Investigational New Drug (IND)

Definition

Investigational New Drug (IND) is a term predominantly used in the pharmaceutical industry. It refers to a new drug that is under investigation in clinical trials but has not yet received approval from regulatory authorities for general use. The IND application must be submitted to, and approved by, the Food and Drug Administration (FDA) in the U.S. before the drug enters the trial phase involving human participants.

Phonetic

The phonetic pronunciation of “Investigational New Drug (IND)” is:Investigational: /ɪnˌvɛstɪˈɡeɪʃənl/New: /njuː/Drug: /drʌɡ/IND: /aɪɛnn’diː/

Key Takeaways

1. An Investigational New Drug (IND) application consists of data gathered from animal experimentations and toxicity studies, manufacturing and processing details, clinical protocols and investigator data. This information is critical in assessing whether it’s secure to proceed to human testing.
2. An IND is a part of the drug development process in the United States and is essential for drugs that have not yet been approved by the Food and Drug Administration (FDA). The application is submitted by the company or research group responsible for the drug’s development and must be approved before clinical trials involving humans can begin.
3. The IND’s approbation is determined solely on safety grounds – it doesn’t have to show efficacy or actual potential benefit. The drug can continue to the clinical trial phase once the IND is approved, which typically includes three stages of testing on different populations and eventually mass production if the drug is shown to be safe and effective.

Importance

The Investigational New Drug (IND) application is crucial in the pharmaceutical industry as it signifies a pivotal step in the drug development process. The IND is filed with the U.S. Food and Drug Administration (FDA) to obtain approval for testing new medications on humans in clinical trials. This application is essential as it provides the FDA with information related to the drug’s safety, manufacturing, and the proposed plan for testing in humans. Therefore, it heavily influences whether the drug’s development can progress, thus dictating its future within the marketplace. An IND’s significance lies in its role in protecting the safety of trial participants and ensuring that the pharmaceutical companies follow rigorous standards to contribute to the safe introduction of new therapeutics into the market.

Explanation

The purpose of an Investigational New Drug (IND) involves creating a pathway for a new pharmaceutical or treatment procedure to ensure safety before being tested in human clinical trials. The IND is a central part of drug development and is intended to protect patients who are partaking in the trials. It’s the regulatory vehicle through which sponsors legally file with the Food and Drug Administration (FDA) to progress from non-clinical tests on animals and the laboratory to tests on humans during clinical trials.The application for IND contains data compiled from laboratory experimentation detailing the pharmacological profile of the drug, its structure, the composition, and how it works in the body. Further more, the application outlines the design for the first few stages of the human clinical trial. The IND is essential for sustaining the progression of new treatments. In essence, the IND application bridges the gap between the discovery of a potential new drug and its marketing, paving the way for clinical investigations that comply with ethical standards and regulatory requirements.

Examples

1. Pfizer and BioNTech’s Investigational New Drug application (IND) for a COVID-19 Vaccine: Pfizer and BioNTech submitted an IND application to the U.S. Food and Drug Administration (FDA) in May 2020 for their vaccine candidate (BNT162) against SARS-CoV-2. Today, this vaccine, known as Pfizer-BioNTech COVID-19 Vaccine, is being widely used globally to combat the COVID-19 pandemic.2. Geron Corporation’s Imetelstat: Geron, a late-stage clinical biopharmaceutical company, filed an IND in 2009 for imetelstat, an investigational drug for the treatment of various types of myeloid malignancies. Imetelstat is now being examined in multiple clinical trials under collaborative development and license agreement with Janssen Biotech, Inc.3. Genentech’s Avastin: Genentech filed an IND for their drug, Avastin, to investigate its efficacy in the treatment of various forms of cancer. Avastin has now been approved by FDA for treating certain types of colon, lung, kidney, and brain cancers.

Frequently Asked Questions(FAQ)

Related Finance Terms

• Phase 1 Clinical Trial
• Food and Drug Administration (FDA)
• New Drug Application (NDA)
• Biologic License Application (BLA)
• Pharmaceutical Research

Sources for More Information

• U.S. Food & Drug Administration
• Clinical Trials Arena
• National Center for Biotechnology Information
• National Cancer Institute