Andy Plump (left)
President, Research & Development
Mwana Lugogo (right)
Chief Ethics & Compliance Officer
Q: How is Takeda’s approach to R&D unique to your company?
Andy: Our team is incredibly agile in their work, which is critical to keeping up with the breakneck speed of science. New modalities like cell and gene therapy offer transformative — or even curative — potential, and we’ve made more substantive and long-term investments in these areas. Through artificial intelligence and machine learning, our scientists are improving and accelerating medicines discovery and development to deliver treatments to patients faster. This agility is present in our R&D, but also in how we work. The R&D team works hand-in-hand with our partners to make quick decisions — either investing to accelerate a promising asset or stopping programs when needed. The agility and dedication of our people is what has helped build our pipeline and position Takeda for the future.
The TEAC was established in recognition of the fast pace of innovation in science and medicine and emerging ethical challenges. It is comprised of a diverse group of professionals that include prominent external ethics experts and selected Takeda leaders. The primary responsibility of the TEAC is to consider emerging ethics topics and provide advice; informing Takeda’s development of robust and principled positions and guidance on these issues.
Mwana: Takeda is committed to be a leader in scientific innovation and in the discovery and development of novel therapies that address significant unmet medical needs. We conduct research that is responsive to the needs and priorities of a broad range of stakeholders and strive to maintain the highest standards of ethics and integrity. While the fast pace of innovation in science and medicine and use of novel technologies provide significant opportunities to develop new approaches to the treatment of debilitating illness, there are conflicting views in society regarding the use of technologies. As technology advances, so must our understanding of ethical considerations. Takeda must consider diverse views and evolving ethical and social concerns when applying new advances in R&D, including supplementing internal reviews with active participation in external forums that encourage science-based policies and serve the public interest.
Q: How are new technologies impacting the way Takeda approaches innovation?
Andy: A promising area of our R&D portfolio is within our orexin type 2 receptor agonist franchise. Orexin is a molecule in the brain that helps regulate sleep. The destruction of neurons that produce orexin is the underlying cause of narcolepsy type 1, a rare chronic sleep disorder characterized by excessive daytime sleepiness (EDS) and cataplexy, a sudden loss of voluntary muscle tone triggered by strong emotions. We’re leading the industry in orexin biology innovation with the discovery of the first-ever, selective small molecule orexin-2 receptor (OX2R) agonists to enter clinical trials. OX2R agonists have the potential to revolutionize Narcolepsy Type 1 treatment by addressing the underlying disease pathophysiology, and based on Takeda’s early clinical results, may provide therapeutic benefits for other disorders characterized by excessive daytime sleepiness. As these and other orexin programs advance, we have an opportunity to deliver a franchise of new medicines that could benefit patients around the world with a variety of sleep disorders.
Mwana: Data obtained during clinical research are fundamental to advancing the field of medicine. While data from clinical research, mainly randomized controlled trials (RCTs), traditionally form the basis for regulatory approvals of new medicines, new frontiers in data sources, analytics and collaborative research are changing the face of modern clinical development. This is being complemented by pharmaceutical and life sciences companies with multiple data points. Data analytics reveal patterns and correlations to generate new insights that can be used to improve treatment and research decisions, productivity and scientific understanding during drug development. As Takeda participates in this burgeoning new secondary use of data ecosystem, we recognize our responsibility to share data that can contribute to scientific understanding by the broader scientific community and spur new treatments for patients. Equally, we recognize the need to use and share data in a way that protects the privacy of individuals by being transparent about how the data will be shared and used. We also make sure to honor their confidentiality if we reuse the data, including using specific de-identification techniques that minimize the risk of re-identification.
Q: How does Takeda make sure you responsibly innovate as a company?
Andy: Responsible innovation is at the core of everything we do. As we advance our research to develop and deliver new treatments to patients, we continually consider how our work affects patients, their families, society, the planet and Takeda in a comprehensible manner. We continually evaluate ethical questions related to advances in science and patient confidentiality in our research. Most importantly, we put patients at the center of our research, moving from developing medicines for patients to developing medicines with patients. We partner with patients and patient organizations throughout the medicine development process to continually sense-check our approach and inform our decision-making, which in turn allows us to focus on the needs of the patients we are honored to serve.
Mwana: We work hard to translate Takeda’s ethical aspirations into action. We proactively deliberate on ethics issues relevant to Takeda’s global enterprise, such as those that advance science and medicine, confidentiality and privacy, protection of human and animal participants in research, and data sharing and secondary use of data. We develop company principle and ethical frameworks to inform decisions and actions throughout our organization.