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 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, scientific consortia, 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 during their work. CDER expects to become more familiar with prospective innovations in drug development, broadening its regulatory perspective. CPIM discussions are non-regulatory, drug product-independent and nonbinding on both FDA and CPIM requesters.
The CPIM is a forum for FDA and stakeholders to discuss potential scientific advancements in drug development. The CPIM does not substitute for formal pre-IND, IND, NDA, BLA, or other regulatory meetings. The CPIM is not a venue for entities to market commercial products to or seek endorsement from the FDA. The CPIM does not permit an in-depth review of data by the FDA.
Potential topics for a CPIM include, but are not limited to, the following:
Watch this video to learn more about the Critical Path Innovation Meeting (CPIM) program.
Hello. In this presentation, I will discuss the Critical Path Innovation Meeting, otherwise known as CPIM, program, including goals of the program, how to request a CPIM, topics and outcomes of past discussions, and where to find additional resources available on the FDA website.
A CPIM is a scientific exchange between FDA staff and external stakeholders. Participants may include individuals from industry, academia, patient advocacy groups, or other government agencies who are interested in discussing methods, technologies, or approaches that may enhance and advance the development of drugs.
For FDA staff, a CPIM provides a forum for exposure to emerging science that can help broaden FDA’s regulatory perspective.
For CPIM requesters, these meetings provide an opportunity to have an open scientific discussion and hear FDA’s perspective on the method, approach, or technology being presented. The advice provided by CDER is nonbinding for the requester and the FDA.
A CPIM does not address or provide advice on a specific approval pathway; address a specific drug approval, development program, FDA policy, or guidance; nor is it a detailed review of data.
Instead, it provides an opportunity to communicate directly with FDA subject matter experts and have an open scientific discussion and exchange of ideas, with a common goal of improving efficiency and success in drug development.
Anyone with a role in drug development can request a CPIM by completing the one-page form on FDA’s website. Once FDA receives the form, CPIM staff evaluates it to determine if CPIM is the appropriate venue for the discussion. Acceptance of a CPIM request is dependent on relevance of the topic to drug development and availability of appropriate FDA expertise to engage in the discussion.
CPIM staff then coordinates the meeting. They identify subject matter experts in CDER’s offices and review divisions to request participation in the area of interest. Depending on the topic, CPIM staff may also invite subject matter experts from other FDA centers—such as the Center for Biologics Evaluation and Research or the Center for Devices and Radiological Health.
We ask to receive slides and presentation materials at a minimum of 2 weeks prior to the scheduled CPIM. The FDA staff who are participating meet in advance to preview the scientific discussion and help participants avoid specific policy or regulatory issues that should not be part of the CPIM.
At the CPIM, which lasts about 90 minutes, the meeting requestor leads the scientific discussion and facilitators help to guide the discussion to meaningful potential next steps, as appropriate.
Following the meeting, CPIM staff will share a brief, high-level summary of the meeting discussion with all the meeting participants and the topic area. The topic for the CPIM is also posted on the FDA’s public website.
CPIM staff can help investigators connect with others in the scientific community exploring similar drug development challenges. The FDA may facilitate subsequent discussions with review divisions or FDA scientific staff. Recommendations at the conclusion of a CPIM may include convening a public workshop or collaborating with other groups, or, in some instances, a meeting has led to technology transfer activities, such as a Research Collaboration Agreement or a Cooperative Research and Development Agreement between investigators and the FDA.
Critical Path Innovation Meetings have focused on specific disease areas, such as rare disease progression studies or the use of biomarkers as clinical trial endpoints. They have also addressed cross-cutting topics such as tools and methods that could more generally apply to the conduct of clinical trials or the quality and evaluation of clinical trial, registry, and other data.
We have many resources available for both FDA staff and prospective meeting requestors on the CPIM website.
In addition, the FDA keeps a complete list of CPIM meeting topics on its website. The FDA also has guidance on CPIM meetings.
In this presentation, I covered the goal of the CPIM; resources about CPIM, including how to request a meeting; what to expect during and after a CPIM; and some topics for CPIMs. Thank you for your interest in the CPIM program.
- 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
CDER will consider 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 be sent electronically to CPIMInquiries@fda.hhs.gov and contain the following:
- Objective of the meeting
- Proposed agenda
- Presentation slides, if any
- Proposed attendees and respective affiliations
For additional information about the CPIM Program, please view the informational webinar and video, or download the podcast.
If you have any questions about the CPIM Program, please contact CPIMInquiries@fda.hhs.gov.
For additional information about other opportunities for engagement with the FDA, please visit the list of other FDA meeting options.
Related Information
- Guidance for Critical Path Innovation Meetings
- Critical Path Innovation Meetings - Policy and Procedures
Resources
Contact Information
Email: CPIMInquiries@fda.hhs.gov