PROGRAM
FOR THE
THIRTIETH ANNUAL MEETING
OF THE
AMERICAN COLLEGE OF
TOXICOLOGY
NOVEMBER 1 – 4, 2009
Palm Springs Convention Center
277 N Avenida Caballeros
Palm Springs, CA 92262-6440
Wyndham Palm Springs Hotel
888 Tahquitz Canyon Way
Palm Springs, CA 92262
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
GENERAL INFORMATION
SOCIAL ACTIVITIES
who will talk on "INTEGRATION OF
PRECLINICAL AND CLINICAL SAFETY
DATA:
A
REGULATORY
PERSPECTIVE";
Sunday–
ANNIVERSARY PARTY
Monday -
2) Tuesday Morning – J. William
Langston, M.D., Scientific Director, CEO
& Founder, The Parkinson’s Institute &
Clinical Center, Sunnyvale, CA who will
talk on “PARKINSON’S DISEASE –
LATEST UPDATES”;
ACT LUNCHEON
BRIDGE LABORATORIES
RECEPTION
Tuesday – SAGE POSTER
RECEPTION
Wednesday
–
WUXI
APPTEC
FAREWELL RECEPTION
3) Wednesday Morning - Bruce N.
Ames, Ph.D., Professor & Senior
Scientist, Children's Hospital Oakland
Research Institute, Oakland, CA who
will talk on “DELAYING AGE-RELATED
DISEASE WITH MICRONUTRIENTS:
TRIAGE THEORY.”
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
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 Twenty First Annual
Furst Award at the Annual Luncheon
during the Thirtieth Annual Meeting in
Palm Springs, CA.
PLENARY LECTURE SERIES
This year the College is fortunate to
have three Plenary Lecturers:
ACT STUDENT TRAVEL AWARD
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.
1) Monday Morning – Douglas C.
Throckmorton M.D., Deputy Director,
US FDA, CDER, Silver Spring, MD
ii
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
2009 PROGRAM OUTLINE
Time
Sunday 11/01
Monday 11/02
Tuesday 11/03
Wednesday 11/04
7:00am
Continental Breakfast
Continental Breakfast
Continental Breakfast
Continental Breakfast
Course I – AM+PM
Study Director Training
Course II
Interaction w Reg Agencies
Course III
Study Monitoring
Course IV
Advanced Topics
Biotherapeutic Drug Dvlpmt
Course V
Drug Abuse Dependence…
Plenary Lecture
Plenary Lecture
Plenary Lecture
9:00
Symp. 1
FDA 101: Introduction to
Office of New Drugs
Symp. 2
The Asthma Epidemic:…..
Symp. 3
Endocrine Dis.(EDSP)
Symp. 13
Consumer Prod.-Hot Topics
Symp. 14
Network Biology in Drug….
Symp. 15
Threshold of Toxicologic
Concern
12:00
Luncheon
DSA Lecture
Awards
Symp. 7
Advancing Reg.Chemicals..
Symp. 8
HIV-From Protest to
Protease and Beyond
Symp. 9
Impact of Product
Comparability Issues…..
AD HOC 2010 Program
Planning Mtg – OPEN TO
ALL – SIGN UP
Symp. 10
Trends In Excipient Sfty…..
Symp. 11
Developmental Immunotoxicity Testing Biopharma.
Symp. 12
Contemporary Issues in
Hearing Loss….
Symp. 16
Hot Topics
Symp. 17
Space Toxicology: …….
Symp. 18
Exposure-Specific Differenc
in Inflammatory…Respirato
Disease
8:00
1:00
Course V I
Drug Transporters…..
Course VII
Use Non-Human Primates….
Course VIII
Consulting in Toxicology
Course IX
Pathology for Toxicologist
1:30
2:00
Symp. 4
Reducing Variables…….
Symp.5
Phospholipidosis: …….
Symp. 6
Combination Products….
ACT Members Meeting
5:30
6:00
6:30
7:00
ACT 30th Anniversary
Party
Sage
Wine/Cheese Poster
Session
WuXI Apptec Reception
Bridge Labs Recpt
iii
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
PROGRAM
30TH ANNUAL ACT MEETING
PALM SPRINGS CONVENTION CENTER
PALM SPRINGS, CALIFORNIA
SUNDAY, November 1, 2009
7:00 am – 8:00 am
Continental Breakfast
Lobby- Convention Center
7:30 am – 5:30 pm
Registration
Lobby- Convention Center
12:00 pm – 5:00 pm
Exhibit Set Up
Oasis I
12:00 pm – 5:00 pm
Poster Set up
Oasis I
6:00 pm – 7:30 pm
ANNIVERSARY CELEBRATION
Catalina/Madera-Hotel
This activity is supported by an educational donation provided by:
AMGEN INC, Thousand Oaks, CA
8:00 am – 4:30 pm
Mesquite DE
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 logistical-, regulatory- and scientific-related
aspects of toxicology studies. The course will be divided into two parts (morning and
afternoon sessions). The morning session will focus on the practicalities of study
1
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
director responsibilities for study conduct, oversight, protocols, animal models, 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. The topics to be covered in
the afternoon session include other scientific aspects of toxicology studies such as
safety pharmacology, assessment of immune function (immunotoxicology) and review
and interpretation of histopathology data.
8:00 am
WELCOME AND INTRODUCTION
Barbara J. Mounho, Ph.D., DABT, Scientific Director, Amgen Inc.,
Thousand Oaks, CA
8:10 am
STUDY CONDUCT & 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 Wolford, Ph.D., DABT, Study Director, Covance Inc., Madison,
WI
9:20 am
PRINCIPLES AND PRACTICES FOR GENERATING QUALITY
DOCUMENTS
Mark D. Walker, DVM, Senior Director, Scientific and Laboratory
Operations, Charles River, 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
ANIMAL MODELS USED IN TOXICOLOGY STUDIES
Laura Conour, DVM, DACLAM, Senior Director, Veterinary Services,
Charles River, Shrewsbury, MA
11:30 am
LUNCH BREAK
1:45 pm
SAFETY PHARMACOLOGY STUDIES
Tom Beck, Ph.D., Associate Director, Safety Pharmacology, Covance
Laboratories, Inc., Madison, WI
2:30 pm
IMMUNOTOXICOLOGY EVALUATION FOR BIOLOGICS
Lynne LeSauteur, Ph.D., Preclinical Services, Charles River, Senneville,
Canada
3:10 pm
Refreshment Break
2
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
3:50 pm
CLINICAL AND ANATOMIC PATHOLOGY FOR STANDARD
PRECLINICAL TOXICOLOGY STUDIES: DATA INTEGRATION AND
INTERPRETATION
Kevin McDorman, DVM, Ph.D., DACVP, Preclinical Services, Charles
River, Reno, NV
______________________________________________________________________
8:00 am – 11:30 am
COURSE #2
Mesquite GH
INTERACTING WITH REGULATORY AUTHORITIES: WHAT TO DO AND
WHAT NOT TO DO
Co-Chairs: Melissa Rhodes, PhD, DABT, Manager, Safety Assessment Projects,
GlaxoSmithKline, Research Triangle Park, NC and Hanan Ghantous, PhD, DABT,
Pharmacologist/Toxicologist Supervisor, US FDA, Silver Spring, MD
During the process of drug development, a Sponsor will need to interact with regulatory
authorities (RA), such as the FDA and the EMEA. In order to effectively interact with
these agencies, the Sponsor must remember that the RA are not the enemy. They have
a genuine concern about the well being of the patients and considerable institutional
knowledge about the design and possible knowledge of other drugs in the same class.
This course will discuss how to effectively interact with the RA so that Sponsors can gain
the greatest benefit from their meetings.
8:00 am
INTERACTING WITH CDER DIVISIONS OF FDA
Jeri El Hage, Ph.D., Senior Consultant, Aclairo PDG, Vienna, VA
8:40 am
INTERACTING WITH CBER DIVISIONS OF FDA
Martin D. Green, Ph.D., Supervisory Toxicologist, US FDA, Vaccine
Research and Review, Division of Vaccines and Related Product
Applications, Rockville, MD
9:20 am
INTERACTING WITH THE FDA: THE "ANIMAL RULE"
Christopher Ellis, Ph.D., Pharmacology/Toxicology Reviewer, US FDA,
Center for Drug Evaluation and Research, Silver Spring, MD
10:00 am
Refreshment Break
10:20 am
INTERACTING WITH EMEA
Christopher
Powell,
FRCPath,
Director
GlaxoSmithKline, Welwyn, United Kingdom
11:00 am
Safety
Assessment,
INTERACTING WITH PMDA
Kazuichi Nakamura, D.V.M., Ph.D., Manager, Shionogi & Co., Ltd.,
Product Development Regulatory Affairs Department, Tokyo, Japan
______________________________________________________________________
3
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
8:00 am – 11:30 am
Primrose C
COURSE #3
STUDY MONITORING AT CROs. KEEPING YOUR SANITY AND ACHIEVING
THE BEST PRODUCT (BEST PRACTICES, PITFALLS, AND KEYS TO
EFFICIENCY
Chair: Paul L. Roney, Ph.D., DABT, Senior Consultant, Toxicology, Kendle International
Inc., Rockville, MD
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). It will also discuss the interactions
between the Study Monitor and the CRO before, during and after the study. It will
conclude with a CRO’s Study Director’s perspective of what makes an effective team
between the Study Monitor and the Study Director. This course is a must for any
toxicologist who is responsible for outsourcing toxicology studies, no matter what sort of
company he/she works for.
8:00 am
INTRODUCTION
Paul L. Roney, Ph.D., DABT, Senior Consultant, Toxicology, Kendle
International Inc., Rockville, MD
8:10 am
OUTSOURCING NONCLINICAL SAFETY STUDIES: BEST
PRACTICES FOR SELECTING A CRO
Jon Daniels, Ph.D., DABT, ERT, Vice President and Senior Toxicologist,
Intrinsik Health Sciences Inc., Mississauga, Canada
8:40 am
AN INDUSTRY VETERAN'S GUIDE TO EFFECTIVE STUDY
MONITORING
Steven M. Snyder, M.S., President, Outsourcing Support Services, Inc.,
Noblesville, IN
9:10 am
STUDY MONITOR THE CRO’s FRIEND OR FOE
Susan McPherson, M.Sc., Manager Toxicology,
Laboratories, Shanghai, China
9:40 am
Charles
River
QA ASSESSMENT
Kate Longman, B.S., RQAP-GLP, Manager, Quality Assurance Research,
MPI Research, Inc., Mattawan, MI
10:10 am
Refreshment Break
10:30 am
LEGAL
AND FINANCIAL ARRANGEMENTS (BALANCING ACT
BETWEEN YOU, THE ATTORNEYS AND SARBANES-OXLEY)
4
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
Clynn Wilker, DVM, Ph.D., DABT, Senior Director, Preclinical Safety
Assessment, Ardea Biosciences, San Diego, CA
11:00 am
Q&A
______________________________________________________________________
8:00 am – 11:30 am
Primrose D
COURSE #4
ADVANCED TOPICS IN BIOTHERAPEUTIC DRUG DEVELOPMENT
Chair: Marque Todd, DVM, MS, DABT, Regulatory Strategy Lead, Pfizer, Inc., La Jolla,
CA
In the past several years, there has been a significant increase in the number of
biotherapeutics that have entered late-stage development and it is projected that this
number will expand rapidly in the next decade. It is expected that a number of these
products will reach the market in the near future. As biotherapeutics are advanced
through the nonclinical development process, there are scientific hurdles and potential
challenges that must be overcome that are unique to later stage development and are
different from those faced with pharmaceuticals. In addition, the regulatory requirements
for clinical trials and product registration are rapidly evolving as worldwide regulatory
agencies gain more experience with biotherapeutics. This course is designed to give
participants practical, up-to-date case-driven information on the following topics in
nonclinical biotherapeutic drug development: reproductive/developmental toxicity and
carcinogenicity testing including the use of homologous proteins, derisking
immunotoxicity and immunogenicity issues, comparability evaluation and testing, risk
management and regulatory strategy considerations.
8:00 am
INTRODUCTION
Marque Todd, DVM, MS, DABT, Regulatory Strategy Lead, Pfizer, Inc.,
La Jolla, CA
8:05 am
REPRODUCTIVE/ DEVELOPMENTAL TOXICITY TESTING OF
BIOTHERAPEUTICS
William J. Breslin, Ph.D., Senior Research Advisor, NSD Safety
Assessment, Eli Lilly and Company, Indianapolis, IN
8:40 am
CARCINOGENICITY TESTING OF BIOTHERAPEUTICS
Marque Todd, DVM, MS, DABT, Regulatory Strategy Lead, Pfizer, Inc.,
La Jolla, CA
9:15 am
DERISKING
STRATEGIES
FOR
IMMUNOTOXICITY
AND
IMMUNOGENICITY ISSUES
Daniel Wierda, Ph.D., Research Fellow, Eli Lilly and Company,
Indianapolis, IN
9:50 am
Refreshment Break
5
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
10:15 am
PRODUCT COMPARABILITY DETERMINATIONS FOR BIOLOGICS:
SCIENTIFIC BASIS FOR REGISTRATION REQUIREMENTS AND
ROLE OF A PRECLINICAL SCIENTIST
James Daniel Green, Ph.D., Senior Vice President, Preclinical and
Clinical Development, Sciences, Biogen IDEC, Inc., Cambridge, MA
10:50 am
RISK MANAGEMENT AND REGULATORY STRATEGY
Jeffrey A. Engelhardt, DVM, Ph.D., DACVP, President and Pathologist,
Engelhardt Consulting, Inc., Camarillo, CA
______________________________________________________________________
8:00 am – 11:30 am
Smoketree A-C
COURSE #5
DRUG ABUSE AND DEPENDENCE ASSESSMENT:
NEUROBEHAVIORAL
SCIENCES
TO
ADDRESS
EVALUATION AND DRUG CONTROL POLICY
APPLICATION OF
DRUG
SAFETY
Chair:
Theodore J. Baird, Ph.D., Senior Director, Safety Pharmacology and
Neurobehavioral Sciences, MPI Research, Mattawan, MI
Due to the innovative and pioneering efforts of specialists in the field of behavioral
pharmacology, predictive methodologies have been discovered and elaborated to
identify and characterize potential abuse and dependence liability issues associated with
either illicit or therapeutic drugs. Recent regulatory guidelines from the International
Conference on Harmonisation (ICH), the European Medicines Agency (EMEA), and the
proposed, and as yet unpublished, federal regulatory guidelines from the United States
Food and Drug Administration (FDA) may come into direct conflict with current
International and National Drug Control Policy laws and regulations with respect to these
study designs (Single Convention on Narcotic Drugs, 1961; Psychotropic Convention
1970; U.S. Comprehensive Drug Abuse and Control Act, 1971). The current regulatory
pressure to conduct these studies under Good Laboratory Practice (GLP) guidelines
sets the stage for a more detailed review by pharmaceutical company experts, IND/NDA
consultants, as well as Contract Research Organizations with respect to ambiguous drug
control and drug enabling policy requirements. This continuing education program will
review the current models needed to comply with current EMEA, FDA, and ICH
guidelines with respect to preclinical abuse liability testing for health agency approval.
The program will also give details of both drug safety and drug control laws and
regulations that must be met for successful review at both health and law enforcement
agencies, and that ultimately will ensure compliance with international and national drug
control requirements. Important distinctions between drug safety and drug control
issues, as well as the appropriate application of neurobehavioral methodologies to
address the questions of abuse versus dependence liability in the preclinical drug
development arena, amid a changing regulatory environment, will be discussed.
8:00 am
AN INTRODUCTION
ASSESSMENT
TO
DRUG
6
ABUSE
AND
DEPENDENCE
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
Theodore J. Baird, Ph.D., Senior Director, Safety Pharmacology and
Neurobehavioral Sciences, MPI Research, Mattawan, MI
8:40 am
DRUG
DEVELOPMENT
IN
THE
CONTEXT
OF
NATIONAL/INTERNATIONAL DRUG CONTROL POLICY
Mr. Frank L. Sapienza, M.S., Partner and Consultant, The Drug and
Chemical Advisory Group, Fairfax, VA
9:45 am
Refreshment Break
10:00 am
DRUG ABUSE AND DEPENDENCE STUDIES:
BACKGROUND,
EXPERIMENTAL PARADIGMS, STUDY EXECUTION, AND DATA
INTERPRETATION
David V. Gauvin, Ph.D., Director, Neurobehavioral Sciences, MPI
Research, Mattawan, MI
11:10 am
PANEL DISCUSSION
______________________________________________________________________
SUNDAY AFTERNOON – 11/1/09
8:00 am- 4:30 pm
COURSE #1
Mesquite DE
STUDY DIRECTOR TRAINING CONTINUED
_____________________________________________________________________
1:00 pm – 4:30 pm
Mesquite GH
COURSE #6
DRUG TRANSPORTERS IN TOXICOLOGY
Chair: Lisa D. Beilke, Ph.D., Research Scientist II, Gilead Sciences, Inc., Foster City, CA
Transporters are expressed in a wide variety of tissues including liver, kidney, intestine,
and brain where they play key roles in the absorption, distribution and excretion of both
xenobiotics and endobiotics. In recent years, the understanding of drug transport
systems has become increasingly important as we begin to comprehend how changes in
their expression and function relate to pharmacological and toxicological consequences.
There are several classes of transporters (ex., organic anion and cation transporters)
with varying tissue distribution, expression and substrate specificity. During liver
disease, a number of intrinsic adaptive responses occur to minimize the detrimental
effects of accumulating endobiotics, such as bilirubin and bile acids. Characteristic
adaptive modifications that occur in the liver relate to expression changes in basolateral
(sinusoidal) and canalicular transport systems which are regulated by transcription
factors and nuclear hormone receptors. The kidney is another site with multiple
transporters involved in the active renal secretion of compounds. Included will be a
discussion of renal transporters and how these transporters affect drug-drug interactions
and contribute to the toxicity of antiviral nucleotides and other therapeutic agents. The
7
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
design of drugs to target specific transporters can be used to more selectively deliver
drugs to a target organ while avoiding distribution to other organs, thereby reducing
potential side effects. Lastly, an understanding of transporters and their related issues in
PKDM will be discussed to provide insight on how to evaluate lead molecules as
substrates or inhibitors in the drug discovery process.
