Program - Society of Toxicology

50 th Anniversary Annual Meeting and ToxExpo
Program Description (Continued)
Wednesday
Abstract # Abstract #
6:55 USE OF PRECISION-CUT LIVER SLICE
CULTURES TO STUDY KUPFFER CELL-
MEDIATED DRUG TOXICITY. ​Nandita
Shangari
7:05 EX VIVO LUNG CULTURE MODELS TO
STUDY RESPIRATORY INFLAMMATION
AND THEIR RELEVANCE FOR IN VIVO. ​
Armin Braun
7:15 CROSS-SPECIES COMPARISON
ON PHARMACOLOGICAL AND
TOXICOLOGICAL ACTIVITIES IN
PRECISION-CUT LUNG SLICES. ​Christian
Martin
7:25 CROSS-SPECIES COMPARISON OF
DRUG METABOLISM AND TOXICITY IN
INTESTINAL SLICES. ​Genny M. Groothuis
7:35 PANEL DISCUSSION/Q&A.
Wednesday Morning, March 9
6:30 AM to 7:50 AM
Room 150
Toxicity Testing: State of Science and Strategies to
Improve Public Health
Informational Session: The Application of the Threshold
of Toxicological Concern Concept to the Preclinical Safety
Assessment of Non-Pharmaceutical Medical Products,
Including Medical Devices and Combination Drug-Device
Products
Chairperson(s): Richard W. Hutchinson, Johnson & Johnson: Ethicon,
Somerville, NJ, and Ronald P. Brown, U.S. FDA, Silver Spring, MD.
Sponsor:
Medical Device Specialty Section
Endorsed by:
Regulatory and Safety Evaluation Specialty Section
Risk Assessment Specialty Section
The Threshold of Toxicological Concern (TTC) is a concept used to estimate
safe exposure levels for chemicals for which toxicological data are
not available. It is based on chemical structure and known safety data for
structurally related chemicals. This value represents a low level of exposure
with negligible risk to humans. The process for demonstrating preclinical
safety or biocompatibility of medical devices often involves a staged
approach starting with a thorough understanding of the chemical composition
of the device, then progressing through in vitro and in vivo bioassays
and ultimately continuing the risk management process through the lifecycle
of the product. The TTC concept is a tool that many risk assessors use to
make decisions early in this staged process, and international committees are
actively developing standardized methods for applying these techniques. In
order to adequately explore this topic, we begin by discussing the history of
the TTC concept along with an overview of the areas that this concept has
been embraced up to this point. We will provide a description of how tolerable
intake levels are set for medical device extractables when an adequate
database of information about the extracted chemical is known. In addition,
information will be provided on how the TTC concept can be used for
extractable chemicals from medical devices for which structural information
is known but the toxicological database is insufficient. Finally, the validation
of a software package in the context of extractable chemicals known to be
relevant to medical devices will be described.
#1767 6:30 THE APPLICATION OF THE THRESHOLD
OF TOXICOLOGICAL CONCERN
CONCEPT TO THE PRECLINICAL SAFETY
ASSESSMENT OF NON-PHARMACEUTICAL
MEDICAL PRODUCTS, INCLUDING
MEDICAL DEVICES AND COMBINATION
DRUG-DEVICE PRODUCTS. ​R. W.
Hutchinson 1 , R. Brown 2 , M. A. Cheeseman 3 and J.
Cammack 4 . 1 Preclinical, Johnson&Johnson: Ethicon,
Somerville, NJ, 2 CDRH, U.S. FDA, Silver Spring,
MD, 3 CFSAN, U.S. FDA, Riverdale, MD and 4 ISIS
Services, San Carlos, CA.
6:30 INTRODUCTION. ​Richard W. Hutchinson
6:35 HISTORY OF THE THRESHOLD OF
TOXICOLOGICAL CONCERN CONCEPT. ​
Mitchell Cheeseman
6:50 USE OF ISO 10993-17 GUIDELINES FOR
SETTING TOLERABLE EXPOSURE LIMITS. ​
Jon Cammack
7:05 THRESHOLD OF TOXICOLOGICAL
CONCERN: APPLICATION TO MEDICAL
DEVICES. ​Richard W. Hutchinson
7:20 CATEGORIZATION OF COMPOUNDS
RELEASED FROM MEDICAL DEVICE
MATERIALS INTO CRAMER CLASSES
USING TOXTREE SOFTWARE. ​Ron Brown
7:35 PANEL DISCUSSION/Q&A.
Wednesday Morning, March 9
6:30 AM to 7:50 AM
Room 144
Education-Career Development Session: From Pilot Grants to
High-End Journals: The Science of Writing
Chairperson(s): Marie C. Fortin, Environmental and Occupational
Health Sciences Institute, Piscataway, NJ, and Anne Loccisano, The
Hamner Institutes for Health Sciences, Research Triangle Park, NC.
Sponsor:
Education Committee
Endorsed by:
Career Resource and Development Committee
Postdoctoral Assembly
Student Advisory Council
Want to learn how to write effective grants and publications, or sharpen
your scientific writing skills to communicate better? As toxicologists, it is
essential that we be able to articulate new ideas in the form of grants and
to disseminate the results of research in the form of scientific publications.
Thus effective communication through writing is fundamental therefore it is
crucial for early career scientists to learn effective writing skills. Publishing
is imperative in academic or non-profit sectors and obtaining sufficient
funding is a necessity when establishing a career and reputation. However,
most scientists do not receive any formal training in writing and these skills
are usually learned by following the style of a mentor or other authors. This
issue is particularly important for graduate students, postdoctoral fellows,
and other early career scientists who would like to enhance their critical
writing skills which are needed for good communication. Our panel of
experts will provide the audience with tactics to write promising NIH grant
applications, general approaches that enhance the publication success of
scientific papers, as well as concrete scientific writing strategies from an
author’s and reader’s standpoint. Attendees will be provided with tips to
enhance their skills that will enable more effective communication of both
their ideas and their science, from grant proposals to publication.
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Education-Career Development Sessions
Exhibitor Hosted Sessions
Featured Sessions
Historical Highlights
Informational Sessions
Platform Sessions