Understanding the IND: The Critical Milestone Between Discovery and Development
- Monique Garrett
- Oct 13
- 6 min read
For biotech or pharmaceutical companies, the Investigational New Drug (IND) application marks a pivotal moment of transition from what works in the lab to what might help people in the clinic. It’s the point where discovery meets the FDA, and science begins its journey toward becoming medicine.
An IND submission represents far more than a regulatory formality. It’s the culmination of years of discovery, experimentation, and refinement; the point where hundreds of data points, experiments, and insights are distilled into a single, coherent story for the FDA. Behind every IND are the scientists who designed preclinical studies, the chemists who perfected formulations, and the teams who documented every detail to demonstrate safety, consistency, and purpose. It’s the first time a sponsor formally asks regulators to review their science and to allow it to move from the lab into clinical trials in humans.
What Is an IND?
Before a new drug can be tested in humans, the FDA must review evidence that it’s reasonably safe to proceed. The IND is that evidence. It’s a comprehensive submission that brings together three key components:
Animal pharmacology and toxicology data – showing the drug’s safety profile and supporting proposed human dosing.
Manufacturing and chemistry information – detailing how the drug is made, characterized, and controlled.
Clinical protocols and investigator information – describing how the first human studies will be conducted and by whom.
Together, these sections tell the story of how the drug was developed, why it’s ready for human testing, and how its safety and quality will be maintained throughout the trial.
Why Is the IND An Important Milestone?
Reaching the IND stage means your science has matured. You’ve demonstrated that your data support human testing and that your organization is prepared to conduct it safely.
For many small and emerging biotech companies, the IND is also the first time multiple disciplines converge. Functions such as manufacturing, regulatory, and clinical operations must work in harmony. It’s often the first major test of coordination and communication across the entire development ecosystem.
This is where experience matters most. INDs are complex, interdependent, and time-sensitive; in smaller organizations, the challenge often isn’t just science, but also the coordination. When research, clinical, manufacturing, and regulatory teams are each moving quickly in their own lanes, even small misalignments can create bottlenecks. A protocol update may not reach the Regulatory Manager in a timely manner. A data refresh could be completed after the narrative was finalized. A version control mix-up might leave contributors working from outdated files. Without clear communication and coordination, these small gaps can quickly compound into costly delays and unnecessary stress.
What’s Inside an IND?
While every IND is unique, certain elements are universal. Together, they tell the scientific and operational story that supports a sponsor’s readiness to begin clinical trials:
Form FDA 1571 This is the formal request submitted to the FDA for authorization to initiate human studies. It establishes the sponsor’s intent, identifies key contacts, and serves as the backbone of the submission package. Every subsequent amendment or update links back to this foundational form.
An introductory statement and general investigational plan This section provides the big picture: what the drug is, how it works, and how the sponsor intends to study it over the coming year. It’s where sponsors articulate their long-term vision for development and demonstrate an understanding of the drug’s intended path from first-in-human testing through later phases.
Investigator brochures and clinical protocols These documents form the operational core of the IND. The investigator’s brochure communicates essential scientific and safety information to investigators, while the clinical protocols lay out exactly how studies will be conducted, including study design, eligibility criteria, dosing strategy, and safety monitoring. Together, they demonstrate that the sponsor can conduct ethical, well-controlled human research.
Chemistry, Manufacturing, and Controls (CMC) documentation The CMC section describes how the investigational product is made, tested, and maintained for quality. It includes details about manufacturing processes, analytical methods, stability data, and specifications that ensure every dose administered to participants is consistent, safe, and traceable.
Preclinical study summaries These provide the bridge between laboratory science and human testing. Summaries of pharmacology and toxicology studies provide insight into how the drug behaves in animal models, the dose ranges tested, and the safety margins established. These data form the scientific justification for the proposed starting dose and dosing schedule in humans.