1:00 pm
FUNDAMENTALS OF ORGANIC ANION TRANSPORT SYSTEMS
Lauren Aleksunes, PharmD, Ph.D., Assistant Professor, Rutgers
University, Ernest Mario School of Pharmacy, Piscataway, NJ
1:40 pm
ORGANIC CATION TRANSPORTERS IN PHARMACOLOGY AND
TOXICOLOGY
Kathy Giacomini, Ph.D., Professor of Biopharmaceutical Sciences,
Cellular and Molecular Pharmacology & Pharmaceutical Chemistry,
University of California, San Francisco, CA
2:20 pm
REGULATION OF TRANSPORTER EXPRESSION OF OBESITY,
DIABETES, AND STEATOHEPATITIS:
IMPLICATIONS FOR
ALTERED DRUG ABSORPTION AND EXCRETION
Angela Slitt, Ph.D., Assistant Professor, Department of Biomedical and
Pharmaceutical Sciences, University of Rhode Island, Kingston, RI
3:00 pm
Refreshment Break
3:10 pm
RENAL ORGANIC ANION TRANSPORTERS AND THEIR ROLE IN
TOXICITY
Tomas Cihlar, Ph.D., Senior Principal Scientist, Biology, Gilead Sciences,
Inc., Foster City, CA
3:50 pm
IMPACT OF DRUG TRANSPORTERS ON PHARMACOKINETICS AND
DRUG METABOLISM
Magang Shou, Ph.D., Director of PKDM, Amgen Inc., Thousand Oaks,
CA
______________________________________________________________________
1:00 pm – 4:30 pm
Primrose C
COURSE #7
USE OF NON-HUMAN
REPRODUCTIVE TOXICITY
PRIMATES
IN
THE
ASSESSMENT
OF
Chair: Angélique Braen, Ph.D., DABT, Toxicologist, Hoffmann-La Roche, Inc., Nutley,
NJ
Sponsored in part by: COVANCE LABS, Madison, WI
This course will focus on the use of non-human primates in the assessment of various
aspects of reproductive toxicity. The course will discuss various study designs and
8
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
provide examples, data interpretation, and regulatory guidance/expectations for these
type of studies.
1:00 pm
INTRODUCTION
Angélique Braen, Ph.D., DABT, Toxicologist, Hoffmann-La Roche, Inc.,
Nutley, NJ
1:40 pm
PRACTICAL ISSUES AND STUDY DESIGN OF REPRODUCTIVE
TOXICOLOGY STUDIES
Gerhard Weinbauer, Ph.D., Director, Res & Safety Assessment, Covance
Laboratories GmbH, Muenster, Germany
2:20 pm
CASE SCENARIOS FROM PHARMACEUTICAL INDUSTRY
Noel Dybdal, D.V.M., Ph.D., DACVP, Senior Pathologist, Genentech, Inc.,
So San Francisco CA
3:00 pm
Refreshment Break
3:20 pm
REGULATORY
GUIDANCE
AND
EXPECTATIONS
FOR
DEVELOPMENTAL EVALUATION (US AND EX-US)
Grace S. Lee, Ph.D., Pharmacologist/Toxicologist, US FDA, CDER,
Division of Pulmonary and Allergy Products, Silver Spring, MD
4:00 pm
Q&A
______________________________________________________________________
1:00 pm – 4:30 pm
Primrose D
COURSE #8
CONSULTING IN TOXICOLOGY
Chair: Patricia Frank, Ph.D., Patricia Frank & Associates, Inc., Evanston, IL
Sponsored in part by: PATRICIA FRANK & ASSOCIATES, INC., Evanston, IL
For many years, toxicology consulting was a part-time filler for academicians or a fallback position for those looking for a “real” job. Today, consulting in all areas of
toxicology including regulatory toxicology (FDA, EPA, and world-wide regulatory bodies),
expert testimony and areas requiring specific functional expertise such as reproductive
toxicology or neurotoxicology is a full-time, recognized and needed profession. Many
toxicologists reach a point in their careers where they are considering consulting as the
next professional step. This course is designed to help those people explore the
different areas of toxicology consulting, determine if consulting is suitable for them as
well as if they are suitable for consulting, and to learn about the business of consulting.
Consultants who have been in business for many years will present their insights and
tips into how to be a successful consultant.
1:00 pm
INTRODUCTION TO CONSULTING
9
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
Patricia Frank, Ph.D., Patricia Frank & Associates, Inc., Evanston, IL
1:10 pm
CONSULTING IN THE PHARMACEUTICAL INDUSTRY
Patricia Frank, Ph.D., Patricia Frank & Associates, Inc., Evanston, IL
1:35 pm
EXPERT TESTIMONY
Richard A. Parent, Ph.D., DABT, FATS, RAC, President, Consultox, Ltd,
Damariscotta, ME
2:00 pm
CONSULTING IN THE CHEMICAL INDUSTRY
Thomas M Dydek, Ph.D., DABT, PE, Senior Toxicologist & Engineer,
Dydek Toxicology Consulting, Austin, TX
2:25 pm
Refreshment Break
2:40 pm
THE BUSINESS OF CONSULTING
Shayne C. Gad, Ph.D., DABT, ATS, Gad Consulting Services, Cary, NC
3:05 pm
TAKING THE PLUNGE-A FEW WORDS FROM A NEW CONSULTANT
Merrill R. Osheroff, Ph.D., DABT, President, Osheroff Consulting Services
LLC, Mattawan, MI
3:30 pm
PANEL DISCUSSION ON CONSULTING
______________________________________________________________________
1:00 pm – 4:30 pm
Smoketree A-C
COURSE #9
PATHOLOGY FOR THE TOXICOLOGIST:
BASIC CONCEPTS
TOXICOLOGIC PATHOLOGY AND PATHOLOGY DATA INTEGRATION
OF
Co-Chairs: Peter C. Mann, DVM, DACVP, Veterinary Pathologist/President of the
Society of Toxicologic Pathology, EPL, Seattle, WA and LuAnn McKinney, DVM,
DACVP, Pathologist, Silver Spring,, MD
Pathology is often a determining endpoint in the safety assessment of drugs and
chemicals. It is extremely important that pathologists clearly communicate with the other
scientists involved in the conduct and reporting of toxicology and hazard identification
studies so that regulatory agencies can easily understand the information in the reports.
This course will include a discussion of the role of the toxicologic pathologist in
toxicology studies and basic principles of toxicologic pathology including terminology and
lesions common to all organs. Additionally the course will focus on integration of clinical
pathology (e.g. serum chemistry, hematology, urinalysis) and morphologic pathology
data as well as pathology endpoints with data not traditionally generated by pathologistsi.e. drug metabolism and distribution, safety pharmacology, genetic toxicology, etc.
1:00 pm
BASIC CONCEPTS IN PATHOLOGY AND THE ROLE OF THE
TOXICOLOGIC PATHOLOGIST
LuAnn McKinney, DVM, DACVP, Pathologist, Silver Spring, MD
10
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
1:40 pm
HISTOPATHOLOGIC PRACTICE AND APPROACHES: RELEVANCE
AND INTERPRETATION IN RISK ASSESSMENT
Dianne Margaret Creasy, Ph.D., FRCPath, Senior Director of Pathology,
Huntingdon Life Sciences, East Millstone, NJ
2:20 pm
THE HISTOPATHOLOGY/ CLINICAL PATHOLOGY CONUNDRUM
Vincent Meador, DVM, Ph.D., DACVP, Senior Director, Toxicology,
Amgen Inc., Seattle, WA
3:00 pm
Refreshment Break
3:30 pm
CONTEXTUAL INTERPRETATION OF IN VIVO DATA
Jeffery A. Engelhardt, DVM, Ph.D., DACVP, FIATP, President and
Pathologist, Engelhardt Consulting, Inc., Camarillo, CA
4:10 pm
Q&A
______________________________________________________________________
6:00 pm
30TH ANNIVERSARY PARTY
Catalina/Madera-Hotel
“A CELEBRATION OF OUR PAST, PRESENT & FUTURE”
________________________________________________________________
MONDAY MORNING, 11/2/09
7:00 am – 8:00 am
Oasis I
7:30 am – 5:30 pm
Continental Breakfast
Registration
Lobby- Convention Ctr
12:00 pm – 5:00 pm
ACT EXHIBITORS
Oasis I
12:00 pm – 5:00 pm
Oasis I
Posters
11
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
8:00 am – 8:45 am
Primrose B
PLENARY LECTURE
DOUGLAS C. THROCKMORTON M.D.
Deputy Director
US FDA, CDER
Silver Spring, MD
“INTEGRATION OF PRECLINICAL AND CLINICAL
SAFETY DATA: A REGULATORY PERSPECTIVE”
______________________________________________________________________
9:00 – 12:00
SYMPOSIUM I
Primrose B
FDA 101: INTRODUCTION TO FDA’S OFFICE OF NEW DRUGS
Co-Chairs: Norman Kim, M.S, DABT, Senior Director, Toxicology and Preclinical
Development, Inotek Pharmaceuticals, Lexington, MA and Timothy McGovern, Ph.D.,
Consultant, SciLucent, Herndon, VA
This symposium is intended to provide an introduction to the U.S. FDA’s Office of New
Drugs (OND) and nonclinical insights of selected divisions within the OND. The OND,
contained in the Center for Drug Evaluation and Research (CDER), is composed of six
distinct offices: Office of Drug Evaluation (ODE) I, ODE II, ODE III, Office of
Antimicrobial Products, Office of Oncologic Drug Products, and Office of Nonprescription
Products. Five of the six offices will be discussed in this session. Speakers will illustrate
the organizational structure of the Divisions within each Office, and will further describe
the functions and operations of the following selected Divisions: Neurology and
Psychiatry (in ODE I), Pulmonary and Allergy (in ODE II), Reproductive and Urology (in
ODE III), Anti-Infective and Ophthalmology (Office of Antimicrobial Products), and the
Office of Oncology Drug Products (Divisions of Drug and Biologic Oncology Products).
Presentations will also include information about the reviewing division, the responsibility
of the pharmacology/toxicology reviewers and their supervisor, interaction with other
pharmacology/toxicology reviewers within and outside their respective divisions, how
consultations with other divisions are dealt with, and how divisions communicate with
sponsoring companies. Nonclinical requirements and recommendations unique to these
divisions in consideration of the target indications and the clinical phases of drug
development will be discussed. A panel discussion will follow presentations.
12
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
9:00 am
INTRODUCTION
Norman Kim, M.S, DABT, Senior Director, Toxicology and Preclinical
Development, Inotek Pharmaceuticals, Lexington, MA
9:10 am
INTRODUCTION TO DIVISION OF ANTI-INFECTIVES
OPHTHALMOLOGY PRODUCTS
Amy Ellis, Ph.D., USFDA. CDER. OND, Silver Spring, MD
9:35 am
INTRODUCTION TO DIVISION OF NEUROLOGY PRODUCTS AND
DIVISION OF PSYCHIATRY PRODUCTS
Paul Roney, Ph.D., DABT, Toxicologist, Kendle International, Rockville,
MD
10:00 am
INTRODUCTION TO DIVISION OF PULMONARY AND ALLERGY
PRODUCTS
Timothy McGovern, Ph.D., Consultant, SciLucent, Herndon, VA
10:25 am
Refreshment Break
10:40 am
INTRODUCTION TO DIVISION OF REPRODUCTIVE AND UROLOGIC
PRODUCTS
Lynnda Reid, Ph.D., Pharmacology/Toxicology Team Leader, US FDA,
CDER, OND, Silver Spring, MD
11:05 am
INTRODUCTION TO DIVISION OF DRUG ONCOLOGY PRODUCTS
AND DIVISION OF BIOLOGIC ONCOLOGY PRODUCTS
David Morse, Ph.D., Principal Consultant, Parexcel Consulting, Bethesda,
MD
11:30 am
PANEL DISCUSSION AND Q&A
AND
______________________________________________________________________
9:00 – 12:00
Primrose C
SYMPOSIUM II
THE ASTHMA EPIDEMIC: RESEARCH AND DEVELOPMENT EFFORTS FOR
MANAGEMENT
Co-Chairs: Matthew Reed, Ph.D., DABT, Director, Preclinical Drug Development,
Lovelace Respiratory Research Institute, Albuquerque, NM and Jerry F. Hardisty, DVM,
DACVP, Fellow IATP, President, Veterinary Pathologist, EPL, Inc., Research Triangle
Park, NC
Sponsored in Part by:
EPL, INC., Sterling, VA and LOVELACE RESPIRATORY
RESEARCH INSTITUTE, Albuquerque, NM
Asthma is a condition characterized by inflammation of the lining of the airways and
intermittent spasm of the underlying smooth muscle. More than 22 million Americans
13
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
have asthma, and it is one of the most common chronic diseases of childhood, affecting
an estimated 6 million children. Occupational asthma is the most prevalent occupational
lung disease in the United States. Approximately 15 to 23 percent of asthma cases in
the United States are due to occupational exposures. Comparatively more is known
about the cause of asthma caused by work (occupational asthma) than about other
forms of asthma. It is often but not always the result of allergy to an inhaled dust or
vapor in the workplace. In the home, exposure to allergens from house dust mites can
be a contributing factor in the development of asthma as well as a cause of its
symptoms. Other allergens from pollen, molds, animal dander etc can cause asthmatic
symptoms. Outside the home in the general environment increase in asthmatic
symptoms has been attributed to exposure to soya bean dust and to oil seed rape. The
contribution to the causation of asthma by irritant gases such as sulphur dioxide,
nitrogen dioxide and ozone is still unclear, although it is known that these substances
can certainly aggravate symptoms in those who are already asthmatic. Since its
pathogenic mechanism(s) are unknown, animal models have been developed to
investigate the various disease processes, as well as to enable study of environmental
and genetic factors which may contribute to disease development. Numerous
parameters can be measured in animal systems, including specific and total
immunoglobulin E (IgE), pulmonary eosinophilia, diaphragm contractions and airflow
muscle hypertrophy. It is recognized that no single factor is sufficient to lead to a
conclusion of occupational asthma, but rather that a selected combination of parameters
is most fitting.
9:00 am
ASTHMA EPIDEMIC: AN OVERVIEW OF DISEASE PROCESS,
ENVIRONMENTAL AND GENETIC FACTORS
David Diaz-Sanchez, Ph.D., Chief, Clinical Research Branch, US EPA,
Chapel Hill, NC
9:30 am
ANIMAL MODELS FOR ASTHMA: CONTROVERSIAL ASPECTS AND
UNSOLVED PROBLEMS
Edward (Ted) G. Barrett, PhD, Staff Scientist, Respiratory Immunology
and Asthma Program, Lovelace Respiratory Research Institute,
Albuquerque, NM
10:00 am
Refreshment Break
10:20 am
NEW TARGETS FOR DRUG DEVELOPMENT IN ASTHMA
Matthew Reed, Ph.D., DABT, Director, Preclinical Drug Development,
Lovelace Respiratory Research Institute, Albuquerque, NM
10:50 am
DEVELOPING PHARMACEUTICALS FOR USE IN ASTHMA: TEST
CASE MDIs
Chet L. Leach, PhD, DABT, Consultant in Pulmonary Drug Development,
Tijeras, NM
11:20 am
PANEL DISCUSSION
______________________________________________________________________
14
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
9:00 – 12:00
SYMPOSIUM III
Primrose D
ENDOCRINE DISRUPTOR SCREENING PROGRAM (EDSP)
Co-Chairs: Irma M. Grossi, Ph.D., MBA, Sr. Director, Preclinical Pharmaceutical
Sciences, RTI Health Solutions, Research Triangle Park, NC and Nelson Wilson, B.S.,
DABT, Director, Laboratory Operations & Toxicology Services, EPL, Inc., Sterling, VA
Sponsored in Part by: EPL, INC., Sterling, VA and RTI INTERNATIONAL, Research
Triangle Park, NC
Since the publication of Rachel Carson’s Silent Spring, there has been concern that
chemicals in the environment might exert profound and deleterious effects on wildlife
populations, and that human health is inextricably linked to the health of the
environment. Endocrine disrupting compounds encompass a variety of chemical
classes, including hormones, plant constituents, pesticides, compounds used in the
plastics industry and in consumer products, and other industrial by-products and
pollutants. Based on this and other evidence, Congress passed the Food Quality
Protection Act in 1996, requiring that USEPA initiate the Endocrine Disruptor Screening
Program (EDSP) to assay pesticide chemicals and environmental contaminants for their
potential to affect the estrogenic, androgenic, or thyroid hormone systems of humans
and wildlife. This symposium will provide an overview of potential problems, the EPA
EDSP program, and mammalian and aquatic tests that have been designed to provide
the answers to these difficult issues. The faculty will include all stakeholders including
scientists from the academic research community, regulatory authorities, contract
research organizations, and industry.
9:00 am
WHAT ARE ENDOCRINE DISRUPTORS AND WHY ARE WE
CONCERNED?
Edward F. Orlando, Ph.D., Assistant Professor of Reproductive Biology,
Department of Animal & Avian Sciences,, University of Maryland,
College Park, MD
9:30 am
UPDATE ON EPA’S APPROACH FOR SCREENING AND TESTING
CHEMICALS FOR POTENTIAL ENDOCRINE EFFECTS (EDSP)
Leslie W. Touart, Ph.D., Senior Ecotoxicologist, US EPA, Washington,
DC
10:00 am
Refreshment Break
10:20 am
ENDOCRINE DISRUPTION IN WILDLIFE AND AQUATIC ANIMALS
Jeffrey Wolf, DVM, DACVP, Veterinary Pathologist, EPL, Inc., Sterling,
VA
10:50 am
DEVELOPMENT OF MAMMALIAN ENDOCRINE DISRUPTOR
SCREENING AND TESTING
Rochelle W. Tyl, Ph.D., DABT, Senior Toxicologist, Research Triangle
Institute, Research Triangle Park, NC
15
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
PANEL DISCUSSION
_____________________________________________________________________
1:20 am
12:00 pm – 2:00 pm
Catalina/Madera - Hotel
ACT LUNCHEON
Welcome and Award Ceremony
Kenneth L. Hastings, Dr.P.H., DABT, President ACT
Lifetime Contribution Award
PATRICIA FRANK, Ph.D.
Patricia Frank & Associates, Inc.
Evanston, IL
ACT President’s Award
Best Paper in the International Journal of Toxicology 2009
Furst Award
Best Student Poster 2009
Student Travel Awards
Marshall Steinberg Award
KEYNOTE SPEAKER & DISTINGUISHED SERVICE AWARDEE
JOHN E. CASIDA, Ph.D.
