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Session Details

ROUNDTABLE Models or Muddles: How Do Animal and In Vitro Models Stack Up?
Wednesday, May 31, 2023 09:15 AM - 10:15 AM  
Room 243
GRP
Roundtable
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

Panelists
Danielle Brooks, PhD, Pharmacology/Toxicology Acting Team Lead, Office of Therapeutic Products, FDA, USA
Lorna Ewart, PhD, Chief Scientific Officer, Emulate, UK
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



Learning Objectives
  1. Discuss the place for different types of models in the development of regulatory applications in relation to GM cell therapies
  2. Discuss innovative approaches to animal models through presentation of successful and innovative case studies
  3. Where, when and how could non-animal studies substitute for or supplement animal studies in regulatory applications
  4. What are the limitations to the use of non-animal studies
  5. What is the current status of the development of non-animal models

 
Bambi Grilley RPh, RAC, CIP, CCRC, CCRP
Director, Clinical Research and Early Product Development
 Baylor College of Medicine
 Moderaor
Danielle Brooks PhD
Pharmacology/Toxicology Acting Team Lead, Office of Therapeutic Products (OTP)
 Food Drug and Administration (FDA)
 Panelist
Lorna Ewart PhD
Chief Scientific Officer
 Emulate
 Panelist
Matthew Hewitt PhD
Vice President, Technical Officer CGT & Biologics
 Charles River Laboratories
 Panelist
James McBlane PhD
Preclinical Assessor, Biologicals Unit
 UK Medicines and Healthcare Products Regulatory Agency (MHRA)
 Panelist
Michaela Sharpe PhD
Senior Nonclinical Director
 Moare Solutions Ltd
 Panelist