“Quantitative decision-making with data rather than empirical thinking”
– Certara’s Modeling & Simulation technology contributes to accelerate new drug development
Certara G.K. held an online press seminar on Wednesday, August 31, 2022, in Tokyo, on the optimization of the drug development process and the role of a drug discovery consulting company.
In Japan, local demand for rapid, safe, and effective drug development is increasing after the COVID-19 pandemic. On the other hand, the Japanese regulatory and market access landscape and costs for clinical trials may incite foreign companies to lower their priority of drug development for the Japanese market, which also may cause more severe ‘drug loss/lag.’ This means that many innovative drugs developed in the West will either have delayed availability or be unavailable to Japanese patients.
Under such circumstances, Professor Naoto Uemura from Oita University, School of Medicine, which was the first Japanese university to have a Clinical Pharmacology department, presented at the seminar. He cited the COVID-19 vaccine and therapeutic drug development as examples. In Japan, most decision-making still relies on empirical thinking, which can hinder the speed of drug development. To overcome this situation, it’s important to use a quantitative clinical pharmacology approach to strengthen clinical development.
James Montalto, Managing Director of Certara G.K., spoke about the growth potential of Certara’s drug discovery consulting business and showed its achievements to date. He also emphasized Certara’s commitment to accelerate innovative drugs to patients with Modeling and Simulation (M&S) and their experiences.
Further, Dr. Mayumi Hasegawa, a drug development consultant at Certara, gave an overview of “Model-Informed Drug Development (MIDD).” It has become entrenched in Europe and America in recent years. She also shared MIDD case studies, including the development of COVID-19 vaccine which Certara’s technology contributed to in Japan.
Session Highlight
Professor Naoto Uemura, MD, Ph.D
Department of Clinical Pharmacology and Therapeutics, Oita University
In Europe and America, quantitative decision-making based on accumulated data has led to earlier decisions on development strategies, not only during COVID-19, but also pre-pandemic. However, drug development in Japan still relies heavily on empirical decision-making, which hinders efficient development. As a result, the number of clinical trials for COVID-19 exceeds 100 in America and Europe, whereas in Japan, it is only 19. We believe that M&S plays an important role in accelerating domestic development and optimizing dosage and administration of pharmaceuticals. There is an urgent need in Japan to develop experts in M&S. We would like to strive for education that “creates people who can create medicines” in academia.
James Montalto
Managing Director, Certara G.K.
Only a small percentage of promising new drug candidates discovered through the latest science and technology like AI have made it to the market. Well-planned strategy from the first stage is necessary for successful development. Certara contributes to the success and acceleration of new drug development by providing M&S software and consulting services. Since 2014, Certara’s solutions have been used in 90% of new drug approvals by FDA. In Japan, we support new drug development for 140 companies including all top 20 companies in R&D investment and the PMDA as our customers. Our mission is to rapidly deliver innovative new drugs, particularly in areas such as rare disease where drug development is challenging.
Mayumi Hasegawa, Ph.D.
Senior Director, Integrated Drug Development, Certara G.K.
“Model-informed drug development (MIDD),” which incorporates knowledge obtained from M&S methods into drug development strategy planning and decision-making, has already been recognized for its usefulness, especially in Europe and United States, to improve the probability of success, shorten the time required for drug development, and reduce costs. On the other hand, due to the lack of know-how and talent, M&S technology is not fully utilized in Japan. This may lead to stagnation of domestic development capacity, which can aggravate drug lag/loss. In the development of COVID-19 vaccine and drugs for intractable diseases for children, etc., Certara is contributing to the optimization of the development process and regulatory filings in Japan with innovative MIDD methods. As the world’s largest MIDD consulting team, we promote the use of MIDD for development in Japan and focus on solutions for drug discovery and development issues.