# Presentation: 531313

## Update From FDA:Office of the Commissioner and Center for Drug Evaluation and Research

- Janet Woodcock, M.D.
- Acting Deputy Commissioner for Operations
- Food and Drug Administration
- April 7, 2005

## Medical Imaging and The Critical Path Initiative

- Central focus of critical path is developing new biomarkers and other evaluative technologies
- Imaging is seen as a key technology for assessing, accelerating development and guiding use of new therapeutic options

## Development of Imaging Technologies as Biomarkers and Surrogate Markers

- Developing these data involves significant time and expense
- Lack of clear commercial pathway limits enthusiasm
- However, absence of data curtails evolution of medical practice as well as medical product development: this situation is very frustrating for therapeutic developers as well as for those working on biomarkers
- Similar conundrum for in vitro diagnostics

## FDA Critical Path Initiative

- FDA seeks mechanisms for qualifying such new biomarkers for regulatory use
- Imaging technologies are at the forefront of our efforts
- We believe that synergy between current drug development programs and imaging networks can be created to get this work done in a cost effective manner

## FDA Critical Path Initiative

- FDA will also begin an initiative to describe the general processes for biomarker and surrogate marker qualification for regulatory use
- This effort should help clarify the pathways for development of these diagnostics

## Critical Path Focus:  Better Utilize Imaging as a Tool in Drug Development

- Overall evaluation of use of imaging in drug development
- Facilitating use of molecular probes and other imaging techniques in early clinical trials
- Use of imaging in development of cancer treatments

## Use of Imaging in Drug Development

- FDA conducted internal survey:  broad use of imaging in multiple therapeutic areas
- Workshop:  DIA Co-sponsored; May 5 & 6, 2005
- Hope to develop specific qualification projects in promising areas
**  **

## Facilitating Use of Molecular Probes and other Imaging Techniques in Early Clinical Trials

- Meeting on RDRC process
- Master file concept for probes
- Draft “Exploratory IND” Guidance
- Draft guidance on laboratory production of clinical supplies

## Exploratory IND

- “Phase 0” studies – prior to traditional drug development Phase 1 trials
- Microdose or low dose-limited period of administration

## Exploratory IND (cont.)

- Toxicology to support use may be similarly abbreviated
- May be used for proof-of-mechanism, screening multiple compounds, microdose, imaging

## Laboratory Production – Draft Guidance

- Appropriate methods and quality control for small scale production
- Explain what should be filed in IND vs. records kept at site
- Reflects FDA’s longstanding position – not previously articulated
- Developed in collaboration with NCI

## Use of Imaging in Development of Cancer Treatments

- Critical Path issue:  Lack mechanism to rapidly incorporate new science/technology into evaluations (e.g. response) done in development trials
- Measurements of tumor size as a surrogate for response
- Measurement of other tumor parameters (e.g. glucose uptake) as a response surrogate
- Combination measurements in composite EPs

## Collaborations with NCI	

- Evaluation of use of FDG-PET in therapeutic cancer trials
- Evaluation of molecular probes
- Review of use of RECIST criteria in cancer trials

## Desired Outcomes

- “Gap analysis” :  Current data on technology used in a particular tumor _vs_ needed data for adoption as response measure in trials
- “Trial analysis” :  What trials, using what active agents, would be needed to fill in these gaps?
- Mechanisms to conduct such studies

## How to Get Such Work Accomplished

- New opportunities for collaboration
- Many stakeholders will have to participate:  FDA, NCI, drug and biologic developers, ?payors, medical imaging industry
- Hope studies can be designed to synergize with ongoing  trials or with clinical care so that expense will not be prohibitive

## Reorganizations within CDER

- Creation of Office of Oncology Drug Products within CDER
- Medical Imaging will be one of three Divisions
- Consolidation of monoclonal antibody imaging agents & other biologics with traditional drug imaging agents
- Progress ongoing – should be complete by summer

## Reorganization: Facilitate Movement of New Science into Cancer Drug Evaluation

- We believe that new imaging technologies as well as pharmacogenomics will be taken up first in cancer drug development
- We hope that this will happen in a deliberate way rather than haphazardly

## Summary

**Imaging technologies are currently very important, and will become even more crucial to cancer therapeutic development**
**FDA, under its critical path initiative, is seeking to advance development of these imaging biomarkers in an organized fashion**

## Summary

- Accomplishing this will require extensive collaboration across many stakeholders—and close attention to IP issues
- NCI and FDA are collaborating in this effort