Through collaboration between all departments, we are endeavoring to develop and review new drugs to deliver our own differentiated value before the competition.
Sohyaku Innovative Research Division (drug development researcher)
Medicinal Chemistry
Mitsubishi Tanabe Pharma is conducting exploratory synthetic studies to create lead compounds, as well as studies in medicinal chemistry that aim to discover candidate compounds by optimizing these lead compounds.
All the way from the beginning of the process to the design of candidate compounds, we clarify the working mechanisms of lead compounds and utilize knowledge of compound synthesis that spans across a wide range of fields, including organic and computational chemistry, drug design and chemical engineering.
In recent years, we have made progress in pharmaceutical molecular design research using computers and are also engaging in exploratory and optimization research in pursuit of drugs that can control interactions between different proteins, as well as drugs containing nucleic acid and peptide.
On the next page, we introduce employees who are currently engaging in this type of work.
Biological Study (pharmacology, screening)
This is a field of research that analyzes and evaluates the effectiveness and usefulness of candidate compounds while applying knowledge from a wide array of fields, including pharmacology, biochemistry, molecular biology and cytobiology.
Mitsubishi Tanabe Pharma is constructing biological activity testing systems and evaluating compounds, both in vivo and in vitro. (In vivo processes utilize pathological animal models while in vitro processes involve cells manufactured through various technologies, including gene recombination, primary cultures and iPS.) We are attempting to discover and evaluate new compounds by putting the in vitro biological activity testing systems that we constructed through high throughput screenings (HTSs).
Additionally, we are engaging in disease analysis, searching for drug development targets and predicting drug effects using a large quantity of biological data and ICT. Furthermore, we are analyzing the pharmacokinetic characteristics and physical properties of drugs, as well as building drug delivery technologies that allow us to control their effects.
On the next page, we introduce employees who are currently engaging in this type of work.
Biologics
Utilizing knowledge in biochemistry, molecular biology,cell and genetic engineering, we are conducting exploratory research regarding potential drug targets, making use of the experience we have accumulated working in the field of biologics (biological preparation) since its early days in Japan. This field involves the study of genes, proteins, cells, tissues and other biomaterial. Mitsubishi Tanabe Pharma is engaging in drug discovery research regarding vaccines and antibody drugs that employ technologies such as protein expression, refinement and analysis. Making use of the achievements we have reached as early participants in Japanese biologics, we are also conducting drug development research that we can apply to cell and gene therapy that involve technologies that include gene recombination, primary cultures and iPS.
DMPK Research (Drug Metabolism and Pharmacokinetics)
Mitsubishi Tanabe Pharma explores the absorption, distribution, metabolism and discharge characteristics of candidate compounds once they have been administered and are inside the body. Pharmacokinetic characteristics greatly influence effectiveness and safety, so nonclinical research is also extremely important. In particular, we are focusing our efforts on predicting how candidate compounds will behave inside the human body, before the development stage.
Specifically, we are engaging in in vivo animal testing using mice and in in vitro testing, which utilizes biomaterial samples, including tissues and cells, obtained from humans and laboratory animals. Additionally, we are conducting in silico testing using computer modeling and simulations.
Safety Research
After conducting exploratory synthetic research, Mitsubishi Tanabe Pharma proceeds with research regarding the safety of candidate compounds, which is performed through nonclinical trials that do not involve humans, including cultured cell and animal testing. We will evaluate safety from a wide variety of viewpoints, including general toxicity, cytotoxicity, genotoxicity and carcinogenicity. Through this type of research, we will make it possible to predict risks involving adverse side effects in humans.
We provide essential data regarding safety by refining candidate compounds and conducting clinical trials. This process requires highly academic knowledge in fields including toxicology, pathology, laboratory animal science, molecular biology and cytobiology. This research is necessary because it allows us to develop drugs that physicians can safely prescribe for their patients.
Ikuyaku Integrated Value Development Division (includes positions in clinical research and development, pharmacovigilance and medical affairs)
Clinical Research and Development
Clinical research and development is a stage in drug development research that involves performing human clinical trials concerning compounds determined to be safe during nonclinical stages of research. The data obtained during clinical research and development is then used to make applications for approval to related authorities and later launch medicinal drugs onto the market. Mitsubishi Tanabe Pharma takes responsibility for the administration of its drugs to both healthy subjects and patients by requesting three-phase clinical trials from medical institutions. In terms of our specific duties, we plan these clinical trials and manage and analyze their results. We also apply for approval with the proper authorities, afterward. The management and promotion of development projects is important during clinical trials, which are often conducted over long periods of time. After these three-phase clinical trials are safely completed, we apply for approval from the appropriate authorities. This approval makes it possible for us to subsequently deliver new drugs to patients.
On the next page, we introduce employees who are currently engaging in this type of work.
