Difficulties in the Development of Precision Medicine

Difficulties in the Development of Precision Medicine

Healthcare Tech Outlook | Tuesday, September 29, 2020

Attaining precision medicine will require skilled management of several complexities associated with it.

FREMONT, CA: Precision medicine is a young and growing field in healthcare. Many of the technologies required to meet the goals of the precision medicine Initiative are in the early stages of development. To date, precision medicine has accomplished many achievements and will help drive a dramatic revolution in the medical community's clinical practices. Even though precision medicine is introducing a new era of significance in medicine, attaining precision medicine is an ambitious objective that is bound to encounter some challenges. Know more here.

Top 10 Genetic Diagnostics Companies - 2020The stage might be set for personalized healthcare to dramatically transform public health. But transitioning from the one-cure-fits-all treatment model to new processes that leverage patients' genetics, lifestyles, and risk factors is a huge task that presents hurdles in both the laboratory and the clinic. The foremost among these is the cost associated with genomic sequencing and the use of companion diagnostic devices. Lack of expertise is another obstacle. Many clinicians may struggle to accurately interpret test results without specialist assistance – a major cost driver for clinics trying to build up-to-date teams with the newest tests.

In clinical research and development, companion diagnostics don't come cheap. Finding and validating biomarkers to navigate targeted therapies is a lengthy task, and analyzing vast data often requires new teams with specialized knowledge. The expense of incorporating new processes into innovative trial designs impacts the list price of personalized drugs that win approval. The complexity of providing sufficient evidence of safety and efficacy can also bring issues where current regulations struggle to accommodate personalized medicine innovations. Personalized medicine developers demand better guidance on designing a successful clinical trial for personalized therapy because absent guidance risk presents suboptimal evidence regarding stratification options.

There is still a long way to go before healthcare can wave goodbye to the blanket drug development that has dominated modern healthcare for decades. Only a sustained and holistic push from regulators, drug developers, clinicians, and governments will be enough to bring precision medicine over the line.

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