Human Organ Systems

How do you improve success of drug development earlier?

Overview

The number of new drugs approved to enter the market continues to decline while the cost of developing those drugs is climbing, driving up the price of using them for patients.

Capabilities Used
Biomedical Solutions

Draper’s Biomedical Solutions capability centers on the application of microsystems, miniaturized electronics, computational modeling, algorithm development and image and data analytics applied to a range of challenges in healthcare and related fields. Draper fills that critical engineering niche that is required to take research or critical requirements and prototype or manufacture realizable solutions.  Some specific examples are MEMS, microfluidics and nanostructuring applied to the development of wearable and implantable medical devices, organ-assist devices and drug-delivery systems. Novel neural interfaces for prosthetics and for treatment of neurological conditions are being realized through a combination of integrated miniaturized electronics and microfabrication technologies.

Materials Engineering & Microfabrication

Draper continues to develop its expertise in designing, characterizing and processing materials at the macro-, micro- and nanoscales. Understanding the physical properties and behaviors of materials at these various scales is vital to exploit them successfully in designing components or systems. This enables the development and integration of biomaterials, 3D printing and additive manufacturing, wafer fabrication, chemical and electrochemical materials and structural materials for application to system-level solutions required of government and commercial sponsors.

Microsystems

Draper has designed and developed microelectronic components and systems going back to the mid-1980s. Our integrated, ultra-high density (iUHD) modules of heterogeneous components feature system functionality in the smallest form factor possible through integration of commercial-off-the-shelf (COTS) technology with Draper-developed custom packaging and interconnect technology. Draper continues to pioneer custom Microelectromechanical Systems (MEMS), Application-Specific Integrated Circuits (ASICs) and custom radio frequency components for both commercial (microfluidic platforms organ assist, drug development, etc.) and government (miniaturized data collection, new sensors, Micro-sats, etc.) applications.  Draper features a complete in-house iUHD and MEMS fabrication capability and has existing relationships with many other MEMS and microelectronics fabrication facilities. 

Only one out of nine drug candidates completes human clinical trials successfully, and typically that one approved drug has to recoup development costs for the failed ones. It would be much more cost-effective to assess the likelihood to success earlier—not just before human trials, but even before beginning animal studies. 

Differences in physiology of humans and other animals limits the ability to predict accurately how safe or effective a drug will be in humans by testing it on animal models. Draper is developing a solution for the pharmaceutical industry’s 88% drug development failure rate. Called PREDICT96, this multiplexed (or high throughput) predictive model enables testing of drugs on cells from human organs and other parts of the body. Draper’s organs-on-a-chip platform uses a dynamic microscale 3D human tissue model rather than a static cell culture. 

Draper’s platform recreates human physiology in an accurate, reproducible, cost-effective and predictive format for testing candidate therapies for safety and efficacy. Used early in the drug discovery process, it should be able to identify effective drugs and ineffective ones, allowing developers to refocus resources on the strong candidates earlier and end unproductive research earlier, minimizing losses. 

PREDICT96 contains wells, seeded with cells of human tissues relevant to the drug to be tested and the disease to be treated; Draper has modeled liver, kidney and other organs and is actively modeling more. Draper also is developing disease models for various human organs. The wells are integrated into a platform incorporating Draper’s novel microfluidics pumping system, which enables flow of nutrients and drug doses to each well. 

The wells of Draper’s Human Organ Systems (HOS) platform are instrumented with sensors to collect data in real time. Draper’s sensors collect better data and more types of data than can be obtained using animal models. An example of data that cannot be collected in an animal but that PREDICT96 can provide is observation of inflammatory or immune response in real time—by watching a neutrophil (a type of white blood cell) penetrate cell or tissue barrier. 

Once programmed, Draper’s PREDICT96 can run automatically in an incubator. This will enable rapid testing of dozens of candidate compounds and early selection of the ones with the most promising results for fast-tracking for continued development. 

By identifying ineffective drugs early in the discovery process, Draper’s HOS platform will enable pharmaceutical companies to focus their R&D funding on effective drugs, saving significant amounts of time and money. Further, more-economical drug development should enable the pursuit of targeted therapies with smaller markets. 

Technical Contact
David O'Dowd