The huge potential of the human genome to reshape drug discovery could be at risk if the life sciences sector fails to manage genomic data effectively. According to Driving value from genomics in life sciences, a new report from KPMG International, companies are facing increasing pressure to meet strict regulations and verify trial and treatment results.
Commenting on the report, Professor Hilary Thomas, Chief Medical Adviser for KPMG, says:
“Genomic data is a vital tool to move the industry from blockbusters to niche busters by leading the drive to personalized medicine. It can speed up clinical trials, improve patient outcomes and cut the cost of care. But with so much data in circulation, companies may struggle to keep it private, secure and reliable.”
As the report observes, there’s been an explosion in genomic data. The exponential growth in computing power and in wearable technologies like smartphones, fitness trackers and heart rate monitors is generating enormous amounts of information. This trend has also brought many new players onto the scene.
Says Professor Thomas:
“Life sciences companies can’t go it alone. Data is available from an expanding range of sources and working collaboratively with biobanks, genetic analysts, laboratories, hospitals, genetic testing services, governments and academia will be increasingly important. But, as more and more parties become involved with data, it’s harder to stay in control.”
KPMG’s report notes that, while data sharing brings many benefits, it also has a dark side for life sciences, in the form of challenging privacy requirements – like the GDPR – and cyber security risks, which often delay research, lowering return on investment and damaging the brand.
According to KPMG’s Professor Thomas:
“We’ve seen cases where clinical trial results have been questioned due to unreliable data. This can be enormously costly and damaging to the company concerned. With more parties involved in the clinical trial process, the chance of data being falsified or tampered with increases significantly. And with companies looking further afield for real-world evidence, any security weaknesses could see potentially corrupted data undermine the veracity of clinical trial results.”
To speed up the pace of innovation, research teams should address the commercial, regulatory, technological and ethical challenges of getting new products to market quicker. All life sciences companies need to keep data safe, secure and reliable. KPMG has identified five pillars of a robust genomic data strategy, which can enable R&D teams to become more fleet of foot in discovering and taking forward new drugs:
Groundbreaking innovations like blockchain can standardize trials and speed up drug development. While novel developments such as data centers in the sea could be a cheap solution to data storage.
Professor Thomas concludes:
“These exciting advances may grab the headlines, but data governance is the real cornerstone of a robust genomic data strategy. Every life sciences company should appoint a Data Protection Officer to oversee genomic data. The race for new products is fierce, but you can’t hope to win if you don’t have accurate and credible clinical trial data.”
Driving value from genomics in Life Sciences takes an in-depth look at how life sciences companies can gather, store, analyze and use genomic data effectively, to accelerate clinical trials, improve treatment regimens and demonstrate drug efficacy. It discusses ongoing challenges of data privacy, reliability and security. The report features expert input from a number of highly experienced KPMG member firm professionals, along with a number of case studies and third-party research.