Exhibitor-Hosted Programs
How to Expedite Drug Development through Use of a Regulatory and Technical Checklist Web-Based Tool
Sunday, November 8
12:00 Noon–12:55 PM
Veranda C
Presented by: RegCheck
This session will illustrate a web-based tool to review study protocols and reports using a series of pharmacology, PK/ ADME, and toxicology checklists annotated to 21 CFR, FDA, ICH and OECD requirements. The output is a list of deficiencies characterized by the tool for severity and paired with suggested corrective action(s).
The Extended One-Generation Reproductive Toxicity Study (EOGRTS): Scientific and Regulatory Considerations in Nonclinical Testing
Sunday, November 8
12:00 Noon–12:55 PM
Veranda E
Presented by: CiToxLAB
In 2011, OECD adopted the EOGRTS as a replacement for the Two-Generation Toxicity Study, based on the testing paradigm initially proposed by ILSI-HESI ACSA. In 2015, REACH annexes VIII, IX, and X were amended, and EOGRTS is now the information requirement for reproductive toxicity. The session provides an overview of the design and current regulatory and scientific trends in the study conduct.
Emerging Applications in Mechanistic and Investigative Toxicology Using exVive3D™ Bioprinted Human Tissue Models
Wednesday, November 11
7:00 AM–7:55 AM
Veranda C
Presented by: Organovo
The high rate of attrition among clinical-stage therapies, often driven by unanticipated safety or efficacy outcomes, underscores the need for in vitro models that better recapitulate in vivo human biology. Here we will present a 3D bioprinting technology and its application to predictive toxicology.
FDA SEND Compliance: Collaborative Sponsor-CRO Workflows for Efficiency Gains and Cost Reduction
Wednesday, November 11
7:00 AM–7:55 AM
Red Rock Ballroom G
Presented by: PointCross Life Sciences, Inc.
Complying with the FDA’s SEND mandate can be expensive, time consuming and resource intensive if companies upgrade their LIMS and acquire SEND generation tools. We will discuss the use of collaborative data specifications with existing CRO reporting processes to drive efficiency gains and reduce costs in your SEND readiness programs.
Leadscope’s Regulatory Submission Tool Supports ICH M7 Guidance
Wednesday, November 11
12:00 Noon–12:55 PM
Veranda E
Presented by: Leadscope
Leadscope will present the “Regulatory Submission Tool.” This new feature in our Model Applier is a wizard-based process that leads a user through the creation of an expert opinion to support an ICH M7. This new reporting format meets all the requirements of ICH M7 Guidance in one integrated solution.
Neuroscience Specialties: Imaging Applications, Novel Models, and Specialized Administration Routes for Nonclinical Testing
Wednesday, November 11
12:00 Noon–12:55 PM
Red Rock Ballroom G
Presented by: Charles River
Impeding the development of therapies to treat neurodegenerative diseases are logistical challenges encountered at the preclinical stage, as research must closely mimic the clinical strategy. We will discuss tools, approaches and models that effectively translate to the clinic, including cerebrospinal administration, a model to evaluate neuroprotection, and imaging biomarkers.
Safety Toxicity and Bio-Distribution Studies for Vaccines
Wednesday, November 11
12:00 Noon–12:55 PM
Veranda C
Presented by: Battelle
Nonclinical vaccine programs are often quite different in design compared to traditional nonclinical therapeutic programs. Battelle will present nonclinical data from several vaccine studies with varying experimental designs that meet the criteria of the regulatory agencies.
