The integration of emerging omics approaches to advance precision medicine: How can regulatory science help?

Abstract

Building on the recent advances in next-generation sequencing, the integration of genomics, proteomics, metabolomics, and other approaches hold tremendous promise for precision medicine. The approval and adoption of these rapidly advancing technologies and methods presents several regulatory science considerations that need to be addressed. To better understand and address these regulatory science issues, a Clinical and Translational Science Award Working Group convened the Regulatory Science to Advance Precision Medicine Forum. The Forum identified an initial set of regulatory science gaps. The final set of key findings and recommendations provided here address issues related to the lack of standardization of complex tests, preclinical issues, establishing clinical validity and utility, pharmacogenomics considerations, and knowledge gaps.

Tackling the translational challenges of multi-omics research in the realm of European personalised medicine: A workshop report

“…Additionally, general concerns around data privacy and regulatory compliance-related restrictions as well as ethical and legal aspects must not be overlooked. When working with multi-omics and/or clinical data there are multiple data security, ethical, and personal information barriers that can present potential roadblocks ( Knowles et al, 2017 ; Adamo et al, 2018 ; Adamo et al, 2020 ). Moreover, each European country has its own national implementations of General Data Protection Regulation (GDPR) for processing personal data ( Vlahou et al, 2021 ).…”

“…Although the outcomes of such initiatives are undoubtably useful and have an impact in PM development and implementation, rapid development also requires fast and flexible ethical, legal and regulatory policy making as well as tackling some technical challenges ( Adamo et al, 2018 ; Misra et al, 2019 ). To support healthcare providers and patients with new tools, it is crucial to facilitate data access, pilot studies for PM, and incorporate learned lessons into future policymaking.…”

Regulatory science

“…The diagnostic tests and therapeutic products emerging through such a complex pathway can pose a greater regulatory challenge. So, understanding the gaps in the areas of standardization of such a complex test, pre-clinical assessment procedure, reviewing clinical utility and validity as well as post-marketing surveillance need regulatory science/research input 8 . Though the challenges are great, these gaps in knowledge and understanding can be bridged by development of goal-oriented collaboration among academia, industry and regulators 9 .…”

“…The large patient population in India can be utilized as a huge clinical and biological resource following ethical guidelines, empowering translational research and product development. Although complete harmonization of all biobanks in India may not be possible, initiative may be taken to develop few major biobanks in different parts of India with well-documented uniform quality-controlled processes of sample collection, processing, analysis and preservation 8 . The Genomics for Understanding Rare Diseases: India Alliance Network (GUaRDIAN) is a good example of the effort of academic institutions in research with translational capability in molecular diagnosis 10 .…”

A Quantitative Framework for Measuring Personalized Medicine Integration into US Healthcare Delivery Organizations

“…A better understanding of the molecular drivers of disease, coupled with the rapidly improving logistics and economics of genetic and genomic testing, has elevated the quality of care provided in a number of clinical areas. These approaches can improve clinical outcomes and reduce costs [ 1 ]. Yet, while research and innovation in personalized medicine (PM), also commonly referred to as “precision medicine,” is surging, its adoption into clinical practice has been comparatively slow.…”