Virtual Bodies For Real Drugs: In Silico Clinical Trials Are The Future | LinkedIn

Yes, a body in a chip.

Traditional clinical trials are equivalent of billions of dollars and years of hard work with no guarantee for the new drug to be approved by regulatory bodies, not to speak about the dangers of testing medication on animals and/or humans. What if we could take a radical turn? What if we conducted clinical trials on virtual bodies that could perfectly mimic human physiology? With the help of artificial intelligence, enhanced computer simulations, and advances in personalized medicine, in silico trials might be a reality in the coming years.

If possible this would be a quantum leap and sea-change for pharmaceutical companies and regulatory agencies. The magic expression is in silicon.

As technologies transform every aspect of healthcare, medicine, and the pharma industry, the monstrous clinical trial enterprise cannot be left out either. One way to modernize the testing The present testing process is applying technologies to the traditional framework, for example through online platforms to seek out participants; while an alternative way is to build a completely new setting. Human organs-on-chips and in silico trials represent the second approach. Researchers of the Wyss Institute have been working on the first strand, human organs-on-chips for years. These microdevices lined by living human cells can mimic the microarchitecture and functions of human organs, and this makes them ideal for replacing clinical testing.

In silico is the term scientists use to describe the modeling, simulation, and visualization of biological and medical processes in computers. The emergence of in silico medicine is a result of the advance of medical computer science over the last 20 years.

As technologies transform every aspect of healthcare, medicine, and the pharma industry, the monstrous clinical trial enterprise cannot be left out either. One way to modernize the drug testing process is applying technologies to the traditional framework, for example through online platforms to seek out participants; while an alternative way is to build a completely new setting. Human organs-on-chips and in silico trials represent the second approach. Researchers of the Wyss Institute have been working on the first strand, human organs-on-chips for years. These microdevices lined by living human cells can mimic the microarchitecture and functions of human organs, and this makes them ideal for replacing clinical testing.  What if these cells could be replaced by software, an artificial intelligence (a virtual body) contained in code? And what if instead of using an actual drug it could be a virtual drug, coded in software.  It sounds like a fantasy, yet so was Google, the internet, and reusable rocket boosters.   Science fiction? Not for long as these futurists predict this evolution.

Certain Phase I studies involve laboratory animals, such as mice.  There is a significant cost to maintaining libraries of genetically altered animals.

No need for lab rats in the future. Source: www.gizmodo.com

We firmly believe that drug development and new therapy experimentation will largely happen through in silico trials in the future, since who would want to test new drugs on animals or humans if we have the possibility to accurately measure the consequences of novel medications or treatment paths virtually. However, we have to mention that regulators will face a new, so far unknown challenge here: they will have to let more and more personalized, cheaper, and more efficient drugs be introduced on the market without being tested on actual humans for years.

Not only clinical trials for new drugs, this also will allow for testing of medical devices, such as cardiac pacemakers in a virtual heart simulation.

FDA Seeks Virtual Heart to Test Medical Devices
By Brandi Vincent,
Staff Correspondent,  Nextgov.com

The Food and Drug Administration is looking for computational software and services modeling the whole human heart to incorporate in a project that aims to evaluate new medical devices and therapies, according to a recently released request for information.

Through an ongoing collaborative project with French software company Dassault Systèmes, the agency hopes to demonstrate how involving computer modeling and simulation, digital evidence and a virtual patient population could potentially speed up the regulatory evaluation and approval processes through which innovative medical solutions go to market.

“We will need a physics-based computational model of a whole human heart, one that includes all critical functions of the heart: electrophysiology, solid mechanics, and fluid dynamics, including all relevant anatomical features (such as ventricles, atria and vessels),” the agency said in the program’s project brief. “The FDA intends to develop a generic medical device that will be virtually implanted in the whole human heart computational model.”

In 2014, FDA initiated its collaboration with Dassault around the company’s simulated 3D heart model, which the duo used to test pacemakers and other cardiovascular devices. Through the new project, researchers will incorporate virtual patients and testing to quicken the pace in which devices are tested and adopted.

“Integration of [virtual patient] data within the clinical trial simplification framework has the power to revolutionize how device companies conduct clinical trials, sustain this paradigm shift, and satisfy patient and provider demands for safety, efficacy and improved access,” the agency said.

Through the trial, researchers will design, manufacture and physically and virtually test a generic medical device on virtual populations and new methods will be created to combine digital evidence from the simulations to physical evidence from real patients. The objective is to receive FDA concurrence on the simulated approach, not to actually obtain approval of the device.

Ultimately, the agency aims to use digital evidence and computer modeling to tackle the delays and costs that hinder patients from trying new treatments.

“Modeling and simulation can help to inform clinical trial designs, support evidence of effectiveness, identify the most relevant patients to study, and assess product safety. In some cases, in silico clinical trials have already been shown to produce similar results as human clinical trials,” Tina Morrison, deputy director of applied mechanics in the FDA’s Center for Devices and Radiological Health, said in a statement.

Interested vendors that can offer the capability to perform whole human heart computations with virtually implanted devices using high-performance cloud-computing should submit capability statements to the FDA by Aug. 12..















Virtual Bodies For Real Drugs: In Silico Clinical Trials Are The Future | LinkedIn: www.knect365.com