Imaging Diagnostics and Theranostics: Meeting Clinical Development Challenges

Publish Date:
June 8, 2017
Presenters:
Prithul Bom, MBA, RAC, ASQ-CSQE, Senior Director of Scientific Affairs and Therapeutic Area Lead for Medical Devices & Diagnostics | Lisa Moore, RN, PhD, Executive Director, Medical Devices & Diagnostics Development | Jeffrey Joseph, Executive Director, Statistics

This is an exciting time to be in clinical research. New tools have evolved in the imaging diagnostic and theranostic space, providing opportunities for improved ways of diagnosis and treatment of cancers and other diseases. Challenges, particularly those associated with translating preclinical research into clinical setting, remain. This presentation will discuss a few diagnostic and theranostic agents currently under development and in use from the lifecycle management perspective, discuss challenges, and the solutions to overcome them.

Key Topics:

  • Regulatory expectations for imaging diagnostic and theranostic investigational products
  • Innovative tools for diagnostic imaging and treatment of cancers and other diseases
  • Partnership between biotechnology and diagnostic imaging agents
  • Some clinical development challenges and Ideas to overcome them
  • Statistical Considerations