U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process (Drugs)
  4. New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products
  5. Transcript: Critical Path Innovation Meeting (CPIM)
  1. Development & Approval Process (Drugs)

Transcript: Critical Path Innovation Meeting (CPIM)

Transcript: Critical Path Innovation Meeting (CPIM)

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.

Back to Critical Path Innovation Meeting (CPIM)