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Monday, November 6, 2017

Novel Drug Delivery Device for Inner Ear Disorders Heads to Preclinical Test, Prompts Formation of Industry Consortium

Draper, CILcare and CBSET invite partners to join consortium to benefit their own R&D 

CAMBRIDGE, MA—The inner ear is one of the most remote and protected spaces in the human body. That configuration is a big reason why disorders of the inner ear remain stubbornly hard to treat. In fact, inner ear disorders comprise the largest and most serious class of diseases responsible for hearing loss, accounting for 250 million people worldwide. Even with a rapidly expanding pipeline of potential inner ear therapeutics, the inner ear, in particular the cochlea, remains a challenging organ for targeted drug delivery.

Now, a novel device for delivering drugs to the inner ear will be put to the test in a biopharmaceutical industry consortium with the goal of addressing and positively impacting the hearing loss epidemic. Draper developed the intracochlear drug delivery device with funding from the National Institute of Deafness and Other Communication Disorders (NIDCD) under a NIH Bioengineering Research Partnership, and in collaboration with clinicians and scientists at Massachusetts Eye and Ear Infirmary, to address a number of major challenges in treating hearing loss. For instance, many therapeutic compounds for treating auditory disorders are toxic or have severe side effects when delivered systemically. Injectable therapies encounter a challenge of another kind:  the inner ear’s protective round window membrane isn’t easy to permeate.

“Today’s treatment of inner ear diseases is hampered by the shortcomings of available drug delivery technology,” said Jeff Borenstein, Lead Scientist for Drug Delivery at Draper. “For diseases of the inner ear, clinical research and treatment have been held back by the need for a safe, direct and effective intracochlear drug delivery method. We address this challenge with Draper’s device—the first implantable and programmable micropump that provides targeted, controllable and extended drug delivery. With this consortium we can advance development and optimize the ICDD as well as accelerate testing and delivery of hearing loss drug candidate compounds and combination therapies on behalf of researchers who invest in the consortium evaluation program.” 

Established in the dynamic life sciences hub of Boston, the CILcare-CBSET-Draper trio is working to assess the ICDD device with the use of CILcare’s hearing loss preclinical models, and the operational support of CBSET’s GLP-compliant and AAALAC-accredited laboratories. 

In the coming months, the trio will initiate activities to invite biopharmaceutical and pharmaceutical companies involved in ear disorders to expand the consortium.

“Hearing loss disorders are a global phenomenon, but there is currently no drug to treat the condition,” said Célia Belline, CEO of CILcare, a leading clinical research organization (CRO) specializing in ear disorders, with offices in Boston, Paris, and Montpellier, France. “Our consortium aims to provide the partnered companies with proof-of-concept data on the efficacy of delivering their compounds using Draper’s ICDD in animal models, an indispensable step before going into human clinical trials.“ 

The program will be led and managed by CILcare in collaboration with Lexington, Mass.-based CBSET, a non-profit research institute that specializes in the advancement of novel therapies. Peter Markham, President and CEO, CBSET, said “this study will help consortium members accelerate their drug development initiatives and support their regulatory submissions. With no effective treatment on the market to cure hearing loss, the need for emerging therapies is growing. We are excited that this collaboration will enable us to contribute to the development of promising therapies.”

CILcare
CILcare Inc. is the world-leading services company for drug development in hearing and otic disorders. Based in Cambridge, Paris and Montpellier, CILcare has developed unique know-how to assess the safety and the efficacy of drug candidates and medical devices in drug-induced hearing loss, noise-induced hearing loss, age-related hearing loss, salicylate-induced tinnitus, noise-induced tinnitus and otitis. In addition to the expertise of the team and the strong support of the scientific board, CILcare also benefits from the large industrial background of its three founders. Learn more about CILcare’s expert biomedical research services or please contact us.

About CBSET
CBSET Inc. – 500 Shire Way, Lexington, Mass. – is the preclinical research leader in critically important therapeutic fields such as interventional cardiology, renal disease and dialysis, chronic drug-resistant hypertension, women’s health, minimally invasive surgery, orthopedics, biological and synthetic tissue repair, drug delivery, bioresorbable devices, and combination medical device and drug-eluting products. Learn more about CBSET’s expert biomedical research services or please contact us.

Draper’s novel intracochlear drug delivery device is an innovative technological solution to treat patients with congenital and degenerative hearing loss. Draper’s device integrates all of the functions needed for intracochlear drug delivery in a single chip. The inner ear contains the sensory organs for hearing and balance. The cochlea is the hearing part of the inner ear, pictured here as a dark blue spiral.
Capabilities Used
Precision Instrumentation

Draper develops precision instrumentation systems that exceed the state-of-the-art in key parameters (input range, accuracy, stability, bandwidth, ruggedness, etc.) that are designed specifically to operate in our sponsor’s most challenging environments (high shock, high temperature, radiation, etc.).  As a recognized leader in the development and application of precision instrumentation solutions for platforms ranging from missiles to people to micro-Unmanned Aerial Vehicles (UAVs), Draper finds or develops state-of-the-art components (gyros, accelerometers, magnetometers, precision clocks, optical systems, etc.) that meet the demanding size, weight, power and cost needs of our sponsors and applies extensive system design capabilities consisting of modeling, mechanical and electrical design, packaging and development-level testing to realize instrumentation solutions that meet these critical and demanding needs.

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. 

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.

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