Exhibitor-Hosted Programs

Submitting Standardized SEND to the FDA: Data Fitment and Review Considerations

Sunday, November 9, 12:00 Noon–12:55 PM
Regency Hall #4

Presented by: PointCross Life Sciences, Inc.

An overview of the US FDA’s e-data submission and JumpStart initiatives for nonclinical studies will be provided. Data fitment requirements, analytics and viewers for reviewing e-data and lessons learned from industry and US FDA implementations will be presented. Benefits of standardizing NDA submissions for early engagement with the FDA will be discussed.

Practicalities of Dermal Administration

Wednesday, November 12, 7:00 AM–7:55 AM
Grand Cypress Ballroom G

Presented by: Huntingdon Life Sciences

Dermal administration for preclinical evaluations presents logistical challenges. The goal is to mimic as closely as possible the clinical (human) situation using an animal model which may have skin similar to a human's but may be anatomically and behaviorally different from a human. This session will discuss techniques and materials that have been developed to assure that test articles applies to animals (primarily rats and minipigs) remain in place and provide appropriate exposure in preclinical studies.

Maintaining Quality and Regulatory Compliance in a Global Setting

Wednesday, November 12, 7:00 AM–7:55 AM
Grand Cypress Ballroom H

Presented by: WuXi AppTec

With the need now to reach larger patient populations faster and quicker, global submissions are an attractive proposition to drug companies. By doing a single program designed to be globally compliant, companies can save time and money as well as reducing the need for repeating studies and thereby reducing animal use.

Zebrafish: Reshaping Toxicity Testing

Wednesday, November 12, 7:00 AM–7:55 AM
Grand Cypress Ballroom I

Presented by: Charles River

Over the past two decades, the zebrafish has transformed from an alternative model to a firmly established workhorse in toxicology research as the need for higher throughput toxicity screens has grown. This presentation will focus on the ways in which zebrafish research is changing the field of toxicology.

Evaluation of Electronic Cigarettes in Testing Tobacco-Related Products

Wednesday, November 12, 12:00 Noon—12:55 PM
Grand Cypress Ballroom G

Presented by: Battelle

E-cigarettes are regarded as less hazardous than traditional combustible tobacco products. However, the health effects from e-cigarettes are not clearly understood. We will present results from the characterization of exposure atmospheres from e-cigarettes and discuss our perspective on how tobacco-related products may be evaluated to comply with the regulations established by the CTP.

Demonstration of New Expert Alert System for In Silico Assessment of Impurities under ICH M7 Guidelines

Wednesday, November 12, 12:00 Noon–12:55 PM
Grand Cypress Ballroom H

Presented by: Leadscope Inc.

ICH M7 guidelines require the use of an expert alert-based and a statistical-based QSAR methodology. This seminar will demonstrate the new Leadscope Model Applier—Genetic Toxicity Expert Alerts system. Additionally, we will review our “consensus prediction” using integrated results from our new Genetox Expert Alerts system and statistical based Genetox QSAR models.

Seizure Liability, qEEG and Sleep Quantification in Nonclinical Drug Development: Regulatory and Scientific Considerations

Wednesday, November 12, 12:00 Noon–12:55 PM
Grand Cypress Ballroom I

Presented by: CiToxLAB

Current topics in Neurotoxicology:

  • EEG strategies to investigate seizure liabilities at early and late stages of drug development.
  • Regulatory considerations that impact study design, species selection and EEG experimental endpoints.
  • qEEG: a sensitive tool in drug development?
  • Quantification of drug effects on sleep patterns.