Simulations Plus and the University of Bath Awarded New FDA Grant
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Insights
The awarded FDA grant to Simulations Plus and its academic partners for the development of a dermal PBBM/PBPK model represents a significant advancement in drug development technology. The enhancement and validation of the TCAT™ model within the GastroPlus® platform will enable a more accurate prediction of topical drug absorption, which is crucial for determining bioequivalence without the need for extensive in vivo studies. This shift towards in vitro data reliance can streamline the regulatory process, potentially reducing the time and cost associated with bringing new topical drugs to market.
Moreover, the integration of pathophysiology data for skin disease populations will allow for a more nuanced understanding of drug performance across different patient demographics. This could lead to more personalized healthcare solutions and improve the safety and efficacy profiles of topical medications. The collaboration between industry and academia in this grant is a testament to the growing trend of leveraging multidisciplinary expertise to tackle complex pharmaceutical challenges.
The collaboration between Simulations Plus and the FDA, facilitated by this grant, underscores the regulatory agency's commitment to embracing innovative scientific methodologies in its decision-making processes. The development of a validated dermal PBBM/PBPK model aligns with the FDA's goals of promoting regulatory science and ensuring that safe and effective drugs are available to patients in a timely manner.
By providing an alternative to in vivo bioequivalence studies, the FDA is signaling its openness to novel approaches that maintain rigorous scientific standards. This could set a new precedent for how bioequivalence is established for topical drugs, potentially influencing future regulatory guidelines and expectations. Companies developing topical formulations may find this model to be an invaluable tool in navigating the regulatory landscape and achieving faster product approvals.
The grant awarded to Simulations Plus for the development of an enhanced dermal PBBM/PBPK model has the potential to impact the pharmaceutical industry significantly. By providing a more efficient pathway to establish bioequivalence for topical products, this project could catalyze innovation in the sector. Companies may be incentivized to invest more in the development of topical formulations, knowing that the regulatory hurdles could be less daunting with the availability of a robust in vitro model.
From an investment perspective, this development could be a positive signal for stakeholders in Simulations Plus and similar companies that specialize in modeling and simulation solutions. As the industry continues to evolve towards more sophisticated in silico methods, the demand for such technologies is likely to increase, potentially driving growth for companies at the forefront of this shift.
Partnership will produce an enhanced, validated dermal PBBM/PBPK model to inform product development and bioequivalence decisions
For this award, the Skin Biosciences group at the University of Bath led by M. Begoña Delgado-Charro, Professor in Biopharmaceutics, and Professor Richard Guy, and partners at the Colorado School of Mines (Professor Annette Bunge) and the University of Reading (Professor Adrian Williams) will generate in vitro data from a series of studies to capture the processes that occur when patients use topical formulations which transform when applied and rubbed into the skin. The scientific team at Simulations Plus will utilize these novel data sets, along with additional pathophysiology information for skin disease populations, to enhance and validate the Transdermal Compartmental Absorption and Transit (TCAT™) model within GastroPlus and determine the impact of changes to relevant quality attributes which impact the predictions of dermal absorption. The resulting outcome will provide the foundation of a viable alternative to in vivo studies for the establishment of bioequivalence (BE) for topical products.
“Collaborating with the University of Bath and other partners on this groundbreaking FDA grant is a remarkable opportunity. Our joint efforts are set to deliver an advanced, rigorously validated, and mechanistic dermal PBBM/PBPK model that leverages novel in vitro experimental designs,” said Dr. Maxime Le Merdy, Associate Director, Research & Collaborations of PBPK Solutions, and lead investigator for this grant for Simulations Plus. “This innovation promises to revolutionize the prediction accuracy of topical drug product performance. By doing so, we aim to significantly expedite the regulatory decision-making process, ultimately benefiting patients and the pharmaceutical industry.”
FDA scientific and program staff will actively collaborate with the University of Bath, Colorado School of Mines, University of Reading, and Simulations Plus. Dr. Le Merdy, with assistance from Dr. Jessica Spires and Dr. Jasmina Novakovic at Simulations Plus, will coordinate modeling and simulation activities of the contract.
“By combining our expertise with Simulations Plus’ cutting-edge research, we are charting a course towards more efficient drug development and safer healthcare solutions. The project will be a great way for both industry and academia to make that leap from research into real life applications, with potential benefits of tangible patient outcomes,” added Dr. Delgado-Charro. “Our primary objective is to enable the creation of innovative models that bridge the divide between in vitro and in vivo data. The comprehensive framework and best practices established through this contract will hold significant value for both the FDA and the companies involved in developing topical formulations.”
Funding for this collaboration is made possible by the Food and Drug Administration through grant award 1U01FD007957-01. Views expressed in this press release do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.
About the Delgado-Charro laboratory in the Department of Life Sciences at the University of Bath
Professor Delgado-Charro’s laboratory focuses on transdermal and topical drug delivery, development of optimized methods to treat nail diseases such as onychomycosis and psoriasis, non-invasive sampling for drug monitoring and pharmacokinetics, and mathematical modeling to predict the accumulation and absorption of chemicals in and across the skin. Her research has been funded by esteemed organizations including the Leo Foundation, the
About Simulations Plus, Inc.
Serving clients worldwide for more than 25 years, Simulations Plus is a leading provider in the biosimulation market providing software and consulting services supporting drug discovery, development, research, and regulatory submissions. We offer solutions that bridge artificial intelligence (AI)/machine learning, physiologically based pharmacokinetics, quantitative systems pharmacology/toxicology, and population PK/PD modeling approaches. Our technology is licensed and applied by major pharmaceutical, biotechnology, and regulatory agencies worldwide. For more information, visit our website at www.simulations-plus.com. Follow us on LinkedIn | X | YouTube.
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