Takeda’s Chinwe Ukomadu and Chris Arendt on Biopharma’s Future

What we asked: “Looking ahead to the next 5–10 years, what will be the key disruptors and/or what can be improved upon in the pharma industry?”

Response from: Chinwe Ukomadu, Head Gastrointestinal & Inflammation Therapeutic Area Unit, Takeda

“Technological advancements such as AI, next generation sequencing, CRISPR and other gene editing technologies have revolutionized drug discovery and development, with global industry and academia collaborations fueling the engine of innovation. Accompanying regulatory shifts (breakthrough and orphan drug designations) have helped streamline the drug approval process. These innovations have led to great strides in deciphering the inner workings of the immune system, highlighting the potential for immune modulation to treat an array of diseases from cancer to countless chronic inflammatory diseases. With all of these advances in science and technology, we cannot forget that patients are at the center of all that we do. We must strive to translate these advances into real benefit for all patients.

“Looking ahead, I foresee a future where biopharma continues to leverage common immunological pathways to address indications in which chronic inflammation is the underlying pathophysiology, positioning us to benefit many more patients. For this to happen, patient voice, experience, and representation will be key, driving us to re-imagine trial design, partly by incorporating novel digital tools and endpoints to pave the way for more decentralized clinical trials and generating data that is relevant to regulators, physicians, and patients. Representation in clinical research will be a pillar of increasing importance for the industry given the updated regulatory guidance and improved understanding of disease state demographics.

“By ensuring participation of diverse populations, we as an industry can enhance the generalizability of our research findings, address health disparities, and most importantly, develop safer and more effective treatments for all patients.”

Response from: Chris Arendt, Chief Scientific Officer and Head of Research, Takeda

“The integration of AI and ML technologies stands to dramatically transform the biopharma industry. Iterative in silico learning systems that benefit from large training datasets and that integrate wet lab validation experiments are starting to deliver significant gains in the quality and speed of target identification, hit finding, and candidate optimization. The preclinical proof-points are encouraging, and the hope is that these strides translate into higher quality clinical candidates delivered more quickly to the patients who can most benefit.

“On the development front, generative AI-based tools may evolve to being able to support patients and practitioners in navigating treatment algorithms and clinical trials. Ensuring that patient genetics, medical histories, and symptoms are weighed against all available clinical study data and real-world evidence could provide optimized, personalized treatment algorithms. Promising clinical trials could also be flagged on a personalized basis based on totality of evidence, including the mechanism of action of the investigational agent and the knowledge base around the relevant disease subtype. Management of privacy and consent will be critical to the integrity of these approaches.

“We may not be far from a future where AI and ML can assist patients and physicians in predicting and managing health outcomes prior to disease inception, as well as in the early stages of disease. The ability to integrate massive real-world datasets with real-time health monitoring and diagnostics holds exciting potential. To really move the needle on human health, we need to develop and deliver medicines much closer to disease inception, when the biology is at its most malleable.”

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