Hot Topics (S20)

Symposium Chair(s)

• Armaghan Emami, PharmD, PhD

  Pharmacologist
  US FDA
  Silver Spring, Maryland, United States

• Marcus Delatte, PhD

  Vice President, Regulatory Strategy
  Regulatory and Drug Development Consulting
  Allucent
  Clarksburg, Maryland, United States

Hot Topic Speaker(s)

• Xuan Chi, PhD

  Supervisory Pharmacologist
  Office of New Drugs, CDER
  US FDA

• Deb Tokarz, DVM, PhD, DACVP

  Senior Pathologist
  EPL, Inc.
  Raleigh, North Carolina, United States

• Jessica Oliphant

  Deputy Director
  Division of Systems Biology
  FDA, NCTR
  Benton, Arkansas, United States

• Alison Wakeford, MA, PhD

  Nonclinical Scientist
  Regulatory and Drug Consulting
  Allucent
  Cary, North Carolina, United States

A traditional part of the final afternoon of the ACT Annual Meeting is the Hot Topics Symposium. Each year this session includes a variety of topics from leading experts focusing on late-breaking regulatory or scientific advances related to toxicology.

Presentations:

• 2:00 PM - 2:05 PM CT

  Introduction
  

  Symposium Chair: Armaghan Emami, PharmD, PhD – US FDA
• 2:05 PM - 2:40 PM CT

  New Draft Guidance on Platform Technology Designation: Key Highlights and a Mock Case Study
  

  Hot Topic Speaker: Xuan Chi, PhD – US FDA
• 2:40 PM - 3:15 PM CT

  Digital Pathology and the Impact of Artificial Intelligence on Toxicologic Pathology Workflow and Reporting
  

  Hot Topic Speaker: Deb Tokarz, DVM, PhD, DACVP – EPL, Inc.
• 3:15 PM - 3:45 PM CT

  Break
• 3:45 PM - 4:15 PM CT

  Neuropsychiatric Concerns and Potential Molecular Mechanisms Associated with Widely Used Medication Montelukast (Singulair®)
  

  Hot Topic Speaker: Jessica J.H. Oliphant – FDA, NCTR
• 4:15 PM - 4:45 PM CT

  Safety Pharmacology Survey 2024: Insights on Investigations of the Nervous System
  

  Hot Topic Speaker: Alison Wakeford, MA, PhD – Allucent
• 4:45 PM - 5:00 PM CT

  Panel Discussion