The Paradigm for Precision Medicine Pipeline

The Paradigm for Precision Medicine Pipeline

Healthcare Tech Outlook | Tuesday, September 20, 2022

Precision medicine has a limited influence due to technological, ethical, and regulatory obstacles.

FREMONT, CA: A new Brookings Institution paper examines how flexible governance may support innovation in precision medicine while safeguarding the public from unforeseen consequences. Personal information, such as DNA sequences, is utilized by precision medicine to prevent, diagnose, and cure disease. This can bring significant issues, such as the privacy of genomic data, the design of clinical trials, and equitable drug delivery. The paper includes global case studies illustrating how governments, businesses, and other stakeholders utilize agile governance procedures in healthcare and asks what the implications could be for precision medicine.

Innovations in technology can fast surpass laws and regulations. This dilemma is referred to as the "pacing problem" and presents particular challenges for governments attempting to develop advanced technologies while ensuring that dangers are addressed with the appropriate policies. Precision medicine has proven susceptible to the "pacing problem,"; yet, nimble governance could aid in its utilization for the public good.

Precision medicine can be compared to a pipeline, extending from laboratory research and development to hospital patient care.

Data acquisition and storage: Health discoveries are made based on large genetic data sets, and individualized therapies are produced. However, the acquisition and storage of personal information are laden with ethical considerations. Some indigenous communities, for instance, expressed concerns over data protection and ownership in the All of Us study program. Agile governance techniques could contribute to developing dynamic systems and infrastructure that allow indigenous people to retain ownership of their genetic information while benefiting from corporate innovation.

Access to information and research: Understanding how genetic material is obtained and anticipating how it may be utilized in domestic and international research is essential for developing effective regulatory frameworks to protect human rights and individual privacy. For instance, the UK's Human Fertilisation & Embryology Authority conducts horizon scanning exercises to predict how precision medicine techniques may impact the future of reproduction within and beyond the UK.

Modernizing clinical trials: Precision medicine is an effective method for treating uncommon diseases, but tiny patient groups can make designing and conducting clinical trials challenging. Decentralized Trials Research Alliance and other industry-led alliances are revolutionizing the conduct of international clinical trials.

Societal advantage: The costly cost of precision medicine treatments, particularly cell and gene therapies, can limit their social use. The Center for Medicare and Medicaid Innovation in the US collaborates with states to enhance access to life-saving treatments to test innovative healthcare payment structures.

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