The billion-dollar market beckons! BeiGene and AstraZeneca have joined the fray

In recent years, with the widespread application of artificial intelligence and digital technology in various industries, the fields of life sciences and healthcare have also begun to undergo profound changes.

Especially in the critical stages of clinical research and drug development, the introduction of AI and digital technology is believed to have enormous potential to reshape the entire industry.

Not long ago, BeiGene's spin-off of a CRO company attracted widespread attention in the industry.

According to its official website, this company named PiHealth mainly provides digital clinical CRO services, integrating advanced analytics and software solutions into drug, diagnostic, and clinical processes.

Following BeiGene's independence, PiHealth announced securing $30 million in Series A funding, led by AlleyCorp and ObviousVentures, with additional investments from InvusCapital and leading global oncology enterprises.

In a similar move, AstraZeneca has also launched the clinical CRO brand Evinova, using artificial intelligence and digital software for clinical development.

BeiGene - PiHealth

BeiGene, as a leading global biopharmaceutical company, has been seeking to enhance the efficiency and quality of its clinical research.

By establishing its own clinical team and advancing global operations, BeiGene not only ensures the initiative and pace of research but also improves communication efficiency and research quality.

Currently, BeiGene's clinical development team has over 3,000 members, conducting approximately 140 clinical projects spanning 48 countries and regions.

With trial sites worldwide, to ensure the collection of clinical data and documents, including the needs for analysis, BeiGene internally began to seek "innovative solutions," including helping increase patient enrollment in cancer trials during the pandemic.

PiHealth's founder and CEO, Geoffrey Kim, was formerly Vice President of Applied Innovation at BeiGene. Geoffrey previously served as Vice President of Oncology Regulatory Science and Strategy at AstraZeneca.

Another co-founder and Chief Operating Officer, Dr. Bobby Reddy, is a dermatologist and former Head of Oncology Regulatory Science and Innovation at AstraZeneca.

In 2021, Geoffrey Kim, Vice President of Applied Innovation at BeiGene, established an innovation team that pioneered methods for integrating different datasets and advancing pipelines through data analysis and strategic development, laying the groundwork for PiHealth's establishment by inventing the FICS technology platform.

As the team grew, BeiGene's digital technology not only served internally but also extended outward. At this point, becoming independent not only reduced financial pressure internally but also ensured customer confidence in data security.

This effort ultimately led to the establishment of PiHealth, becoming an integral part of BeiGene's "de-CRO-ization" strategy.

PiHealth's core advantage lies in its frontend interoperable capture software (FICS), which not only enables data connectivity at PiHealth sites during trials but also utilizes artificial intelligence and machine learning to optimize clinical trial behaviors.

AstraZeneca - Evinova

In November 2023, the globally renowned biopharmaceutical company AstraZeneca announced the official launch of its new global health technology division - Evinova.

This newly established department is dedicated to significantly reducing the time and cost of drug development, improving patient care experiences, alleviating the burden on global healthcare systems, and ultimately enhancing treatment outcomes through innovative digital medical solutions.

Evinova will provide comprehensive services to pharmaceutical companies, biotechnology firms, and CRO companies, covering three major areas: trial solutions, research design and planning, and pipeline asset management.

Through these services, Evinova aims to drive the digital transformation of clinical trials, optimize trial designs, and improve the efficiency and success rate of drug development.

In terms of trial solutions, Evinova can collect clinical trial data, including primary and secondary endpoints, not only from traditional trial sites but also from patients' homes using networked medical devices and sensors.

Evinova's technology platform supports remote medical services, remote patient monitoring, and direct drug delivery to patients, enhancing the flexibility and accessibility of clinical trials.

As an independent business entity within AstraZeneca, Evinova will be led by Cristina Duran, AstraZeneca's current Global Chief Digital Health Officer.

Duran stated that the establishment of Evinova aims to bring AstraZeneca's achievements in digital health technology, including the application of artificial intelligence, to the entire industry and drive the development of the digital health field. She emphasized that unified industry solutions are more effective in advancing the progress of the entire medical and healthcare industry than individual efforts.

Evinova has established strategic partnerships with leading global CRO companies Parexel and Fortrea to jointly provide digital solutions.

These solutions, collectively referred to as the "Evinova Drug Development Suite," comprise a combination of various digital applications designed to provide virtual access and remote patient monitoring services.

The suite can be used in 40 countries and regions, supporting 80 languages, greatly enhancing the globalization and localization capabilities of clinical trials. By using historical data to predict trial trends, feasibility, and costs, Evinova can provide customers with more accurate and efficient clinical research management services.

Conclusion

AI CRO combines the powerful data processing capabilities of artificial intelligence with the specialized clinical research experience of CRO, aiming to improve the efficiency and quality of drug development, reduce costs, and accelerate the process of bringing new drugs to market.

Through automation and intelligent tools, AI CRO can optimize clinical trial designs, expedite data collection and analysis, enhance data accuracy, and support the development of personalized medicine.

However, AI CRO also faces a series of challenges, including ensuring data security and patient privacy, dealing with the complexity of large-scale datasets, and ensuring transparency and interpretability of AI algorithms. A balance must be struck between technological innovation and regulatory compliance to ensure the ethical and reasonable use of technology.