Novel Biobank Launched by MHRA (UK) and Genomics England for Better Understanding of Genetic Impact on Medication Safety

The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has made a recent announcement stating that it will be the pioneer among drug safety regulators worldwide by launching its own genetic biobank

Novel Biobank Launched by MHRA (UK) and Genomics England for Better Understanding of Genetic Impact on Medication Safety
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The MHRA and Genomics England are partnering to pilot a novel genetic research resource, namely a biobank. This initiative aims to enhance our understanding of how an individual’s genetic composition can influence the safety of their medicines.

The Yellow Card biobank, designed to store genetic data and patient samples, will operate alongside the MHRA’s Yellow Card reporting site, which handles reports of suspected side effects and adverse incidents related to medications and medical devices. This initiative is part of a larger plan aimed at implementing personalized medicine approaches.

By utilizing the wealth of genetic information stored in the biobank, scientists will be able to determine whether a particular genetic trait is responsible for a medication’s side effects. Consequently, doctors will be empowered to prescribe medications more effectively by utilizing rapid screening tests that consider patients’ genetic makeup. This innovative approach will ensure that individuals throughout the UK receive the safest and most suitable medications for their specific genetic profiles.

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Adverse drug reactions (ADRs), also known as side effects, remain a considerable challenge for the NHS, contributing to one out of every 16 hospital admissions. A deeper comprehension of the underlying mechanisms behind these adverse reactions could facilitate the advancement of pharmacogenetic testing approaches. The valuable data collected by the Yellow Card biobank would empower screening tests, aiding in the identification of potential ADRs. By employing these strategies, we can proactively prevent adverse drug reactions rather than merely reacting to them.

The biobank pilot officially commenced on June 1, 2023, and participant recruitment will begin later this year, specifically on the 1st of September. The sequencing of participants’ genetic material is scheduled to start in the spring of 2024, and the initial research findings from the pilot are expected to be published in 2025. Genomics England will provide support to the MHRA by utilizing their reliable and secure infrastructure for the sequencing and storage of genetic material.

The initial stage of the pilot phase will involve the utilization of allopurinol, a medication associated with uncommon but severe skin reactions such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Additional subjects to be addressed during this pilot phase will be announced in the future.

Patients who actively participate will be visited at home by a nurse, who will collect a blood sample for inclusion in the biobank and subsequent sequencing. The information of the participants will be anonymized and stored within a secure research platform overseen and administered by Genomics England.

Additional details regarding participation will be provided at a later time. Furthermore, individuals who have previously submitted a Yellow Card report regarding the pilot topics may receive inquiries about their willingness to participate. If a healthcare professional has submitted a report on behalf of a patient, they may be requested to assist in reaching out to the affected patient and determining their interest in involvement.

Dr. June Raine DBE, MHRA Chief Executive, said:

“We are excited by the upcoming launch of the Yellow Card biobank, which demonstrates that we are at the absolute forefront of innovation in the field of drug safety monitoring.

“Almost a third of adverse reactions to medicines could be prevented with the introduction of genetic testing.

“The biobank will help us move towards our goal of personalised medicine – which, when achieved, means patients across the UK will receive the safest medicine for them, based on their genetic makeup.

“This has the potential to transform our safety monitoring activities – enabling us to meet a real need by using high-quality patient data to reduce side effects of medicines.”

Professor Matt Brown, Chief Scientific Officer for Genomics England, said:

“We are thrilled to embark on this transformative partnership with the MHRA, as we delve into the genomics of severe adverse drug reactions.

“Many of these reactions are influenced by underlying genetic risk factors, substantially heightening an individual’s vulnerability.

“By joining forces with the MHRA, we are poised to gain greater understanding of these genetic influences – discoveries that will be vital if we are to move to harness the power of genomics to proactively protect patients from these harms.

“Together, we hope that this is the first step towards redefining the future of drug safety.”

Steve Barclay, Health and Social Care Secretary, said:

“Adverse drug reactions place a huge strain on the NHS, costing the health service over £2 billion a year – so it’s vital that we tackle this issue to help us cut waiting lists and get patients the tailored care they need.

“Developing a better understanding of our DNA can transform outcomes for patients, through improved treatments and sped-up diagnosis for conditions such as cancer and rare diseases.

“We’re backing research programmes with £175 million, like this biobank, which will harness the UK’s genomic capabilities to help patients receive safe, effective medicines.”