Collaboration with University of Connecticut Aims to Streamline Drug Development and Regulatory Approvals Using Innovative Simulation Technology
Simulations Plus, Inc., a leader in biosimulation and medical communications for the biopharma sector, has announced the receipt of a new grant from the U.S. Food and Drug Administration (FDA). The funding will support the application of physiologically based pharmacokinetic (PBPK) modeling via the GastroPlus® platform to build and validate mechanistic in vitro-in vivo correlations (IVIVCs) for long-acting injectable (LAI) drug formulations. This collaboration with the University of Connecticut’s School of Pharmacy, Department of Pharmaceutical Sciences, seeks to explore the relationship between the key attributes of LAI formulations and physiological factors at the injection site to improve drug release and absorption predictions.
The project will utilize GastroPlus’ PBPK platform to create predictive models that link in vitro and in vivo data for marketed LAI suspension products, using innovative systems for testing. Dr. Diane Burgess, a distinguished professor of Pharmaceutics and the Pfizer Endowed Chair of Pharmaceutical Technology at the University of Connecticut, and her team will generate the necessary experimental data. Simulations Plus, alongside other collaborators, will integrate this data to develop PBPK models that can validate IVIVCs, offering an alternative to traditional in vivo studies for bioequivalence (BE) assessments.
This initiative is particularly relevant in the context of the growing importance of LAI formulations, which are designed to improve patient compliance by providing extended drug release. However, preclinical and clinical evaluations for new formulation designs are time-consuming and costly. Dr. Daniela Silva Ryan, Scientist II at Simulations Plus and the principal investigator for the grant, expressed optimism that PBPK modeling could help streamline these processes, reducing development time and costs while facilitating regulatory approval for both innovative and generic formulations.
The collaboration between the FDA, Simulations Plus, and the University of Connecticut marks an important step toward more efficient development and approval of LAI technologies. Dr. Burgess emphasized the value of this partnership, which seeks to bridge the gap between animal and human data, ultimately enhancing understanding of the complex interactions between formulation properties and injection site physiology.
This work will be supported by FDA funding through grant award 1U01FD008304-01. The views expressed in the announcement do not necessarily reflect the official policies of the Department of Health and Human Services.
Commentary by YourDailyFit columnist Alice Winters:
Simulations Plus’ latest collaboration with the FDA represents a significant milestone in the evolution of drug formulation and regulatory science. By leveraging PBPK modeling to reduce reliance on in vivo testing for long-acting injectable (LAI) products, the initiative addresses two major pain points in the biopharmaceutical industry: time and cost. Traditional clinical and preclinical testing for new drug formulations is notorious for its expense and duration. This new approach promises not only to streamline development but also to foster innovation in the delivery mechanisms of drugs, especially in the realm of LAIs, which are becoming increasingly vital in chronic disease management.
The use of PBPK modeling is particularly notable, as it is a sophisticated tool that simulates how a drug behaves in the human body. The ability to correlate in vitro data with real-world drug performance through these models could dramatically enhance the accuracy of bioequivalence assessments. This could also open the door to faster approval processes for generic versions of LAI formulations, increasing access to essential treatments. Moreover, the move to use this technology for the development of IVIVCs will significantly improve predictive modeling in pharmaceutical development.
In terms of scientific rigor, Dr. Burgess’ and Dr. Silva Ryan’s involvement highlights the caliber of expertise behind this project. Dr. Burgess, renowned for her work in pharmaceutical technology, brings immense credibility to the research, while Dr. Silva Ryan’s practical experience with PBPK modeling ensures that the project remains focused on achievable and impactful outcomes.
However, while the use of PBPK modeling in reducing the need for extensive animal testing and clinical trials is commendable, it does raise questions about the long-term reliability of virtual simulations in capturing all the complexities of human drug metabolism. There is still the potential for discrepancies between simulation-based predictions and real-world outcomes. While PBPK models are invaluable, they must continue to evolve to address the nuanced variables involved in drug absorption, distribution, metabolism, and excretion.
In terms of market impact, the focus on LAI technologies aligns with the broader trend in biopharma toward more patient-centered, compliance-enhancing treatments. LAIs, which allow for less frequent dosing, have proven highly beneficial in treating chronic conditions, particularly in patients who struggle with adherence to oral medication regimens. By accelerating the regulatory pathways for these formulations, Simulations Plus and its collaborators could substantially improve the availability of such treatments, making them more accessible and potentially more affordable.
Finally, the strategic collaboration between the FDA, the University of Connecticut, and Simulations Plus demonstrates a clear understanding of the need for industry partnerships in advancing pharmaceutical technologies. The role of the FDA in supporting this project reflects an ongoing commitment to regulatory modernization, ensuring that scientific innovations align with patient needs and safety standards.
In conclusion, this initiative marks an important step forward in pharmaceutical development, offering the promise of faster, cheaper, and more efficient pathways for bringing long-acting injectable formulations to market. It is a promising glimpse into the future of drug development, where simulation technologies will likely play an increasingly pivotal role in shaping the efficiency and efficacy of healthcare delivery.
