In recent years, pharmaceutical companies, especially those in the U.S. and Europe, are adopting a new approach to drug discovery and development that incorporates patients' voices in the process.
Through patient engagement (PE), researchers are becoming aware of the importance of understanding the needs of the patients, from issues they experience with their symptoms and treatment regimens to improvements that can make their daily lives better. By including patients’ voices from the early stages of the drug discovery research process, new medicines can be developed to better meet their needs.
However, there are many potential issues that drug discovery researchers at pharmaceutical companies need to be mindful of when they communicate directly with patients, and very few guidelines exist to help them. The reality is that, across the globe, PE in drug research is still in its infancy.
This is the backdrop against which Daiichi Sankyo Company, Ltd. (Daiichi Sankyo) joined forces with Takeda Pharmaceutical Company in Japan to produce the “Patient Engagement Guidebook from Research Phase in Drug Discovery.” The guidebook is packed with information for pharmaceutical company teams working in drug discovery research and development. For example, it includes what legal and ethical issues they need to be aware of when communicating with patients as part of drug research and development and how to build a relationship of mutual trust between the company and patients.
In this interview, we talked to project members from both companies about what motivated them to produce the guidebook and what difference they hope it will make.
Takeda Pharmaceutical Company PCET members:
Rie Kunisada
Hiromi Fukuda
Daiichi Sankyo COMPASS members:
Fumihiko Okada
Akiko Miyano
Takeda PCET members (from left): Kunisada-san and Fukuda-san
Start with the concept: patient centricity and engagement
The Patient Centricity Expansion Team (ET) at Takeda Pharmaceutical and the COMPASS Compassion for Patients S (COMPASS) Team at Daiichi Sankyo are both cross-departmental teams engaged in initiatives to develop a deeper understanding of patients' needs and concerns in their daily lives. The teams had been active for some time before they embarked on the joint project to create the guidebook.
Ms. Kunisada (Takeda Pharmaceutical): It is essential that we listen to our patients in order to promote PE, but there were difficult hurdles for researchers to overcome in order to start communicating with patients. One issue was the extremely rigid ways people tended to interpret internal and external rules and regulations. Also, although guidelines already existed in the form of the “Patient and Public Involvement (PPI) Guidebook” published by the Japan Agency for Medical Research and Development（AMED）, it mainly dealt in development stages, so there was very little information for non-clinical stages.
Since 2014, the two companies have been working together, with researchers taking the initiative, to collaborate in areas where they are not in competition. In December 2019, we held a joint workshop on the concept of patient-centric drug research and development, where we discussed ideas for promoting the concept of patient centricity (PC) and patient engagement (PE) in the pharmaceutical industry. One of the ideas that came up in the group work session was to produce a guidebook that summarizes the dos and don'ts for researchers when working with patients. This led to the collaboration between PCET and COMPASS to develop the guidebook.
Dr. Okada (Daiichi Sankyo): While we must comply with laws, such as the Pharmaceutical and Medical Device Act* and the Protection of Personal Information Act, when communicating with patients, we knew from our experience that there were other issues we needed to overcome in order to build mutual trust. We decided to pool together the know-how and experience PCET and COMPASS have each accumulated over the years and create a guidebook on working with patients.
Although PCET and COMPASS are based in different companies, we share the same vision about what goals we want to achieve. This made the collaboration smooth, and the members gained many insights through the project, which began in 2020.
Ms. Miyano (Daiichi Sankyo): It was a big challenge to put the specialized knowledge of our experts in writing and organize it into a set of guidelines. We tried to define terms such as “PC” and “PE” as we took the discussions forward and went through numerous reviews both within and outside our companies to finalize the content. After we released the first edition, Dr. Kaori Muto, professor of the Department of Public Policy, Human Genome Center, the Institute of Medical Science at The University of Tokyo, gave us advice that we should first and foremost present the general idea rather than worrying about the exact definitions of the terms, commenting, "The fact that we are shifting from the old physician-centric approach to patient centricity is in itself a progress."
Ms. Naomi Sakurai, President of Cancer Solutions Co., Ltd., who previously gave a talk at our joint workshop, also served as an advisor, and we released the final version in April 2021.We received a positive response from other pharmaceutical companies as well as academic institutions and patient advocacy groups.
Ms. Fukuda (Takeda): In addition to the guidance of Ms. Naomi Sakurai, the Japan Patients Association also took a supervisory role to ensure the guidebook included the perspectives of patients' groups. When Ms. Kunisada and Dr. Okada appeared on PPI Japan's webinar, "Everybody's Radio PPI," to talk about the project, we received requests from several pharmaceutical companies to show them the guidebook, which made us very happy.
Daiichi Sankyo COMPASS members (from left): Miyano-san and Okuda-san
Deeper and stronger ties through the pandemic
The guidebook project coincided with the start of the COVID-19 pandemic, but the wide-scale adoption of remote working actually made the collaborative process more efficient and helped to strengthen the bond between the two companies.
Dr. Okada (Daiichi Sankyo): Before the pandemic, it was challenging to coordinate everyone's schedules each time we held a face-to-face meeting. With online meetings becoming the norm, physical distance and time became less of a constraint. Whether someone was from inside or outside the company was no longer an issue. We were able to go beyond workshop discussions and take ideas into concrete action to achieve results.
Ms. Fukuda (Takeda): The timing worked out very well for both companies, and we were also fortunate to have such fantastic team members. Everyone was so enthusiastic even though this project was not their main focus. I think we succeeded because everyone taking part passionately believed in patient centricity and engagement.
Ms. Kunisada (Takeda): We really have a good camaraderie. Some COMPASS members even put PCET logo stickers on their PCs in solidarity!
The art installation at the entrance to Ipark is also coincidentally a
compass!
The Final goal—patients' perspective in drug discovery
The two companies have just released an updated version of the guidebook (for reference, here in Japanese) to incorporate feedback from different stakeholders. They are also co-hosting a “Healthcare Café” event with other pharmaceutical companies, where the concept of PE advocated in the guidebook will be put into practice through conversations with patients.
Dr. Okada (Daiichi Sankyo): The Healthcare Café event will provide an opportunity for participating companies to share their knowledge and gain a deeper understanding of PE. The starting point of drug discovery is to know our patients. The activities of COMPASS and the PE Guidebook are a means to ensure that we develop new medicines that will benefit our patients.
Ms. Kunisada (Takeda): As I mentioned at the in-house event jointly held by the two companies to mark the release of the PE Guidebook, our ultimate aim is to deliver our patients the medicines they need as quickly as possible. We believe that we can achieve this goal by incorporating the patient's voice into drug discovery—by getting closer to see things through the lens of the patient's perspective combined with our own expertise as we innovate.
Creating the PE Guidebook was never meant to be our end goal; it is the starting point of our journey as we move toward the ultimate goal of drug discovery with patients.