Director, Professor of Entomology & Toxicology
Environmental Chemistry & Toxicology Laboratory
Department Environmental Science, Policy & Management
University of California, Berkeley, CA
“MECHANISM-BASED TOXICOLOGY: NICOTINE
VERSUS NEONICOTINOID INSECTICIDES”
16
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
MONDAY AFTERNOON, 11/2/09
2:00 – 5:00
SYMPOSIUM IV
Primrose D
REDUCING VARIABLES AFFECTING INTERPRETATION OF TOXICOLOGY
STUDIES
Co-Chairs: David L. Hopper, DVM, Ph.D., DABT, Director of Toxicology, BASi, Mount
Vernon, IN and Jerry F. Hardisty, DVM, DACVP, Fellow IATP, President/ Veterinary
Pathologist, EPL, Inc., Research Triangle Park, NC
Sponsored in Part by: BASi, West Lafayette, IN and HARLAN LABORATORIES,
INC., Indianapolis, IN
There are many variables that can affect the interpretation of toxicity studies. These
variables include environmental, physical, chemical and biological factors that may
influence the response of the test species to test article exposure. Other critical factors
include the selection of the test animal that is most appropriate for the study being
conducted. A thorough knowledge of the spectrum of spontaneous disease in rodents,
dogs and non-human primates is critical when interpreting findings in studies designed
to minimize the number of animals on test. The selection of the appropriate diet and
understanding the potential the effects of non-nutrients that may be present as dietary
contaminants is critical. This symposium will discuss these factors and provide guidance
to optimize the study design to manage or eliminate study variables.
2:00 pm
TRUST ME – I’M A PATHOLOGIST
Peter C. Mann, DVM, DACVP, Manager, EPL Northwest, EPL, Inc.,
Seattle, WA
2:30 pm
RODENT DIETS AND NUTRITION AS A STUDY VARIABLE
Graham Tobin, Ph.D., Director, Technical Services, Teklad Diets Europe,
Harlan Laboratories UK Limited, Bicester, United Kingdom
3:00 pm
USE OF PLACEBO, VEHICLE, AND POSITIVE CONTROLS AND
RECOVERY GROUPS TO AID IN STUDY INTERPRETATION
Klaus Weber, PhD, Dr. rer.nat., Dipl.Biol.,Vet.-Ing., Head of
Pathology/Diagnostics, Chief Scientific Officer, RCC Ltd., Harlan Inc.,
Itingen, Switzerland
3:30 pm
Refreshment Break
3:50 pm
OPTIMIZING THE DESIGN OF PRELIMINARY TOXICITY STUDIES
FOR PHARMACEUTICAL SAFETY TESTING
David L. Hopper, DVM, Ph.D., DABT, Director of Toxicology, BASi, Mount
Vernon, IN
4:20 pm
PANEL DISCUSSION
______________________________________________________________________
17
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
2:00 – 5:00
SYMPOSIUM V
Primrose C
PHOSPHOLIPIDOSIS:
EVALUATION
NONCLINICAL
ASSESSMENT
AND
RISK
Chair: Elizabeth Huggins Romach, Ph.D., DABT, Director, Safety Assessment Projects,
GlaxoSmithKline, Research Triangle Park, NC; Co-Chair: James Willard, Ph.D.,
Pharmacologist, US FDA, CDER, Silver Spring, MD
Phospholipidosis observed in nonclinical studies continues to be an active area of
regulatory interest relevant to the progression of clinical studies and the approval and
marketing of pharmaceutical products as well as an active area of research to improve
knowledge of the mechanisms and the clinical implications. This symposium will present
and summarize the history of drug-induced phospholipidosis, including important
chemical structural features and classes of pharmaceuticals that have been associated
with phospholipidosis, and discuss morphologic/diagnostic criteria and impact on a drug
development program. The discussion of morphology will address diagnostic criteria,
including potential target organs, light microscopic changes suggestive of
phospholipidosis and ultrastructural evaluations and diagnostic criteria and will discuss
potential clinical biomarkers. Human risk assessment and regulatory implications will be
discussed and illustrated by a case study. The final presentation will be an update on
progress of the CDER Phospholipidosis Working Group initiative and will include a panel
session. The presentations should be of interest to drug development project team
leaders, toxicologists, pathologists, and clinical research managers involved in
pharmaceutical drug discovery and development preclinical and clinical research
activities, or discussions with regulatory agencies
2:00 pm
HISTORY OF DRUG INDUCED PHOSPHOLIPIDOSIS
Mark J. Reasor, Ph.D., DABT, Professor of Physiology and
Pharmacology,, West Virginia University Health Sciences Center,
Morgantown, WV
2:35 pm
MORPHOLOGIC
EVIDENCE
OF
PHOSPHOLIPIDOSIS,
AND
POTENTIAL BIOMARKERS FOR CLINICAL APPLICATION
Richard A. Peterson, DVM, Ph.D., DACVP, Director, Molecular and
Ultrastructural Pathology, GlaxoSmithKline, Research Triangle Park, NC
3:15 pm
Refreshment Break
3:35 pm
THE IMPACT OF PHOSPHOLIPIDOSIS ON DRUG DEVELOPMENT;
ILLISTRATING HUMAN RISK ASSESSMENT WITH A CASE HISTORY
James S. MacDonald, Ph.D., DABT, President, Chrysalis Pharma
Consulting, LLC, Chester, NJ
4:10 pm
THE SLIPPERY SLOPE: EXPERIENCES OF THE CDER
PHOSPHOLIPIDOSIS WORKING GROUP
James Willard, Ph.D., Pharmacologist, US FDA, CDER, Silver Spring,
MD
18
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
4:45 pm
PANEL SESSION
______________________________________________________________________
2:00 – 5:00
SYMPOSIUM VI
Primrose B
COMBINATION
PRODUCTS:
SAFETY
CONSIDERATIONS
PHARMACEUTICALS WHEN ADMINISTERED IN COMBINATION
OTHER PHARMACEUTICALS, DEVICES, OR BIOLOGICS
FOR
WITH
Co-Chairs: Nancy Holmes, Ph.D., DABT, Assistant Director, Toxicology, Alcon
Laboratories, Inc., Fort Worth, TX and Tracey Zoetis, M.S., Managing Consultant,
SciLucent, LLC, Herndon, VA
Sponsored in Part by: ALCON LABORATORIES, INC., Fort Worth, TX
Medicine is being advanced by the combination of drug, device and/or biologic
products. Drugs combined with drugs treat multiple etiologies of a single disease.
Drugs or biologics combined with the right device can enhance delivery to targeted
tissues. Combination products are currently being used in the treatment of a broad array
of indications including coronary artery disease, diabetes, asthma, and chronic
ulcers. Challenges encountered by toxicologists in the design and conduct of studies to
support the development of combination products will be discussed. The Symposium
will begin with a Pathologist’s perspective on diagnosing the effects of each component
and their combination in a product. Nonclinical study designs to test the combination of
drugs, devices and/or biologic products will be presented, followed by a case study that
illustrates the process. Finally, the FDA review and approval process for combination
products will be presented. Presentations will focus on practical aspects of nonclinical
testing and regulatory approaches. This symposium will provide information necessary
to design, conduct, and prepare regulatory submissions to support clinical trials with
combination products.
2:00 pm
MICROSCOPIC EVALUATION OF COMBINATION PRODUCTS IN
NONCLINICAL STUDIES – CHALLENGES, METHODS, AND
EXAMPLES
Daniel J. Patrick, DVM, DACVP, Principal Pathologist, MPI Research,
Mattawan, MI
2:35 pm
NONCLINICAL TESTING STRATEGIES FOR COMBINATION
PRODUCTS
Tracey Zoetis, M.S., Managing Consultant, SciLucent, LLC, Herndon, VA
3:10 pm
Refreshment Break
3:35 pm
A CASE STUDY: SAFETY EVALUATION OF OPHTHALMIC DRUGDEVICE COMBINATION PRODUCTS
Alan P. Brown, Ph.D., DABT, Senior Toxicologist, NAMSA, Northwood,
OH
19
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
4:05 pm
REVIEW AND APPROVAL PROCESS FOR COMBINATION
PRODUCTS
Brian E. Harvey, M.D., Ph.D., Vice President Regulatory Policy, sanofiaventis, Bethesda MD
4:40 pm
PANEL DISCUSSION
______________________________________________________________________
5:30 pm
MEMBERS’ MEETING (Members Only)
Primrose C
Call to Order - President, Kenneth L. Hastings, Dr.P.H., sanofi-aventis, Bethesda MD
Minutes from 2008 Annual Meeting - Secretary, Elaine V. Knight, Ph.D., Johnson &
Johnson Pharma R&D, L.L.C., Raritan, NJ
Officers Reports
President - Kenneth L. Hastings, Dr.P.H., sanofi-aventis, Bethesda MD
President Elect – Carol S. Auletta, MBA, DABT, Huntingdon Life Sciences, East
Millstone, NJ
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, A. Wallace Hayes, Ph.D., DABT, FATS,
Harvard School of Public Health, Andover, MA
Publications Committee - Editor-in-Chief, Mary Beth Genter, Ph.D, DABT, University of
Cincinnati, Cincinnati, OH
7:00 pm - 9:00 pm
Catalina/Madera-Hotel
BRIDGE LABORATORIES RECEPTION
_______________________________________________________
20
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
TUESDAY MORNING, 11/3/09
7:00 am – 8:00 am
Oasis I
Continental Breakfast
7:30 am – 5:30 pm
Registration
Lobby – Convention Ctr
12:00 pm – 4:00 pm
ACT EXHIBITORS
Oasis I
Last Day
12:00 pm – 5:00 pm
Oasis I
Posters
8:00 am – 8:45 am
Primrose B
PLENARY LECTURE
J. WILLIAM LANGSTON, M.D.
Scientific Director, CEO & Founder
The Parkinson’s Institute & Clinical Center
Sunnyvale, CA
“PARKINSON’S DISEASE – LATEST UPDATES”
________________________________________________________________
9:00 – 12:00
Primrose B
SYMPOSIUM VII
ADVANCES IN REGULATING CHEMICALS IN EUROPE, U.S. AND CANADA:
THE INTERSECTION OF SCIENCE AND POLICY
Chairs: Richard A. Becker, Ph.D., DABT, Senior Toxicologist, 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
There have been significant changes in the assessment and regulatory management
approaches for commodity chemicals globally. In Europe, the law enacting Registration,
21
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
Evaluation, Authorization and Restriction of Chemical substances (REACH), which
entered into force in June 2007, requires manufacturers to obtain health, safety and
environmental information on their chemical substances and to register this information
in a European Chemicals Agency database. Progress with implementing REACH will be
discussed. In 2006, Canada completed the systematic prioritization and categorization
of the approximately 23,000 existing substances on the Canadian Domestic Substances
List (DSL) based on considerations of Persistence, Bioaccumulation and Inherently
Toxic to the Environment and Greatest Potential for Human Exposure and Inherently
Toxic to Humans, yielding three possible outcomes: no further action required, the
chemical substance is determined to be toxic and measures may be needed for control,
or it is placed on the Priority Substances List (PSL) and subjected to an in-depth
assessment. Progress with the Canadian DSL process will be discussed. In the U.S.,
the Toxic Substances Control Act (TSCA), enacted in 1976, governs the regulation and
management of commodity chemicals. Recognizing advances that have been made,
ideas on approaches to improve the use of risk-based methods to enhance the U.S.
system will be discussed. The efforts of the international chemicals industry to
implement a global system to enhance health, safety and environmental protection for
chemical production and use will also be presented. Advances in technologies will soon
permit rapid screening of thousands of substances using genomics, high throughput
screening and computational profiling; the promise and challenges of applying these
approaches to improving chemical assessments and management actions will be
discussed.
9:00 am
REACH IMPLEMENTATION: EARLY LESSONS FOR HEALTH DATA
REQUIREMENTS
Richard D. Phillips, Ph.D., DABT, Senior Science Advisor, ExxonMobil
Petroleum & Chemical, Machelen, Belgium
9:25 am
REQUIRING GREATER ACCOUNTABILITY FOR CHEMICAL USE IN
CANADA
Fe de Leon, Researcher, Canadian Environmental Law Association,
Toronto, Canada
9:50 am
IMPROVING THE CHEMICAL REGULATORY SYSTEM IN THE US
Charles M. Auer, B.S., Charles Auer & Associates, LLC, Poolesville MD
10:15 am
Refreshment Break
10:35 am
ICCA GLOBAL PRODUCT STRATEGY:
BUILDING PUBLIC
CONFIDENCE IN CHEMICALS
Gregory G. Bond, PhD, MPH, FACE, Corporate Director of Product
Responsibility, The Dow Chemical Company, Midland, MI
11:00 am
CHALLENGES AND OPPORTUNITIES FOR ASSESSING AND
REGULATING
CHEMICALS WITH GENOMICS
AND HIGH
THROUGHPUT MOLECULAR SCREENING TECHNIQUES
Richard A. Becker, Ph.D., DABT, Senior Toxicologist, American
Chemistry Council, Arlington, VA
________________________________________________________________
22
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
9:00 – 12:00
Primrose D
SYMPOSIUM VIII
HIV – FROM PROTEST TO PROTEASE AND BEYOND
Co-Chairs: Laine Peyton Myers, Ph.D., Pharmacology/Toxicology Reviewer, US FDA,
Silver Spring, MD and Grushenka H. I. Wolfgang, PhD, DABT, Vice President, Drug
Safety Evaluation, Gilead Sciences, Inc., Foster City, CA
March 20, 1987 saw the initial approval of the first anti-HIV pharmaceutical (AZT,
azidothymidine, a nucleoside reverse transcriptase inhibitor) which was a major
landmark in the history of the AIDS epidemic in the US. With the need for rapid approval
of drugs to treat HIV, the US Food and Drug Administration restructured and established
the Division of Antiviral Products (1988) and created the accelerated approval process
for serious or life-threatening illnesses (Federal Register, 1992). Since the rapid
approval of the first nucleoside analogs, there are now 6 classes of anti-HIV drug
products. These classes of anti-HIV drugs consist of ~30 different approved drug
products. Different toxicities have been identified for each class. This symposium will
cover the historical perspectives and current paradigms of HIV treatment, the classes of
anti-HIV medications, US regulatory perspectives and industry challenges in nonclinical
toxicity assessment, as well as current clinical practices to manage the clinical toxicology
associated with anti-HIV medications.
9:00 am
INTRODUCTION
MECHANISMS
OF
ACTION,
HISTORICAL
PERSPECTIVE, AND CHANGES IN DRUG DEVELOPMENT
PARADIGMS
Jeffrey S. Murray, M.D., Deputy Director, Division of Antiviral Products,
US FDA, CDER/OAP/DAVP, Silver Spring, MD
9:35 am
NONCLINICAL SAFETY ASSESSMENT OF ANTI-HIV THERAPEUTICS
– A REGULATORY PERSPECTIVE
Laine Peyton Myers, Ph.D., Pharmacology/Toxicology Reviewer, US
FDA, CDER/OAP/DAVP, Silver Spring, MD
10:15 am
Refreshment Break
10:30 am
NONCLINICAL SAFETY ASSESSMENT OF ANTI-HIV THERAPEUTICS
– AN INDUSTRY PERSPECTIVE
Grushenka H. I. Wolfgang, PhD, DABT, Vice President, Drug Safety
Evaluation, Gilead Sciences, Inc., Foster City, CA
11:10 am
CLINICAL SAFETY AND TOLERABILITY OF ANTIRETROVIRAL
THERAPY
Richard Haubrich, M.D., Professor of Medicine, University of California
San Diego, Division of Infectious Diseases, San Diego, CA
11:50 am
Q&A
______________________________________________________________________
23
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
9:00 – 12:00
Primrose C
SYMPOSIUM IX
IMPACT OF PRODUCT COMPARABILITY ISSUES IN BIO-THERAPEUTIC
SAFETY ASSESSMENT PROGRAMS – ROLE OF NONCLINICAL
ASSESSMENTS
Co-Chairs: Laura Andrews, Ph.D., DABT, Vice President – Pharmacology and
Toxicology, Genzyme Corporate, Framingham, MA and James D. Green, Ph.D., DABT,
Senior Vice President - Preclinical and Clinical Development Sciences, Biogen Idec Inc.,
Cambridge, MA
Sponsored in part by: Charles River, Wilmington, MA
The concept of product comparability is one which has been developed within the
biotechnology industry over the last decade; however, the advent of biosimilar
manufacturers and the establishment of new regulatory guidances in this area that
address preclinical, clinical and quality requirements have impacted innovator
companies and their ability to make process changes. In 2005, ICH issued the
document "Q5E Comparability of Biotechnological/Biological Products Subject to
Changes in their Manufacturing Process." This guidance describes how to assess if a
manufacturing change necessitates an additional clinical study to demonstrate the safety
and efficacy of a biological product or whether nonclinical biochemical, bioactivity,
pharmacokinetic and toxicology assessments would be sufficient. Recent additional
guidance documents from Europe and Canada are also setting the stage for
considerations of product comparability. This symposium will address product
comparability studies for biotherapeutic products and how changes during the
development process may affect the type and extent of necessary nonclinical
comparability assessments. In addition to specific discussions around biologic and gene
therapy comparability, this session will also provide a regulatory perspective on
comparability assessments and will include case studies which highlight the challenges
in biotherapeutic product comparability assessments.
9:00 am
CURRENT PERSPECTIVE ON COMPARABILITY ISSUES: SUMMARY
OF DIA MEETING
Mary Ellen Cosenza, Ph.D., DABT Executive Director, Regulatory Affairs,
Amgen Inc., Thousand Oaks, CA
9:20 am
PRECLINICAL COMPARABILITY ASSESSMENTS OF A BIOLOGIC
PRODUCT
Laura Andrews, Ph.D., DABT, Vice President – Pharmacology and
Toxicology, Genzyme Corporate, Framingham, MA
9:50 am
CDER PERSPECTIVE ON COMPARABILITY OF A BIOLOGIC
PRODUCT
M. Stacey Ricci, Sc.D., Toxicologist, US FDA, CDER, Office Oncology
Drug Products, Office of New Drugs, Silver Spring, MD
10:20 am
Refreshment Break
24
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
10:40 am
GENE THERAPY COMPARABILITY
Timothy MacLachlan, Ph.D., Genzyme Corporation, Framingham, MA
11:20 am
CBER PERSPECTIVE ON COMPARABILITY
Ramjay Vatsan, Ph.D., GTB/Division of Cellular & Gene Therapies, US
FDA, OCTCT/CBER, Rockville, MD
11:40 am
WRAP UP AND DISCUSSION SESSION
James D. Green, Ph.D., DABT, Senior Vice President - Preclinical and
Clinical Development Sciences, Biogen Idec Inc., Cambridge, MA
TUESDAY AFTERNOON, 11/3/09
12:00 noon – 1:15 pm
AD HOC 2010 PROGRAM PLANNING MEETING
Smoketree C
Open to all – sign up, in advance, at registration desk
________________________________________________________________
1:30 – 5:00
Primrose C
SYMPOSIUM X
TRENDS IN EXCIPIENT SAFETY EVALUATION
Co-Chairs: Robert E. Osterberg, Ph.D., ATS, Senior Consultant, Aclairo PDG., Inc.,
Vienna, VA and Christopher C. DeMerlis, M.S., Manager, Regulatory Affairs, Colorcon,
Inc., West Point, PA
Sponsored in part by: INTERNATIONAL PHARMACEUTICAL
EXCIPIENTS COUNCIL-AMERICAS (IPEC),
Arlington, VA
Excipients are used in all drug products and in most food products. New technologies
are being tested to increase the amount or rate of absorption and new and novel
excipients may be included amongst them. New physical approaches such as
nanoparticles of drug and excipients or lysosomes may offer better drug delivery,
especially of hard-to-absorb or difficult-to-formulate oral drugs. New excipients may
improve or mask the flavor of foods, drugs and dietary supplements. Recently,
impurities in drug products have become subject to greater scrutiny and various national
and international guidelines, guidances and regulations have been proposed and some
have been accepted for use; excipient evaluation can be included in these efforts. This
symposium will discuss new developmental concepts, guidelines/guidances and
regulations involving impurities in excipients, new drug delivery systems involving
excipients and thoughts for possible improvement to these guidelines. This symposium
will offer information to members of the food additive, drug, dietary supplement, cosmetic
manufacturers and regulators regarding the safety of these new and/or promising areas
of product development.
