The Art and Science of Making New Medicines

Our Approach to Patient-Focused Drug Development

For most of the history of modern drug development, patients have not been given the opportunity to take an active role in the clinical design and implementation process. In fact, there was a time when it was unheard of for patients to be part of the process of designing a clinical study or defining a drug development strategy. But today, it is imperative patients have a voice.

At Daiichi Sankyo, we are invested in addressing complex challenges across the clinical trial process, given that only approximately 1 in 10 potential medicines that enter phase 1 clinical testing are ultimately approved by the U.S. Food and Drug Administration and make it to patients. We focus intensely on patient recruitment, enrollment and trial retention, to ensure these aspects of the development process do not potentially hinder the promising medicines we are developing from reaching patients.

Our efforts are part of a growing and vital movement to ensure patients are given a more central and proactive role in managing their own healthcare, and with “Compassion for Patients” at our core, we carefully ponder key questions before we embark on a new trial. Is our study design inadvertently creating barriers to patient access or continuing care? If so, how can we adjust or what else can we offer to help educate, enroll and retain patients?

Engaging patients in conversation about these questions is crucial. My colleague Morgan Bowling, PharmD, Manager, Scientific Engagement, Global Oncology Medical Affairs put it well. “As scientists, we follow the data – and there is certainly no shortage of census data and other literature to guide us,” Morgan says. “However, all those data only tell part of the story about those living with the disease. We need the patients we’re developing the medicine for to fill in the blanks, and to help us understand the patient experience in the way the numbers can’t. If we don’t do this, we run the risk of inadvertently boxing patients out of a study, when our goal is to bring them in.”

How We Connect with Patients

We believe drug development is a fusion of art and science. With purpose and rigor, we develop life-changing solutions for the patients of today and tomorrow. We unite cutting-edge technology and science with an unwavering passion for engaging patients. We use the art of conversation with our people, scientists, health care providers and advocates to unearth important truths that exist for patients and caregivers, understanding experiences with cancer and other diseases are not “one-size fits all.”

The opportunities to connect with the community through conversation are everywhere:

• Patient Speakers – we invite patients in to share their stories with us, and recently launched an initiative known as “In Their Shoes” to offer our employees opportunities to immerse themselves in the patient experience (Read More HERE)
• Patient-Provider Exchange – patients and providers invite Daiichi Sankyo in to listen to their discussions
• Advisory Boards – we convene with patients, and the advocacy groups representing them, to seek advice and counsel on unmet needs
• Community Conferences & Events – we “show up” whenever there is an opportunity for our team to engage with the community in natural, informal settings where they are already gathering

Through these conversations – which we ensure happen early, often and with regularity – we receive valuable patient and caregiver input that informs our research and clinical trial design.

Putting Our Words Into Action

It doesn't end there: we turn the knowledge gained from patients, caregivers and patient advocacy groups into action. Since we’ve formalized our approach to blending the art of conversation into the science of drug development, we’ve introduced:

• A more formalized process to weave learnings into the development of trial protocols
• Efforts to diversify and decentralize clinical trials, meaning that we identify clinical trial sites in the communities that represent the diverse patients that we serve to ensure trial participation does not present a hardship
• A feedback loop with our advocacy partners, so they have a sense of how and what they and their patients share is being put to use

These conversations have tangible impact on our work. They allow us to better serve patients and make us stronger as an organization. We believe the blending of art and science is key to charting the future of drug development, as we develop innovative solutions for people in need and make sure that the patient voice is heard.