Mounting Frustration Over Clinical Trial Recruitment

“At this rate, we may have no choice but to delay the release of our drug,” says Mr. Tanimoto, who at the start of 2023 was assigned to head new drug development operations in the US at ONO ’s US subsidiary, ONO PHARMA USA (OPUS). Primary central nervous system lymphoma is one of several highly malignant brain tumors, and the reason why Mr. Tanimoto was getting frustrated was because as work was underway to develop the new drug to treat this disease, for which there is no cure in the US, dark clouds kept gathering over his team’s efforts to implement clinical trials, a critical step in the process of releasing new drugs.

Drug candidates are administered to patients through clinical trials, and thus, clinical trials serve as the gateway for pharmaceutical products to go out into the world. Patients who participate in these clinical trials are recruited through medical institutions, but if a predetermined number of patients are not recruited, manufacturers have no way of sufficiently evaluating the efficacy and safety of their drugs, which means that the drugs don’t get released.
This was the very dilemma that Mr. Tanimoto's team was facing, as they were having trouble recruiting clinical trial participants as planned.

Mr. Tanimoto had worked on a wide range of clinical trials before, both big and small, over his twenty-plus years at the Company, but he really felt like the wool had been pulled over his eyes as time kept passing by relentlessly with no solutions in sight.
“I just don’t get it… We already obtained consent from the doctors cooperating in the clinical trial, and otherwise made all the necessary preparations in terms of formal procedures, just as we have done in Japan,” says Mr. Tanimoto, as he reflects back on his mounting frustration over the situation. Eventually, Mr. Tanimoto and his team decided to visit the medical institutions cooperating in the clinical trial, which were all scattered in different locations across the US, and met directly with doctors and hospital staff to find out what was causing the issue.

Conveying Our Passion

After visiting nearly 10 medical institutions and speaking with doctors, Mr. Tanimoto realized something.
ONO’s strong desire to contribute to the lives of patients and their families in the US through the new drug in development, and the company’s passion for developing innovative drugs, which has always been at the forefront of its activities, were not being communicated sufficiently to doctors through online meetings, which have become commonplace since the coronavirus pandemic. This failure to convey the company’s passion and dedication ultimately hindered efforts to recruit clinical trial participants. On the other hand, Mr. Tanimoto also noticed a lack of solidarity within his team.
The direct visits were a success. Thanks to Mr. Tanimoto and his team’s efforts to carefully convey the company’s sincerity, the number of patients raising their hand to participate in the clinical trial quickly soared, and development of the drug began to take off. Mr. Tanimoto recalls, “We were determined to be the pharmaceutical company to launch a drug in the US on its own for the first time, and to deliver it to as many patients as possible. By carefully conveying Ono’s strong passion and commitment, something which is unique to our company today, we were able to get through to the hearts of doctors and hospital staff. This experience has taught me once again that the solutions to our problems can always be found in the front lines of our business activities.”
The new drug is set to hit the US market in 2026. In the meantime, Mr. Tanimoto and his team will continue to do everything in their power to ensure that the drug is successfully released so that it can be delivered to as many patients as possible.

The Significance of Officially Entering the US Market

So why is the company making a full-fledged attempt to officially enter the US market? President Dr. Toichi Takino says, “This is the first step toward realizing our dream as a pharmaceutical company of delivering medicines directly to patients around the world.”
For many years, ONO has conducted clinical trials and has sold its own products mainly in Japan. Over this past decade, the Company has expanded business to South Korea and Taiwan to promote development. For example, our main product has been delivered to patients around the world thanks to the help of our partner pharmaceutical companies in Western countries.
If we become able to conduct clinical trials and market our products on our own in the US, where many patients are in dire need of our medications, it will bring us that much closer to truly becoming a “global specialty pharma” that continues to deliver innovative drugs to the world. Our expansion into the US market will become a milestone for the Company's subsequent growth as a pharmaceutical company.