From a domestic company to a global player SHIONOGI

 

In this age when the true value of medicines is in question, Shionogi researches, produces and prmotes medicines with the patient’s perspective in mind.                                   

Global Development Division
Senior Executive Officers Dr. Toshinobu Iwasaki 

Interview date: November 21, 2019
Q1 Trends in Drug Development

The time to question the true value of medicine.

The probability of a potential new drug reaching the market has declined over time, and has been reported to be as low as one in every 30,000 compounds created. Therefore, the cost required to bring one product to market is higher than ever before. Also, drug development for diseases with no current effective treatment is ever more difficult, as mechanisms driving these diseases can be very complex; making it very difficult to perform clinical trials to develop these drugs. In recent years, the emergence of innovative medicines, such as cancer immunotherapy, has no doubt saved many patients. On the other hand, the cost of treatment for these medicines can be in the millions or tens of millions of yen. This makes access to these medicines a major economic problem. We must take into account the economic accessibility of the medication for the patient, in addition to scientific evaluations of safety and efficacy, in order to provide more truly worthwhile  medicines to patients.

In order to truly develop drugs with value, in an industry with limited resources both human and economic, we believe that the knowing when and how to quickly and efficiently deploy these resources is the key to success. It is for this purpose that the pharmaceutical industry is working to speed up and streamline the drug development process, including the active incorporation of innovative technologies and the creation of synergetic effects through collaborations with other companies.

Q2 Regarding the policy of Shionogi Pharmaceutical’s Development Division

Shionogi's strengths lie in its never-give up attitude, and its "Commitment as Creators"

We strive to develop highly-valued "medical products" (I specifically do not refer to them as pharmaceuticals here) that meet unmet medical needs. The basis for our actions is always the scientific in nature. Developmental goals (unmet medical needs and how to make them truly valuable to the patient) are identified, established, and development plans are thoroughly discussed, and the data obtained are assessed on the based on the evidence acquired. 

Shionogi strives to apply its key strength, its “Dedication to creating value “, to each and every step of this process with unyielding commitment.

 

"Unmet medical needs" are always defined by the patient's perspective

Firstly, we define what is meant by the word “unmet medical need”; whether it is the effectiveness of the drug required, how safe the drug is, the price, the utility of the drug, and other things that patients’ may voice so that we can determine what is necessary from the patient’s perspective. 

In order to do this, we are working on patient centricity activities so we can materialize the thoughts and wishes of the patients in our drug development process.

We have and continue to develop as many new medical products required by patients as we can.

 

What is a high-value medical product?

We capture value for our products from three perspectives:

① Efficacy

Based on the overarching premise that it is safe, we pursue the creation and introduction of compounds with strong physiological activities, which can be expected to have high efficacy, in cooperation with research laboratories and other related departments.

② Improving the Utility via the Mixing of Technologies

Specifically, we aim to improve safety/efficacy and convenience by combining pharmaceuticals and digital medicine. We are also developing prescription device applications targeting psychiatric disorders, and also medical products that go beyond the concept of pharmaceuticals to date.

③ Maximizing Value with Information

Currently, we are developing new treatments for depression at Shionogi. During the treatment of depression, there are many cases of patients that terminate their treatment prematurely due to  side effects, or not feeling any positive effects of their treatment. However, in order to make a full recovery, unless there are intolerable side effects, patients should be able to complete their treatment regimen. We believe, in order to overcome the difficulties of the treatment, it is important for patients, their families, and healthcare professionals to be able to quantitatively and remotely monitor their compliance status and the severity of depression. In order to fulfill this need, we believe that to providing medication management and remote status monitoring as additional information using the latest digital technology in addition to depression treatment drugs will increase the value of these medical products.

Q3 What is required to implement this policy?

Changing from a Domestic Company 塩野義 to a Global Company Shionogi.

We at Shionogi currently believe that we must transform into an organization that is not restricted by the norms of the pharmaceutical industry. We would like to change from our current title, “Shionogi Pharmaceutical Company” to simply “SHIONOGI”. Just as IT companies have expanded their vision and entered the motor vehicle industry, pharmaceutical companies have also begun to enter other industries. In other words, there will be no barriers to expansion into any industry in the future. If we continue to engage in and be limited by only existing concepts and actions in the pharmaceutical industry, we will not be able to collaborate with different industries, and we will not be able to expand the possibilities of developing new medical products that meet the needs of patients. However, it is of paramount importance for SHIONOGI to continue toresearch, produce, and promote medical products with the patient's perspective in mind.

Q4 What are the characteristics of Shionogi?

Highly safe medical products

"Reliable and Innovative," is our current vision for the development division of Shionogi. I believe Shionogi is currently a "reliable" company. This is a very important trait in the pharmaceutical industry. Our industry’s history contains various episodes of drug-related safety incidents that have threatened patients around the world, but Shionogi has never had such an incident. This is reflection of the values we hold dear at Shionogi, values we have practiced, meaning our actions are based on the basic policy of producing only " the best possible medicines to protect the health and wellbeing of the patients we serve." and we take pride in this. In addition to this positive culture, we intend to continue our innovative initiatives, specifically the development of therapeutic digital medicines, and to establish a culture of being "Reliable and Innovative" at the Shionogi Development Headquarters.

Q5 On Future Global Development

Evolution into a truly global company

When Ospemifene (a drug used to treat vaginal atrophy) was approved in the United States and Europe, Shionogi entered the global market. With Naldemedine (an opioid-induced constipation treatment), we were able to create a foundation with our own hands that can be cultivated globally in Japan and the United States. We were able to realize that even as a Japanese company, in this industry it is expected that we be able to develop and sell drugs outside Japan on a global scale. Additionally, more seriously than ever before, we should think of "delivering the necessary medicines to the local communities that need them." If medicines are needed for patients worldwide, they should be developed globally. However, we believe that it is also important for Shionogi to develop medicines that meet the needs of each region, and to optimize and efficiently implement practices to do so. In this endeavor, we appointed a global director for each function and clarified the role of each function. This has resulted in an increase in speed and precision of decision-making and increased transparency of each function. Regarding management of development projects, project leaders will be appointed with the appropriate resources regardless of region, based on the idea that project leaders for each product should be the focus of development activities. Through these efforts, we hope to continue to grow into a real global company.