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Journey to an IND Submission

Writer's picture: Jayshwini SanghaniJayshwini Sanghani

The critical role of medical writing for regulatory interactions, nonclinical IND sections and preparing for clinical trials


The path from drug discovery to submitting an Investigational New Drug (IND) application is a pivotal chapter in the journey of drug development. It’s a complex, multifaceted process where medical writing plays a central role, ensuring that every document is clear, structured, and compliant with stringent regulatory standards. This blog unpacks the key stages of this journey and highlights how skilled medical writers elevate the process to success. Additionally, we will provide useful links to resources for writing documents necessary for IND submission.


What is an IND?


An IND is a request for authorization from the U.S. Food and Drug Administration (FDA) to administer an investigational drug or biologic to humans. This authorization is a prerequisite for beginning clinical trials in the United States, ensuring that the clinical investigation is conducted safely and ethically.


Nonclinical data and preparing for an IND: Building the foundation


Before an IND application can be submitted, extensive groundwork is laid. This phase involves:


  • Nonclinical reports summarizing critical nonclinical findings

  • Literature reviews to gather background information

  • Grant proposals to secure funding for enter clinical studies


Medical writers meticulously summarize nonclinical data in reports, including laboratory research, animal studies, and any non-human studies, to evaluate the safety and biological activity of the investigational drug. These reports form the basis for submitting an IND, ensuring that all necessary safety information is adequately documented before the drug can be administered to humans.


[See supporting document for a link to the BioCelerate Nonclinical Report Templates]


Preparing for Clinical Trials


Transitioning to clinical trials demands a suite of well-crafted documents, including the Phase 1 protocol and a comprehensive IB. Each must adhere to the Common Technical Document (CTD) format, and the nonclinical data must be structured into these distinct modules:


  • Nonclinical overviews

  • Nonclinical summaries

  • Nonclinical reports


By carefully aligning these documents with FDA expectations, medical writers set the stage for seamless regulatory review.

CTD Modules for an IND

[See the supporting document for a further breakdown of the modules, as well as a link to the official FDA CTD Module site]


Pre-IND Meetings


Engaging with regulatory authorities, like the FDA, before submitting an IND application is highly beneficial. Pre-IND meetings provide an opportunity to align on development pathways, regulatory requirements, and key aspects of the application. Medical writers are instrumental in preparing briefing packages and meeting request letters, which include nonclinical data, study designs, and clinical development plans.


The Investigator’s Brochure


One of the key documents in the pre-IND phase is the Investigator’s Brochure (IB). This organic document is regularly updated as new data becomes available. It serves as a source document for many key submissions and provides crucial information such as:


  • Pharmacology: How the drug interacts biologically

  • Toxicology: Potential adverse effects

  • Safety findings: Key risks identified in preclinical tests


As the investigational drug progresses, medical writers ensure the IB is meticulously updated to reflect the latest available data.


[See supporting document for a link to the ICH GCP IB Guidance]


Phase 1 protocol


Phase 1 protocols are a foundational element in IND submissions. Crafting these protocols demands precision and clarity, as they outline the study design, participant inclusion criteria, dosing regimen, and methods for monitoring subjects.


Medical writers ensure Phase 1 protocols are clear, scientifically robust, and compliant with regulations, aiding in smoother regulatory review and approval.


[See supporting document for a link to the TransCelerate Common Protocol Template]


Post-IND Submissions


Securing IND approval is merely the beginning. The IND is a living project that requires constant monitoring, updates, and nurturing to maintain compliance. Key responsibilities of the Sponsor include submitting protocol amendments, safety reports, and annual reports.

Each submission must be precise, comprehensive, and timely – an area where medical writers excel, bridging the gap between science and regulatory compliance.


Reporting responsibilities of Sponsor:

Post-IND reporting responsibilities

How Morula Health can support you


At Morula Health, we provide expert medical writing services that streamline your journey from discovery to early-phase clinical trials. By partnering with us, you gain access to experienced professionals who deliver high-quality submissions tailored to regulatory preferences, maximizing your application’s success.


Conclusion


The journey from discovery to IND submission is intricate, demanding, and ultimately rewarding. With experienced medical writers as your allies, you can navigate this process with clarity and confidence, increasing the chances of first-time approval.


Ready to make your IND journey a success? Please contact us!


Additional Resources




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