First-in-Class Respiratory Therapy:
INTERACT Meeting Strategy.
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Summary.
A US biotech SME developing first-in-class therapies for respiratory diseases engaged Arriello for FDA regulatory support ahead of early-stage development. Initially planning a Type B Pre-IND meeting, Arriello’s GAP assessment identified key scientific uncertainties and recommended an INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs) meeting to obtain earlier, more appropriate FDA feedback.
Arriello defined the regulatory strategy, developed a focused briefing package, and supported the full meeting process. FDA feedback validated the proposed approach and provided clear guidance on nonclinical models, inhalation toxicology, and early clinical development.
Arriello continues to support the client as they strengthen their data packages in preparation for a future Pre-IND meeting and Phase 2 progression.
Challenges.
The client, developing novel small molecule therapies for chronic respiratory diseases, was preparing to engage the FDA during early clinical development. Their initial plan was to proceed directly with a Type B Pre-IND meeting.
Even so, our GAP assessment revealed several challenges:
- Scientific and translational uncertainties across non-clinical and early clinical data,
- Gaps in inhalation-specific toxicology strategy,
- Limited clarity on biomarker selection and mechanism of action,
- Questions around whether the Phase 1 design could support expansion into COPD patient populations.
These factors indicated that the program had not yet reached the level of maturity expected for a Pre-IND interaction. Proceeding prematurely risked inefficient use of regulatory engagement and potentially unclear or limited feedback from the FDA.
Solution.
We recommended pursuing an INTERACT meeting to enable early scientific dialogue with the FDA. Our team:
- Designed a clear regulatory pathway aligned with program maturity.
- Prepared a focused scientific briefing package.
- Reviewed all nonclinical, CMC, and early clinical data.
- Developed a structured question and position matrix to guide discussions.
- Managed the INTERACT meeting request and agency coordination.
- Prepared the client for FDA interaction and supported the meeting as an observer.
The INTERACT meeting provided valuable and constructive FDA feedback across several critical areas:
- Confirmation of non-clinical model considerations.
- Guidance on optimizing inhalation toxicology strategy.
- Input on early clinical development planning and study design.
Importantly, FDA feedback closely aligned with the risks and gaps identified during Arriello’s GAP assessment, validating the strategic shift from a Pre-IND to an INTERACT meeting.
Following the meeting, Arriello delivered a detailed debrief and outlined two potential regulatory pathways to address FDA recommendations.
Our Holistic Approach.
Arriello developed a tailored regulatory strategy that repositioned the client’s FDA engagement approach.
This approach ensured that the discussion remained targeted, scientifically robust, and aligned to the client’s key development uncertainties. The client has since progressed with one of the two potential regulatory pathways. Arriello continues to support the client in preparation for:
- A future Type B Pre-IND meeting;
- Regulatory alignment for Phase 2 development;
- Ongoing refinement of their global regulatory strategy.
Need early FDA regulatory advice for your development program?
Arriello can help you assess your regulatory readiness, identify key development gaps and choose the right FDA engagement strategy, from INTERACT meetings to future Pre-IND planning.
Contact Arriello and speak with our regulatory experts to discuss your program.
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