In a dozen years since the completion of the Human Genome Project, the healthcare industry is moving rapidly to develop treatments that can be tailored to the unique genetic code of each patient. One catalyst for this transformation to personalized treatment is the Next Generation Sequencing (NGS) systems. The first human genome sequenced cost US $3B and took 13 years to complete[1]. Today, sequencing a single human genome costs about US $1,000 and takes less than a day. NGS is now attainable for many organizations, resulting in an abundance of data.
According to the 2015 Progress Report[2] issued by the Personalized Medicine Coalition, 45 novel new drugs (NNDs) approved by FDA’s Center for Drug Evaluation and Research in 2015 were either new molecular entities or new therapeutic biologics. Of the 45 NNDs, 28 percent were classified as personalized medicine, a nearly 50 percent increase year-over-year. 5 of these personalized NNDs are oncology targeted, representing 35 percent of all NNDs for oncology approved in 2015. With these and future NNDs, doctors will soon be able to customize treatments – for cancers, cholesterol, schizophrenia and more – based on the status of a patient’s biomarkers e.g. ALK, EGFR, CYP2D6, et al.
The march to personalized medicine is quickening due to: government initiatives; industry collaborations; and innovations in big data, analytics, and infrastructure technologies.
A new era of initiatives, collaborations, and technologies
Government agencies are funding large scale genome projects with the end goals of creating more effective drugs and therapies that will benefit the population as a whole. For instance, The 100,000 Genomes Project at Genomics England, a wholly owned company of the Department of Health in the UK, will analyze 100,000 genomes of 70,000 participants from across the country. Another example is the Qatar Genome Project with the support of the Qatar government and Sidra Medical.
Besides these large scale government projects, pharmaceuticals and non-pharmaceuticals like Nestle are actively engaged in genomics research. With the cost of developing a new drugs and therapies now estimated at US $2.5B, pharmaceuticals, healthcare providers, and other 3rd parties are partnering to save money, to accelerate innovation, and to lower risk.
- A shrinking pool of potential drug and diagnostic targets are requiring a focus on disease areas that are increasingly rare and/or complex.
- Completion of clinical trials are being hampered by a larger number of patient eligibility requirements; and a more stringent regulatory environment threatens to delay the drug approval process.
- Shifting models of medication access and reimbursement, combined with shorter periods of data exclusivity and intellectual property protection, are leaving these organizations uncertain that they will recoup their investments successfully.
As such, collaborative efforts are currently underway to accelerate innovation and shorten R&D timelines.
A new UK project called Advanced Digital Design of Pharmaceutical Therapeutics (ADDoPT), is one such collaboration among leading universities, government agencies and pharmaceuticals to simplify and streamline development of tools and methodologies for targeted patient groups, grouped by genomic analysis.
IBM’s role in accelerating discovery
Vendors including IBM have a role to play in facilitating innovation. In addition to advancing cognitive healthcare with Watson and investments in open source initiatives such as Spark, IBM is partnering with leading healthcare providers to address the IT challenges faced by researchers, clinicians, and healthcare providers. To enable researchers and providers to their tools of choice including open source and cognitive applications, IBM developed the IBM Reference Architecture for Genomics. This architecture as well as IBM software defined offerings will help organizations design a high performance, open eco-system for sequencing, translational research and genomics medicine.
Part 2 of this blog will provide more detailed examples of collaborations, technologies and how IBM’s role in this industry wide transformation to personalized medicine.
Come visit IBM at HIMSS16, Booth #5932 to learn more about IBM’s Real World Evidence solutions and IBM’s role in genomic medicine.
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[1]http://openpowerfoundation.org/blogs/imperial-college-london-and-ibm-join-forces-to-accelerate-personalized-medicine-research-within-the-openpower-ecosystem/
This blog is authored by Jeff Hong (Global Industry Marketing Lead, Software Defined Infrastructure, IBM Systems) and Jane Yu (IBM Worldwide Industry Architect, Healthcare & Life Sciences)