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

EXHIBITOR HOSTED SESSIONS
EXHIBITOR HOSTED SESSIONS
MONDAY, MARCH 7
9:15 AM to 10:15 AM, Room 140A
Phototoxicology: Current Practices and Regulatory Status
Presented by: Charles River
Phototoxic risk can be assessed during drug development from
candidate screening through Phase IV. When and how to evaluate
for phototoxic potential is not always clear and the changing
regulatory status adds additional uncertainty. The tools for
phototoxicity testing and how current/upcoming regulations may
affect these approaches will be presented.
9:15 AM to 10:15 AM, Room 140B
The Impact of Intravital Microscopy Imaging and 3D
Image Reconstruction on Early Discovery Analysis
Presented by: Covance
Intravital microscopy is a technique that provides quantitative, in
vivo molecular imaging at subcellular resolution, resulting in a
cost-effective approach to accelerate preclinical drug development.
State-of-the-art multiphoton microscopy combined with novel
surgical techniques and multiple fluorophores allow in vivo imaging
at subcellular resolution. The impact of this technology to facilitate
an understanding of efficacy and safety will be discussed.
9:15 AM to 10:15 AM, Room 156
Logistic and Technical Challenges of Conducting
Developmental Toxicity Studies in Nonhuman Primates
Presented by: MPI Research
The preclinical safety testing of biotherapeutics poses a particular
challenge in selecting a relevant animal species for use in
toxicology studies. The nonhuman primates are most frequently
used for developmental and reproductive toxicity testing when
commonly used rodents and/or rabbits are not pharmacologically
relevant species. In this presentation, the logistical and technical
challenges when conducting developmental toxicity testing in
nonhuman primates will be presented and discussed.
10:30 AM to 11:30 AM, Room 156
HepaRG, Novel Human Hepatic Cells for In Vitro Tox
Presented by: Biopredic Inc
Biologics present an ongoing challenge to both PK/PD assessment
and safety/immunotoxic effects. This session will discuss issues
around assay development, impact of immunogenicity on PK/
efficacy, and risk-based approach to determine what, if any,
additional safety immune-based endpoints should be assessed.
10:30 AM to 11:30 AM, Room 140B
From Guidelines to Protocol: Lessons from
EDSP Validation
Presented by: Harlan Laboratories, Inc.
This session will discuss the challenges faced in developing
laboratory test protocols from the original OPPTS guidelines that
were issued, as well as the final resolution of those challenges.
A summary of validation data will be presented along with a
perspective on interpreting results obtained from the assays.
10:30 AM to 11:30 AM, Room 156
First in Human Monoclonal Antibody Development
Strategies for the Treatment of Cancer Patients
Presented by: Huntingdon Life Sciences
Monoclonal antibodies have demonstrated to provide huge
healthcare benefits in treatment of cancer. Designing and
performing the optimal IND enabling nonclinical safety package
is very important. Some non-standard approaches are discussed
which highlight the need for focus upon the pathophysiology of
disease, the biology of the drug target and the risks that need to be
considered with drug intervention.
11:45 AM to 12:45 PM, Room 140A
Nonclinical Evaluation of Drug-Abuse Liability
Presented by: Porsolt
Evaluation of abuse liability is currently a major topic in drug
safety. Recent documents from European and U.S. authorities
provide guidance as to how to address this issue, but many issues
remain. This session will explore this topic from the point of view
of pharma companies, regulatory agencies, and CROs.
11:45 AM to 12:45 PM, Room 156
Urine and Blood Based Biomarkers for
Detecting Nephrotoxicity
Presented by: Rules-Based Medicine
Hear the pertinent facts from a recent set of publications by the
Predictive Safety Testing Consortium (PSTC) Nephrotoxicity
Working Group on qualifying a panel of seven biomarkers for
preclinical studies of nephrotoxicity. Data demonstrating the utility
of the biomarkers for human kidney injury will also be presented.
11:45 AM to 12:45 PM, Room 140B
Knockout Rats As More Effective Preclinical Models
Presented by: Sigma Life Science
Knockout models for disease have been limited mostly to mice,
which may not accurately reflect the physiology in humans.
Advances in genetic engineering have extended the species
available, enabling the creation of targeted knock-outs in rats,
rabbits, zebrafish, and swine. An expert panel will discuss
genetic engineering technologies used to develop more relevant
translational animal models.
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