51st Annual Meeting & ToxExpo - Society of Toxicology
51st Annual Meeting & ToxExpo - Society of Toxicology
51st Annual Meeting & ToxExpo - Society of Toxicology
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<strong>Society</strong> <strong>of</strong> <strong>Toxicology</strong> 2012<br />
Exhibitor Hosted Sessions<br />
Exhibits<br />
TUESday<br />
Development Challenges for Antibody Drug<br />
Conjugates (ADCs)<br />
Tuesday, March 13, 8:30 AM–9:30 AM<br />
Presented by:<br />
MPI Research<br />
ADCs combine the targeting potential <strong>of</strong> mAbs with the pharmacology<br />
<strong>of</strong> small molecules. These are significant challenges in the<br />
development <strong>of</strong> ADCs such as lot variation as well as the need to<br />
simultaneously determine safety margins for intact ADC, drug-free<br />
mAb, and small molecules that are released in vivo.<br />
Human Induced Pluripotent Stem Cell Technology<br />
in Predictive and Mechanism-Based Drug<br />
Discovery and Toxicity Testing Using Photometric-<br />
Based Assays<br />
Tuesday, March 13, 8:30 AM–9:30 AM<br />
Presented by:<br />
Promega Corporation<br />
Human iPSC-technology and photometric assays provide rapid and<br />
predictive assessments <strong>of</strong> viability/toxicity and ADME properties<br />
during drug development. This tutorial will highlight recent developments<br />
in human iPSC-derived cell types from CDI and reporter assays<br />
from Promega while demonstrating the advantages <strong>of</strong> these technologies<br />
in accurate assessment <strong>of</strong> drug-induced cellular responses.<br />
Current Strategies for Juvenile Toxicity Testing<br />
Tuesday, March 13, 9:45 AM–10:45 AM<br />
Presented by:<br />
Charles River<br />
Since issuance <strong>of</strong> the pediatric rule 14 years ago, we have conducted<br />
over 300 juvenile toxicity studies in rodent and nonrodent animals<br />
for numerous therapeutics (large and small molecule) and chemicals.<br />
This seminar will cover what we have learned, current global regulatory<br />
expectations, and program designs including species, dose routes,<br />
and evaluation.<br />
Experience Results: Lessons Learned Developing<br />
New Anticancer Drugs and Biotherapeutics<br />
Tuesday, March 13, 9:45 AM–10:45 AM<br />
Presented by:<br />
Accelera Srl<br />
Case stories from the direct experience <strong>of</strong> safety assessment for<br />
different drug development programs, including some marketed<br />
products, are presented with special emphasis on anticancer drugs<br />
and biotherapeutics. Challenges, key issues, and lessons learned are<br />
described in the context <strong>of</strong> scientific and regulatory requirements.<br />
Developing a Novel Gene Therapy Product<br />
for the Treatment <strong>of</strong> Rare X-Linked Disease<br />
Tuesday, March 13, 9:45 AM–10:45 AM<br />
Pathology Peer Review: Who, What, When, Where,<br />
Why, and How<br />
Tuesday, March 13, 8:30 AM–9:30 AM<br />
Presented by:<br />
Vet Path Services<br />
This presentation will cover pathology peer review in the industrial,<br />
GLP setting, with discussions <strong>of</strong> who does a peer review, what the peer<br />
review achieves, when it is performed, why should a peer review be<br />
done, and how a pathologist goes about a peer review. It will highlight<br />
current common practices in the current regulatory environment.<br />
Presented by:<br />
Huntingdon Life Sciences<br />
Safety assessment <strong>of</strong> gene therapy products is a complex business<br />
with multiple safety risks. Standard paradigms do not exist and<br />
approaches must be designed on a case-by-case basis. A case study will<br />
be discussed that highlights considerations for a gene therapy to treat<br />
an x-linked disease.<br />
Innovative Models and Techniques<br />
for the Investigation <strong>of</strong> Nanotoxicity<br />
Tuesday, March 13, 11:00 AM–12:00 Noon<br />
Presented by:<br />
Fraunh<strong>of</strong>er ITEM<br />
The session will focus on the state <strong>of</strong> the art and future <strong>of</strong> in vivo inhalation<br />
tests, innovative in vitro and ex vivo models as significant tools<br />
in inhalation toxicology, and sensitive methods to detect lung damage<br />
potentially induced by nanoparticles including carbonanotubes.<br />
118<br />
SOT’s 51 st <strong>Annual</strong> <strong>Meeting</strong>