---
title: "Am I ready for an INTERACT meeting?"
slug: "am-i-ready-for-an-interact-meeting"
updated: 2025-05-12T18:13:33Z
published: 2025-05-12T18:13:33Z
canonical: "bgtcplaybook.document360.io/am-i-ready-for-an-interact-meeting"
---

> ## Documentation Index
> Fetch the complete documentation index at: https://bgtcplaybook.document360.io/llms.txt
> Use this file to discover all available pages before exploring further.

# Am I ready for an INTERACT meeting?

Overall, you can consider an INTERACT meeting if you have begun the development process for your asset but have not yet reached the stage of Pre-IND meeting readiness.

You should have proof-of-concept data from *in vitro* and *in vivo* pre-clinical studies to demonstrate preliminary evidence of efficacy and safety for discussion at the INTERACT meeting – it would be premature to request a meeting if you do not – but you should not be as far along as having conducted your pivotal pre-clinical studies (e.g., definitive toxicology studies) – in fact, this would be considered too advanced for INTERACT. [[2]](/v1/docs/ref-interact-meeting)

Please see below for a checklist to guide you in assessing if you are at the appropriate timing for an INTERACT meeting.

Pro tip:

Note that these are **best practice recommendations** for when an INTERACT meeting would be most useful to a Sponsor. The FDA denies about **two-thirds of all INTERACT meeting requests**, with the most common reason being that the meeting request is submitted too early or too late in development. In order to increase the likelihood of securing a meeting, do your best to check off as many items on this list to ensure you are at the **optimal stage of readiness**!

| **INTERACT Meeting Readiness Assessment Checklist** |
| --- |
| **Minimum pre-clinical** | - A defined investigational product and formulation, or product-derivation strategy - A defined indication - Proof of concept data (*in vitro* and/or *in vivo*) - An identified animal model for pharmacology studies (if applicable) |
| **Minimum** CMC | - A defined “bench top” manufacturing process, working towards defined GMP process - Ideas for/preliminary purity and potency testing |
| **Clinical** | - Preliminary dose range working towards a definitive dose range |
| **Patient Engagement** | - Preliminary engagement with patients and/or patient advocacy groups (PAGs) - Understanding of patient journey, primary symptoms/endpoints, and major unmet needs |

Prior to proceeding, let us do one final check to ensure you are ready to initiate the INTERACT meeting preparation.

![Flowchart showing INTERACT readiness steps: check requirements, take Pre-IND assessment if more ready, or prepare for INTERACT](https://cdn.document360.io/a7cea773-7486-41ac-bd50-afa0255ce01f/Images/Documentation/image(82).png)

**Accessible description of the flowchart**

Flowchart with decision points and actions related to INTERACT readiness assessment requirements. It starts with the question "Have you checked all readiness assessment requirements?" If "No," it suggests "Consider completing these requirements before trying." If "Yes," it asks, "Do you have more ready at this current stage than what is listed in the checklist?" If "Yes," it suggests taking the Pre-IND readiness assessment. If "No," it advises proceeding to INTERACT meeting preparation.

Efficacy refers to how well a therapy provides the expected therapeutic effect on a disease or symptom under ideal and controlled circumstances

Person or entity who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. Sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator.

Chemistry, Manufacturing, and Controls (CMC) - Crucial activities when developing new pharmaceutical products. CMC involves defining manufacturing practices and product specifications that must be followed and met in order to ensure product safety and consistency between batches.

Good Manufacturing Practice (GMP) - Compilation of various guidelines/guidance documents/directives issued and elaborated by international organizations and institutions, in collaboration with pharmaceutical industry and several national regulatory authorities in different regions and countries, in order to be guaranteed the highest standards of efficacy, quality and safety in any process that involves the manufacture of health products.

Patient Advocacy Groups (PAGs) are organizations that promote the needs and priorities of patients. These patient groups collectively represent the perspective and interests of patients with rare diseases.