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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>

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