Genomics: The Promised Land of Breakthroughs for Pharma
Source: Genetic Literary Project
Pharma’s breakthroughs have been scarce of late. A good portion of clinical trials on new medicines fail and current drugs don’t work equally well in all patients living with the same condition. The reason underlying both facts is that regardless of how well a drug does in pre-clinical experiments or clinical trials, once it is given to the widely genetically variable population, it does not stand up to the challenge. Naturally, health researchers from both academic and industrial settings have seen the root of the problem and are taking action to remedy the situation. Life science companies are increasingly participating in large scale genome-wide association (GWA) studies, but does the study of the human genome hold the key to innovative treatments?
Let’s get personal
It might be hard to imagine moving from the “one size fits all” medication to a drug that is perfectly tailored to each patient’s needs based on their genotypic intricacies. The good news is that we know how to do this. In 2009, it was shown that a genetic variation in one of the genes encoding for interferon (a group of signaling proteins made and released by host cells in response to viruses) affected the clearance of hepatitis c virus (HCV) infection and the response of patients who carried the variation to treatments. After several independent replications of the same result, the European Association of the Study of the Liver (EASL) and the American Association for the Study of Liver Diseases (AASLD) recommend testing for this genetic variation to assist in deciding the treatment regime of patients with the HCV. This is one real-world example that brings us closer to understanding why not every drug is good for every patient.
United we stand
Some countries have taken initiative and are organising GWA studies with the assistance of universities, hospitals and biobanks. The first study of unprecedented magnitude is the UK Biobank project, initiated in 2006 with the purpose of building the largest open-access resource of health, lifestyle and biological data from 500,000 volunteers. Having collected a massive number of donor DNA samples that need to be sequenced, in 2017 GSK together with Regeneron Genetics Center took over this part of the UK Biobank project. At the beginning of 2018, Regeneron announced that to complete the DNA sequencing sooner, they formed a “pre-competitive” consortium with another 5 collaborators (AbbVie, Alnylam Pharmaceuticals, AstraZeneca, Biogen and Pfizer Inc.), each of which will commit $10 million for the cause.
The UK Biobank project has already led to dozens of publications on the peculiarities of the human genome in respect to various diseases such as peripheral artery disease, breast cancer, cardiovascular disease, and dementia. Furthermore, the data from the UK Biobank can be used to inform on the efficacy and side-effects of drugs currently prescribed to patients. It is only a matter of time before one of these studies translates into a drug that targets a certain group of patients, or even into a diagnostic marker that will help discriminate the various patient groups that respond differently to the same treatment.
For the more recent FinnGen study, launched in Finland in 2017, the participation of the pharmaceutical industry has been even more extensive. The FinnGen study is funded by Business Finland (a public funding agency) and no less than 9 international pharmaceutical companies: Abbvie, AstraZeneca, Biogen, Celgene, Genentech, GSK, Merck & Co., Pfizer and Sanofi. This study is similar to the UK Biobank, but data is gathered from people living with medical conditions, as opposed to the UK Biobank that includes healthy volunteers. An important factor in both studies is that the data can be accessed by scientists to perform further analyses. Harnessing the global network of health-related research and putting as much brain power as possible into this effort can only speed up the journey to personalised medicine.
Perspectives and challenges
Although action is being taken towards pharma utilising genomic data to manufacture personalised medication, the project is still in its infancy and its future is likely to hold many challenges. Even when the complete genomic data for either the UK Biobank or the FinnGen projects are available, it will take several years before researchers return findings that can be utilised by pharma for personalised medicine. Also, experts suggest caution when it comes to storing and distributing the massive amount of data these studies will generate.
Based on the increasing participation of pharma in GWA studies, it is clear the industry is willing to take on the challenge. In fact, in 2016 over 60% of the GSK drug discovery programs were based on human genetic evidence. The expectations of pharma from GWA studies are high, based on their increasing participation and initiatives to accelerate certain pipelines on their own expenses. Undoubtedly, developing drugs that target an individual patient’s needs will have tremendous benefits for the patients themselves and will allow societies all over the world to reduce healthcare expenses. In January 2018, the vice president of AstraZeneca, in one of the company’s press releases regarding the FinnGen project, said “…we believe [the power of genomics] will help transform the discovery and development of innovative new precision medicines.”