Program - Society of Toxicology

50 th Anniversary Annual Meeting and ToxExpo
Program Description (Continued)
Abstract # Abstract #
complexity of safety evaluations and dedication of resources as a compound
advances through development. Ultimately, the experiences gained over
the course of this time informs whether the de-risking strategy pursued
has been effective. As shown in the area of development of T2D drugs, the
knowledgebase upon which decisions are made is limited because scientists
do not fully understand the relationship of different therapeutics for
T2D to unwanted cardiovascular toxicities. However, standard models of
cardiovascular toxicity have been established and provide some reassurance
of a compound’s safety. In those cases, though, where there is evidence
of a relationship, investigators still cannot say how well their preclinical
models and early clinical phase monitoring predict the observed outcome
when a therapy is given over a life-time. Against this backdrop a debate of
best practices in cardiovascular safety testing will ensue based on a current
understanding of the state of science in the areas of safety pharmacology,
toxicology-pathology, and clinical pharmacology. Ultimately, our panel of
experts will advocate for integration of information emerging from each of
these scientific disciplines that will lead to de-risking the potential adverse
cardiovascular outcomes of T2D drugs.
Wednesday Afternoon, March 9
1:30 PM to 4:15 PM
Room 206
Workshop Session: Meeting the Challenges of Respiratory
Toxicology Testing—In Search of Best Practices
Chairperson(s): James Wagner, Michigan State University, East Lansing,
MI, and Flemming Cassee, RIVM, Netherlands, Bilthoven, Netherlands.
Sponsor:
Inhalation and Respiratory Specialty Section
Endorsed by:
Cardiovascular Toxicology Specialty Section
Nanotoxicology Specialty Section
Occupational and Public Health Specialty Section
Wednesday
#2468 1:30 DE-RISKING THE POTENTIAL FOR
CARDIOVASCULAR TOXICITY OF TYPE
2 DIABETIC DRUGS: PRECLINICAL AND
CLINICAL STRATEGIES. ​A. S. Bass 1 and P.
K. Hoffmann 2 . 1 Global Safety Assessment, Merck
& Co., Kenilworth, NJ and 2 Preclinical Safety,
Novartis, East Hanover, NJ.
1:30 INTRODUCTION. ​Alan Bass
#2469 1:35 ADVERSE CARDIOVASCULAR RISK
ASSOCIATED WITH THERAPEUTICS FOR
TYPE 2 DIABETES: CHALLENGES TO
IDENTIFYING ACCURATE, PREDICTIVE
PRECLINICAL MODELS OF TOXICITY. ​A.
S. Bass. Global Safety Assessment, Merck & Co.,
Kenilworth, NJ.
#2470 2:07 MODELING CARDIOVASCULAR TOXICITY
OF THERAPIES FOR TYPE 2 DIABETES IN
VITRO. ​P. Hoffmann. Novartis, East Hanover, NJ.
Sponsor: P. Bentley.
#2471 2:39 CARDIOVASCULAR TOXICITY OF TYPE 2
DIABETES DRUGS, PRECLINICAL IN VIVO
MODELS AND SPECIALIZED PROTOCOLS
FOR IDENTIFYING CARDIOVASCULAR
RISK. ​P. C. Levesque. Discovery Toxicology,
Bristol-Myers Squibb, Pennington, NJ. Sponsor: A.
Bass.
#2472 3:11 PRECLINICAL MODELING OF
CARDIOVASCULAR RISK FOR TYPE 2
DIABETES DRUGS: A PATHOLOGIST’S
PERSPECTIVE. ​B. R. Berridge. Safety
Assessment, GlaxoSmithKline, Research Triangle
Park, NC. Sponsor: A. Bass.
#2473 3:43 CLINICAL MODELING OF
CARDIOVASCULAR TOXICITY OF TYPE
2 DIABETES DRUGS: REGULATORY
EXPECTATIONS AND EXPERIENCE. ​D. E.
Gutstein. Clinical Research, Merck & Co., Rahway,
NJ. Sponsor: A. Bass.
Inhalation exposure to airborne materials in the home, workplace, and
outdoors can produce adverse responses in the airways of both healthy and
compromised individuals. Creating comparable exposure/response scenarios
in laboratory animals presents significant challenges for the respiratory
toxicologist, and over the last decade a number of new approaches have
been adopted that complement or replace older practices. However many of
these new advances are neither widespread nor widely accepted. Indeed the
choices of airway exposure, and types and methods of data collection can
provide the researcher with an array of disparate results, thereby creating
a challenge for meaningful risk assessment. We will examine the value of
popular and perhaps controversial methodological approaches to evaluate
toxic airway responses. Beginning with a critical survey of exposure techniques,
presentations will expand into the limitations of animal models, the
predictive value of acute responses for chronic and functional responses,
the special challenges with testing nanomaterials, and the evolution on in
vitro approaches. Together the presentations are intended to foster scientific
discussions and debate that may unify our thinking on the best practices for
respiratory toxicology testing, and in the long term provide research tools to
improve human health.
#2474 1:30 MEETING THE CHALLENGES OF
RESPIRATORY TOXICOLOGY TESTING -IN
SEARCH OF BEST PRACTICES. ​J. Wagner 1
and F. Cassee 2 . 1 Michigan State University, East
Lansing, MI and 2 RIVM, Bilthoven, Netherlands.
1:30 INTRODUCTION. ​James G. Wagner
#2475 1:38 DOSING THE RESPIRATORY TRACT. ​G.
Oberdörster. Environmental Medicine, University of
Rochester, Rochester, NY.
#2476 2:05 CAN ANIMAL INHALATION AND
INTRATRACHEAL INSTILLATION (IT)
STUDIES BE MADE TO SIMULATE HUMAN
EXPOSURE SCENARIOS? ​G. E. Hatch.
National Health and Environmental Effects Research
Laboratory, U.S. EPA, Research Triangle Park, NC.
#2477 2:31 SAMPLING THE AIRWAY: IMPROVING
THE PREDICTIVE AND TOXICOLOGICAL
VALUE OF BRONCHOALVEOLAR LAVAGE. ​
U. P. Kodavanti. EPHD/NHEERL/ORD, U.S. EPA,
Research Triangle Park, NC.
#2478 2:57 SCREENING FOR TOXIC AIRWAY
RESPONSES: THE COMPARATIVE
TOXICOLOGICAL VALUE OF PULMONARY
FUNCTION TESTING APPROACHES. ​J.
Wagner. Michigan State University, East Lansing,
MI.
334
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