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Drug development is no cakewalk. Pharmaceutical companies are obliged to prove drug safety and efficacy to Regulatory authorities at every single stage of drug development. Based on the authority’s approval or disapproval only, the companies can further go into later stages of drug development and/or can relook into the entire developmental process. This process of seeking approvals from the Regulatory authorities begins right from the pre-clinical stage of drug development where companies perform certain investigational studies such as in vitro (test tube or cell culture) and in vivo (animal) experiments with which preliminary efficacy, toxicity, pharmacokinetic and safety data of the drug is yielded.
Following preliminary investigational studies, companies submit the derived data to the Regulatory authorities in the form of an Investigational New Drug (IND) application. As Regulatory authorities are responsible for protecting and promoting public health, they stringently scrutinize the contents of submitted IND and verify whether the drug is safe for human testing or not. But what exactly does an IND contain?
What Does an IND Contain?
An IND contains information about Chemistry, Manufacturing, and Controls (CMC), Non-clinical and Clinical studies of a drug which can be categorized as:
- Animal Pharmacology and Toxicology Studies- It contains preclinical data establishing that the drug is reasonably safe for initial testing in humans.
- Manufacturing Information- It contains Information about the composition, manufacturer, stability, and controls used for manufacturing the drug. It also ensures that the company is able to manufacture sufficient batches of the drug to meet the patient’s need.
- Clinical Protocols and Investigator Information- It contains protocols to determine if the initial trials of the drug will expose human subjects to needless risks and include qualifications of the clinical investigators who will oversee the administration of the compound.
What Happens After an IND Submission?
After the submission of an IND application, the Regulatory authorities review it and determine whether it is safe for companies to proceed to the clinical trials stage. If Regulatory authorities detect any discrepancies, they may place a clinical hold on the IND, which prohibits the start of clinical studies until the gap is addressed properly.
In order to avoid such discrepancies, companies should carefully prepare/compile an IND by identifying and avoiding all the possible pitfalls right from the first step.
Pitfalls En-route an IND Submission
- Disorganized IND enabling studies, the submission, and the overall development plan
- Inclusion of unnecessary information and disorganized data in the IND application as it might lead to increased review time
- Failing to provide relevant justifications or supporting data regarding the toxicology studies
- Failing to properly match the results of pre-clinical testing to the clinical protocol
- Insufficient or incorrect stability data
- Failing to adhere to the Regulatory guidelines
Merely decoding the pitfalls without proper action may not serve the purpose of successful IND submission. The key factor here is to support the IND application for better review with the following components:
Components That Make a Flawless IND Submission
- Cover Letter addressing to the Director of review division and it must be signed by the Sponsor of IND applications. As stated by the FDA, it should include:
- Submission Identifier: “Initial Investigational New Drug Application”
- A brief explanation of the intended investigation (type and title of study)
- Investigational new drug product’s name and proposed formulation
- Disease or condition under investigation
- IND manufacturer’s name and contact information (if applicable)
- Reference to an existing IND application (if applicable)
- Table of contents to permit FDA reviewers to locate items in the application quickly and easily
- Introductory Statement and General Investigational Plan
- CMC Information
- Pharmacology Toxicology Information
- Investigator’s Brochure
- Clinical Protocols
- Summary of Previous Human Experience with the Investigational Drug
As it is clear that how significant is an IND submission to proceed with clinical testing, it is necessary for companies to quickly enable themselves for error-free IND compilation with necessary details. But the fact here is that not every drug manufacturer has in-house Regulatory expertise. Sometimes they may have to consult an expert Regulatory partner for quick assistance. In such times, agility is all that matters. Stay informed. Stay Compliant.
