Skip to main content
Innovative FDA Program to Evaluate Nonanimal Organ-on-a-Chip Technology
In an exciting development for drug development and patient care, the FDA has officially accepted the first submission of an organ-on-a-chip technology under its Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program. This significant milestone not only highlights the modernization of drug evaluation processes but also reflects a growing recognition of the need for innovative tools in assessing drug safety.
What is the ISTAND Pilot Program?
Launched in December 2020, the ISTAND pilot program is designed to provide essential scientific and logistical support to developers of Drug Development Tools (DDTs). Its goal is to ensure that novel technologies are integrated into the drug development and regulatory review processes more swiftly and efficiently. By fostering collaboration between the FDA and DDT developers, the program aims to expedite the delivery of new therapeutics to patients who need them.
The importance of ISTAND cannot be overstated. It holds the potential to serve as a critical bridge between emerging scientific technologies and regulatory approval, ensuring that innovations can be effectively utilized to improve patient care. The Physicians Committee actively works to support the ISTAND program, recognizing that it is vital to the future of drug development.
Introducing the Liver Chip
The tool recently accepted into the ISTAND program is a liver chip. This organ-on-a-chip technology is specifically designed to assess the risk of drug-induced liver injury (DILI) in potential drug candidates and to create human-relevant data for the candidate drug’s Investigational New Drug (IND) submission. This risk assessment and relevant data creation will provide stronger safety assurance for the regulatory decision-making that goes into Phase I clinical trials. DILI is a significant concern in drug development, often leading to costly late-stage failures. With four human liver cell types, the liver chip model allows researchers to monitor signs of drug induced damages in real time and compare drugs’ relative risks. The liver chip offers a more accurate and humane alternative to animal testing methods, allowing for better predictions of how a drug will affect human liver function.
Implications for Drug Development
The acceptance of the liver chip into the ISTAND program marks a pivotal step in the evolution of drug development. Once approved, companies can confidently use the tech for the approved context of use without the need to provide additional data or meet with the agency to seek approval to use the method.
By utilizing advanced models that closely mimic human biology, researchers can gain insights that are not possible with animal experiments. This action could reduce the numbers of animals used in testing while enhancing the predictive power of preclinical studies.
As the FDA continues to support innovative approaches, we can expect a more streamlined pathway for promising therapeutics. This shift has the potential to significantly shorten the timeline from drug discovery to patient access, ultimately improving health outcomes.
Looking Ahead
The FDA’s acceptance of the Liver-Chip DDT into the ISTAND program is a beacon of hope for the future of drug development. As we move toward more innovative and humane scientific practices, we can anticipate a new era in medicine—one where therapies are developed faster, safer, and with greater consideration for patient health. The commitment to integrating cutting-edge technologies is a promising step forward, and we look forward to seeing how this will reshape the landscape of drug development in the coming years.