25
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
1:30 pm
INTRODUCTION
Christopher C. DeMerlis, M.S., Manager, Regulatory Affairs, Colorcon,
Inc., West Point, PA
2:05 pm
EXCIPIENTS IN NEW AND SPECIALIZED AREAS OF DRUG
DELIVERY
David W. Hobson, Ph.D., DABT, Principal, LoneStar PharmTox LLC,
Boerne, TX
2:40 pm
CURRENT AND FUTURE METHODS FOR THE SAFETY
ASSESSMENT OF EXCIPIENTS
Robert E. Osterberg, Ph.D., ATS, Senior Consultant, Aclairo PDG., Inc.,
Vienna, VA
3:15 pm
Refreshment Break
3:35 pm
EXISTING PROCEDURES FOR INGREDIENT SAFETY EVALUATIONS
WITH APPLICATIONS TO EXCIPIENTS: PCPC, GRAS, FDA & FEMA
Jeffrey J. Yourick, Ph.D., DABT, Chemical S&T Manager, Chemical
Medical Countermeasures, Chemical and Biological Technologies
Directorate Defense Threat Reduction Agency, Fort Belvoir, VA
4:10 pm
TOXICOLOGICAL CONCERN FOR IMPURITY SAFETY
Timothy J. McGovern, Ph.D., Senior Consultant, SciLucent LLC,
Herndon, VA
4:45 pm
Q&A
______________________________________________________________________
1:30 – 5:00
Primrose B
SYMPOSIUM XI
DEVELOPMENTAL
IMMUNOTOXICITY
(BIO)PHARMACEUTICALS
TESTING
OF
Co-Chairs: Mark Collinge, Ph.D., Principal Scientist, Immunotoxicology, Pfizer, Inc.,
Groton, CT and Jacintha M. Shenton, Ph.D., Principal Toxicologist, MedImmune Inc.,
Cambridge, UK
Sponsored in part by: ILSI-HESI IMMUNOTOXICOLOGY TECHNICAL
COMMITTEE, Washington, DC
Regulatory guidances on the subject of developmental immunotoxicity (DIT) safety
testing highlight this area as an important concern that warrants sponsor attention,
especially in the case of suspected immunosuppressive drugs. However, there are no
accompanying recommendations concerning what studies would be appropriate for
evaluating the potential immunotoxic effects on the developing fetus or neonate. This
lack of specific guidance for DIT studies reflects the general paucity of information
relating to the sensitivity and relevance of the non-adult versus the adult immune
systems. Moreover, there is little comparative data regarding toxic effects of chemicals
26
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
or drugs on discrete windows of early immune system development. Other complicating
factors include differences in placental transport and fetal drug exposures between
rodents and non-human primates (NHPs), especially with regard to DIT testing of
biopharmaceuticals. These factors have led in many cases to the default position that
biopharmaceuticals are best tested in NHP because of the known similarities in immune
system development compared with humans. In contrast, the chemical industry
routinely uses a rat DIT and DART testing model. Given the desire to limit the use of
NHPs for research, this symposium will address under what circumstances it may, or
may not, be appropriate to use the rat model for DART and DIT testing of
biopharmaceuticals. Speakers will address best practices for the chemical industry
regarding DIT testing, review our current basic understanding of the developing immune
systems in rodents, NHPs and humans, and also compare and contrast scientific
reasons behind the different industry approaches to DIT testing. A panel discussion will
follow the presentations to solicit audience input on recommendations posed by the
presenters with the intent that the sum information will guide a subsequent workshop on
this subject in the near future.
1:30 pm
CURRENT APPROACHES TO ASSESS RISK TO THE DEVELOPING
IMMUNE SYSTEM: SOME PRACTICAL CONSIDERATIONS
Michael P. Holsapple, Ph.D., A.T.S., Executive Director, ILSI Health and
Environmental Sciences Institute (HESI), Washington, DC
2:00 pm
CRITICAL WINDOWS IN DEVELOPMENT OF THE RODENT
AND PRIMATE IMMUNE SYSTEM
Kenneth Landreth, Ph.D., Professor of Microbiology, Dept Microbiology,
Immunology & Cell Biology, West Virginia University, Morgantown, WV
2:30 pm
COMPARATIVE DEVELOPMENT OF THE IMMUNE SYSTEM IN
PRIMATES
Prof. Dr. Eberhard Buse, Director Pathology, Covance Laboratories
GmbH, Muenster, Germany
3:00 pm
Refreshment Break
3:20 pm
DRAFT OECD RECOMMENDATIONS FOR DIT TESTING
Michael Woolhiser, Ph.D., Science & Technology Leader, Toxicology &
Environmental Research and Consulting, The Dow Chemical Company,
Midland, MI
3:50 pm
A ROSE IS A ROSE IS [NOT] A ROSE: WHY THE APPROACH TO DIT
EVALUATION OF (BIO)PHARMACEUTICALS IS UNIQUE
Leigh Ann Burns Naas, Ph.D., DABT, Senior Director, Pfizer Global R&D,
San Diego, CA
4:20 pm
PANEL DISCUSSION
______________________________________________________________________
27
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
1:30 – 5:00
SYMPOSIUM XII
Primrose D
CONTEMPORARY ISSUES IN HEARING LOSS – FROM THE BENCH TO THE
BEDSIDE
Co-Chairs: Leslie Lemke, Ph.D., DABT, Assistant Director, Pharmaceutical Toxicology,
Alcon Laboratories, Fort Worth, TX and Mary Beth Genter, Ph.D., DABT, Associate
Professor, University of Cincinnati, Cincinnati, OH
Sponsored in part by: MPI RESEARCH, Mattawan, MI
Chemically-induced hearing loss, or ototoxicity, is an often-overlooked endpoint in
toxicology studies, despite the fact that certain pharmaceuticals, solvents, and noise are
known risk factors for hearing loss in humans. This symposium brings together speakers
who can address methodological issues, as well as occupational risk factors, quality of
life issues, and contemporary thoughts on interventions. The symposium should be of
interest to a broad audience of those attending the ACT annual meeting, and, given that
this topic is not widely addressed in scientific meetings, should provide new fundamental
and practical information to those attendees in the chemical and pharmaceutical
industries, as well as those in academia and occupational medicine.
1:30 pm
INTRODUCTION AND OVERVIEW
Mary Beth Genter, Ph.D., DABT, Associate Professor, University of
Cincinnati, Cincinnati, OH
1:35 pm
PRACTICAL APPROACHES FOR OTOTOXICITY TESTING INTENDED
FOR REGULATORY SUBMISSION
Leslie Lemke, Ph.D., DABT, Assistant Director, Pharmaceutical
Toxicology, Alcon Laboratories, Fort Worth, TX
2:15 pm
HISTOPATHOLOGIC EVALUATION OF THE EAR
Kenneth A. Schafer, DVM, Ph.D., DACVP, Senior Pathologist, Vet Path
Services, Mason, OH
3:00 pm
Refreshment Break
3:15 pm
CHEMICAL INTERACTIONS IN THE AUDITORY SYSTEM
Thais C. Morata, Ph.D., Research Audiologist, National Institute for
Occupational Safety and Health, Hearing Loss Prevention Section,
Cincinnati OH
4:00 pm
DEVELOPMENT OF A DRUG TO TREAT HEARING LOSS
Josef Miller, P.D., Ruth and Lynn Townsend Professor of Communication
Disorders, Kresge Hearing Research Institute, University of Michigan,
Ann Arbor, MI
______________________________________________________________________
28
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
5:30 pm - 7:00 pm
Oasis I
POSTER SESSION & RECEPTION
Sponsored by: SAGE
WEDNESDAY MORNING, 11/4/09
7:00 am – 8:00 am
Primrose Foyer
Continental Breakfast
7:30 am – 3:30 pm
Registration
Lobby- Convention Ctr
8:00 am – 8:45 am
Primrose B
PLENARY LECTURE
Sponsored in Part By:
WIL RESEARCH LABORATORIES, LLC, Ashland, OH
BRUCE N. AMES, Ph.D.
Professor and Senior Scientist
Children's Hospital Oakland Research Institute
Oakland, CA
“DELAYING AGE-RELATED DISEASE WITH
MICRONUTRIENTS: TRIAGE THEORY”
________________________________________________________________
29
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
9:00 – 12:00 Primrose C
SYMPOSIUM XIII
CONSUMER PRODUCTS – HOT TOPICS
Co-Chairs: Tracey L. Spriggs, Ph.D., DABT, Director Toxicology, GlaxoSmithKline
Consumer Healthcare, Parsippany, NJ and Jon F. Lalko, B.S., Senior Test Program
Specialist, R.I.F.M., Woodcliff Lake, NJ
Sponsored in part by: GLAXOSMITHKLINE CONSUMER
HEALTHCARE, Parsippany NJ
This Hot Topics session will include presentations on current issues of interest related to
consumer products. Presentations will span different types of consumer products,
including drugs, food and cosmetics and will raise awareness as well as provide
informative updates on such topics as bisphenol A exposure and safety, fragrance
allergen risk assessment, food allergen labeling in the United States, alternatives to
animal testing and their importance for the Cosmetics Directive in Europe and OTC
cough cold medications in children and root causes for overdose.
9:00 am
INTRODUCTION
Tracey L. Spriggs, Ph.D., DABT, Director Toxicology, GlaxoSmithKline
Consumer Healthcare, Parsippany, NJ
9:05 am
BISPHENOL A: GHOST OR VILLIAN?
Calvin C. Willhite, Ph.D., Staff Toxicologist, State of California,
Department of Toxic Substances Control, Berkeley, CA
9:35 am
DERMAL RISK ASSESSMENT FOR FRAGRANCE ALLERGENS
Jon F. Lalko, B.S., Senior Test Program Specialist, R.I.F.M., Woodcliff
Lake, NJ
10:05 am
Refreshment Break
10:25 am
FOOD ALLERGY UPDATE
Felicia B. Billingslea, Director, Food Labeling & Standards Staff, Office of
Nutrition, Labeling and Dietary Supplements, US FDA, CFSAN, College
Park, MD
10:55 am
ALTERNATIVES TO ANIMAL TESTING: STATE OF PLAY FOR EU
COSMETICS 7TH AMENDMENT 2009 ENDPOINTS
Pauline McNamee, Ph.D., Principal Scientist, Procter & Gamble
Technical Centres Ltd., Egham, United Kingdom
11:25 am
ROOT CAUSES OF OVERDOSE WITH OTC COUGH AND COLD
MEDICINES IN CHILDREN
Edwin Kuffner, M.D., Senior Director, Medical Affairs, McNeil Consumer
Healthcare, Ft. Washington, PA
______________________________________________________________________
30
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
9:00 – 12:00
Primrose D
SYMPOSIUM XIV
NETWORK BIOLOGY IN DRUG DEVELOPMENT (USE OF COMPUTER
MODELING TO PREDICT PHYSIOLOGICAL RESPONSES)
Chair: Kenneth J Olivier Jr, Ph.D., Associate Director of Toxicology, Merrimack
Pharmaceuticals, Cambridge, MA
Sponsored in Part by: MERRIMACK PHARMACEUTICALS, Cambridge, MA
Network Biology has many connotations, but is defined here as the practice of using
computer models of known biological systems and quantitative experiments to better
predict physiological responses related to disease. Recent efforts have led to a better
understanding of how biological systems interact, resulting in more accurate predictions
of efficacy and toxicity, to the benefit of patients. Integrating computational modeling
techniques with known biological processes, quantitative measurements, and animal
studies will refine our predictive models and improve their ability to identify key
molecule(s) in disease modulating system(s), thereby accelerating the development of
therapeutics. For example, using in vitro and in vivo studies to define the EGFR system
supports efficacy and safety evaluations and their relevance to human oncology
patients. In today’s drug discovery and development environment, with low productivity
and success, it is imperative to move forward with several methods supporting advanced
therapeutic discovery and development paradigms and platforms with a higher
probability of success in a target patient population. This symposium will review the
current academic, industrial and regulatory application of Network Biology in drug
discovery and predicting toxicity.
9:00 am
INTRODUCTION
Kenneth J Olivier Jr, Ph.D., Associate Director of Toxicology, Merrimack
Pharmaceuticals, Cambridge, MA
9:10 am
A SYSTEMS BIOLOGY APPROACH TO DEVELOPING TARGETED
THERAPIES
Matt Onsum, Ph.D., Senior Scientist, Computational Biology, Merrimack
Pharmaceuticals, Cambridge, MA
9:40 am
DATA-AND SIMULATION-DRIVEN SYSTEMS FOR PREDICTIVE
TOXICOLOGY
Alan H. Roter, Ph.D., Vice President Informatics, Entelos, Inc., Foster
City, CA
10:10 am
Refreshment Break
10:30 am
INTEGRATING EXPERIMENTAL, TEXT MINING, AND ANALYTICAL
PREDICTION METHODS IN DRUG DISCOVERY
Carolyn Cho, Ph.D., Director, Target Generation Unit, Pfizer RTC,
Cambridge, MA
31
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
11:00 am
USING SYSTEMS BIOLOGY AND PERSONAL GENOMES TO
DELIVER PERSONALIZED DRUG COMBINATIONS
Hamid Bolouri, Ph.D, Visiting Associate Faculty, Division of Biology,
California Institute of Technology, Pasadena, CA
11:30 am
FDA-CDER USE OF MODELING AND SIMULATION WITH AN
EMPHASIS ON SYSTEMS BIOLOGY AND SAFETY
Robert Powell, PharmD., Independent Consultant, Bethesda, MD
______________________________________________________________________
9:00 – 12:00
Primrose B
SYMPOSIUM XV
THRESHOLD OF TOXICOLOGIC CONCERN
Chair: Joel Bercu, M.P.H., Risk Assessment Toxicology, Eli Lilly and Company,
Indianapolis, IN; Co-Chair: William J. Brock, Ph.D., DABT, ATS, Brock Scientific
Consulting, LLC, Montgomery Village, MD
The threshold of toxicological concern (TTC) is a method by which risk assessment
decisions can be made based on limited toxicity data
sets or purely on structure. Its applications have grown to several different industries
such as food, pharmaceuticals, and personal care products to name a few. This course
will discuss the background of the TTC and some of its assumptions. It then will discuss
some of the practical applications where the TTC is applied. The TTC is used in
pharmaceuticals for the control of genotoxic impurities. It also used to limit leachables /
extractables for polymers that come in contact with a pharmaceutical such as stoppers
and vials. Finally, the TTC is used for personal care products to demonstrate safety
while limiting animal testing. In conclusion, this course will demonstrate appropriate
applications of the TTC allowing the toxicologist to make decisions based on limited
data.
9:00 am
INTRODUCTION
Joel Bercu, M.P.H., Risk Assessment Toxicology, Eli Lilly and Company,
Indianapolis, IN; Co-Chair: William J. Brock, Ph.D., DABT, ATS, Brock
Scientific Consulting, LLC, Montgomery Village, MD
9:10 am
APPLICATION OF THRESHOLD OF TOXICOLOGICAL CONCERN IN
FOOD SAFETY DECISIONS
David H. Bechtel, Ph.D., Vice President/Senior Scientific Consultant,
CanTox U.S. Inc., Bridgewater, NJ
9:45 am
MANAGEMENT
OF
GENOTOXIC
IMPURITIES
IN
PHARMACEUTICALS WITH THE THRESHOLD OF TOXICOLOGICAL
CONCERN
Timothy Joseph McGovern, Ph.D., Consultant, SciLucent LLC, Herndon,
VA
10:20 am
Refreshment Break
32
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
10:45 am
USE OF THRESHOLD OF TOXICOLOGICAL CONCERN IN THE RISK
ASSESSMENT OF PERSONAL CARE PRODUCTS
Susan Felter, Ph.D., Principal Scientist, Proctor & Gamble, Cincinnati, OH
11:20 am
USE OF THE THRESHOLD OF TOXICOLOGICAL CONCERN (TTC)
FOR EXTRACTABLES/LEACHABLES EVALUATION STRATEGIES
RELEVANT
TO
PHARMACEUTICAL
CONTAINER/CLOSURE
SYSTEMS
Courtney Callis, M.P.H., DABT, Associate Senior Toxicologist, Eli Lilly &
Company, Bozeman, MT
______________________________________________________________________
WEDNESDAY AFTERNOON, 11/4/09
1:30 – 5:00
Primrose D
SYMPOSIUM XVI
HOT TOPICS
Co-Chairs: Drew A. Badger, Ph.D. DABT, Senior Director, Toxicology & Regulatory
Affairs, Amira Pharmaceuticals, San Diego CA and Mary Ellen Cosenza, Ph.D., DABT,
Executive Director, Regulatory Affairs, Amgen Inc., Thousand Oaks, CA
Sponsored in part by: SCILUCENT, LLC, Herndon, VA
The Hot Topics session will provide a timely and critical overview of key updates to the
International Conference on Harmonization (ICH) Guidelines that have a significant
impact on Pharmaceutical Safety Evaluation. Presentations will be provided by
members of the ICH working committee which offers a unique insider look into the
process and rationale behind some of the changes. Presentations will focus on two key
revisions including the comprehensive multi-disciplinary guideline, M3 (Non-Clinical
Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals) and the
safety guideline S2 (Guidance on Genotoxicity Testing and Data Interpretation for
Pharmaceuticals intended for Human use). The newly created safety guideline S9
(Nonclinical evaluation for anticancer pharmaceuticals) will also be discussed. In
addition to ICH updates, a 10-minute overview of FDA’s “Animal Rule” will be presented
as an additional emerging topic. This session is critical for regulatory toxicologists in the
pharmaceutical industry as well as those that are impacted by evolving regulatory
requirements which includes a majority of ACT attendees including industry, CRO, and
academic scientists.
