Continuing Education Courses

CE1—Friday, July 23, 12:00 Noon–3:30 PM ET

• Moving a Drug into the Clinic: Using PK/PD Modeling to Assess Benefit/Risk and Guide Dosing in Early Trials
  (sponsored by the American College of Toxicology)

  Co-Chairs: Ryan J. Hansen, PhD, Eli Lilly & Company; and Andrew Vick, PhD, Charles River Laboratories

  The process of advancing potentially therapeutic molecules from discovery to early clinical trials can be costly, time consuming, and be associated with considerable uncertainty and risk. There are three key areas where uncertainty and risk need to be evaluated, and important decisions made regarding the future of a candidate molecule: transition to first-in-human development, predicting the human efficacious dose, and selecting the maximum recommended starting dose and dosing scheme for the first in human trial. In this session we will discuss how PKPD and other quantitative pharmacology approaches can be applied to provide a more quantitative assessment of feasibility and risk, and inform better decision making for drug candidates.

  The Therapeutic Index: A Tool for Informing Molecule Selection and Advancement—Potential
  Jay Tibbitts, DVM, PhD, Surrozen, South San Francisco, CA

  Translating PK/PD from Animals to Humans, and Predicting the Human Efficacious Dose—Potential
  Brian Stoll, PhD, AbbVie, South San Francisco, CA

  Predicting the Optimal Dose and Dose Regimen in Early Clinical Trials
  Jessica Hawes, PhD, US FDA/CDER, Silver Spring, MD

CE2—Friday, August 27, 12:00 Noon–3:30 PM ET

• Stem Cell-Derived Therapy Nonclinical Safety Assessment

  Co-Chairs: Kevin Keane, DVM, PhD, FIATP, Novo Nordisk A/S; Jerrold M. Ward, DVM, PhD, DACVP, Global VetPathology; and Ricardo Ochoa, DVM, PhD, DACVP, Pre-Clinical Safety Inc.

  This continuing education course will cover the nonclinical aspects of stem cell-derived therapies intended for human disease indications requiring replacement tissues such as type I diabetes, Parkinson's disease, ocular (macular) degeneration, and myocardial infarction. An introductory lecture on the current state of stem cell differentiation protocols and in vitro characterization will begin the course. The presentations will emphasize the design, implementation, and interpretation of nonclinical studies which are required for regulatory submissions. The topics covered will include considerations of the animal model, cell implant methods, immunological evaluation, and cell fate determination methods. Current regulatory guidances will be also covered and end-of-course panel discussion will be used to wrap up the course.

  Gene Therapy via Hematopoietic Stem Cells
  Curt I. Civin, University of Maryland School of Medicine, Baltimore, MD

  Stem Cell-Derived Models of Neurodegeneration
  Valina A. Dawson, Institute for Cell Engineering, Johns Hopkins Medicine, Baltimore, MD

  Regulatory Update on Nonclinical Studies with Stem Cell-Derived Products
  Ricardo Ochoa, Preclinical Safety, Inc., Hollywood, FL

  Combining Stem Cell-Derived Products with Biomaterials for Long-Term Implants
  Kevin Keane, Novo Nordisk A/S, Måløv, Denmark

CE3—Friday, September 24, 12:00 Noon–3:30 PM ET

• Applications of Artificial Intelligence and Machine Learning in Toxicologic Pathology

  Co-Chairs: Famke Aeffner, DVM, PhD, DACVP, Amgen; Oliver C. Turner, BSc(Hons), BVSc, MRCVS, PhD, DACVP, DABT, Novartis Institutes for Biomedical Research; and Manu S. Sebastian, DVM, PhD, DACVP, DABT, ACLAM, MD Anderson Cancer Center

  Artificial intelligence (AI) and machine learning (ML) are transforming all aspects of health care—including drug development. This CE course aims at introducing this technology to toxicologists and toxicologic pathologists, as well as highlighting promise and pitfalls. To illustrate the power of machine learning, the session concludes with presentations highlighting practical applications, presented by colleagues with hands-on experience.

  Introduction to Artificial Intelligence and Machine Learning
  Famke Aeffner, DVM, PhD, DACVP, Amgen, South San Francisco, CA; and Oliver C. Turner, BSc(Hons), BVSc, MRCVS, PhD, DACVP, DABT, Novartis Institutes for Biomedical Research, East Hanover, NJ

  General Uses of AI in Drug Development: AI and ML in Other Aspects of Drug Development
  Manu S. Sebastian, DVM, PhD, DACVP, DABT, ACLAM, MD Anderson Cancer Center, Smithville, TX

  General Uses of AI in Drug Development: Overview of Partnerships Formed by Pharma with AI Companies in the Pathology Space
  Bhupinder Bawa, DVM, MVSc, PhD, DACVP, AbbVie, North Chicago, IL

  Implementation: Preparing Pathology Data for ML Experiments
  Jürgen Funk, DVM, FTA Pathology, Roche, Basel Switzerland

  Implementation: IT Infrastructure Requirements
  Julie Boisclair, DVM, DES, MSc, DACVP, DABT, Novartis Institutes for Biomedical Research, Novartis Pharma AG, Basel, Switzerland

  Practical Examples: Performance of the Differential Ovarian Follicle Count Using Deep Neuronal Networks
  Heike A. Marxfeld, PhD, DECVP, EBVS, BASF SE, Ludwigshafen, Germany

  Practical Examples: Deep Learning AI in Decision Support for the Bench Toxicologic Pathologist
  Daniel G. Rudmann, DVM, PhD, DACVP, FIATP, Charles River Laboratories, Broomfield, CO

Continuing Education Chair:
Darlene Dixon, DVM, PhD, DACVP, NIEHS/NTP

Continuing Education Co-Chair:
Sanjeev Gumber, BVSc, MVSc, PhD, DACVP, Yerkes National Primate Research Center, Emory University