As a co-founder and chief technical officer of closely held EyeKor, which helps clients navigate the ever-changing landscape of ophthalmic clinical trials, Dr. Yijun Huang, a bioengineering executive, cut his teeth developing software and hardware solutions for ophthalmic imaging applications, both in academic and industrial situations. They include VP of engineering at Topcon Medical Systems, a major Japanese manufacturer of ophthalmic devices. He was also a member of Fundus Photograph Reading Center at the University of Wisconsin-Madison, which acts as a central imaging lab collecting and interpreting images from various ophthalmic clinical trials. In this interview with BioTuesdays, Dr. Huang discusses EyeKor’s Excelsior software platform for imaging data management, its market penetration and a recent collaboration with Clearside Biomedical (NASDAQ:CLSD).
Let’s begin with a brief history of EyeKor.
My two partners and I founded EyeKor in 2012 to be a software-as-a-service company that provides imaging management services for CROs and reading centers, specializing in ophthalmic clinical studies. We were driven to develop methodologies related to ophthalmic imaging and analysis to increase efficiency, gain additional insights, shorten development time, and reduce costs for ophthalmic clinical trials. Our goal is to provide clinical trial sponsors with image and data management services, ranging from clinical trial imaging experts, reading centers with expertise across a broad range of ocular testing, consultants in clinical trial design, experts in ophthalmic data reading and interpretation, as well as site-training, certification and monitoring. Our imaging expertise covers a full spectrum of ocular testing methods, including but not limited to, fundus photography and angiography, optical coherence tomography, fundus autofluorescence imaging, corneal endothelial cell analysis, dark adaptation, and electrophysiological testing.
What are the advantages of Excelsior?
Excelsior is a first-of-its kind application with cloud-based architecture designed to enhance efficiency and accuracy in the collection and interpretation of data from ophthalmic clinical trials. It is designed to allow principal investigators, clinical trial sponsors, and data flow managers to access the real-time progression of their data through each workflow stage and track the actual time spent against a target time from a web browser. Excelsior is the only software that has received FDA 510(k) clearance for use as a data management system for ophthalmic clinical trials. The software platform also is compliant with the Health Insurance Portability and Accountability Act, which sets the standard for electronic security of sensitive patient data, and can provide a full audit trail for data management and analysis.
Can you explain how you interact with reading centers?
Reading centers act as central imaging laboratories in the collection, interpretation and analysis of ophthalmic images in clinical studies. While they excel in a research perspective, a common concern is image management that is required to meet strict regulatory guidelines for clinical trials. This can lead to difficulties managing diverse ophthalmic modality types, standardizing imaging outputs, harmonizing computing infrastructure and tracking workflow and study progress. EyeKor solves these issues, enabling reading centers to provide diverse grading services in many ophthalmology disorders, while EyeKor focuses on workflow tracking, performance metrics, data display and reviewer access, as well as providing training and certification for sponsors and imaging professionals and imaging technologies.
How successful have you been in terms of market penetration?
As of April 2017, nearly 5,800 users, including trial sponsors, staff, clinical site coordinators and technicians, had used the Excelsior platform in 50 clinical trials in 39 countries. Excelsior has participated in four Phase 1 studies; eight Phase 1/2s; 17 Phase 2s; and 21 Phase 3 studies. In total, we have been engaged with nearly 9,000 subjects enrolled in these studies at 865 global clinical sites, of which about half were in the U.S. We also have managed more than six million ophthalmic images.
Can Excelsior bridge the gap between preclinical and clinical trials?
Our Preclinical platform brings the advanced management capabilities of its flagship clinical trial system to the preclinical phase of development where image analysis plays a key role in advancing treatments to the next stage of development. By providing a centralized hub for all preclinical activities, our Preclinical platform allows trial managers to funnel a variety of imaging data into a single system, eliminating the risks of human error while saving time in the process. In addition, our platform allows the study sponsor to have high-resolution, quantitative, in vivo, and real-time assessment of the examined animal retinas during the entire course of a preclinical study.
Clearside Biomedical and EyeKor recently entered a strategic collaboration. What are you doing for Clearside?
The creation of a strategic collaboration between Clearside and EyeKor enables both partners to invest in the relationship to mutual benefit. Clearside is developing advanced clinical and preclinical drug candidates using a unique delivery approach to the back-of-the-eye through the suprachoroidal space for patients suffering from sight threatening diseases like uveitis, retinal vein occlusion, diabetic macular edema and wet age-related macular degeneration. Excelsior will enable Clearside and its contract research organizations to manage the ocular images and other data collected during its clinical and non-clinical trials, enhancing the efficiency and accuracy of data collection and interpretation. It will also allow scientists, principal investigators, data managers and reading center graders to access and track data in real time. We see this as a great collaboration because we admire Clearside’s culture, scientists and commitment to data quality, and through Excelsior, we can facilitate the management of images from all of their studies for cost containment and efficiency, both preclinical and clinical, all the way through NDA filing and beyond.