1:30 pm
INTRODUCTION
Drew A. Badger, Ph.D. DABT, Senior Director, Toxicology & Regulatory
Affairs, Amira Pharmaceuticals, San Diego CA
33
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
1:40 pm
UPDATE ON ICH GUIDELINE M 3 (R2) NON-CLINICAL SAFETY
STUDIES FOR THE CONDUCT OF HUMAN CLINICAL TRIALS FOR
PHARMACEUTICALS
Mary Ellen Cosenza, Ph.D., DABT, Executive Director, Regulatory Affairs,
Amgen Inc., Thousand Oaks, CA
2:15 pm
CHANGES TO ICHS2 (GUIDANCE ON GENOTOXICITY TESTING AND
DATA INTERPRETATION FOR PHARMACEUTICALS INTENDED FOR
HUMAN USE): IMPACT ON EARLY DRUG DEVELOPMENT
David Jacobson-Kram,
Ph.D.,
DABT,
Associate
Director,
Pharma/Toxicology, US FDA - CDER, OND, Silver Spring, MD
3:05 pm
THE ANIMAL RULE: DO WE HAVE ADEQUATE GUIDANCE?
Kenneth L. Hastings, Dr.P.H., DABT, Associate VP, Regulatory Policy,
sanofi-aventis, Bethesda MD
3:20 pm
Refreshment Break
3:40 pm
UPDATE ON ICH GUIDELINE S 9 NONCLINICAL EVALUATION FOR
ANTICANCER PHARMACEUTICALS
John K. Leighton, Ph.D., Associate Director, Pharmacology, US FDA,
CDER/OND/OODP, Silver Spring, MD
4:30 pm
DISCUSSION
______________________________________________________________________
1:30 – 5:00
SYMPOSIUM XVII
Primrose B
SPACE TOXICOLOGY: HUMAN HEALTH DURING SPACE OPERATIONS
Co-Chairs: Noreen N. Khan-Mayberry, Ph.D., NASA Space Toxicologist, Space
Toxicology Office – Space Life Sciences, Houston, TX and John T. James, Ph.D., NASA
Chief Toxicologist, Space Toxicology Office – Space Life Sciences, Houston, TX
Space Toxicology is a unique and targeted discipline for spaceflight, space habitation
and occupation of celestial bodies including planets, moons and asteroids. Astronaut
explorers face distinctive health challenges and limited resources for rescue and medical
care during space operation. A central goal of space toxicology is to protect the health of
the astronaut by assessing potential chemical exposures during spaceflight and setting
safe limits that will protect the astronaut against chemical exposures, in a physiologically
altered state. In order to maintain sustained occupation in space on the International
Space Station (ISS), toxicological risks must be assessed and managed within the
context of isolation, continuous exposures, reuse of air and water, limited rescue
options, and the need to use highly toxic compounds for propulsion. As we begin to
explore other celestial bodies in situ toxicological risks, such as inhalation of reactive
mineral dusts, must also be managed.
1: 30 pm
HISTORY OF SPACEFLIGHT TOXICOLOGY
34
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
John T. James, Ph.D., NASA Chief Toxicologist, Space Toxicology Office
– Space Life Sciences, Houston, TX
2:00 pm
SPACECRAFT
MAXIMUM
ALLOWABLE
CONCENTRATIONS
(SMACs)
Rochelle W. Tyl, Ph.D., Senior Fellow, RTI International, Research
Triangle Park, NC 27709
2:30 pm
SPACECRAFT WATER EXPOSURE GUIDELINES (SWEGs)
Kenneth E. Thummel, Ph.D., Professor, Dept of Pharmaceutics,
University of Washington Department of Physics, Seattle, WA
3:00 pm
Refreshment Break
3:20 pm
RISK-BASED MONITORING OF SPACECRAFT POLLUTANT
Noreen N. Khan-Mayberry, Ph.D., Space Toxicologist, NASA, Houston,
TX
3:50 pm
LUNAR DUST PULMONARY TOXICITY
Chiu-wing Lam, Ph.D., Senior Toxicologist, Wyle Laboratories, Houston,
TX
4:20 pm
Q&A
______________________________________________________________________
1:30 – 5:00
Primrose C
SYMPOSIUM XVIII
EXPOSURE-SPECIFIC DIFFERENCES IN INFLAMMATORY PATTERNS AND
RELATIONSHIP TO CHRONIC RESPIRATORY DISEASE
Chair: Hans-Juergen Haussmann, Ph.D., Consultant, Roesrath, Germany: Co-Chair:
Jack R. Harkema, DVM, PhD, DACVP, University Distinguished Professor, Michigan
State University, East Lansing, MI
Sponsored in part by: PHILIP MORRIS INTERNATIONAL, Lausanne,
Switzerland
COPD is one of the most common causes of morbidity and mortality. This disease
encompasses emphysema, chronic bronchitis, and obstructive bronchiolitis. Exposures
to noxious stimuli that can ultimately lead to COPD initially elicit pulmonary or airway
inflammatory processes, which can display exposure-specific commonalities as well as
differences in the local and time-dependent accumulation of inflammatory cells and
mediators. In this symposium, inflammatory patterns stemming from exposure to various
aerosols, including nano-materials and cigarette smoke, and a transgenic model for
airway surface dehydration will be presented and compared. Even within such groups of
exposures, differences in response exist. For example, particle-induced inflammatory
reactions depend on particle surface characteristics. Also, given that cigarette smoking
35
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
is responsible for about 90% of COPD in developed countries, there is interest in
developing cigarettes that generate a different smoke composition than conventional
ones leading to differences in inflammatory responses. However, regardless of the type
of exposure, there is insufficient knowledge at present to predict if changes in
inflammatory patterns can be linked to changes in the risk of developing the various
forms of COPD as well as of potential co-morbidities, such as lung cancer. Establishing
such relationships would be of tremendous advantage for the development of practical
pathways for intervention or therapy.
1: 30 pm
INTRODUCTION
Hans-Juergen Haussmann, Ph.D., Consultant, Roesrath, Germany
1:40 pm
RESPIRATORY TRACT LINING FLUIDS (RTLFs): FIRST REACTANTS
WITH CIGARETTE SMOKE
Carroll E. Cross, M.D., Pulmonary-Critical Care Medicine, University of
California Davis Medical School, Sacramento, CA
2:15 pm
MODELING
CIGARETTE
SMOKE-INDUCED
INFLAMMATORY
RESPONSES RELATED TO COPD BASED ON MECHANISTIC DATA
Michael Peck, Ph.D., Associate Principal Scientist, Philip Morris
International Research & Development, Neuchatel, Switzerland
2:50 pm
Refreshment Break
3:15 pm
ULTRAFINE PARTICLES, INFLAMMATION, AND HUMAN HEALTH
Mark W. Frampton, M.D., Professor of Medicine & Environmental
Medicine, University of Rochester Medical Center, Rochester, NY
3:50 pm
ASSESSING THE ROLE OF SURFACE CHARACTERISTICS IN
NANOPARTICLE-RELATED
PULMONARY
TOXICITY
AND
INFLAMMATION
David B. Warheit, Ph.D., DABT, ATS, DuPont Haskell Global Centers,
SHRC, Newark, DE
4:25 pm
DEVELOPMENT OF CHRONIC BRONCHITIS AND EMPHYSEMA IN
BETA-EPITHELIAL NA+ CHANNEL-OVEREXPRESSING MICE: ROLE
OF AIRWAY SURFACE DEHYDRATION IN THE PATHOGENESIS OF
COPD
Jack R. Harkema, DVM, PhD, DACVP, University Distinguished
Professor, Michigan State University, East Lansing, MI
_____________________________________________________________________________
6:00 pm – 7:30 pm
Catalina – Hotel
WuXi AppTec FAREWELL RECEPTION
36
AMERICAN COLLEGE OF TOXICOLOGY 30TH 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 3,
2009 from 5:30 pm until 7:00 pm. You have been 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 1,
2009. 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 3, 2009.
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.
37
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
SYMPOSIA AND CONTINUING EDUCATION COURSE CHAIRS
AND SPEAKERS
Lauren Aleksunes, PharmD., Ph.D.
Assistant Professor
Rutgers University
Ernest Mario School of Pharmacy
Dept of Pharmacology & Toxicology
160 Frelinghuysen Road
Piscataway, NJ 08854-8020
T: 732-445-0200
Email: lauren.aleksunes@gmail.com
Theodore J. Baird, Ph.D.
Senior Director, Safety Pharmacology &
Neurobehavioral Sciences
MPI Research
54943 N. Main Street
Mattawan, MI 49071-9399
T: 269-377-5181 F: 269-668-4151
Email: ted.baird@mpiresearch.com
Edward (Ted) G. Barrett, Ph.D.
Staff Scientist
Lovelace Respiratory Research Institute
Respiratory Immunology & Asthma
Program
2425 Ridgecrest Drive, SE
Albuquerque, NM 87108
T: 505-348-9417 F: 505-348-8567
Email: tbarrett@lrri.org
Bruce N. Ames, Ph.D.
Professor
Children's Hospital Oakland Res Inst
5700 Martin Luther King Jr. Way
Oakland, CA 94609-1673
T: 510-450-7625 F: 510-597-7128
Email: bames@chori.org
Laura Andrews, Ph.D.
Vice President, Pharmacology/Toxicology
Genzyme Corporation
1 Mountain Road
P. O. Box 9322
Framingham, MA 01701
T: 508-271-3713 F: 508-270-2088
Email: laura.andrews@genzyme.com
David H. Bechtel, Ph.D.
Vice President/Sr Scientific Consultant
CanTox U.S. Inc.
1011 Route 22 West, #200
Bridgewater NJ 08807
T: 908-429-9202 F: 908-429-9260
Email: dbechtel@cantox.com
Charlie M. Auer, M.S.
Charles Auer & Associates, LLC
17116 Campbell Farm Road
Poolesville, MD 20837
T: 301-525-3467 F: 301-972-8246
Email: auer.charlesm@gmail.com
Tom Beck, Ph.D.
Associate Director, Safety Pharmacology
Covance Laboratories, Inc.
3301 Kinsman Blvd.
Madison, WI 53704
T: 608-245-7095 F: 608-242-7944
Email: tom.beck@covance.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
Richard A. Becker, Ph.D., DABT
American Chemistry Council
1300 Wilson Blvd.
Arlington, VA 22209
T: 703-741-5210 F: 703-741-6210
Email:
rick_becker@americanchemistry.com
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
38
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
Lisa D. Beilke, Ph.D.
Research Scientist II
Gilead Sciences, Inc.
Drug Safety Evaluation
333 Lakeside Drive, Bldg. 324
Foster City, CA 94404
T: 650-522-6361 F: 650-522-5266
Email: lisa.beilke@gilead.com
William J. Breslin, Ph.D.
Senior Research Advisor, NSD Safety
Assessment
Eli Lilly and Company
Lily Corporate Center
Bldg. 87/4, Drop Code 1940
Indianapolis, IN 46285
T: 317-433-3601
Email: breslin_william_j@lilly.com
Joel Bercu, M.P.H.
Risk Assessment Toxicology
Eli Lilly and Company
Lilly Corporate Center
Indianapolis, IN 46285
T: 317-277-4749 F: 317-276-1268
Email: jpbercu@lilly.com
William J. Brock, Ph.D., DABT, ATS
Brock Scientific Consulting, LLC
19909 Hamil Circle
Montgomery Village, MD 20886
T: 301-519-3666 F: 301-926-4792
Email: billbrock@comcast.net
Felicia B. Billingslea
Director
Food Labeling and Standards Staff
Office of Nutrition, Labeling and Dietary
Supplements
US FDA/CFSAN
5100 Paint Branch Parkway
College Park, MD 20740
T: 301-436-2372
Email: felicia.billingslea@fda.hhs.gov
Alan Perry Brown, Ph.D., DABT
Senior Toxicologist
NAMSA
6750 Wales Road
Northwood, OH 43619
T: 419-662-4408 F: 419-666-2954
Email: abrown@namsa.com
Leigh Ann Burns Naas, Ph.D., DABT
Senior Director
Pfizer Global R&D
Drug Safety Research and Development
10646 Science Center Dr.
San Diego, CA 92121
T: 858-526-4908 F: 858-678-8290
Email: leighann.burns@pfizer.com
Hamid Bolouri, Ph.D.
Visiting Assoc Faculty, Biology
CA Institute of Technology
Div Biology - MC 147-75
1200 E California Blvd
Pasadena, CA 91125
T: 206-350-7040 F: 206-350-7040
Email: hbolouri@caltech.edu
Prof Dr Eberhard Buse
Director Pathology
Covance Laboratories GmbH
Kesselfeld 29
Muenster 48163
Germany
T: +49 251 9798-145 F: +49 251 784697
Email: eberhard.buse@covance.com
Gregory G. Bond, Ph.D., MPH
Corporate Director Prod Responsibility
The Dow Chemical Company
Environment, Health & Safety
1803 Building
Midland, MI 48674
T: 989-636-9063 F: 989-636-1875
Email: ggbond@dow.com
Courtney M. Callis, M.P.H., DABT
Associate Senior Toxicologist
Eli Lilly and Company
1140 South Pinecrest Drive
Bozeman, MT 59715
T: 317-277-5067
Email: callis_courtney_m@lilly.com
Angélique Braen, Ph.D., DABT
Toxicologist
Hoffmann-La Roche, Inc.
340 Kingsland Street
Nutley, NJ 07110
T: 973-235-3860 F: 973-235-4710
Email: angelique.braen@roche.com
39
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
John E. Casida, Ph.D., Director
Professor of Entomology and Toxicology
Environmental Chemistry & Toxicology Lab
Dept of Environmental Science, Policy and
Management
University of California
114 Wellman Hall
Berkeley, CA 94720-3112
T: 510-642-5424 F: 510-642-6497
E-mail: ectl@nature.berkeley.edu
Diane M. Creasy, Ph.D., FRCPath
Senior Director of Pathology
Huntingdon Life Sciences
100 Mettlers Road
P. O. Box 2360
East Millstone, NJ 08875
T: 732-873-2550 x2680 F: 732-873-3992
Email: creasyd@princeton.huntingdon.com
Prof Carroll E. Cross, M.D.
Pulmonary-Critical Care Medicine
UC Davis Medical Center
4150 V Street, Suite 3400
Sacramento, CA 95817
T: 916-734-3564 F: 916-734-7924
Email: cecross@ucdavis.edu
Carolyn Cho, Ph.D.
Director, Target Generation Unit
Pfizer RTC
620 Memorial Drive
Cambridge, MA 02139
T: 617-551-3334 F: 617-551-3082
Email: carolyn.cho@pfizer.com
Jon Daniels, Ph.D., DABT, ERT
Vice President and Senior Toxicologist
Intrinsik Health Sciences Inc.
Development and Regulatory Services
6605 Hurontario Street, #500
Mississauga, ON L5T 0A3
Canada
T: 905-364-7814 F: 905-364 7816
Email: jdaniels@intrinsikscience.com
Tomas Cihlar, Ph.D.
Sr. Principal Scientist, Biology
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
T: 650-522-5637
Email: tomas.cihlar@gilead.com
Mark Collinge, Ph.D.
Principal Scientist, Immunotoxicology
Pfizer, Inc.
MS 8247-1206
Groton, CT 06340
T: 860-686-3092 F: 860-441-5499
Email: mark.collinge@pfizer.com
Fe de Leon
Researcher
Canadian Environmental Law Assoc.
130 Spadina Avenue
Suite #301
Toronto, ON, M5V 2L4
CANADA
T: 416-960-2284 x223 F: 416-960-9392
Email: deleonf@cela.ca
Laura Conour, DVM, DACLAM
Senior Director, Veterinary Services
Charles River
Preclinical Services
334 South Street
Shrewsbury, MA 01545
T: 508-925-6000 F: 508-925-6340
Email: laura.conour@crl.com
Christopher C. DeMerlis, M.S.
Manager, Regulatory Affairs
Colorcon, Inc.
415 Moyer Blvd.
West Point, PA 19486
T: 215-661-2766 F: 215-661-2366
Email: cdemerlis@colorcon.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
David Diaz-Sanchez, Ph.D.
Chief, Clinical Research Branch
US EPA
NHEERL, ORD
104 Mason Farm Road
Chapel Hill, NC 27599
T: 919-966-0676 F: 919-966-6271
Email: diaz.sanchez.david@epa.gov
40
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
Noel Dybdal, D.V.M., Ph.D., DACVP
Senior Pathologist
Genentech, Inc.
Safety Assessment, Pathology
1 DNA Way
So San Francisco, CA 94080
T: 650-225-1425 F: 650-225-2797
Email: nod@gene.com
Mark W. Frampton, M.D.
Professor, Med & Environmental Med
University Rochester Medical Center
601 Elmwood Avenue
Box 692
Rochester, NY 14624-8692
T: 585-275-4861 F: 585-273-1114
Email: frampton@urmc.rochester.edu
Thomas M Dydek, PhD, DABT, PE
Senior Toxicologist & Engineer
Dydek Toxicology Consulting
5208 Avenue H
Austin, TX 78731
T: 512-280-5477 F: 512-280-8900
Email: dydek@tox-expert.com
Patricia Frank, Ph.D.
Patricia Frank & Associates, Inc.
417 Dewey Avenue
Evanston, IL 60202
T: 847-864-6535 F: 847-864-6580
Email: patfrank@att.net
Shayne C. Gad, Ph.D., DABT, ATS
Gad Consulting Services
102 Woodtrail Lane
Cary, NC 27518
T: 919-233-2926 F: 919-233-2927
Email: scgad@ix.netcom.com
Amy Ellis, Ph.D.
Pharmacologist
US FDA
CDER/HFD-520
10903 New Hampshire Ave., Bldg 22
Silver Spring, MD 20093
T: 301-796-1400 F: 301-796-9882
Email: amy.ellis@fda.hhs.gov
David V. Gauvin, Ph.D.
Director, Neurobehavioral Sciences
MPI Research
54943 N. Main Street
Mattawan, MI 49071
T: 269-668-3336 x1613 F: 269-668-4151
Email: david.gauvin@mpiresearch.com
Christopher Ellis, Ph.D.
