In October 2018, the Food and Drug Administration (FDA) issued Standard Operating Policy and Procedure (SOPP) – SOPP 8214 Version 1.0: INTERACT Meetings with Sponsors for Drugs and Biological Products. This document details recommendations for the Center for Biologics Evaluation and Research (CBER)’s engagement with sponsors (such as industry and investigators) in an early development discussion of a new biologic product.
This new procedure outlines the process of engaging in an INitial Targeted Engagement for Regulatory Advice on CBER ProducTs (INTERACT) meeting with CBER representatives in order to gain informal, preliminary consultation on development-related issues across a wide range of aspects of the development program, including:
- Chemistry Manufacturing Controls (CMC)
- pharmacology/toxicology
- non-clinical
- clinical or delivery device
These interactions are an opportunity for sponsors to confirm CBER’s expectations regarding product development programs and to help define an efficient product development regulatory pathway. This new SOPP replaces the legacy “pre-pre-IND” (Investigational New Drug Application) meeting which was also an informal, non-binding, scientific discussion primarily between CBER nonclinical review disciplines and the sponsor.
“It’s also aimed at helping innovators meet the FDA’s science-based requirements more effectively,” says Peter Marks, M.D., Ph.D., director of the CBER. “These meetings have the potential to help streamline development by helping sponsors avoid unnecessary preclinical or other preparatory studies or plan initial clinical development strategies.”
To be clear, the INTERACT meeting is intended for novel products that introduce unique challenges such as unknown safety profiles, complex manufacturing or delivery device issues, or novel testing methodologies, but it is not a prerequisite to requesting a pre-IND meeting. At a minimum, a specific investigational product or a product-derivation strategy to evaluate in a clinical study must have been identified.
An INTERACT meeting is most effective when preliminary preclinical data (proof-of-concept and some safety) have been generated but definitive preclinical safety studies to support an IND has not yet begun (generally definitive studies of designs for IND-enabling safety studies are discussed in a pre-IND meeting). Initial FDA advice received in an INTERACT meeting is non-binding.
Example topics discussed in an INTERACT meeting might be:
- early product characterization and preclinical proof-of-concept studies
- new delivery devices
- overall early-phase clinical trial design elements
- critical issues or deficiencies for sponsors to address in the development of innovative products such as those utilizing complex manufacturing technologies and/or cutting-edge test methodologies
Although no formal performance goals are set around INTERACT meetings, CBER will endeavor to schedule INTERACT meetings within 21 calendar days and hold the meeting within 90 calendar days of receipt of the request, as the availability of CBER resources allow. INTERACT meetings will be held as teleconference only, generally for one hour. Succinct meeting packages (not more than 50 pages) in support of INTERACT meetings are to be submitted with the meeting request to CBER by email to INTERACT-CBER@fda.hhs.gov. A cover letter, but no FDA forms, are required.
As INTERACT meetings are about an hour and topics often complex, it is important to bear this in mind when settling on the topics for discussion and, if necessary, consult with a strategic partner to maximize your time. Key issues for consideration should be clearly identified and presented.
The request and package should include the following:
- A description of the product and disease or condition being treated or prevented
- A summary of information about the product development to date and future development plans, if appropriate
- A brief statement summarizing the purpose of the meeting
- A list of questions for discussion, grouped by topic, with a summary for each question to explain the need or context for the question; questions regarding combination products should be grouped together
- A summary of data to support discussion organized by topic and question
- A list of all participants, with their titles and affiliations, who will attend the meeting from the sponsor’s organization, including consultants and interpreters
- The sponsor may also include suggested dates and times (e.g., morning or afternoon) for the meeting; non-availability dates and times should also be included; the suggested timeframes will only be considered within the context of CBER resource availability
It is important to note that INTERACT meeting requests can be denied. Reasons may be the stage of development is either premature or too advanced for an INTERACT meeting. If an IND has already been opened or pre-IND meeting has already been conducted, generally an INTERACT meeting request will be denied. The FDA may recommend that the sponsor submit a pre-IND meeting request instead.
Other reasons might be that the requested feedback is not appropriate for an INTERACT meeting or a previous meeting for the same purpose has already been held and no substantially new information has become available. If deemed appropriate, the FDA may indicate to the sponsor that they should proceed to a pre-IND meeting.
CBER may provide written comment or feedback to the sponsor’s queries prior to the meeting when it is appropriate as an informal, non-binding consultation – the FDA will not issue meeting minutes. A sponsor may produce meeting minutes, but these will not be reviewed by CBER in any manner and they will not alter CBER’s INTERACT meeting comments (written or oral) and or be considered official minutes of the INTERACT meeting (even if submitted to CDER).
The advice acquired in an INTERACT meeting should be considered when preparing the final protocols for the definitive preclinical studies to support the pre-IND meeting package and it is recommended to address all INTERACT comments and responses in the pre-IND package.
In conclusion, the INTERACT meeting can be an invaluable engagement with the agency to inform the successful planning and execution of a novel product development program. Familiarity with SOPP 8214 will ensure the most effective INTERACT meeting. For more assistance preparing for this meeting, contact our Regulatory Affairs Strategy group today.
References:
U.S. Food and Drug Administration. (2018, June 22). FDA In Brief: FDA announces program to enhance early communications with biological product developers.
U.S. Food and Drug Administration. (2018, October 1). SOPP 8214: INTERACT Meetings with Sponsors for Drugs and Biological Products.
U.S. Food and Drug Administration. (2019, May 3). INTERACT Meetings (Initial Targeted Engagement for Regulatory Advice on CBER products).