Annual Meeting & ToxExpo Annual Meeting & ToxExpo Annual ...

EXHIBITOR HOSTED SESSIONS
2:15 PM to 3:15 PM, Room 140B
Nonhuman Primate (NHP) Infant Age and Relevance
of Postnatal and Juvenile Assessments: Principles for
Understanding Specific Endpoints in Study Designs
Supporting Biologics Regulatory Submissions
Presented by: SNBL USA, Ltd.
In regulatory-mandated NHP pre-/post-natal and juvenile studies,
infant development milestones and test compound pharmacology
dictate the types of parameters to monitor. The pertinent question is
how to identify critical parameters from the numerous possibilities
that exist. This presentation will highlight approaches to take and
provide examples of background data and interpretation.
2:15 PM to 3:15 PM, Room 156
Utility of Hematopoietic Colony Forming Cell
(CFC) Assays in Drug Development
Presented by: STEMCELL Technologies, Inc.
A potential side effect of anticancer and some antiviral/
antimicrobial drugs is damage to the hematopoietic (blood) system.
Compounds that impair cell proliferation and differentiation can
result in neutropenia, anemia or thrombocytopenia. This talk
outlines the value of hematopoietic in vitro clonogenic assays for
prediction of hematotoxicity.
2:15 PM to 3:15 PM, Room 140A
How to Comply with the EPA’s Endocrine Disruption
Screening Program
Presented by: WIL Research Company, Inc.
The U.S. EPA’s Endocrine Disruption Screening Program (EDSP)
was established in response to growing concern that humans and
animals may exhibit adverse endocrine effects due to environmental
chemicals. The first tier in the U.S. EPA’s EDSP includes a suite
of specific assays designed to look at endocrine effects at the
molecular, receptor, and functional levels. These assay will be
reviewed in this session.
3:30 PM to 4:30 PM, Room 156
New Pre-Clinical Assays for Predicting Cardiotoxicity
Presented by: ChanTest Corporation
Sudden Cardiac death from non-cardiac drugs is the cardiotoxicity
issue for regulatory agencies. Greater predictivity will be achieved
by using Stem Cell-derived Human Cardiomyocytes and cardiac
ion channel screens, and by considering rate-dependent effects on
telemetered QT. Case reports that resolve discordances with the
traditional S7B approach will be presented.
3:30 PM to 4:30 PM, Room 140A
Screening of Drug Candidates with Idiosyncratic
Hepatoxic Potential: Concepts and Approaches
Presented by: In Vitro ADMET Laboratories, LLC (IVAL)
Experimental assessment of idiosyncratic drug toxicity is elusive
due to the rarity of the events and the lack of appropriate animal
models.
The multiple parameter hypothesis of idiosyncratic drug toxicity
and promising experimental approaches based on the hypothesis
will be described.
3:30 PM to 4:30 PM, Room 140B
Announcing EPA’s Clean Air Research Centers: Science
to Protect Health in a Multipollutant Atmosphere
Presented by: U.S. EPA
The U.S. Environmental Protection Agency is investing $32 million
in new Clean Air Research Centers (CLARCs). The CLARCs
will investigate exposures to air pollution mixtures, atmospheric
transformation products, and associated health outcomes to
determine impacts across life stages, amongst vulnerable
populations, and within high-risk communities.
TUESDAY, MARCH 8
9:15 AM to 10:15 AM, Room 140B
LiverPool: Pooled Human Cryopreserved Hepatocytes
and Their Advantages Across Diverse
ADME-Tox Applications
Presented by: Celsis In Vitro Technologies
The patented LiverPool TM pooled hepatocyte product, provides an
average response that is optimal for ADME-Tox studies.
Advances in pre-pooling have further increased the usefulness of
pooled human hepatocytes including their ability to meet targeted
activity profiles. Applications like transporter and inhibition will be
discussed.
9:15 AM to 10:15 AM, Room 140A
Preclinical Cellular Therapeutic Safety Testing
Presented by: Charles River
Cell-based therapies present unique challenges for the evaluation
of safety, cell survival, differentiation and distribution, and the
potential for tumor formation in the appropriate animal model.
These specifically designed preclinical studies with different
approaches provide valuable information for assessment of potential
clinical and regulatory risks of these promising therapies.
9:15 AM to 10:15 AM, Room 156
Predicting the Human Clinical Dose
Presented by: MPI Research
Allometric scaling has been the primary technique for human dose
prediction. The development of humanized ADME reagents has
led to techniques where the metabolic characteristics of a drug are
taken into account to improve the accuracy of predicting human
clinical doses and potential drug/drug interaction issues.
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EXHIBITOR HOSTED SESSIONS