Pharmacology/Toxicology Reviewer
US FDA
CDER
10903 New Hampshire Ave, Bldg. 22
Silver Spring, MD 20993
T: 301-796-0715 F: 301-796-9883
Email: christopher.ellis@fda.hhs.gov
Mary Beth Genter, PhD, DABT
Associate Professor
University of Cincinnati
3223 Eden Ave., ML 670056
144 Kettering Lab
Cincinnati, OH 45267-0056
T: 513-558-6266 F: 513-558-4397
Email: marybeth.genter@uc.edu
Jeffrey A. Engelhardt, DVM, PhD, DACVP
President & Pathologist
Engelhardt Consulting, Inc.
5407 Castillo de Rosas
Camarillo, CA 93012
T: 805-603-9529 F: 805-445-7105
Email: jaengelhardt@ymail.com
Hanan N. Ghantous, Ph.D., DABT
Pharmacologist/Toxicologist Supervisor
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
Susan Felter, Ph.D.
Principal Scientist
Procter & Gamble
P. O. Box 538707
Cincinnati, OH 45253
T: 513-627-1958 F: 513-627-1927
Email: felter.sp@pg.com
41
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
Kathy Giacomini, Ph.D.
Professor, Biopharmaceutical Sciences,
Cellular & Molecular Pharmacology &
Pharmaceutical Chemistry
University of California
1550 4th Street
Rock Hall, Room RH-584F
San Francisco, CA 94143
T: 415-476-1936 F: 415-502-4322
Email: kathy.giacomini@ucsf.edu
Jack R. Harkema, DVM, PhD, DACVP
University Distinguished Professor
Michigan State University
Dept Pathobiology & Diagnostic Invest
212 Food Safety & Toxicology Bldg
East Lansing, MI 48824
T: (517) 353-8627
Email: harkemaj@msu.edu
Brian Harvey, M.D., Ph.D.
Vice President Regulatory Policy
sanofi-aventis
4520 E.W. Highway, Suite #210
Bethesda, MD 20814
T: 307-771-4264 F: 901-771-4287
Email: brian.harvey@sanofi-aventis.com
James Daniel Green, Ph.D.
Senior Vice President
Biogen Idec MA Inc.
Preclin/Clinical Development Sciences
14 Cambridge Center
Cambridge, MA 02142
T: 617-679-2129 F: 617-679-3463
Email: james.green@biogenidec.com
Richard Haubrich, M.D.
Professor of Medicine
University of California, San Diego
Division of Infectious Diseases
150 West Washington, #100
San Diego, CA 92103
T: 619-543-8080 F: 619-298-0177
Email: rhhaubrich@ucsd.edu
Martin (Dave) Green, Ph.D.
Supervisory Toxicologist
US FDA
Vaccine Research & Review
Div Vaccines/Related Prod Applications
1401 Rockville Pike,
Rockville, MD 20852
T: 301-827-5989
Email: martin.green@fda.hhs.gov
Hans-Juergen Haussmann, Ph.D.
Toxicology Consultant
Ueberhoefer Feld 36a
Roesrath 51503
Germany
T: 49-2205-8940384 F: 49-2205-8940385
Email: hansj.haussmann@t-online.de
Irma Marisa Grossi, Ph.D., MBA
Senior Director, Preclinical Pharmaceutical
Sciences
RTI Health Solutions
3040 Cornwallis Road
Res Triangle Park, NC 27709
T: 919-541-6707 F: 919-541-5956
Email: ggrossi@rti.org
David W. Hobson, Ph.D., DABT
Principal
LoneStar PharmTox LLC
613 Pleasant Valley Drive
Boerne, TX 78006
T: 210-269-6169 F: 830-229-5782
Email: dave@lonestarpharmtox.com
Jeri El Hage, Ph.D.
Senior Consultant
Aclairo Pharmaceutical Development Group
1950 Old Gallows Road, Suite 300
Vienna, VA 22182
T: 703-506-6760 x310
Email: jelhage@aclairo.com
Nancy Holmes, Ph.D., DABT
Assistant Director, Toxicology
Alcon Laboratories, Inc.
6201 South Freeway
Ft Worth, TX 76134-2099
T: 817-615-5340 F: 817-302-4533
Email: nancy.holmes@alconlabs.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
42
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
Michael P. Holsapple, Ph.D., A.T.S.
Executive Director
ILSI Health/Environmental Sci Inst (HESI)
1156 Fifteenth Street, NW, Second Floor
Washington, DC 20005
T: 202-659-3306 x151 F: 202-659-3617
Email: mholsapple@hesiglobal.org
Jon F. Lalko, B.S.
Senior Test Program Specialist
R.I.F.M.
50 Tice Blvd
3rd Floor
Woodcliff Lake, NJ 07677
T: 201-689-8089 x108 F: 201-689-8090
Email: jlalko@rifm.org
David L. Hopper, DVM, Ph.D., DABT
Director of Toxicology
BASi
10424 Middle Mt. Vernon
Mount Vernon, IN 47620
T: 812-985-3400 x106 F: 812-985-3406
Email: dhopper@basinc.com
Chiu-wing Lam, Ph.D.
Senior Toxicologist
Wyle Labs - Space Life Sciences
2101 NASA Parkway
SF-23
Houston, TX 77058
T: 281-483-3058
Email: chiu-wing.lam-1@nasa.gov
David Jacobson-Kram, Ph.D., DABT
Associate Director, Pharma/Toxicology
US FDA - CDER, OND
10903 New Hampshire Ave
Silver Spring, MD 20993
T: 301-796 0175 F: 301-796 9856
Email: david.jacobsonkram@fda.hhs.gov
Kenneth Landreth, Ph.D.
Professor, Microbiology/Immun/Cell Biol
West VA School of Medicine
Dept Microbiology/Immun/Cell Biology
P. O. Box 9177
Morgantown, WV 26506-9177
T: 304-293-4067
Email: klandreth@hsc.wvu.edu
John T. James, Ph.D.
NASA Chief Toxicologist
Space Tox Office-Space Life Sciences
2101 NASA Parkway
SF-23
Houston, TX 77058
T: 281-483-7122 F: 281-483-3058
Email: john.t.james@nasa.gov
James William Langston, M.D.
Scientific Director, CEO and Founder
The Parkinson’s Institute & Clinical Center
675 Almanor Avenue
Sunnyvale, CA 94085
T: 408- 542.5633 F: 408-734-8455
Email: jwlangston@parkinsonsinstitute.org
Noreen N. Khan-Mayberry, Ph.D.
Space Toxicologist
NASA
2201 NASA Parkway, SF-23
Houston, TX 77058
T: 281-483-1876 F: 281-483-3058
Email: noreen.n.khan-mayberry@nasa.gov
Chet L. Leach, Ph.D., DABT
Consultant in Pulmonary Drug Development
5 Calle De Oro
Tijeras, NM 87059
T: 505-401-3701
Email: chetleach@msn.com
Norman N. Kim, M.S., DABT
Senior Director, Toxicology
Inotek Pharmaceuticals Corporation
33 Hayden Avenue, 2nd Floor
Lexington, MA 02421
T: 781-676-2119 F: 781-676-2155
Email: nkim@inotekcorp.com
Grace S. Lee, Ph.D.
Pharmacology/Toxicology Reviewer
US FDA. CDER
White Oak, Bldg 22, Room 3321
10903 New Hampshire Avenue
Silver Spring, MD 20993
T: 301-796-5062 F: 301-796-9728
Email: grace.lee@fda.hhs.gov
Edwin Kuffner, M.D.
Senior Director, Medical Affairs
McNeil Consumer Healthcare
7050 Camp Hill Road
Ft. Washington, PA 19034
T: 215-273-8569
Email: ekuffner@mccus.jnj.com
43
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
John K. Leighton, Ph.D.
Associate Director, Pharmacology
US FDA
CDER/OND/OODP
Building 22, Room 2204
10903 New Hampshire Avenue
Silver Spring, MD 20993
T: 301-796-2330 F: 301-796-9867
Email: john.leighton@fda.hhs.gov
Peter C. Mann, DVM, DACVP
Manager, EPL Northwest
EPL, Inc.
2544 13th Avenue West
Seattle, WA 98119
T: 206-284-1900 F: 206-284-1901
Email: pmann@epl-inc.com
Kevin S. McDorman, DVM, Ph.D., DACVP
Division Director
Charles River Laboratories
Preclinical Services, Nevada
6995 Longley Lane
Reno, NV 89511
T: 775-682-2230
Email: kevin.mcdorman@crl.com
Leslie E. Lemke, Ph.D.
Assistant Director, Pharmaceutical Tox
Alcon Laboratories, Inc.
6201 South Freeway
Fort Worth, TX 76134
T: 817-551-4644 F: 817-615-3496
Email: leslie.lemke@alconlabs.com
Timothy Joseph McGovern, Ph.D.
Consultant
SciLucent LLC
585 Grove Street Suite 300
Herndon, VA 20170
T: 703-435-0033 F: 703-435-0440
Email: t.mcgovern@scilucent.com
Lynne LeSauteur, Ph.D.
Director, Immunology
Charles River
22022 Transcanadienne
Senneville, QC, H9X 3R3
Canada
T: 514-630-8290 F: 514-630-8230
Email: lynne.lesauteur@crl.com
LuAnn McKinney, DVM, DACVP
1923 Grace Church Road
Silver Spring MD 20910
T: 301-588-1759
Email: mck2005@gmail.com
Kate Longman, B.S., RQAP-GLP
Manager, Quality Assurance Research
MPI Research
54943 North Main Street
Mattawan, MI 49071-9399
T: 269-668-3336 x1340 F: 269-668-4151
Email: kate.longman@mpiresearch.com
Pauline McNamee, Ph.D.
Principal Scientist
Procter & Gamble Technical Centres Limited
Rusham Park Innovation Centre
Whitehill Lane
Egham, Surrey TW20 9NW
United Kingdom
T: 44 1784 498458 F: 44 1784 271026
Email: mcnamee.pm@pg.com
James S. MacDonald, Ph.D., DABT
President
Chrysalis Pharma Consulting, LLC
385 Route 24 - Suite 1G
Chester, NJ 07930
T: 908-956-0035
Email: jmacdonald@chrysalispharm.com
Susan McPherson, M.Sc.
Scientific Program Manager
Charles River
2F, Building 4
998 Halei Road
Zhang-Jiang Hi-Tech Park Pudong
Shanghai, 201203, China
T: 86 21 50795172
Email: sue.mcpherson@crl.com
Timothy MacLachlan, Ph.D.
Staff Scientist II
Genzyme Corporation
1 The Mountain Rd
P. O. Box 9322
Framingham, MA 01701
T: 508-270-2247 F: 508-872-9080
Email: tim.maclachlan@genzyme.com
44
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
Vincent Meador, DVM, Ph.D., DACVP
Senior Director, Toxicology
Amgen Inc.
1201 Amgen Court West - J4144
Seattle, WA 98199
T: 206-265-8020 F: 805-499-2936
Email: vmeador@amgen.com
Jeffrey S. Murray, M.D.
Deputy Director, Div Antiviral Products
US FDA
CDER/OAP/DAVP
10903 New Hampshire Avenue
Silver Spring, MD 20903
T: 301-796-1500 F: 301-796-9883
Email: jeffrey.murray@fda.hhs.gov
Josef Miller, Ph.D.
Ruth & Lynn Townsend Professor
Kresge Hearing Research Institute
Univ MI, Dept Otolaryngology
Ann Arbor, MI 48109
T: 734-764-8111 F: 734-764-0014
Email: josef@umich.edu
Laine Peyton Myers, Ph.D.
Pharma/Toxicology Drug Reviewer
US FDA
CDER / Div of Antiviral Products
10903 New Hampshire Ave
Silver Spring, MD 20903
T: 301-796-2217 F: 301-796-9883
Email: laine.myers@fda.hhs.gov
Thais C. Morata, Ph.D.
Research Audiologist
NIOSH
Hearing Loss Prevention Section
4676 Columbia Parkway, C47
Cincinnati, OH 45226
T: 513-533-8487 F: 513-533-8510
Email: tmorata@cdc.gov
Kazuichi Nakamura, DVM, Ph.D.
Manager
Shionogi & Co., Ltd.
Product Development Reg Affairs Dept
2-17-5 Shibuya, Shibuya-ku
Tokyo 150-8673 , JAPAN
T: 81 3-3406-8165 F: 81 3-3406-8099
Email: kazuichi.makamura@shionogi.co.jp
David Morse, Ph.D.
Principal Consultant
Parexel Consulting
4600 East West Highway, Suite 350
Bethesda, MD 20814
T: 301-634-8010
Email: david.morse@parexel.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: 617-441-7776
Email: kolivier@merrimackpharma.com
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
Matt Onsum, Ph.D.
Senior Scientist, Computational Biology
Merrimack Pharmaceuticals
One Kendall Square
Bldg. 700, 2nd Floor
Cambridge, MA 02139
T: 617-441-1025 F: 617-491-1386
Email: monsum@merrimackpharma.com
Ian C. Munro, Ph.D., FATS, FRCPath
Executive Vice President, Senior Scientific
Consultant
Cantox Health Sciences Intl
2233 Argentia Drive, #308
Mississauga ON L5N 2X7
Canada
T: 905-542-2900 F: 905-542-1011
Email: imunro@cantox.com
Edward F. Orlando, Ph.D.
Assistant Professor of Reproductive Biology
University of Maryland
Dept. Animal & Avian Sciences (ANSC)
3121 ANSC Bldg.
College Park, MD 20742-2311
T: 301-405-6386 F: 301-405-7980
Email: eorlando@umd.edu
45
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
Merrill R. Osheroff, Ph.D., DABT
President
Osheroff Consulting Services LLC
8418 Parkstone Terrace
Mattawan, MI 49071
T: 269-375-6656 F: 269-375-6656
Email: mroshe@aol.com
Richard D. Phillips, Ph.D., DABT
Senior Science Advisor
ExxonMobil Petroleum & Chemical
Hermeslaan 2
Machelen 1831
Belgium
T: 322-722-2550 F: 322-722-4209
Email: richard.d.phillips@exxonmobil.com
Robert E. Osterberg, Ph.D., ATS
Senior Consultant
Aclairo PDG., Inc.
1950 Old Gallows Road, Suite 300
Vienna, VA 22182
T: 703-506-6760 x302 F: 703-506-0142
Email: rosterberg@aclairo.com
Christopher Powell, FRCPath
Director Safety Assessment
GlaxoSmithKline
Welwyn HERTS AL6 9AR
United Kingdom
T: 44 7789 928617 F: 44 1438 782070
Email: christopher.j.powell@gsk.com
Richard A. Parent, PhD, DABT, FATS, RAC
President
Consultox, Ltd
P. O. Box 1239
Damariscotta, ME 04543
T: 207-563-2300 F: 207-563-8990
Email: rparent@consultox.com
Robert Powell, PharmD
Independent Consultant
7822 English Way
Bethesda, MD 20817
T: 301-656-5472
Email: bob.powell49@gmail.com
Daniel J. Patrick, DVM, DACVP
Principal Pathologist
MPI Research
LS14 - 54943 N Main Street
Mattawan, MI 49071
T: 269-668-3336 x1292 F: 269-668-4151
Email: daniel.patrick@mpiresearch.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
Michael Peck, Ph.D.
Associate Principle Scientist
Philip Morris International R&D
Quai Jeanrenaud 5
Neuchatel 2000
Switzerland
T: +41 58 242 2282 F: +41 58 242 2811
Email: michael.peck@pmintl.com
Mark J. Reasor, Ph.D., DABT
Professor, Physiology & Pharmacology
West Virginia University Health Sciences
Center
Dept Physiology & Pharmacology
School of Medicine
Morgantown, WV 26506
T: 304-293-2418 F: 304-293-3850
Email: mreasor@hsc.wvu.edu
Richard A. Peterson, DVM, PhD, DACVP
Director, Molecular/Ultrastructural Path
GlaxoSmithKline
5 Moore Drive
Safety Assessment, 9.3009.2D
Res Triangle Park, NC 27709
T: 919-315-2450 F: 919-483-0131
Email: richard.a.peterson@gsk.com
Matthew D. Reed, Ph.D.
Director, Preclinical Drug Development
Lovelace Respiratory Research Inst
2425 Ridgecrest Drive, S.E.
Albuquerque, NM 87108
T: 505-348-9451 F: 505-348-4980
Email: mreed@lrri.org
46
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
Lynnda Reid, Ph.D.
Pharmacology/Toxicology Team Leader
US FDA
CDER- White Oak Bldg. 22
10903 New Hampshire Ave.
Silver Spring, MD 20993
T: 301-796-0984 F: 301-796-9897
Email: lynnda.reid@fda.hhs.gov
Frank L. Sapienza, M.S.
Partner and Consultant
The Drug and Chemical Advisory Group
4911 Heversham Court
Fairfax, VA 22032-2323
T: 703-239-8871 F: 703-978-0893
Email: contactus@thedcag.com
Ken Schafer, Ph.D., DVM, DACVP
Senior Pathologist
Vet Path Services, Inc.
6450 Castle Drive
Mason, OH 45040-9412
T: 513-469-0777
Email: kschafer@vetpathservicesinc.com
Melissa Rhodes, Ph.D., DABT
Manager, Safety Assessment Projects
GlaxoSmithKline
5 Moore Drive
Res Triangle Park, NC 27709
T: 919-483-6908 F: 919-483-0131
Email: melissa.c.rhodes@gsk.com
Jacintha M. Shenton, Ph.D.
Principal Toxicologist
MedImmune Inc.
Aaron Klug Building
Granta Park
Cambridge, CB21 6GH, United Kingdom
T: 44 1223 898 266 F: 44 1223 898 001
Email: shentonj@medimmune.com
M. Stacey Ricci, Sc.D.
Toxicologist
US FDA
Division of Biologic Oncology Products
Office of Oncology Drug Products
Office of New Drugs
Center for Drug Evaluation & Research
White Oak Building 22, Room 2324
10903 New Hampshire Avenue
Silver Spring, MD 20993
T: 301-796-2320 F: 301-796-9849
Email: stacey.ricci@fda.hhs.gov
Magang Shou, Ph.D.
Director of PKDM
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, CA 91320-1799
T: 805-447-4247
Email: mshou@amgen.com
Elizabeth H. Romach, Ph.D., DABT
Director Safety Assessment Projects
GlaxoSmithKline
Safety Assessment
P. O. Box 13398
5 Moore Dr - 9.2126
Res Triangle Park, NC 27709-3398
T: 919-483-8708 F: 919-483-0131
Email: beth.h.romach@gsk.com
Angela Slitt, Ph.D.
