ARMI believes that it is important to provide updates on new U.S. Food and Drug Administration (FDA) programs that assist sponsors in advancing product development so that beneficial, novel technologies may make earlier appearances to the market for patient and consumer use. One such program recently launched by FDA is known as the INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER producTs) meeting program, which acts as a formalized version of what were previously called pre-pre-IND meetings. The INTERACT meeting program is designed to provide sponsors of biological products regulated by the Center for Biologics Evaluation and Research (CBER) with FDA advice early in product development, with focus on critical preclinical, clinical, and manufacturing considerations. This program also provides an opportunity to introduce new products, technologies, and indications to the FDA, allowing the reviewers to familiarize themselves with novel products early in the process.
The INTERACT meeting program was not created to introduce a new process or requirement to sponsors of biological products. INTERACT meetings are simply a formalized continuation of the pre-pre-IND meetings held for sponsors by CBER staff members. The original pre-pre-IND meetings were spearheaded by the Pharmacology/Toxicology branches in the Office of Tissues and Advanced Therapies (OTAT) at CBER to provide sponsors with assistance in the design of their preclinical testing program. For sponsors of novel products or products for rare diseases, these meetings provided crucial early feedback from the FDA on preclinical testing expectations. Both sponsors and the FDA found that these interactions led, in general, to better submissions.
Now that an official INTERACT program has been created, these early-interaction meetings have been extended for use in CBER’s Office of Blood Research and Review (OBRR) and Office of Vaccine Research and Review (OVRR). INTERACT meetings provide sponsors with nonbinding advice from the FDA that can assist in early product characterization and preclinical proof-of-concept study design. Discussions on early-phase clinical trial design elements can occur, and critical deficiencies in the current product development pathway may be identified for the sponsor to address prior to a pre-IND meeting. Examples of topics that fall within the scope of an INTERACT meeting include discussions on the use of appropriate preclinical models, necessary toxicology studies, CMC issues and testing strategies to demonstrate product safety to support first-in-human studies, and adequacy of selected animal models as well as possible study design modifications to ensure the judicious use of animals.
Prior to requesting an INTERACT meeting with the FDA, sponsors must have a specific investigational product or a product-derivation strategy to evaluate in a clinical study for which some degree of product development activities have taken place. Although formalization of the pre-pre-IND program into the INTERACT program also means there will be an increase in resources dedicated to seeing this program succeed, the Agency has emphasized that an INTERACT meeting request may be denied if at least one of the following circumstances exist: there is an insufficient availability of CBER resources, the questions submitted for discussion fall outside of the scope for an INTERACT meeting, the stage of development is either too premature or too advanced for an INTERACT meeting, or a meeting for the same purpose has already taken place and substantial new information has not been accrued in the interim.
Unlike the pre-IND program, the meeting request must be accompanied by the meeting package at the time of the request. The meeting package should be brief and include a description of the product and the condition to be treated, a summary of the projected product development pathway, a summary of the meeting’s purpose, an explanation of the questions to be discussed, data to support discussion, a list of expected meeting participants along with their titles, and suggestions for available times to meet.
The timeline for scheduling and holding INTERACT meetings is very similar to the timeline for the Pre-Submission program for devices. CBER has committed to scheduling an INTERACT meeting within 21 calendar days upon receipt of the meeting request, with a soft goal of holding the meeting within 90 calendar days of receipt of the request. Much like the previous pre-pre-IND program, CBER reviewers may send responses to the sponsor’s questions proposed in the meeting request no later than one day before the meeting to facilitate discussion. Also like the pre-pre-IND program, INTERACT meetings will be held for one hour, typically via teleconference.
Further detail on INTERACT meeting expectations can reviewed in the procedure, SOPP 8214, INTERACT Meetings with Sponsors for Drugs and Biological Products. Members who are unclear on whether or not an INTERACT meeting would be beneficial for advancing their product can schedule a meeting with BioFabConsulting experts, Dr. Richard McFarland and Dr. Robinson-Zeigler.