Pre-Clinical Data Supports Drug Clearance to Clinical Stage
In brief, an Investigational New Drug (IND) application is like a permission slip from the FDA to initiate human testing of a new drug in the clinical stage. More technically, current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement. The IND is the means through which the sponsor technically obtains this exemption from the FDA. It is important because it provides the FDA with the pre-clinical data necessary to authorize clearance of the drug to proceed to the clinical stage.
The application must contain information in three broad areas:
- Animal Pharmacology and Toxicology Studies – It is in this pre-clinical research stage where MRIGlobal performs much of its work as it relates to the IND application, providing pre-clinical data to permit an assessment as to whether the product is reasonably safe for initial testing in humans. Read more about our work in this area in “Saving Lives Through Pre-Clinical Toxicology Research.” For certain studies, it is required by the FDA that this data is shared in the SEND (Standard for Exchange of Non-clinical Data) format, which we provide. Also included in this step are any previous experiences with the drug in humans, which is often due to approvals and use in foreign markets.
- Manufacturing Information – Information provided in this area pertains to the composition, manufacturer, stability, and controls used for manufacturing the drug substance and the drug product. This information is assessed to ensure that the company can adequately produce and supply consistent batches of the drug.
- Clinical Protocols and Investigator Information – This includes detailed protocols for proposed clinical studies to assess whether the initial-phase trials will expose subjects to unnecessary risks. Also, information on the qualifications of clinical investigators, professionals (generally physicians) who oversee the administration of the experimental compound, to assess whether they are qualified to fulfill their clinical trial duties. This also includes manufacturer commitments to obtain informed consent from the research subjects, to obtain review of the study by an institutional review board (IRB), and to adhere to the investigational new drug regulations.
Following submission of the application, we also provide continued access to our Study Director and other MRIGlobal scientific experts to help reconcile any questions between pre-clinical and clinical research steps. Our experience with IND-enabling services provides clients with an extensive range of services and unmatched expertise to facilitate the initiation and successful completion of IND-enabling programs.
GETTING STARTED AT MRIGLOBAL
Contact MRIGlobal for further information about our work with chemical and biological threat agents. Through an interdisciplinary approach, we provide scientific and subject matter expertise for development of medical countermeasures research against these threats.
To discuss how we can help your project be successful, contact us today.
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