Assistant Professor
Dept Biomed. & Pharmaceutical Sciences
University of Rhode Island
41 Lower College Road
Kingston, RI 02881
T: 401-874-5020 F: 401-874-5787
Email: jagtox@yahoo.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 x1363 F: 301-838-3182
Email: roney.paull@kendle.com
Steven M. Snyder, M.S.
President
Outsourcing Support Services, Inc.
6569 Braemar Avenue
Noblesville, IN 46062
T: 317-408-0286 F: 317-770-7750
Email: info@outsource-support.com
Alan H. Roter, Ph.D.
Vice President, Informatics
Entelos, Inc.
110 Marsh Drive
Foster City, CA 94404
T: 650-572-5518 F: 650-572-5401
Email: roter@entelos.com
47
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
Tracey L. Spriggs, Ph.D., DABT
Director Toxicology
GlaxoSmithKline Consumer Healthcare
1500 Littleton Road
Parsippany, NJ 07054-3884
T: 973-889-2503 F: 973-889-2469
Email: tracey.l.spriggs@gsk.com
Rochelle W. Tyl, Ph.D., DABT
Senior Fellow
RTI International
HLB-124 - 3040 Cornwallis Rd
P. O. Box 12194
Res Triangle Park, NC 27709
T: 919-541-5972 F: 919-541-5956
Email: rwt@rti.org
Douglas C. Throckmorton MD
Deputy Director
US FDA
CDER
10903 New Hampshire Ave.
Silver Spring, MD 20903
T: 301-796-5400
Email: douglas.throckmorton@fda.hhs.gov
Ramjay Vatsan, Ph.D.
Biologist
GTB/Div Cellular & Gene Therapies
US FDA
OCTGT/CBER
Room 235N
Woodmont Office Complex
1401 Rockville Pike
Rockville, MD 20852
T: 301-827-6041 F: 301-827-9796
Email: ramjay.vatsan@fda.hhs.gov
Kenneth E. Thummel, Ph.D.
Professor, Dept of Pharmaceutics
University of Washington
Department of Physics
Dept Physics Health Science Building
H-wing, Room H272
Seattle, WA 98195-7610
T: 206-543-9434 F: 206-543-3204
Email: thummel@u.washington.edu
Mark D. Walker, D.V.M.
Senior Director
Charles River
Scientific and Laboratory Operations
6995 Longley Lane – MS-A1
Reno, NV 89511
T: 775-682-2329 F: 775-682-2100
Email: mark.walker@crl.com
Graham Tobin, Ph.D.
Director, Technical Services
Teklad Diets Europe
Research Models & Services
Harlan Laboratories UK Ltd.
Station Road
Blackthorn, Bicester, OXON, OX25 1TP,
UNITED KINGDOM
T: +44 1869 243241 F: +44 1869 246759
Email: gt@harlan.com
David B. Warheit, PhD, DABT, ATS
DuPont Haskell Global Centers
SHRC, S320, Room 303
1090 Elkton Road
Newark, DE 19711-3507
T: 302-366-5322 F: 302-366-5207
Email: david.b.warheit@usa.dupont.com
Marque D. Todd, D.V.M., M.S., DABT
Associate Research Fellow
Pfizer Inc.
Drug Safety R&D
10646 Science Center Dr (CB4)
San Diego, CA 92121
T: 858-952-4467 F: 858-678-8290
Email: marquee.todd@pfizer.com
Klaus Weber, Ph.D., MS Biol, DVM
Head, Pathology/Diagnostics, CSO
RCC Ltd., Harlan Inc.
Zelgliweg 1
Itingen, CH-4452
Switzerland
T: +41 61-975 1268 F: +41 61-971 7725
Email: kweber@harlan.com
Les Touart, Ph.D.
Senior Ecotoxicologist
US EPA
EPA Headquarters, Ariel Rios Bldg
1200 Pennsylvania Ave
Washington, DC 20460
T: 202-564-8468
Email: touart.les@epa.gov
Gerhard Weinbauer, Ph.D.
Director, Res & Safety Assessment
Covance Laboratories GmbH
Kesselfeld 29
Muenster, D-48163
Germany
T: 49 251 9798206 F: 49 251 784697
Email: gerhard.weinbauer@covance.com
48
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
Daniel Wierda, Ph.D.
Research Fellow
Eli Lilly and Company
Lilly Res Labs, Immunotoxicology
Lilly Corporate Center, DC 0730
Indianapolis, IN 46285
T: 317-277-4227 F: 317-277-4436
Email: dwierda@lilly.com
Grushenka Wolfgang, Ph.D., DABT
Vice President, Drug Safety Evaluation
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, CA 94404
T: 650-522-5993 F: 650-522-5266
Email: gwolfgang@gilead.com
Suzanne R. Wolford, Ph.D., DABT
Study Director
Covance Inc.
3301 Kinsman Blvd
Madison, WI 53704
T: 608-242-2721 F: 608-242-2736
Email: suzanne.wolford@covance.com
Clynn Wilker, DVM, Ph.D., DACT
Sr. Director, Preclinical Safety Assess.
Metabasis Therapeutics, Inc.
11119 North Torrey Pines Road
La Jolla, CA 92037
T: 801-622-5592 F: 858-622-5583
Email: wilker@mbasis.com
Michael Woolhiser, Ph.D.
Science & Technical Leader
The Dow Chemical Corporation
Toxicology & Environ Res & Consulting
1803 Building
Midland, MI 48674
T: 989-636-7549 F: 989-638-9863
Email: mwoolhiser@dow.com
James Willard, Ph.D.
Pharmacologist
US FDA
CDER
10903 New Hampshire Ave
Silver Spring, MD 20903-0002
T: 301-796-1163 F: 301-796-9841
Email: james.willard@fda.hhs.gov
Jeffrey J. Yourick, Ph.D., DABT
Chemical S&T Manager
Chemical Medical Countermeasures
Chemical & Biological Technologies
Directorate Defense Threat Reduction
Agency
8725 John J Kingman Road
Stop 6201
Fort Belvoir, VA 22060-6201
T: 703-767-3372 F: 703-767-1892
Email: jeffrey.yourick@dtra.mil
Calvin C. Willhite, Ph.D.
Staff Toxicologist
State of California
Dept Toxic Substances Control
700 Heinz Street, Suite 200
Berkeley, CA 94710
T: 510-540-3766 F: 510-540-3819
Email: calvinwillhite@hotmail.com
Nelson H. Wilson, B.S., DABT
Director, Lab Operations & Toxicology
Services
EPL., Inc.
P. O. Box 169
Sterling, VA 20167-0169
T: 703-471-7060 x238 F: 703-471-8447
Email: nwilson@epl-inc.com
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
Jeffrey C. Wolf, DVM, DACVP
Veterinary Pathologist
EPL, Inc.
P. O. Box 169
Sterling, VA 20167-0169
T: 703-471-7060 x242 F: 703-471-8447
Email: jwolf@epl-inc.com
49
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
SYMPOSIA ABSTRACTS
50
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
POSTER ABSTRACTS
67
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
ABSTRACT AUTHORS
Abbott, M. – P2
Achard, S. – P63
Adams, S. – XIV
Agrawal, M. – P49
Ahmad, I. – P68
Albretsen, J.C. – P29, P37, P38
Allamneni, K.P. – P14
Allison, D. – P7
Alschuler, R. – XII
Amato, M. – P62
Ammons, S. – P9
An-chun, C. – P4
Andrews, L. – IX
Aratani, K. – P61
Arima, A. – P7
Atterson, P. – P40, P41
Auer, C.M. – VII
Auyeung-Kim, D. – P32
Avalos, J. – P46, P47
Balsa, D. – P53
Baneux, P. – P26
Barrett, E. – II
Bauman, M. – P6
Bechtel, C. – P5
Beck, M.J. – P34, P35
Becker, C. – P50
Becker, R.A. – VII
Bee, W.H. – P6, P15
Beedanagari, S.R. – P51
Beevers, C. – P55
Bernard, P. – P31
Beyer, J. – P8
Billingslea, F.B. – XIII
Blair, E. – P16, P19, P42
Blasi, E. – P57
Bolouri, H. – XIV
Bond, G.G. – VII
Borghoff, S. – P36, P58
Bouchard, G.F. –P16, P19, P42
Bourgeois, B. – P64
Braen, A.P.J.M. - P1, P7
Brown, A.P. – VI
Brown, L. – P16, P19, P42
Buckman, B. – P9
Burleson, F.G. – P12
Burns Naas, L.A. – XI
Buse, E. – XI
Butala, J. – P62
Callis, C. – XV
Cao, L. – P5
Caron, S. – P24
Catala, A.R. – P1
Caylak, H. – P65
Cerven, D. – P46, P47
Chanda, S. – P20
Chandra, S.A. – P11
Chellman, G. – P32
Chen, C-W. – P20
Chen, Z. – P61, P67
Chengelis, C. – P13
Chihaya, Y. – P7
Cho, C.R. – XIV
Choo, E.F. – P14
Cimon, K. – P2
Clarke, E. – P48
Cobb, T. – P40
Copeman, C. – P24
Cosandier, P. – XVIII
Cosenza, M.E. – IX
Cross, C.E. – XVIII
Crowder, K.C. - P6
Cui, L. – P61, P67
Cunningham, M.J. – P52
D’Amico, L.J. – P27
Dai, R. – P56
Dalton, J.A. – P17
Dambach, D.M. – P14
Davies, M.H. – P2
Davis, J. – P36, P58
De Leon, F. – VII
DeGeorge, G. – P52
De-kang, Z. – P4
Demady, D.R. – P17
DeMerlis, C.C. – X
Der. K. – P5
Diaz, D. – P14
Diaz-Sanchez, D. – II
Diters, R. – P2
Dixon, L.A. – P69
Donahue, D.A. – P46, P47
Dos Santos, G. – P49
Draper, K. – P26
Duan, Y. – P28
Dubach, J. – P26
86
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
Dumont, C. – P32
Dybdal, N. – P7
Edmiston, J. – P66
Edwards, T. – P41
Ellis, A. – I
El-Morsy, A.M.A. – P59
Empie, M. – P13
Eppler, S. – P8
Espinoza, Y. – P5
Fariss, M. – P66
Farthing, D. – P66
Felter, S.P. – XV
Feng-juen, B. – P4
Ficheux, H. – P39
Fisher, T.F. – P25, P45
Fitzgerald, J. – XIV
Fjordholt, M. – P55
Forster, R. – P31
Frampton, M.W. – XVIII
Frantz, S.W. – P17
Fraser, S. – P32
Freebern, W.J. – P12
Froget, G. – P39
Frost, G.I. – P6, P15
Fuhrer, D. – P9
Garcia, G. – XIV
Gasper, C. – P5
Genc, O. – P65
Geng, W. – P1
Gibbs, A. – P18
Gill, K. – P18
Glaza, S.M. – P29, P37, P38
Glazier, G. – P44
Gleason, T. – P41
Gordon, C. – P30
Gozubuyuk, A. – P65
Grabiel, R. – P13
Gregson, R.L. – P22
Gribkoff, V.K. – P17
Grubor, B. – P12
Gu, J. – XIV
Hackett, T. – P36
Haggerty, H.G. – P2, P12
Hankinson, O. – P51
Harkema, J.R. - XVIII
Harms, B. – XIV
Harrill, A. – XIV
Harvey, B.E. – VI
Hassan, M.S. – P59
Haubrich, R. – VIII
Hawi, A. – P54
Hayes, A.W. – P70
Heiser-Wong, M. – P37
Hentz, K.L. – P21
Hernandez-Reyes, J. – XII
Hiraragi, H. – P14
Hoberman, A. – P15, P21
Hobson, D.W. – X
Holsapple, M.P. – XI
Hopper, D.L. – IV
Huang, X. – P56
Hughes, P. – P13
Huhalov, S. – XIV
Hunter, D.L. – P60
Imbert, D. – P20
Ingersoll, E. – P17
Irons, T.D. – P60
Islam, N. – P68
Iverson, B. – P58
James, J.T. – XVII
Janer, G. – P53
Janke, H. – P2
Jessen, B. – P57
Jordan, H. – P10
Joseph, A. – P61
Jumanca, O. – P43
Kadambi, A. – XIV
Kamel, K.I. – P59
Kangas, L. – P22
Kashyap, M.P. – P49
Kaufman, L. – P47
Kavakli, K. – P65
Kearney, K. – P41
Keener, M.J. – P11
Khan, M.I. – P68
Khan-Mayberry, N.N. – XVII
Kirkland, D. – P55
Kolaitis, G. – P1
Kolodzieyski, L. – P33
Kopp, G. – P41
Korgaonkar, C.K. – P13
Krieger, R.I. – P61, P67
Kruger, C.L. – P70
Krull, D.L. – P11
Kuffner, E. – XIII
Kumar, V. – P49
La, N. – P14
Lalayeva, N. – P6
Lalko, J.F. – XIII
Lam, C. – XVII
Landreth, K.S. – XI
Lange, R. – P2
87
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
Lauriault, V. – P7
Lawson, C. – P16, P19
Leach, C.J. – II
LeBlanc, A. – P30
Legrand, J.J. – P39
Leigh, H. – P42
Leleu, C. – P63
Lemarchand, T. – P31
Lemke, L. – XII
LePrell, C. – XII
Leroy, P. – XVIII
LeSauteur, L. – P32
Li, C-Q. – P28
Li, Y. – P67
Lillard-Wetherell, K. – P31
Lin, H. – P50
Lin, S. – P50
Liu, A. – P56
Liu, J. – P16, P19, P42
Liu, R.C. – P6
Liu, X. – P56
Liu, Y. – P56
Lombard, C. – P66
Lopez, T. – P67
Lu, S. – P57
Luo, W. – P56
Luo, Y. – P25, P45
Luo, Y. – P25, P45
Lu-yong, Z – P4
Ma, J. – P5
MacDonald, J.S. – V
MacLachlan, T. – IX
MacPhail, R. – P60
Madsen, T. – P16, P19
Mahdi, A.A. – P68
Mahdi, F. – P68
Makori, N. – P6
Mann, P.C. – IV
Mansell, P. – P22
Marit, G. – P13
Martinez-Ceballos, E. – P69
Mathis, C. – XVIII
McDonagh, C. – XIV
McGovern, T.J. – I, X, XV
McGrath, P. – P27, P28
McKallip, R. – P66
McKeever, K. – P8
McNamee, P.M. – XIII
Mejia, L.A. – P13
Merlos, M. – P53
Merrill, C. – P10
Meyer, K. – P5
Miller, J. – XII
Moehlenkamp, J. – P2
Momas, I. – P63
Morata, T.C. – XII
Morse, D. – I
Moser, G. – P36, P58
Mould, A.P. – P29, P37, P38
Mulder, G.B. – P25, P45
Munro, I.C. – XV
Murli, H. – P54
Murray, J.S. – VIII
Myers, L.P. – VIII
Nadal, T. – P53
Nadjsombati, S. – P15
Neal, B.H. – P21
Nemec, M.D. – P34, P35
Newcomb, D. – P15
Newhard, W. – P47
Nielsen, U. – XIV
Novilla, M. – P13
Onsum, M. – XIV
Orlando, E.F. – III
Ortega, S. – P7, P8
Osterberg, R.E. – X
Owens, J. – P64
Pace, E. – XIV
Padilla, S. – P60
Padnos, B. – P60
Paisley, S. – P54
Pan, L. – P9
Parish, J. – P18
Park, D. – P27
Patrick, D.J. – VI
Peck, M. – XVIII
Perron, J. – P1
Persoz, C. – P63
Peterson, R.A. – P11, V
Phillips, R.D. – VII
Piehl, M. – P46
Pilcher, G.D. – P12
Popke, E.J. – P17
Powell, R. – XIV
Pratt, L. – P52
Prefontaine, A. - P24
Qi-hui, L. – P4
Randhawa, G.S. – P49
Rangan, V. – P64
Raphael, Y. – XII
Reasor, M.J. - V
Reed, K.L. – XVIII
88
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
Reid, L. – I
Reed, M. – II
Reilly, T.P. – P2
Ricci, M.S. – IX
Roney, P. – I
Roter, A.H. – XIV
Ruddock, W. – P43
Sahambi, S. – P30
Salcedo, T.W. – P2
Sanderson, T.P. – P12
Sankaran, G. – P67
Satterwhite, C.M. – P32
Sayes, C.M. – XVIII
Schafer, K.A. – XII
Schoeberl, B. – XIV
Schulze, G.E. – P2
Schutzsack, J. – P18, P55
Schweizer, M. – P13
Seiwert, S. – P9
Seng, W.L. – P27
Seta, N. – P63
Setser, J. – P40
Shaler, T. – P50
Shellhammer, L. – P40
Siddiqui, M.A. – P49
Siler, S. – XIV
Slade, M. – P12
Smith, S.Y. – P22, P44
Sokolowski, S.A. – P57
Song, W. – P61
Sperisen, P. – XVIII
Sproul, P. – P36
Stankowski, Jr., B.L.F. - P54
Stokes, A. – P10
Stoll, R. – P54
Stuart, I. – P55
Stump, D.G. – P34, P35
Sugarman, B.J. – P6, P15
Tarrant, J. – P14
Tasker, E.J. – P17
Tellier, P. – P1
Thummel, K.E. – XVII
Tobin, G. – IV
Toot, J.D. – P34, P35
Tourt, L.W. – III
Trimble, M.W. – P29, P37, P38
Trudel, Y. – P24, P44
Tsusaki, H. – P8
Tucker, C. – P66
Tweats, D. – P55
Tyl, R.W. – P21, III, XVII
Unoje, O. – P61
Vaidyanathan, A. – P8
Valin, M. – P31
Varsho, J.S. – P34, P35
Vatsan, R. – IX
Vega, H. – P67
Voltz, D. – P62
Vuillaume, G. – XVIII
Walker, D. – P2, P26
Wang, Z.S. – XVIII
Warheit, D.B. – XVIII
Washer, G. – P30
Weber, K. – P23, IV
Wei-guo, S. – P67
Weinberg, J. – P62
Wells, S.Q. – P12
Welsh, T. – P26
Wen, Z. – P4
Willard, J.M. – V
Willhite, C.C. – XIII
Wilson, D. – P21
Wohlsen, A. – XVIII
Woicke, J. – P2
Wolf, J.C. – III
Wolfgang, G.H.I. – VIII
Woolhiser, M. – XI
Xi, P. – P4
Yohe, J. – P40
Younan, J. – P33
Yourick, J.J. – X
Yousef, M.I. – P59
Yucel, O. – P65
Zepeda, M. – P6
Zhan, L. – P4
Zheng-li, C. – P4
Ziemer, E. – P13
Zoetis, T. – VI
89
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
THANK YOU TO OUR EXHIBITORS
Advion BioServices
Ithaca, NY
www.advion.com
Charles River
Wilmington, MA
www.criver.com
Aperio
Vista, CA
www.aperio.com
C.I.T.
