Critical Path Innovation Meetings (CPIM)
The Critical Path Innovation Meeting (CPIM) was developed by CDER to address issues in drug development identified in the 2004 FDA publication, Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products Challenges and Opportunities Report. The report identified several areas of product development in need of improvement, including “technical methods such as animal or computer-based predictive models, biomarkers for safety and effectiveness, and new clinical evaluation techniques,” and cited a need “to create better tools for developing medical technologies [and] a knowledge base built not just on ideas from biomedical research, but on reliable insights into the pathway to patients.”
The CPIM is a means by which the Center for Drug Evaluation and Research (CDER) and investigators from industry, academia, patient advocacy groups, and government can communicate to improve efficiency and success in drug development. The goals of the CPIM are to discuss a methodology or technology proposed by the meeting requester and for CDER to provide general advice on how this methodology or technology might enhance drug development. CDER will identify some of the larger gaps in existing knowledge that requesters might consider addressing in the course of their work. CDER expects to become more familiar with prospective innovations in drug development, broadening its regulatory perspective. The discussions and background information submitted through the CPIM are drug product-independent and nonbinding on both FDA and CPIM requesters. The meeting does not substitute for formal pre-IND, IND, NDA, or BLA meetings.
Potential topics for a CPIM include, but are not limited to, the following:
- Biomarkers in the early phase of development and not yet ready for the Biomarker Qualification Program (BQP)
- Clinical Outcome Assessments in the early phase of development and not yet ready for the Clinical Outcome Assessment Qualification Program
- Natural history study designs and implementation
- Emerging technologies or new uses of existing technologies
- Innovative conceptual approaches to clinical trial design and analysis
Requests for a CPIM should include the following information:
- Name of requester
- Date of request
- Description of organization
- A document, no more than 5-6 pages in length, containing the background and purpose of the meeting, steps taken in advancing the project, and specific questions for the FDA (if needed). We request summaries only (i.e. no primary data).
- Desired outcome of the meeting.
CDER considers the suitability of a request for a CPIM and may suggest other means to address issues presented by requesters, inside and outside FDA, as appropriate. If a CPIM is suitable, CDER will request a preparation package in advance of the meeting.
The preparation package should contain the following:
- Objective of the meeting
- Proposed agenda
- Presentation slides, if any
- Proposed attendees and respective affiliations
Appropriate FDA experts attend as resources allow. CDER will send a meeting summary to requesters.
Food and Drug Administration
10903 New Hampshire Avenue
WO Building 21, Room 4547
Silver Spring, MD 20903-0002
Scientific Lead: James Kaiser, 301-796-1237
Project Manager: Alicia Barbieri Stuart, 301-796-3852