FDA INTERACT Meetings: A Guide for Emerging Biotechs

How Emerging Biotechs Use FDA INTERACT Meetings to Avoid Costly Missteps

By Lane Jaeckle Santos, Ph.D., RAC

The most expensive FDA question is the one you ask too late.

A biotech company can pivot after receiving an unexpected answer from FDA. It is much harder to recover after completing a toxicology program, committing to a manufacturing strategy, or selecting a translational model that FDA does not consider appropriate.

This risk is especially acute for small developers. Emerging biotech companies often advance genuinely novel therapies with lean teams and limited capital. That capital is usually earmarked for specific value-creating milestones. They may have only one opportunity to select an appropriate translational model, choose a viable vector, or manufacture representative precursor material.

When existing FDA guidance does not adequately address a complex development challenge, an INTERACT meeting may provide an opportunity to ask the agency a consequential question while the company can still act on the answer.

What Is an FDA INTERACT Meeting?

INTERACT stands for INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs.

Historically referred to as a pre-pre-IND meeting, it is now a formal, early-stage FDA interaction for novel products and development programs facing unique or complex challenges, which typically occurs:

• After the sponsor has identified the investigational product and generated preliminary proof-of-concept data, or
• Before definitive toxicology studies have been designed and conducted, and before the pre-IND meeting

This creates a critical strategic window: the program must be mature enough for FDA to evaluate a real proposal, and early enough for the sponsor to change course.

An INTERACT meeting is not intended to review an entire development program or replace a pre-IND meeting. It’s designed to facilitate IND-enabling work when a scientific issue, technology, or development decision could otherwise delay progress toward first-in-human studies.

What Questions Can an FDA INTERACT Meeting Address?

INTERACT meetings are most valuable when a sponsor faces a targeted issue that cannot be resolved confidently through existing FDA guidance or established precedent. Depending on the product, these targeted issues typically fall into a few categories:

Product & Manufacturing

• New approach methodologies
• Novel, decentralized, point-of-care, or unconventional manufacturing approaches
• Product characterization, analytical testing, or potency development
• Comparability following changes in process, scale, site, equipment, or materials
• Starting-material quality and donor-to-donor variability
• An innovative device used with a drug or biologic

Related Reading: Navigating the CMC Journey in Radiopharmaceuticals

Translational & Nonclinical Models

• The relevance of surrogate, humanized, or alternative models
• The direction of an IND-enabling toxicology strategy
• Proof-of-concept, vector tropism, biodistribution, persistence, shedding, or pilot safety studies
• Cell migration, engraftment, differentiation, or tumorigenicity

Related Reading: Behind the Scenes of an FDA Type C Meeting: A Case Study in Using Gap Analysis to Align Nonclinical Strategy in a Rare Pediatric Disease

Novel Modalities & Long-Term Risk

• Genome-editing specificity and genomic integrity
• Long-term risks associated with durable gene expression or permanent genomic modification

Related Reading: Key Challenges with Orphan Drug Development for Rare Disease Treatments

These are not minor technical questions. The answers can determine which development path a company chooses, which studies are conducted, which clinical material is manufactured, which vendors are engaged, and how capital is allocated.

A productive INTERACT meeting does not begin with: “What does FDA think we should do?”

It begins by defining the development problem, establishing a scientifically supported sponsor position, and developing focused questions that FDA can meaningfully evaluate.

FDA is best positioned to provide actionable feedback when the company clearly explains what it proposes to do, why the approach is appropriate, and which decision depends on the agency’s response.

Why an FDA INTERACT Meeting Request Might Be Denied

The potential value of an INTERACT meeting does not mean every program or question qualifies.

At a 2024 FDA workshop, the agency reported that, of 212 INTERACT meeting requests, 86 were denied, approximately 41% denial rate.

A request may be denied because:

• The program is too early or too advanced
• The investigational product is not sufficiently defined
• The meeting package does not support a productive discussion
• The questions are better suited to a pre-IND or another meeting type
• The sponsor is seeking general education rather than advice on a targeted development issue

For a small biotech company, selecting the correct FDA interaction can be just as important as preparing the package itself.

How Facet Helps Companies Prepare for an FDA INTERACT Meeting

Facet Life Sciences does not begin by simply writing an INTERACT package.

We begin by determining whether INTERACT is the right FDA meeting type, which development decisions genuinely require FDA input, and how the company should position those questions to obtain feedback it can act on.

Facet brings regulatory, nonclinical, clinical, CMC, and operational expertise together to help sponsors:

• Assess whether an INTERACT meeting is the right engagement with FDA for the program
• Identify the issues with the greatest strategic and financial consequences
• Distinguish questions requiring FDA input from those the company should resolve internally or are addressed by regulation, guidance, or precedent
• Establish clear, scientifically supportable sponsor positions
• Prepare a focused, combined meeting request and background package
• Align company leadership and technical experts before the interaction
• Lead meeting preparation and the discussion with FDA, as needed
• Translate FDA feedback into prioritized development actions

The goal is not simply to secure a meeting.

The goal is to ensure that FDA feedback provided in the meeting is clear and actionable.

Takeaway: Ask While You Can Still Act on the Answer

An INTERACT meeting cannot eliminate development risk, and FDA may not agree with the sponsor’s preferred approach.

That does not make the interaction unsuccessful. What makes an FDA meeting successful is a clear pathway forward.

Learning that FDA has concerns before launching an expensive study is far more valuable than learning it after the study is complete. For a small biotech company, the right question at the right time can influence years of development work, millions of dollars in investment, and the ability to reach the clinic.

Considering an FDA INTERACT meeting? Speak with an expert at Facet to determine whether your program would benefit from this type of FDA meeting.