Data Science
Data science involves managing and analyzing the clinical data obtained through clinical trials. This work is essential for securing data reliability and quality. Specifically, data science involves designing clinical report forms, reviewing data gathered from medical institutions and conducting statistical analyses. Using data science, Mitsubishi Tanabe Pharma provides support that ensures highly reliable clinical trial results. This involves providing specialized statistical advice throughout all clinical trial stages, including planning, conducting, evaluation and reporting. We regard our global clinical trial initiatives, which target global standardization of clinical trial data, to be important moving forward.
Quality & Vigilance Division
Pharmacovigilance
Drugs may be effective in treating diseases but also carry the risk of side effects. For this reason, on a daily basis, all pharmaceutical companies collect, analyze and share information regarding how their drugs can be used to maximize patient benefit and minimize patient risk. Pharmacovigilance is described as “the monitoring of drug safety” and involves sharing information regarding drug side effects globally, regardless of the country in which they occurred, in an effort to improve safety management everywhere. Currently, Mitsubishi Tanabe Pharma sells about 120 varieties of drugs that are widely used for medical treatment. Pharmacovigilance staff face a large mission that involves determining how to maximize the benefits and minimize the risks of these drugs by scientifically analyzing, evaluating and globally sharing data gathered from around the world.
On the next page, we introduce employees who are currently engaging in this type of work.
Medical Affairs
Medical affairs (MA) and medical science liaison (MSL) staff hold highly specialized and academic medical and scientific knowledge. Separate from staff that handle sales activities, MA and MSL staff promote proper use and value optimization of our products from medical and scientific standpoints, both inside and outside the Company. Outside the company in particular, we participate in medical and scientific discussions and conferences with medical specialists and researchers. Through these activities, we are contributing to providing solutions for unmet medical needs.
Production Technology & Supply Chain Management Division (researchers; technical research)
Process Development
Chemistry, manufacturing and control (CMC) involves handling information appropriately regarding the chemistry, manufacturing and quality management of drug substances and drug manufacturing. At the same time, process development refers to the design of manufacturing processes that allow candidate compounds to be put into production and the research conducted to optimize their manufacturing methods. With these activities, we will produce optimal manufacturing methods, while remaining aware of quality, safety and cost. We are also engaging in the manufacture of drug substances for use in preclinical and clinical trials. Furthermore, we are conducting scale-up discussions aimed at commercial production and transferring technologies to our production sites.
Elsewhere, we are promoting the cultivation of new technology in the field of process development to establish more efficient manufacturing methods.
Pharmaceutical Research
When developing new drugs, we conduct research that involves adding functionality to pharmacologically active compounds to maximize their potential and converting them into ideal product forms of superior quality that are easy for patients to use. Our work involves everything from formulating new drugs to process and package design and research regarding the establishment of production systems. By manufacturing and supplying test drugs at the clinical trial stage, we support reliable clinical trial performance.
Mitsubishi Tanabe Pharma is also engaged in developing new manufacturing processes that will allow for more efficient production of higher quality drugs. Additionally, we are conducting basic research regarding drug formulation and packaging in order to develop new dosage forms and package varieties, as well as acquire related and innovative technologies.
On the next page, we introduce employees who are currently engaging in this type of work.
Physical Property Analysis
Mitsubishi Tanabe Pharma conducts physical property analysis for a wide variety of candidate compounds, ranging from low-molecular drugs to biomedicine. To evaluate the quality of candidate compounds, we develop testing methods and conduct various physicochemical evaluations, including structural analyses and physical property, formulation property and safety evaluations. To make the process comprehensive, we also perform biochemical, microbiological and biopharmaceutical evaluations. We are transferring these testing methods, which have already been established at some production facilities, to the rest of our facilities and are engaging in developing new and fundamental technologies related to analysis conducted by our young researchers.
Mitsubishi Tanabe Pharma is aiming for higher-quality drug development by conducting research and development throughout its drugs’ entire lifecycles, including the initial and post-market stages.
Sales & Marketing Division (medical representatives)
Medical Representatives (MRs)
MRs primarily work to promote and ensure proper use of our drugs. Specifically, they provide detailed information regarding the quality, safety and effectiveness of our drugs to medical personnel, such as physicians and pharmacists, in a timely manner. Additionally, they perform important work such as collecting information regarding the effectiveness of drugs after use and confirming whether or not side effects that had been unclear before launch are occurring in patients. Mitsubishi Tanabe Pharma analyzes this wide-ranging information from various angles. Then, the MRs communicate our findings to medical personnel as new information.
We consider contributing to patient medical treatment through initiatives like these to be one of our great missions.
On the next page, we introduce employees who are currently engaging in this type of work.
Staff
Staff Positions
General staff support activities that allow us to fulfill our social mission of delivering drugs to patients. They include personnel working in a wide variety of fields, including general affairs, accounting and finance, personnel administration, public relations, legal affairs and international business. Our experts in each of these fields are always conscious of what they can do through their work each day to contribute to patient medical treatment.
On the next page, we introduce employees who are currently engaging in this type of work.