Fifteen years ago, along with my three partners —all experts from the pharmaceutical industry— we founded PhinC Development with a bold and disruptive vision: to place modeling at the heart of drug development. At that time, we had already anticipated the evolution of pharmacometric practices and highlighted the benefits of modeling in drug development. Since then, our goal has been to support small and medium-sized pharmaceutical or biotech companies throughout the stages of drug development, from preclinical to proof-of-concept in patients, in an operational and personalized way.
Over the past 15 years, we have witnessed modeling and simulations play an increasingly crucial role in the successful development of drug candidates. The Model-Informed Drug Development (MIDD) approaches —that we systematically promote— enable us to accurately predict how drugs will behave in the human body, characterize the pharmacological effect, optimize dosing regimens, and identify and mitigate potential risks before clinical trials even start. By using pharmacokinetic and pharmacodynamic modeling, we can simulate different scenarios enabling us to gain an in-depth understanding of drug mechanisms of action and make key informed decisions throughout the development process. The benefits of modeling and simulation have become undeniable. Not only they save time and resources by reducing the number of required clinical trials, they also help to improve the assessment of safety and efficacy of drugs under development.
Regulators are increasingly recognizing the value of these practices and encouraging their use in the drug approval process. By adopting these innovative approaches, we can not only optimize the development of new therapeutics but also ensure that they meet the highest standards. Moreover, as drug development evolves, modeling approaches have proven to be particularly effective in addressing the specificity and complexity of New Chemical Entities (NCEs) and New Biological Entities (NBEs). These drug candidates often present unique challenges in terms of pharmacokinetics, pharmacodynamics, and safety profiles, and modeling allows us to tailor our strategies to meet these challenges with precision.
Today, we mark an important milestone in our journey. After 15 years in existence, we are more convinced than ever that pharmacometrics and Quantitative System Pharmacology (QSP) provide effective solutions in pharmaceutical development. By adopting a holistic approach of all available technologies, we continually enhance our service offerings such as machine learning, artificial intelligence, and advanced bioinformatics platforms.
We have always been committed to research, innovation, and collaboration with our partners in the pharmaceutical industry. Our expertise in integrated modeling enables us to tackle the complex challenges of drug development by identifying the best approaches and optimizing clinical strategies. Today, more than ever, as the pharmaceutical industry rapidly evolves, we are proud to contribute to transforming the landscape of drug development by promoting disruptive methodologies.
