The recent advancements in microphysiological systems (MPS) and their ability to recreate the in vivo environment within an in vitro system have led to the development of novel assays, including the Visikol blood-brain barrier (BBB) assay. The BBB is a highly selective barrier that separates the central nervous system (CNS) from the rest of the body and regulates the exchange of molecules between them. The BBB is a complex and dynamic structure, making it challenging to study within in vitro systems. The Visikol BBB assay provides a unique opportunity to study the BBB in a controlled environment, allowing researchers to gain a better understanding of its properties and functions.
FDA Modernization Act 2.0
Recently, through the passage of the FDA Modernization Act 2.0 , the FDA has opened the door for the use of these models in more widespread applications. The FDA Modernization Act 2.0 aims to streamline the drug development process and make it more efficient, while also ensuring the safety and efficacy of new drugs. One of the key provisions of the act is the use of MPS, which includes the Visikol BBB assay as well as its other advanced in vitro assays, as part of the Investigational New Drug (IND) submission process.
The IND submission process is the first step in the approval process for a new drug. During the IND submission process, the sponsor of the drug must provide data demonstrating the safety and efficacy of the drug in animal studies. The use of the Visikol BBB assay as part of the IND submission process will provide the FDA with additional information on the safety and efficacy of new drugs.
Visikol’s BBB Assay
The Visikol BBB assay is particularly useful for studying the CNS effects of new drugs. The BBB is known to be a major obstacle for the CNS delivery of drugs, and the Visikol BBB assay provides a unique opportunity to study the BBB in a controlled environment. The assay can be used to study the transport of drugs across the BBB, as well as their distribution within the CNS. This information can then be used to optimize the formulation of new drugs to improve their CNS delivery.
The Visikol BBB assay is a valuable tool for the drug development process, and its use as part of the IND submission process is becoming more widespread now that the FDA Modernization Act 2.0 has passed. The assay provides a unique opportunity to study the BBB in an in vitro environment, allowing researchers to gain a better understanding of its properties and functions. The assay can be used to study the transport of drugs across the BBB, as well as their distribution within the CNS, and to study the potential toxic effects of new drugs on the BBB. The use of the Visikol BBB assay as part of the IND submission process will provide the FDA with additional information on the safety and efficacy of new drugs, making the drug development process more efficient and ensuring the safety and efficacy of new drugs.
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