUAL MEETING
NOVEMBER 6 - 9, 2011
ARIZONA BILTMORE
PHOENIX, AZ
103