• OTP does not send an acknowledgement email or letter following OTP’s receipt of the request. However,  OTP will send the decision to grant or deny the meeting request, along with the meeting date, if granted, or reasons for denial by Day 21. INTERACT meetings are typically scheduled as teleconferences.
• SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products states that INTERACT meetings will be held within 75 calendar days of receipt of the meeting request.
• OTP will try to inform the sponsor in advance if any specific review discipline will not be able to participate (e.g., if the clinical review team is not available due to workload / competing priorities).

The meeting package should be submitted with the meeting request. OTP will evaluate the meeting request and package for completeness and appropriateness for an INTERACT meeting based upon the meeting criteria described in SOPP 8101.1: Regulatory Meetings with Sponsors and Applicants for Drugs and Biological Products. OTP expects meeting packages to be succinct and not to exceed 50 pages.

Below are best practices for Chemistry, Manufacturing, and Controls (CMC), pharmacology/toxicology (P/T), and clinical content of an INTERACT meeting package.

Chemistry, Manufacturing, and Controls (CMC)

The CMC section of the INTERACT briefing package should provide:

1. A summary or high-level description of the product, its manufacturing process and the proposed characterization and lot release tests.
2. The sponsor’s position and justification for all of the sponsor’s questions.
3. References to published information related to the product, along with copies of the publications.

OTP recommends that sponsors refer to:

• Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs)
• Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs)

Pharmacology / toxicology

The pharmacology/toxicology section of the INTERACT briefing package should provide:

1. A comprehensive summary of all preclinical (in vitro and in vivo) studies conducted thus far using the intended clinical product, and the results obtained. Contributions from publications that the sponsor considers relevant to their program should be integrated into this summary, and copies of each publication should also be provided.
2. A detailed discussion, with protocol outlines, regarding the additional preclinical proof-of-concept studies the sponsor thinks they need to conduct to adequately support administration of the intended clinical product in the target patient population.
3. The sponsor’s position and justification for all questions the sponsor poses.
4. Questions regarding definitive preclinical safety studies are discussed in the pre-IND meeting and should not be included in the INTERACT package.

OTP recommends that sponsors refer to the FDA guidance “Guidance for Industry: Preclinical Assessment of Investigational Cellular and Gene Therapy Products.”

Clinical

In the context of an INTERACT, clinical comments are generally high-level recommendations regarding the overall clinical development program, and do not focus on details of a specific clinical protocol.

The INTERACT briefing package should describe:

1. the disease of interest
2. target study population
3. available natural history information/data on the condition
4. available treatment options for condition and
5. brief outline of first-in-human study

OTP recommends that sponsors refer to the FDA guidance “Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; Guidance for Industry.”

Not all product development programs qualify for an INTERACT meeting. Listed below are examples of reasons for denying an INTERACT meeting request:

• A meeting was previously held for this product.
• A meeting package does not accompany the INTERACT meeting request.
• The meeting package is substantially deficient, significantly limiting the ability to provide constructive feedback.
• The questions are focused on jurisdiction or regulatory pathway. OTP does not use INTERACT meetings to answer questions about:
  • Whether a product is appropriately regulated as a drug, device, and/or biological product or combination product, or what Center or Office should be the lead in review. For such questions, the sponsor may contact OTP Policy Group at OTP_ADP@fda.hhs.gov.
  • Or whether it is appropriately regulated solely under Section 361 of the PHS Act and regulations in 21 CFR Part 1271. For such questions, the sponsor may visit the Tissue Reference Group website at https://www.fda.gov/vaccines-blood-biologics/tissue-tissue-products/tissue-reference-group or contact the Tissue Reference Group in OTP at TissueReferenceGroup@fda.hhs.gov.
• The stage of the product development program is premature or too advanced for an INTERACT meeting. For example:
  • A request may be premature if:
    • The sponsor does not specify the investigational clinical product.
    • The sponsor does not provide preclinical proof-of-concept (POC) or other pilot data.
    • The sponsor has not conducted any preclinical studies (e.g., proof-of-concept studies) with their intended clinical product.
  • A request may be too advanced for an INTERACT meeting and more appropriate for a pre-IND meeting if:
    • The sponsor has completed proof-of-concept (POC) and some safety studies and is at the point of design and conduct of definitive toxicology studies
    • The sponsor has defined the manufacturing process to be used for the clinical studies and has developed assays and preliminary lot release criteria.
    • The preclinical testing and manufacturing process for the product uses the same or a similar platform as for other product(s) submitted to OTP by the same sponsor.
    • Clinical data exist from previous studies for the same product and clinical indication.