No “Regulatory” Issues ? No Specific Products ? No Clinical Utility Claims ? No GMP/Chemistry Issues


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No “Regulatory” Issues ? No Specific Products ? No Clinical Utility Claims ? No GMP/Chemistry Issues

SCIENCE ISSUES: What are the characteristics of a good PET imaging probe? How can we facilitate probe development?

PET Imaging as an Extension of Pharmacokinetics/Pharmacodynamics FDA/CDER has had an historic interest in development and applications of PK/PD tools.

Noninvasive Functional Imaging drug delivery to target (kinetics, PK) assess modulators of delivery (transport) drug impact on target (dynamics, PD) inhibit enzyme, process, receptor angiogenesis, blood flow, energetics

Hendrikse, de Vries et al. Cancer Res (99)

Pharmacodynamics via PET Imaging WHAT DO YOU WANT TO KNOW? - - Does treatment impact the desired target? - - What is the minimum/maximum dose? - - How to select interval between courses?

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HYPOTHESIS: Noninvasive imaging can change how we develop therapies, and how we select drugs for individuals

Two-Stages of Hypothesis Testing 1 - Does Drug Impact Target as Intended? (inhibit enzyme; decrease vessel count) ** major role for noninvasive images as biomarkers 2 - Any Clinical Benefit? (increased survival; improved Q.O.L.) ** only controlled clinical trials can evaluate as surrogate endpoints

• FDG has been the probe which has jumpstarted the field, and many clinical studies will continue to be conducted to determine the utility of FDG. • There’s More to PET Than FDG!

Nonclinical Development of a Probe for PET Imaging Should Complement the Development of a Therapeutic Agent, or Class of Agents

How Can a Consortium of Academia/Industry/Government Facilitate Nonclinical Aspects of PET Imaging Probe Development?

Author: CDER User