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Impact of Precision Medicine and Genomics on Patient Treatment
Posted on August 26th, 2016 by Dr. Makarand Jawadekar, Ph.D in Chemistry
In January of 2015, President Barack Obama launched the Precision Medicine Initiative, which brought to the forefront the growing understanding and need for individually tailored and customized treatments for patients.
Historically, drugs have been prescribed to the masses without taking into account the patient’s genetic make-up. But now, with the advances in technology and understanding of the genome sequence, scientists and the general public are coming to the agreement that new sources of data, such as genetics, should also be utilized when developing and determining case-by-case treatment. Also, since the cost of goods of each dose of a new biologic entity (NBE) has escalated to ever-higher levels, the need for precision, customization and value generation has grown in the eyes of consumers, patients and payers. One cannot fathom prescribing expensive monoclonal antibodies to a ‘non-responder’ patient population. Also, a need for having some sort of tool which can do companion diagnostics (CDx) has certainly emerged as a ‘must’ rather than a ‘high want’.
So how does this emerging trend affect pharmaceuticals and medicine in developing pre-clinical candidates for further development? Under the umbrella of precision medicine is pharmacogenomics, the science of how genes affect patients’ responses to drugs. There is also the study of how specific genes are correlated with specific diseases. As more data are collected about the human genome, more insights can be drawn about how genes are related to disease and drug response. And as a result, adverse events can foreseeably decrease, patient outcomes can improve and pharmaceutical companies can gain a better understanding about whom to recruit for their early-stage safety studies, proof-of-concept and late-stage efficacy study clinical trials.
As it relates to pharmaceuticals, genomic data can also be used to power drug research and development in identifying potential drug candidates. A good example of this is the San Diego-based company Illumina, and how it sells multi-million-dollar DNA-sequencing machines to drug researchers. These machines can sequence an individual’s genome in less than 24 hours, identifying specific mutations while providing information about potential drug candidates that can block the mechanisms of mutations that are causing a disease (1).
For the past few years, a startup named Global Gene Corp has also been on the mission of improving clinical understanding. This Singapore-based company collects and analyzes patients’ genomic information. The company’s end goal is to empower physicians, doctors who are prescribers, providers, and pharmaceutical companies with this data, enabling them to make more informed decisions in the development and applications of new therapies. Boasting what is now one of India’s biggest stores of genetic information, Global Gene Corp has the leverage to provide this data to other companies at a premium cost (2). Their motto is “Transforming preventive healthcare through genetics”.
In addition, the new CRISPR technique (Clustered Regularly Interspaced Short Palindromic Repeats), among other gene therapies, uses genomics to target and edit out mutated DNA. For diseases ranging from cystic fibrosis to cancer, this technique has the potential to target and remove the genes that are found to cause the illness. According to Craig Venter, co-founder of DNA sequencing company Human Longevity Inc., “We are learning that we are DNA software driven species, and that your software determines everything about your life, including how long you are going to live” (3). It’s a very interesting way to think about how we prevent getting sick to begin with and also build up the immune system to fight any potential known or unknown pathogens (including microbial and/or viral) from causing any reversible or irreversible damage.
With genomics, medicine has been equipped with a new source of knowledge to identify and help cure certain disease areas. It also offers hope to create ‘first in class’ as well as ‘best in class’ therapies for extending human life, with higher quality of life. This offers a wide and deep amount of potential for the development and applications of new therapeutics for humankind.
Enable better understanding of biological processes underlying disease progression and treatment response with Pathway Studio.
All opinions shared in this post are the author’s own.
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Dr. Makarand Jawadekar, Ph.D
Independent Pharma Professional
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