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The Wake Forest Institute for Regenerative Medicine (WFIRM) and Oracle Health Sciences have teamed as part of the Innovation Quarter's iQ Healthtech Labs™ to develop a consortium of industry, government, and academic members that will study novel approaches to establishing the safety of new drugs that are nearing clinical investigation in humans and FDA approval.

The collaboration brings together Oracle's unparalleled infrastructure for data analytics with WFIRM's Body-on-a-Chip program to provide next-generation technologies for drug development, drug candidate screening, and personalized medicine. Body-on-a-Chip is a system of miniaturized organs, also called "organoids," that can be used to detect harmful and adverse effects of drugs before they are tested in humans.

This collaboration represents a cornerstone program for the newly established iQ Healthtech Labs, a physical and virtual hub that leverages the unique, world-class intellectual anchors that exist within the Wake Forest Medical Center's Innovation Quarter and seeks to pair them with industry and commercial partners to develop breakthrough ideas. One of the key focus areas of iQ Healthtech Labs is a Personalized Care & Precision Medicine Sector, which helps develop and refine novel approaches to improve and transform healthcare through understanding drug effects at the level of the individual, rather than a one-size-fits all approach to medicine.

The vision for the program is to use WFIRM's Body-on-a-Chip technology to evaluate the toxicity of drugs across a wide range of human tissues. The data will be analyzed with advanced machine learning that is being co-developed with Oracle Labs and Oracle for Research to uncover specific characteristics of molecules that might indicate potential toxicity in humans. The platform can also be used to identify drugs that can be most effective for specific diseases, including antidotes for outbreaks such as the current COVID pandemic.

"These technologies will allow drug companies to prioritize drug candidates based upon the relative chance that a drug would be safe and effective, and can also play a significant role in the emerging field of personalized medicine," said Anthony Atala, MD, director of WFIRM. "Because our Body-on-a-Chip systems can be created from the patient's own cells, we have the ability to look at the best drug treatments for an individual's specific disease. The platform can also help to identify people with certain genetic characteristics that make them more or less sensitive to a specific drug. We are excited to join with Oracle to deliver on the promise of this new approach."

WFIRM selected Oracle because of its deep subject matter expertise and experience both in the technology and the application areas of drug development, which will make this collaboration truly powerful.

"We are honored to be a part of this extraordinary approach to clinical research and clinical care," said Steve Rosenberg, senior vice president and general manager, Oracle Health Sciences. "Together, Oracle and WFIRM will continue to push the innovation envelope in both data analytics and medical research. We recognize that the same machine learning algorithms that Oracle uses to evaluate toxicity in terms of molecular structure could also take into account the unique disease characteristics of an individual whose cells were used in creating the organoids."

"Being able to create approaches to medicine that take into account an individual's unique genetic makeup is critical in today's world of medicine," said Jane Shen, PharmD, head of sector development for the Innovation Quarter. "That's why iQ Healthtech Labs is focused on creating partnerships like this one with WFIRM and Oracle that bring together powerful leaders to advance innovative solutions."

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