The FDA previously announced their plan to hire 50 new employees specifically to manage the influx of gene therapy applications. Currently, they have approximately 800 applications awaiting review and they expect they will begin to receive 200 new applications each year by 2025. Of these, they estimate they will be able to approve 10-20 each year.
It’s clear that the dream of personalized medicine is becoming more and more of a reality. But as it does, we need to work harder to ensure it is an accessible reality for all patients.
“Providing large numbers of patients with personalized therapies requires a new digital foundation that supports the patient journey.”
A new alliance between Vineti and CareMetx should help relieve many of the burdens which could impede patient access to this novel development.
Vineti is a software platform that combines clinical data and manufacturing data to simplify the development of individualized gene therapies. It works through the development process, the regulatory approval process, and the commercialization process, to ensure each step is both safe and as efficient as possible for patients. Vineti calls their software the Personalized Therapy Management Platform. Their ultimate hope is that this platform will accelerate the filing process for gene therapies which could change patient lives.
CareMetx is an organization that provides technological hub services to pharmaceutical companies. It was co-founded by Robert Dresing, who was previously the President of the Cystic Fibrosis Foundation. He was in this position from 1984 to 1994, just at the time that gene therapy research for cystic fibrosis (CF) began. This investigation was initiated practically immediately after the CF gene was discovered, aiming to provide new options for patients as soon as possible.
Gene therapies are now growing at an exponential rate for more diseases that we could imagine. These include rare genetic diseases, sickle cell disease, various forms of inherited anemias, and many types of cancers.
CareMetx has just created a new division called OutcomeRx which has a main focus on personalized medicine. CareMetx has been working to increase patient access to novel treatment for the past 30 years. They believe their new collaboration with Vineti will enhance their contributions and advocacy efforts within the realm of personalized medicine.
A New Alliance
These companies believe that by joining their forces, they will be able to solve some of the challenges currently present within personalized medicine. These challenges surround the supply chain, accessibility of treatments, patients ability to pay for their treatments, and the monitoring of patient’s longterm health. They say they will work to combat these problems all while ensuring the safety of these new complex treatments.
The goal is to streamline the process of getting new gene therapies to the patients who need them most. In this way they hope to ease the burden for patients who are already dealing with so much. Their collaborative efforts are all patient-centered. The ultimate goal is that personalized medicine will become the norm for all patients.
The pharmaceutical industry is ever-evolving and therefore we need patient advocacy organizations to evolve in order to best support patient needs. Vineti and OutcomeRx hope that this collaboration will foster this type of support. They explain that this industry necessitates technological solutions which are as innovative as the science behind personalized medicine. They believe they can offer that.
You can read more about this new collaboration here.