INTERACT vs. Pre-IND Meetings: Navigating Early FDA Pathways for Biopharma Startups

In the United States, the Food and Drug Administration (FDA) offers two pivotal early-stage meetings for biopharmaceutical companies: the Initial Targeted Engagement for Regulatory Advice on CBER/CDER Products (INTERACT) meeting and the Pre-Investigational New Drug (Pre-IND) meeting. Each serves distinct purposes within the drug development process, and understanding their differences is crucial for startups aiming to navigate the regulatory landscape effectively. 

INTERACT Meetings 

The INTERACT meeting is designed for novel products that present unique challenges due to unknown safety profiles, complex manufacturing technologies, or innovative devices. It provides an opportunity for sponsors to obtain initial, non-binding advice from the FDA regarding chemistry, manufacturing, and controls (CMC), pharmacology/toxicology, and early clinical aspects of the development program. This meeting is particularly beneficial when a sponsor has identified the investigational product to be evaluated in a clinical study and conducted some preliminary preclinical proof-of-concept studies but has not yet designed and conducted definitive toxicology studies. 
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/otp-interact-meetings 

Pre-IND Meetings 

The Pre-IND meeting serves as a platform for sponsors to discuss their development programs and seek regulatory guidance before submitting an IND application. It allows for the review and feedback on the design of preclinical studies, the initial IND study, and product manufacturing and quality controls needed to initiate human studies. This meeting is appropriate when the sponsor has defined the manufacturing process to be used for the clinical studies, developed assays and preliminary lot release criteria, and completed proof-of-concept and possibly some preliminary preclinical GLP safety/toxicology studies. 
https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/otp-pre-ind-meetings 

Key Differences 

• Timing in Development: INTERACT meetings are intended for earlier stages of development, prior to definitive toxicology studies, while Pre-IND meetings are suitable when the development program is more advanced, with defined manufacturing processes and completed proof-of-concept studies. 

• Purpose and Focus: INTERACT meetings focus on obtaining initial advice on early product characterization and preclinical proof-of-concept studies, whereas Pre-IND meetings provide detailed feedback on IND-enabling studies, including CMC, pharmacology/toxicology, and clinical trial design. 

Strategic Considerations for Startups 

Choosing the appropriate meeting type is critical for startups to align their development programs with FDA expectations, optimize resources, and mitigate risks. Engaging in an INTERACT meeting can be advantageous for addressing novel challenges early, while a Pre-IND meeting is beneficial for refining plans as the program progresses toward clinical trials. 

Worth mentioning that FDA may decide, after getting an INTERACT briefing package to advice the company that it is too early for such interaction, meaning that the level and amount of data is not mature enough for such an interaction. While in other cases the FDA will change the format of the meeting to a Pre-IND or a Type C meeting if the sponsor focus is the clinical development of the product.  

Recent FDA Trends 

The FDA has been enhancing its engagement with sponsors through initiatives like the introduction of Type D meetings, which provide a mechanism for addressing narrow questions that can be resolved in a shorter timeframe. Additionally, the formalization of INTERACT meetings reflects the FDA’s commitment to facilitating early communication, especially for innovative products that may present unique challenges. 
 

Conclusion 

For biopharma startups, understanding the distinctions between INTERACT and Pre-IND meetings is essential for effective regulatory strategy. By selecting the appropriate meeting type and engaging with the FDA at optimal stages, companies can enhance their development programs, ensure compliance, and expedite the path to market.