Murrieta Genomics and Alliance Research Centers Partner to Bring Genomic Sequencing to Clinical TrialsMarch 26, 2019 3:22 am Comments Off on Murrieta Genomics and Alliance Research Centers Partner to Bring Genomic Sequencing to Clinical Trials
Murrieta Genomics, the genomic sequencing business incubator, has agreed with Alliance Research Centers, a comprehensive clinical research site management organization, to offer genomic sequencing services to trial sponsors and participants as an additional service.
The purpose of the service is to enable utilization of genomic sequencing data along with clinical trial information to better inform sponsors of clinical trial results while enhancing the cumulative trial information available to the industry and regulators. Recent statements from the FDA point to the possibilities of using pharmacogenomics, but stated the need to collect data for a more complete understanding of the role and utility of DNA variants in response to therapeutics.
“Pharmaceutical companies are constantly working to bring new treatments to market in the safest and most responsible way with the ultimate goal of advancing patient care,” stated Justin Deck, CEO of Alliance Research Centers. “The promise of incorporating genetic information into patients’ records will help us reduce trial costs and speed drugs to market.”
A patient’s genomic predisposition is a significant factor in the patient’s response to medication choices and dose. With the rapid development of cost-effective, massively parallel molecular genotyping methods, pharmacogenomics has become increasingly important. Pharmacogenomics can be used to identify patients with increased risk profiles that could lead to adverse effects or a decreased response at standard dosage recommendations.
By identifying the genetic risks and the most effective therapy for each patient, clinicians may improve the efficacy of treatment, select patients that are most likely to benefit from a particular treatment, and decrease the risk of adverse drug events. This will have the added benefit of reducing clinical trial timelines and cost. The cost savings of using pharmacogenomics will continue into the clinical practice better matching the patients to the treatment, thereby increasing the overall efficiency of a given treatment and reducing the chance of a costly adverse event.
There are also tremendous efforts in the pharmaceutical industry to lower the cost for drug development; pharmacogenomics may help this effort in three ways: 1) better matching the patient to the best approved drug for their genomic make up; 2) improving patient selection in trials to eliminate adverse effects, and increase the likelihood of success of large phase II and phase III clinical trials; and 3) providing broader opportunity to repurpose existing drugs for targeted therapy.
The Food and Drug Administration (FDA) stated that with more scientific study, there is great potential for pharmacogenomics to be goliath game changers in targeting optimal patient outcomes. In addition, the Agency recently released a document providing guidance to industry on enrichment strategies that can be used in clinical trials intended to demonstrate effectiveness (and in some cases safety) of human drugs and biological products. Changes made to the guidelines incorporated suggestions related to study design and analysis, specific patient populations to be studied, and genomic strategy considerations. There is so much more to learn about the use of these tests for specific medications, what the results mean, and how we can apply the information to improve a patient’s health.
“We believe that genomic sequencing will become a standard procedure in future clinical trials,” said Brandon Young, CTO of Murrieta Genomics. “Bringing Alliance Research Centers to the Murrieta Innovation Center and working together with them to advance the research into pharmacogenomics underscores our commitment to innovation and will assist our incubator companies as they begin their studies and trials.”
Murrieta Genomics has recently announced collaborative partnerships with the University of California, Riverside, Encrypgen, SeqOnce Biosciences and is working with several additional organizations to add to the scope of research and services available to its incubator clients and the several healthcare technology companies situated in the Murrieta Innovation Center.
Tags: alliance research centers, clinical trials, genomics, personalized medicine, pharmacogenomics, Precision Medicine
This post was written by mgjay