Presenters: Jeff Norenberg, PharmD, Ph.D. | Vice President, Chemistry, Invicro
Denise Ferraiolo, B.A. | Senior Vice President, Clinical Operations, Invicro
Clinical trials of drug candidates sometimes often employ imaging radiotracers to provide information regarding drug distribution (PK), drug action (PD), metabolism and potential toxicities. The need to generate high quality and timely data from clinical sites throughout the world has led to an increase in demand for manufacturing and distribution of investigational radioligands for imaging and therapy spanning from discovery to clinical trial deployment.
This webinar will present an overview of external manufacturing network management and tracer distribution to illustrate the support of worldwide clinical trials using novel radioligands for imaging in drug development.
In this webinar, the presenters will:
- Discuss the processes and challenges in translating radiotracers from discovery and validation of target engagement to clinical investigations in human research subjects
- Review the process for establishing radiochemistry production of investigational radioligands by Contract Manufacturing Organizations (CMOs)
- Provide an overview on how to satisfy multi-jurisdictional regulatory requirements for production and use of investigational drugs (radiotracers) in clinical trials, e.g. IND, IMPD, CTA, etc.
- Provide an overview of tracer distribution logistics including dose ordering, transport of doses and tracking and delivery
