Research and Development (R&D) Organization

Advances in biology, information, and digital technologies are changing the concept of disease by elucidating the changes that occur in the healthy body before the onset of disease. In the midst of these changes, in order to correctly understand disease conditions and create treatments, it is important to view disease as a continuum (Disease Continuum) rather than just understanding the onset and progression of the disease, and to deeply understand the biological changes within the body (Human Biology), such as genome information, cellular mechanisms, and pathophysiology, that are linked to the root causes. Therefore, from July 2022, we have reformed our R&D organization to Deep Human Biology Learning (DHBL) with the intention of shifting to a drug discovery approach based on Human Biology, starting from our own unique clinical data.

Message from Chief Scientific Officer (Dr. Takashi Owa, Senior Vice President)

We considered that traditional drug discovery methods are not necessarily based on the cause or pathology of the patient's disease, and decided to change our strategy. We then dug deep into the similarities among the various diseases that people develop, and decided to make that human biology the root of our drug discovery research. In other words, we have revamped our research approach, believing that the seemingly completely different pathological conditions that occur in a wide variety of human diseases, may actually have similar causes and common mechanisms. The boundaries between the areas of neurology and oncology, which were previously separate and independent research groups, have been broken down, encouraging communication and collaboration among scientists with diverse backgrounds and expertise. This has created an environment conducive to the generation of novel ideas from unconventional perspectives, leading to the proposal and execution of innovative drug discovery projects. This organizational structure is based on the original concept that the starting point of drug discovery research should be the search for similarities between the root causes and pathogenic mechanisms behind various human diseases. For example, disruption of protein homeostasis in the body is not limited to a single disease, but can lead to many diseases, including dementia and cancer.

Under this new drug discovery and development organization which we call Deep Human Biology Learning (DHBL), we will continue to realize revolutionary innovations and contribute to relieving patients’ and the peoples’ anxiety over health.

Overview of DHBL

Figure 1: DHBL organizational structure (as of February 6, 2024)

DHBL drug discovery and development consists of five drug discovery research “Domains”, five “Functions” supporting drug discovery research (foundation, the three functions, and fulfillment), and the DHBL office (Figure 1). Domains are responsible for leading drug discovery projects from formulation of drug discovery hypotheses to regulatory approval. These “Domains” are not based on a disease domain axis, but on a drug discovery research axis relying on biology. The five Domains (protein, cell, microenvironment, aging, and coexistence with microorganisms) represent the biological requirements for people to live a healthy life, and were carefully selected based on our in-depth knowledge from research results.
On the other hand, the five Functions are the R&D functions that support DHBL drug discovery and development, and aim to incorporate technological innovations in their respective areas of responsibility to build a state-of-the-art technological foundation. The HBI (Human Biology Integration) Foundation is responsible for discovering drug discovery hypotheses based on Human Biology through comprehensive analysis utilizing AI and other technologies by adding our proprietary clinical data to genomic and pathophysiological information. The most significant feature of the DHBL organization is the placement of this HBI foundation upstream of the entire DHBL. It is named “Foundation” to represent its role as the basis of DHBL drug discovery and development.

The three functions (DCV, DEG and PPD) are responsible for screening with humanized disease models using the latest technologies such as iPS and organoids, selection of optimal modalities to maximize target engagement and synthesis of Real Medicine, safety and pharmacokinetics, and evaluation of active pharmaceutical ingredient and drug formulations.
In Clinical Evidence Generation (CEG) fulfillment, we aim to prove DHBL drug discovery hypothesis in clinical trials and obtain regulatory approval. We named this “fulfillment” with the meaning of realizing contribution to patients. CEG conducts patient-oriented clinical trials. The Human Biology data from the patients who participate in our clinical trials will become the seeds for the next drug discovery. DHBL drug discovery and development does not follow a one-way path from discovery to the clinic, but rather aims for a high-speed, unbroken drug discovery loop from discovery to the clinic and back again.

The DHBL Office takes a holistic view, improving efficiency and productivity through optimal resource allocation and portfolio strategy, making quick decisions, building a data utilization infrastructure, and achieving open innovation and advanced alliances.