An Investigational New Drug (IND) application is a critical step for companies aiming to test their new drug candidates in humans. Preparing for the first IND can be tricky, especially for early-stage companies. Here are five potential challenges they might face in regulatory submission planning, compilation, and publishing in eCTD (electronic Common Technical Document) format.
1. Understanding Regulatory Requirements for INDs
Challenge: Early-stage companies, especially those without prior experience, may struggle to fully grasp the specific requirements and expectations of regulatory agencies for IND submissions. As standards and formats change over time, it is important to keep up with current submission requirements. Gaining a foundational understanding takes time and effort.
Implication: Incomplete or incorrect submissions can lead to delays, requests for additional information, or outright rejection of the IND application. Responding to the agency’s requests for additional information can significantly extend the timeline for acceptance, delaying the initiation of clinical trials and redirecting resources from other projects or priorities. This results in increased time, effort, and costs that can have a significant impact on the company’s development and commercialization plans.
2. Data Format and Quality Control
Challenge: Ensuring that all data, especially non-clinical and early clinical data, is submitted in the correct format, according to regulatory guidance.
Implication: Data discrepancies or quality issues can jeopardize the acceptance of the IND application and delay clinical trials. Failure to present data in the format required by the FDA can lead to significant financial implications for early-stage companies. Addressing data format discrepancies often necessitates additional data conversion, validation, and quality checks, incurring unexpected costs. Moreover, these unplanned activities can strain limited budgets, potentially diverting funds from other critical areas of development or necessitating additional rounds of fundraising.
3. eCTD Compilation and Technical Challenges
Challenge: The eCTD format has specific technical and structural requirements. Companies may face challenges in compiling their data and documents in this format, especially if they lack specialized software or expertise.
Implication: Errors in eCTD compilation can lead to a technical rejection, requiring resubmission and causing delays. Addressing technical challenges often requires specialized software, expertise, or external consultants.
4. Resource Limitations
Challenge: Early-stage companies often operate with limited resources, both in terms of personnel and finances. They might not have dedicated regulatory teams or the necessary software tools for eCTD compilation.
Implication: Limited resources can lead to oversights, missed deadlines, and increased reliance on external consultants, which can be costly and time-consuming. Operational strains can compromise the quality of the submission and increase the risk of errors, omissions, and inconsistencies. Regulatory landscapes are dynamic, with guidelines and requirements evolving over time. Companies with limited resources might struggle to stay updated and adapt to these changes, increasing the risk of non-compliance or misaligned submissions.
5. Planning for Future IND Submissions
Challenge: While focusing on the immediate IND submission, companies might overlook the need to plan for the lifecycle maintenance of the IND. This will be an immediate need once the application is submitted and accepted. IND information amendments, protocol amendments, safety reports, and annual reports are a few types of time-sensitive maintenance submissions that are required for an active IND.
Implication: Lifecycle maintenance submissions require tools, processes, and resources with a practical understanding of the regulatory requirements for eCTD submissions. If one of these critical components is missing, the company risks compliance.
The eCTD format requires specific software tools for compilation, validation, and submission. These tools ensure that the submission meets the technical specifications set by regulatory agencies. Effective lifecycle maintenance demands systematic processes to gather, review, and submit data. This includes processes for data validation, quality checks, internal reviews, and timely submissions. Knowledgeable personnel with hands-on experience in regulatory submissions are crucial. They bring a practical understanding of the nuances, expectations, and requirements of regulatory agencies.
Key Takeaways
Addressing these challenges often requires a combination of internal expertise, external consultation, meticulous collaboration and planning, and specialized software and processes. Building this infrastructure can be overwhelming for early-stage teams but is essential for success.
Early-stage companies also have the option to outsource their submission publishing and management activities to a trusted partner like WAYS. This can be a cost-effective option that enables the team to gain experience before building internal regulatory operations capabilities. It relieves operational pressure at a critical stage in the company's growth while making sure that compliance is a priority.
Each team has different requirements as they move their products through development. The factors impacting their decisions will be different. The WAYS team is happy to share our experiences and help early-stage teams make the most of their first IND.
Contact us to learn more about how we work with small and growing teams.