Chemistry External Manufacturing and Network Management

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:

  1. Discuss the processes and challenges in translating radiotracers from discovery and validation of target engagement to clinical investigations in human research subjects
  2. Review the process for establishing radiochemistry production of investigational radioligands by Contract Manufacturing Organizations (CMOs)
  3. 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.
  4. Provide an overview of tracer distribution logistics including dose ordering, transport of doses and tracking and delivery

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Vice President, Chemistry, Invicro

Dr. Norenberg has over 30 years of experience in radiopharmacy and radiopharmaceutical sciences. He obtained his PharmD at the University of Washington and Ph.D. in molecular medicine at Erasmus University in Rotterdam, The Netherlands. For 27 years prior to joining Invicro, he was a Professor of Pharmacy and Anesthesiology, at the University of New Mexico (UNM) and a Member of the UNM NCI-designated Comprehensive Cancer Center, conducting basic and clinical research in the discovery and development of targeted radioligands for molecular imaging and therapy. Dr. Norenberg has received >$26M in extramural funding, resulting in more than 100 scholarly works, and level issued patents. He has been the PI/Co-PI on 13 Phase I first-in-human studies of investigational drugs, and over 100 grants and sponsored research agreements.

To enable this work, Dr. Norenberg maintained an FDA-Registered Testing Facility and performed cGMP-compliant boutique manufacturing of early-phase novel drugs for use in clinical research. From 2015 until his departure from UNM, he led the NIH/NCI-designated UNM Dedicated In Vivo Testing Center which evaluated high-risk drug candidates selected by the NCI NExT program for safety and efficacy in the treatment of cancers. Dr. Norenberg joined Invicro in January 2020 to lead the Chemistry External Manufacturing & Network Management activities.



Senior Vice President, Clinical Operations, Invicro

Ms. Ferraiolo has 20 years of experience in clinical research, managing and executing early Phase I through Phase 3 trials in neurodegenerative disease. More specifically, Ms. Ferraiolo has more than ten years of leadership experience in oversight of imaging trials, including expertise in areas such as project management, data management and core lab operations. Ms. Ferraiolo has a strong background in imaging operations and the conductance of imaging trials, with a focus on standardized analysis and outcome methods.

At Invicro, Ms. Ferraiolo oversees the Imaging Services group responsible for site qualification, supply management, and image receipt, processing and transfer.