Exhibitors

Exhibitor-Hosted Programs

Juvenile Safety Assessment Challenges and Testing Strategies

Sunday, November 6
12:00 Noon–12:55 PM
Laurel C

Presented by: Charles River
This presentation will address some of the obstacles with studies in juvenile animals related to specialty endpoints or routes of delivery as well as approaches to overcome them. Discussion topics include cardiovascular assessment, immunophenotyping, and T-cell dependent antibody response (TDAR) evaluation in juvenile dogs, and approaches to inhalation exposure of neonatal/juvenile rodents, and dogs.

Cardiac Safety Evaluation: Is CiPA the Approach to Take?

Sunday, November 6
12:00 Noon–12:55 PM
Laurel A

Presented by: CiToxLAB
In 2014, FDA introduced the comprehensive proarrhythmia assay (CiPA) in which drug effects on cardiac ion channels are to be assessed. The approach aims to leverage the full spectrum of models including in silico, in vitro, nonclinical, and clinical data. The session will discuss CiPA foundations, current challenges, and future paths.

Advantages in Utilizing an Integrated In Silico Solution for ICH M7 Expert Review

Sunday, November 6
12:00 Noon–12:55 PM
Kent B

Presented by: Lhasa Limited
The ICH M7 guideline permits the expert assessment of mutagenicity based upon two in silico predictions, but does not describe how this should be done. This talk will focus on the process of expert assessment together with the semiautomated preparation of a report for regulatory submission.

Evaluating the Quality and Proficiency of a DART GLP Program

Wednesday, November 9
7:00 AM–7:55 AM
Laurel A

Presented by: Battelle
The complexity and specialization of developmental and reproductive toxicology (DART) studies can make it challenging for sponsors to know the right questions to ask
their CRO partners the right questions. This presentation will provide guidance on evaluating the quality and proficiency of a DART GLP program, with examples highlighting procedures, staff training, validation, and data interpretation.

The CRO, the Client, and the Consultant: A Tale of Three Perspectives

Wednesday, November 9
7:00 AM–7:55 AM
Laurel C

Presented by: BioReliance Corporation
A leading consultant in the field will describe the role of a Toxicology consultant in advising clients, identifying CROs, and managing study designs, results, and the entire client/CRO relationship.

Juvenile Toxicity Studies—Challenges and Practical Advice

Wednesday, November 9
7:00 AM–7:55 AM
Kent B

Presented by: Envigo
Juvenile toxicity studies present scientific and logistical challenges to toxicologists and testing laboratories. This session will discuss regulatory requirements and logistical
challenges, including study design, animal numbers/ages, dose administration (by various routes), multiple end points, scheduling, subgroups, and special necropsy considerations. Examples and case studies will be presented to illustrate issues and provide advice.

Best Practices for Creating Submission-Ready SEND Packages

Wednesday, November 9
12:00 Noon–12:55 PM
Kent B

Presented by: Instem
Join a panel of industry experts to hear about best practices for creating submission-ready SEND packages, with focus on the most challenging areas such as multi-site integration, verification against study report, define-xml generation, study data reviewers guide, and final package integration with eCTD.

CASE Ultra: Combining Statistical and Rule-Based Methodologies for ICH M7 Submissions

Wednesday, November 9
12:00 Noon–12:55 PM
Laurel A

Presented by: MultiCASE Inc.
MultiCASE Inc, the leading provider of in silico toxicology solutions for chemical and pharmaceutical industries, will share its experience in implementing and combining
statistical and expert rule-based methodologies for better performance and regulatory acceptance. Highlights, interpretation scenarios, and case studies will be presented.

Evaluation of the Tobacco Heating System 2.2—A Candidate Modified Risk Tobacco Product

Wednesday, November 9
12:00 Noon–12:55 PM
Laurel C

Presented by: Philip Morris International
Discover our integrated program to assess the potential toxicological risks of candidate MRTPs. In this context we will show how systems toxicology advances our mechanistic understanding of toxicity, enables the improvement of study designs, and accelerates the development of biomarkers for clinical application.