Beyond these core components, INDs often contain additional materials tailored to the product’s complexity. Sponsors developing biologics or gene therapies, for example, may include immunogenicity data or viral safety testing, while small molecule programs might feature pharmacokinetic or metabolism studies to explain how the drug is absorbed and processed in the body. Products delivered through devices or combination systems may require device specifications and performance testing. Some INDs also include genotoxicity, reproductive, or carcinogenicity data for products intended for long-term use, and comparative bioavailability or bridging studies when multiple formulations are under evaluation. Depending on the program, sponsors might also submit investigator financial disclosures, environmental assessments, or pediatric study plans.
Every inclusion serves a purpose. It establishes the scientific and regulatory foundation for a safe and well-structured clinical trial. Together, these elements convey a clear message to reviewers: that the sponsor understands its product, its risks, and its responsibility to conduct human research with rigor and integrity.
How is an IND Submitted to the FDA?
Once the IND content files are finalized, the next step is preparing them for electronic submission. The FDA requires all INDs to be submitted in electronic Common Technical Document (eCTD) format, a highly structured framework that organizes every file, metadata tag, and hyperlink in a consistent, reviewable way.
The eCTD breaks the IND into five modules, from administrative information to detailed study reports, and uses a defined folder structure and lifecycle operators to manage updates over time. This format allows reviewers to navigate the submission efficiently and ensures that any future amendments, safety reports, or annual updates integrate seamlessly with the original application.
Building and validating an eCTD submission requires specialized tools and expertise. Publishers must ensure that every document follows FDA specifications, links function properly, and validation checks pass before the package is transmitted through the agency’s Electronic Submissions Gateway (ESG).
How to Prepare for IND Success
The best INDs don’t come together at the eleventh hour. They’re built through thoughtful planning and collaboration. Sponsors who succeed tend to:
Start publishing preparation early, even while scientific content is still being written. Early coordination between authors, publishers, and regulatory leads can save significant time later in the process. Beginning the publishing setup while documents are still in development allows teams to establish consistent naming conventions, file structures, and metadata that prevent confusion when deadlines tighten. It also gives contributors a clear understanding of how their materials will fit into the final submission, reducing last-minute formatting errors and ensuring a smoother path to compilation and validation.
Engage a submission management partner who understands both FDA expectations and the operational realities of tight timelines. A strong partner does more than assemble documents. They manage eCTD complexity. They understand the FDA’s technical rejection criteria, eCTD structure, and validation standards, ensuring that every file, hyperlink, and lifecycle operator meets specifications before submission. They also know that in real life, content doesn’t always arrive in perfect sequence or on schedule. Sections evolve, data updates come late, and authoring continues right up to the deadline. An experienced regulatory operations team plans for that reality, building flexible publishing strategies that can absorb change without chaos. They maintain control of versioning, track late-breaking updates, and keep communication flowing so the final IND package is accurate, compliant, and on time.
Plan for lifecycle management, not just the initial submission. An IND isn’t a one-and-done event. It’s the foundation for every amendment, safety update, and annual report that follows. The structure it has today will influence how efficiently future updates can be prepared and published. Sponsors that adopt a lifecycle mindset from the outset establish stronger version control, reduce rework, and stay inspection-ready throughout development. Building for the long term from the start ensures each subsequent submission builds seamlessly on the one before it.
A Milestone Achievement
At the IND stage, you need a partner you can trust. The WAYS team recognizes the enormous time, effort, and collaboration it takes to reach the IND milestone. Our role is to honor that work by managing your submission with the same care and discipline that got you here. We anticipate technical requirements, navigate late-stage changes, and ensure your IND is organized, validated, and ready for review. Most importantly, we move forward with you, helping your science take its next step without unnecessary stress or disruption.
For practical guidance, see our related posts: Five Challenges that Early-Stage Companies Should Consider When Planning for Their First IND
No drama. No trauma. We are Submission-ready.
Contact the WAYS team to get your next IND on track!
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