Evreux, France
www.citox.com
BASi
West Lafayette, IN
www.basinc.com
CorDynamics, Inc.
Chicago, IL
www.cordynamics.com
Battelle
Columbus, OH
www.battelle.org
Covance Laboratories, Inc.
Madison, WI
www.covance.com
Biological Test Center
Irvine, CA
www.biologicaltestcenter.com
Data Sciences International
St. Paul, MN
www.datasci.com
BioReliance
Rockville, MD
www.bioreliance.com
EPL, Inc.
Sterling, VA
www.epl-inc.com
Bridge Laboratories
Gaithersburg, MD
www.bridgelaboratories.com
Eurofins Product Safety
Laboratories
Dayton, NJ
www.productsafetylabs.com
Calvert Laboratories Inc.
Olyphant, PA
www.calvertlabs.com
Evotec (UK) Ltd.
Abingdon, United Kingdom
www.evotec.com
Cerep Inc.
Redmond, WA
www.cerep.com
Experimur
Chicago, IL
www.experimur.com
CeeTox, Inc.
Kalamazoo, MI
www.ceetox.com
Harlan Laboratories, Inc.
Indianapolis, IN
www.harlan.com
Cellular Dynamics International
Madison, WI
www.cellulardynamics.com
90
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
HemoGenix, Inc.
Colorado Springs, CO
www.hemogenix.com
MPI Research
Mattawan, MI
www.mpiresearch.com
Histo-Scientific Research Labs
Mount Jackson, VA
www.hsrl.org
National Library of Medicine
Bethesda, MD
http://roxnet.nlm.nih.gov
Histotox Labs., Inc.
Boulder, CO
www.histotoxlabs.com
Pacific BioLabs
Hercules, CA
www.pacificbiolabs.com
Huntingdon Life Sciences Inc.
East Millstone, NJ
www.huntingdon.com
PDS Preclinical Data Systems, Inc.
Mount Arlington, NJ
www.pds-america.com
IIT Research Institute (IITRI)
Chicago, IL
www.iitri.org
PreLabs, LLC
Oak Park, IL
www.prelabs.com
ITR Canada
Baie d’Urfe, Canada
www.itrlab.com
ReachBio LLC
Seattle, WA
www.reachbio.com
JRF America
King of Prussia, PA
www.jrfonline.com
Ricerca Biosciences, LLC
Concord, OH
www.ricerca.com
LAB Research Inc.
Laval, Canada
www.labresearch.com
RTI International
Research Triangle Park, NC
www.rti.org/drugdev
Leadscope, Inc.
Columbus, OH
www.leadscope.com
SAGE
Thousand Oaks, CA
www.sagepub.com
Lovelace Respiratory Research Institute
Albuquerque, NM
www.lrri.org
SAI (Strategic Applications)
Libertyville, IL
www.
Maccine Pte Ltd
Singapore Science Park II, Singapore
www.maccine.com
Seventh Wave Labs
Chesterfield, MO
www.7thwavelabs.com
Marshall BioResources
North Rose, NY
www.marshallbio.com
Sinclair Research Center, Inc.
Columbia, MO
www.sinclairresearch.com
91
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
SNBL USA, Ltd.
Everett, WA
www.snblusa.com
Tucker-Davis Technologies
Alachua, FL
www.tdt.com
Southern Research Institute
Birmingham, AL
www.southernresearch.org
Vet Path Services (VPS)
Mason, OH
www.vetpathservicesinc.com
SRI International
Menlo Park, CA
www.sri.com/biosciences
WIL Research Laboratories, LLC
Ashland, OH
www.wilresearch.com
WuXi AppTec
St. Paul, MN
www.wuxiapptec.com
92
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
AMERICAN COLLEGE OF TOXICOLOGY - 2009
PRESIDENT
PRESIDENT ELECT
VICE PRESIDENT
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
Russette M. Lyons, Ph.D.
Meningitis Core Project Team Leader
Novartis Vaccines & Diagnostics, Inc.
350 Massachusetts Avenue
75SS/172L
Cambridge MA 02139
T: (617) 871-3112
Email: russette.lyons@novartis.com
SECRETARY
TREASURER
PAST PRESIDENT
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
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
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
COUNCILORS - 2009 Only
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.
Sr.Vice President of Drug Sfty Eval.
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
Jos J.W.M. Mertens, Ph.D., DABT
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
COUNCILORS - 2009- 2011
Drew A. Badger, Ph.D. DABT
Senior Director, Tox & Reg Affairs
Amira Pharmaceuticals
9535 Waples Street, #100
San Diego, CA 92121
T: 858-228-4688 F: 858-228-4788
Email: drew.badger@amirapharm.com
Grace M. Furman, Ph.D., DABT
President/CEO
Paracelsus, Inc.
128 Daphne Street
Leucadia. CA 92024
T: (760) 271-2858
Email: paracelsus.inc@cox.net
EDITOR-IN-CHIEF
Mary Beth Genter, PhD, DABT
Associate Professor
University of Cincinnati
3223 Eden Ave., ML 670056
144 Kettering Lab
Cincinnati OH 45267-0056
T: 513-558-6266 F: 513- 558-4397
Email: marybeth.genter@uc.edu
93
Suzanne R. Wolford, Ph.D., DABT
Study Director
Covance Inc.
3301 Kinsman Blvd
Madison. WI 53704
T: 608-242-2721 F: 608-242-2736
Email: suzanne.wolford@covance.com
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
ACT COMMITTEES – 2009
AWARDS COMMITTEE
Russette M. Lyons, Ph.D. - Chair
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
2009-2011
David R. Compton, Ph.D., DABT
Principal Research Investigator - Toxicology
sanofi-aventis
Drug Safety Evaluation
1041 Route 202-206 - MC: JR2-103A
P. O. Box 6800
Bridgewater NJ 08807-0800
T: (908) 541-5328 F: (908) 231-2629
Email: david.compton@sanofi-aventis.com
EDUCATION COMMITTEE
David G. Serota, Ph.D., Chair, Nancy Holmes, Ph.D., Suzanne Wolford, Ph.D., Co-Chairs
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
2009 - 2011
Michael Aschner, Ph.D.
Professor
Vanderbilt University Medical Center
1162 21st Ave. South-B-3307 MCN
Dept Pediatrics-Medical Ctr North
Nashville TN 37232-2495
T: (615) 322 8024 F: (615) 322 6541
Email: michael.aschner@vanderbilt.edu
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
Melissa Rhodes, Ph.D., DABT
Project Manager, Safety Assessment
GlaxoSmithKline
5 Moore Drive
Res Triangle Pk NC 27709
T: 919-483-6908 F: 919-483-0131
Email: melissa.c.rhodes@gsk.com
FINANCE COMMITTEE
Mary Ellen Cosenza, Ph.D., DABT, Chair
2007-2009
Anthony L. Kiorpes, Ph.D., DVM
Consultant
2470 Skyline Drive
Bloomington, MN 55425
T: 952-854-9060
Email: a.kiorpes@att.net
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
94
2009 - 2011
Steven M. Snyder, M.S.
President
Outsourcing Support Services, Inc.
6569 Braemar Avenue
Noblesville IN 46062
T: 317-408-0286 F: 317-770-7750
Email: info@outsource-support.com
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
MEMBERSHIP COMMITTEE
Norman N. Kim, M.S., DABT, Chair
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
2009 - 2011
Ted Alan Birkebak, Ph.D., DVM
sanofi-aventis
Drug Safety Evaluation (JR2-103A)
1041 Route 202-206
Bridgewater NJ 08870
T: 908-231-3408
Email:
ted.birkebak@sanofi-aventis.com
NOMINATING COMMITTEE
A. Wallace Hayes, Ph.D., Chair
2009
Diann L. Blanset, Ph.D.
Senior Director, Preclin Development
Medarex, Inc.
519 Route 173W
Bloomsbury NJ 08804
T: 908-479-2446 F: 908-479-2402
Email: dblanset@medarex.com
2009
Ronald J. Christopher, Ph.D., DABT
Senior Director, Development
Takeda San Diego, Inc.
10410 Science Center Driv e
San Diego CA 92121
T: 858-731-3651
Email: ron.christopher@takedasd.com
OUTREACH COMMITTEE
A. Wallace Hayes, Ph.D., Chair
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
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
95
2009 -2011
Alan H. Stokes, Ph.D., DABT
Sr Scientific Investigator-Tox
GlaxoSmithKline
RD9-2126
Five Moore Drive
Res Triangle Pk NC 27709-3398
T:919-315-2598 F:919-483-6858
Email: alan.h.stokes@gsk.com
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
ELECTED PROGRAM COMMITTEE
Carol S. Auletta, MBA, DABT, Chair
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
2009-2011
Scott Coleman, Ph.D.
Director Invest/Mech Tox
Cubist Pharmaceuticals, Inc.
65 Hayden Ave
Lexington MA 02421
T: 781-860-8643
Email:
scott.coleman@cubist.c om
PUBLICATIONS COMMITTEE
Mary Beth Genter, Ph.D., DABT, 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
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
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
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
96
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
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
PROGRAM COMMITTEE
Carol S. Auletta, MBA, DABT, Huntingdon Life Sciences, , Program Chair
Angélique Braen, Ph.D., DABT, Hoffmann-La Roche, Inc., Nutley, NJ
William J. Brock, Ph.D., DABT, ATS, Brock Scientific Consulting, LLC,
Montgomery Village, MD
Mary Ellen Cosenza, Ph.D., DABT, Amgen Inc., Thousand Oaks, CA
William C. Hall, VMD, Ph.D., DACVP, Hall Consulting, Inc., Mount
Airy, MD
Jerry F. Hardisty, D.V.M., EPL, Inc., Res Triangle Park, NC
Kenneth L. Hastings, Dr.P.H., DABT, sanofi-aventis, Bethesda, MD
Jon F. Lalko, B.S., R.I.F.M., Woodcliff Lake, NJ
Russette M. Lyons, Ph.D., Novartis Vaccines & Diagnostics, Inc.,
Cambridge, MA
Timothy Joseph McGovern, Ph.D., Scilucent LLC, Herndon VA
Kenneth J. Olivier, Jr., Ph.D., Merrimack Pharmaceuticals, Cambridge,
MA
Melissa Rhodes, Ph.D., DABT, GlaxoSmithKline, Research Triangle
Park, NC
ANNIVERSARY PROGRAM COMMITTEE
Tracey L. Spriggs, Ph.D., DABT, GlaxoSmithKline Consumer Healthcare,
Parsipanny, NJ and David R. Compton, Ph.D., DABT, sanofi-aventis,
Bridgewater, NJ, Chairs
Carol S. Auletta, MBA, DABT, Huntingdon Life Sciences, East
Millstone, NJ
Leigh Ann Burns Naas, Ph.D., DABT, Pfizer Global R&D, San Diego, CA
Mary Ellen Cosenza, Ph.D., DABT, Amgen Inc., Thousand Oaks, CA
Nancy Holmes, Ph.D., DABT, Alcon Laboratories, Inc., Ft Worth TX
Alan H. Stokes, Ph.D., DABT, GlaxoSmithKline, Res Triangle Park, NC
97
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
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 (Deceased)
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
98
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
This activity is supported by educational donations provided by
30th ANNUAL MEETING SPONSORS – 2009
Alcon Research, Inc.
Bristol-Myers Squibb Company
Fort Worth, TX
www.alconlabs.com
Princeton, NJ
www.bms.com
Allergan
Calvert Laboratories
Irvine, CA
www.allergan.com
Olyphant, PA
www.calvertlabs.com
Altria Client Services, Inc.
Charles River
Richmond, VA
www.altria.com
Wilmington, MA
www.criver.com
American Chemistry Council
Covance Laboratories, Inc.
Arlington, VA
www.americanchemistry.com
Madison, WI
www.covance.com
Amgen Inc.
Eli Lilly and Company
Thousand Oaks, CA
www.amgen.com
Indianapolis IN
www.lilly.com
BASi
EPL, Inc.
West Lafayette, IN
www.bastox.com
Sterling, VA
www.epl-inc.com
Battelle
Experimur
Columbus, OH
www.battelle.org/hhs/toxicology
Chicago, IL
www.experimur.com
Biogen Idec MA Inc.
ExxonMobil Biomedical Sciences,
Inc.
Cambridge, MA
www.biogen.com
Annandale, NJ
www.exxonmobil.com
Boehringer Ingelheim
Ridgefield, CT
www.boehringer-ingelheim.com
Genentech, Inc.
South San Francisco, CA
www.gene.com
Bridge Laboratories
Gaithersburg, MD
www.bridgecro.com
99
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
Gilead Sciences, Inc.
Merrimack Pharmaceuticals
Foster City, CA
www.gilead.com
Cambridge, MA
www.merrimackpharma.com
GlaxoSmithKline
MPI Research
Research Triangle Park, NC
www.gsk.com
Mattawan, MI
www.mpiresearch.com
GlaxoSmithKline Consumer
Healthcare, LP
Parsippany, NJ
Patricia Frank & Associates
Evanston, IL
patfrank@att.net
www.gsk.com/products/consumer_healt
hcare
Pfizer Inc.
Harlan Laboratories, Inc.
Groton, CT
www.pfizer.com
Indianapolis, IN
www.harlan.com
Philip Morris International
Hoffmann-La Roche, Inc.
Lausanne, Switzerland
www.philipmorrisinternational.com
Nutley, NJ
www.rocheusa.com
Ricerca Biosciences, LLC
Huntingdon Life Sciences
Concord, OH
www.ricerca.com
East Millstone, NJ
www.huntingdon.com
RTI International
Research Triangle Park, NC
www.rti.org/drugdev
ILSI-HESI Immunotox Technical
Committeee
Sage
Washington, DC
www.ilsi.org
Thousand Oaks, CA
www.sagepub.com
International Pharmaceutical
Excipients Council
sanofi-aventis
Arlington, VA
www.ipec.org
Bridgewater, NJ
www.sanofi-aventis.com
LAB Research Inc.
Schering-Plough Research
Institute
Laval, Canada
www.labresearch.com
Lafayette, NJ
www.schering-plough.com
Lovelace Respiratory Research
Institute
Seventh Wave Labs
Albuquerque, NM
www.lrri.org
Chesterfield, MO
www.7thwavelabs.com
100
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
Southern Research Institute
Birmingham, AL
www.southernresearch.org
WIL Research Laboratories, LLC
SciLucent, LLC
WuXi AppTec
Herndon, VA
www.scilucent.com
St. Paul, MN
www.wuxiapptec.com
Tucker-Davis Technologies
Wyeth Research
Alachua FL
www.tdt.com
Chazy, NJ
www.wyeth.com
Ashland, OH
www.wilresearch.com
101
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
30TH 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
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
Stephen B. Harris, Ph.D.
Stephen B. Harris Group, San Diego, CA
steve@sbjgrp.com
102
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
Alan C. Katz, M.S., DABT
toXcel LLC, Gainesville, VA
akatz@toxcel.com
Veronique Lauriault, Ph.D., DABT
Tox Consult, LLC, San Francisco CA
veronique@comcast.net
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
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
Robert J. Staab, Ph.D.
Regulatory and Technical Association, Old Lyme, CT
rta1ali1@aol.com
Michael J. Tomlinson, DVM, PhD, DACVP
NOVA Pathology, Oak Harbor WA
mtomlins@whidbey.net
N. Jonathan Wosu, DVM, MS, PhD, DACVP
N. Jonathan Wosu – Consulting Pathologist, Piscataway, NJ
wosu@optonline.net
103
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
ACT CORPORATE MEMBERSHIP - 2009
Abbott Laboratories, Abbott Park, IL
Alcon Research, Inc., Fort Worth, TX
Allergan, Irvine, CA
Altria Client Services, Inc., Richmond, VA
American Chemistry Council, Arlington, VA
American Petroleum Institute, Washington, DC
Amgen Inc., Thousand Oaks, CA
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
BioReliance, Rockville, MD
Boehringer Ingelheim, Ridgefield, CT
Bristol-Myers Squibb, PRI, Princeton, NJ
Cantox Health Sciences International, Mississauga, Canada
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
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
J&J Pharma Co (Centocor/J&J PRD/Tibotec), Radnor, PA
MannKind Corporation, Valencia, CA
MPI Research, Mattawan, MI
Novartis Pharmaceutical Corporation, East Hanover, NJ
P&G Pharmaceuticals Inc., Mason, OH
Pfizer Inc., Groton, CT
Purdue Pharma, LP, Cranbury, NJ
R. J. Reynolds Tobacco Co., Winston-Salem, NC
sanofi-aventis US, Bridgewater, NJ
Schering-Plough Research Institute, Lafayette, NJ
Sequani Limited, Ledbury, United Kingdom
Takeda Global R&D, Lake Forest, IL
WIL Research Laboratories, LLC, Ashland, OH
Wyeth Research, Chazy, NY
104
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
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
**************************************
ACT 33rd ANNUAL MEETING
NOVEMBER 4 -7, 2012
OMNI ORLANDO
CHAMPIONSGATE, FL
105
AMERICAN COLLEGE OF TOXICOLOGY 30TH ANNUAL MEETING
________________________________________________________________________
Sponsored by
American College of Toxicology
“TOXICOLOGY FOR INDUSTRIAL AND REGULATORY
SCIENTISTS”
Date: April 26 - 30, 2010
This course, taught by distinguished experts, is designed to provide a basic training in
toxicology. Participants will obtain an overall understanding of the principles of nonclinical
safety evaluation with emphasis on the practical application of these principles and
interpretation of nonclinical safety data. The course topics will include principles and
application of toxicology, carcinogenicity, genetic toxicology, reproduction/developmental
toxicology, immunotoxicology, safety pharmacology, statistics, clinical pathology,
pathology, biomarkers, PK/ADME, safety evaluation of biotechnology derived products,
and regulatory considerations. The course will also include a workshop of nonclinical
assessment and development strategy of a drug.
Sponsored in conjunction with Society of Toxicologic Pathology
“PATHOLOGY FOR NON-PATHOLOGISTS”
Date: May 10 - 13, 2010
This course will be taught by highly respected pathologists with current, relevant
experience in toxicologic pathology. Lectures will cover anatomy and physiology of the
hematopoietic and musculoskeletal systems, spontaneous and chemically-induced
pathological changes, clinical pathology and case examples.
Location for both courses:
Falls Church, Virginia, USA
Contact information/inquiries at ACT:
Phone: (301) 634-7840
Emails: clemire@actox.org
ekagan@actox.org
Website: www.actox.org
106