Emulate Events

It’s always an event when we spend time together

Loading Events
:

International Society for Cell & Gene Therapy

May 31, 2023 — June 3, 2023
Learn More

Synopsis

The use of animal models to evaluate product safety is a well-established component of drug and biological therapeutics development. However, their use in the developing cell and gene therapy products is problematic in that it is difficult to find optimal models. More globally, recent developments—including difficulty sourcing non-human primates, the creation and improvement of non-animal models such as organoids and Organ-on-a-Chip technology, and changes in the regulatory requirement for animal studies prior to initiating studies in human subjects—have further focused interest on different approaches to defining safety.  

Key Objectives:

  • Discuss the place for different types of models in the development of regulatory applications in relation to GM cell therapies 
  • Evaluate alternative approaches to animal models through presenting successful and innovative case studies
  • Where, when, and how non-animal studies could substitute for, or supplement, animal studies in regulatory applications 
  • What the limitations to the use of non-animal studies are
  • What the current status of the development of non-animal models is

Featured Event

May 31, 2023

9:15 am  — 10:15 am EDT

6:15-7:15 AM PDT /
2:15-3:15 PM BST /
3:15-4:15 PM CEST

Models or Muddles: How do animal and in vitro models stack up?

Discuss the complexity with pre-clinical challenges—where we were, where we are now, where we are going.

Moderator: Bambi Grilley, RPh, RAC, CIP, CRC, CCRP, Director, Clinical Research and Early Product Development, Baylor College of Medicine, USA  

Panelist(s):  

  • Danielle Brooks, PhD, Pharmacology/Toxicology Acting Team Lead, Office of Therapeutic Products, FDA, USA
  • Lorna Ewart, PhD, Chief Scientific Officer, Emulate
  • Matthew Hewitt, PhD, Vice President, Technical Officer CGT & Biologics, Charles River Laboratories, USA 
  • James McBlane, PhD, Preclinical Assessor, Biologicals Unit, UK Medicines and Healthcare Products Regulatory Agency (MHRA), UK 
  • Michaela Sharpe, PhD, Senior Nonclinical Director, Moare Solutions Ltd, UK 

Speaker Spotlight

Lorna Ewart, PhD

Chief Scientific Officer, Emulate

Bambi Grilley

RPh, RAC, CIP, CRC, CCRP, Director, Clinical Research and Early Product Development, Baylor College of Medicine, USA

Danielle Brooks, PhD

Pharmacology/Toxicology Acting Team Lead, Office of Therapeutic Products, FDA, USA

Matthew Hewitt, PhD

Vice President, Technical Officer CGT & Biologics, Charles River Laboratories, USA

James McBlane, PhD

Preclinical Assessor, Biologicals Unit, UK Medicines and Healthcare Products Regulatory Agency (MHRA), UK

Michaela Sharpe, PhD

Senior Nonclinical Director, Moare Solutions Ltd, UK