Conference Agenda
* All times shown are Eastern Standard Time (EST)
Wednesday, Nov. 8
10 - 11:15am
Welcome and Opening Keynote: Ophthalmic biomarkers, a regulatory perspective
Dr. Cunningham will review the regulatory perspective regarding ophthalmic biomarkers, their current state, and needs for the future.
Brad Cunningham, MSE, PGC-AIML, RAC Captain, USPHS
Assistant Office Director, Office of Ophthalmic, Anesthesia, Respiratory, ENT, & Dental Devices, Center for Devices and Radiological Health
FDA
11:15 - 11:25am
BREAK
11:25am - 12:40pm
Making ocular biomarkers count: Validity and standardization for ocular fluids
Organizers: Penny A. Asbell, MD, FACS, MBA, FARVO, Katherine S. Held, PhD, and Rachel Redfern, OD, PhD, FAAO
There is a lack of standardized operating processes for the small volume samples (tears, aqueous, vitreous) available for ocular biomarker analysis and therefore it is difficult to interpret results and compare results between different research groups; this impedes our ability to develop validated ocular biomarkers. Through brief talks and Q&A, current research and future needs to address this gap will be discussed.
- Challenges for small volume ocular biomarker detection- tear film research today — Marlies Gijs, PhD
- Standardized approaches for ocular fluid analysis — Virginia L. Calder, PhD
- Ocular Biomarkers for Systemic Disease — Sarah F. Hamm-Alvarez, PhD, FARVO
- Proteomic methods for ocular fluid analysis — Ashok Sharma, PhD
- Assay development to improve sensitivity and reproducibility for Ocular Biomarkers — Swati Gupta, PhD
12:40 - 12:50pm
BREAK
12:50 - 2:05pm
Omics-based biomarkers
Organizer: Sanjoy K. Bhattacharya, M.Tech, PhD
The mass spectrometric omics technologies (proteomics, metabolomics, lipidomics) are going through a rapid quantum leap. Single-cell omics are now a possibility but there is a big technological gap, and the integration of different omics remains a challenge. In this session, we will discuss the advancement of standards that allow multi-system plex-based labeled quantification beyond the current plex-based quantitation, the new systems that enable single-cell mass spectrometric omics, and the spatial omics complementing other approaches.
- The new peptidomic standards for multi-organism axon regeneration proteomics — Sanjoy K. Bhattacharya, M.Tech, PhD
- Multiomics analysis of trabecular meshwork cytoskeletal-extracellular matrix interactions — Padmanabhan P. Pattabiraman, PhD
- Plasma metabolomics in primary open-angle glaucoma — Wonkyu Ju, PhD
- Multi-organism Lipidomics pertinent to axon regeneration — Jennifer Arcuri, PhD
- Metabolomics in Glaucoma and its relationship with other omics — Dongfeng Chen, MD, PhD
Biomarkers for corneal infections
Organizer: Nakul Shekhawat, MD, MPH
There are few objective, precise, reproducible, and clinically relevant measurements of corneal infection severity and response to treatment. Such measurement challenges hamper researchers’ ability to discern which diagnostics and treatments work best for corneal infections. This panel session will review the current state of corneal biomarker research, identify existing gaps and why they matter, and describe how state-of-the-art techniques such as high-resolution corneal imaging, next-generation genomic sequencing, and artificial intelligence are being used to improve the classification, measurement, and prediction of corneal infection subtype, severity, and treatment response.
- Thuy Doan, MD, PhD
- Travis K. Redd, MD, MPH
- Nakul Shekhawat, MD, MPH
Retinal imaging of cellular and molecular biomarkers
Organizers: Professor M. Francesca Cordeiro MBBS, PhD, FARVO and Ash Jayagopal, PhD
The eye is one of the few places in the body where, due to the transparent media, it is possible to image processes at a molecular and cellular level. Up to now, OCT and OCTA have relied on a "black box" AI approach to identifying retinal biomarkers. However, retinal cellular imaging enables real-time assessment with proven mechanisms of action at a cellular or molecular level. This session includes a discussion of these recent technologies, their analysis, and how these measures can be utilized as retinal biomarkers. An emphasis will be on how these enabling technologies can be integrated into clinical trials and clinical pathways.
- Imaging Single Cells as Retinal Biomarkers - Part 1 DARC — M. Francesca Cordeiro, MBBS, PhD, FARVO
- Imaging Single Cells as Retinal Biomarkers - Part 2 Adaptive Optics — Ethan A. Rossi, PhD
- Molecular Imaging in the Retina - Part 1 — Ashwath Jayagopal, PhD
- Molecular Imaging in the Retina - Part 2 — Imam Uddin, MD, PhD
The growing need for ocular surface biomarkers: several approaches and a wide range of diseases
Organizers: Edoardo Villani MD, FEBO and Penny A. Asbell, MD, FACS, MBA, FARVO
Ocular surface biomarkers are quickly evolving but the lack of standardization is a major issue. Moreover, there is a lack of sharing of knowledge among basic scientists, clinical scientists, and clinicians. This session is focused on the growing need for validated ocular surface biomarkers (diagnostic, prognostic, predictive) and surrogate endpoints, to be used in both clinical practice and research. Several approaches will be discussed, including methods based on tear fluid or conjunctival epithelium sampling (cytokines, proteomics, metabolomics, lipidomics) as well as imaging techniques (in vivo confocal microscopy, OCT, infra-red…).
- The need for validated biomarkers for ocular surface diseases: implications for clinical practice and research — Edoardo Villani MD, FEBO
- Tear cytokines: potential and broken promises — Penny A. Asbell, MD, FACS, MBA, FARVO
- Proteomics: powerful in research, but what about clinical applications? — Antonio Di Zazzo, MD
- Metabolomics and lipidomics biomarkers: how long is the way to go? — Raoul Kanav Khanna, MD
- Tear film and ocular surface imaging: evolving technologies and persisting limits — Pedram Hamrah, MD, FACS, FARVO
2:05 - 2:15pm
BREAK
2:15 - 3:30pm
Tear fluid biomarkers for clinical applications: Are we there yet?
Organizer: Marlies Gijs, PhD
Wrap up your day with a lively and interactive debate. Listen as experts outline their divergent perspectives then form your own opinion based on the arguments. The pro's and con's of three hot topics will be discussed and weighed.
Debate topics
- Are we ready for tear biomarkers as an additional tool in routine clinical practice? — Arkasubhra Ghosh, PhD and Jelle Vehof, MD, PhD
- Should Schirmer’s strips become the one and only collection method in tear biomarker studies? — Nienke van de Sande and Suzanne Hagan, PhD
- Can tear biomarkers have added value for non-ocular disorders? — Paul Lingor, MD and Menglu Yang, MD, PhD
Thursday, Nov. 9
10 - 11:15am
Insights into systemic health and disease through ophthalmic biomarkers
Organizers: Lisa Zhuoting Zhu, MD, PhD and Ching-Yu Cheng, MD, PhD
Advances in retinal imaging modalities are enabling growth in oculomics, the study of the association of ophthalmic biomarkers with systemic disease. This session will highlight the latest advancements and discoveries in oculomics. Additionally, the challenges and opportunities associated with the utilization of retinal biomarkers for screening and risk stratification of systemic diseases will be extensively discussed. By engaging in these presentations, researchers will be better equipped to design research projects that contribute significantly to the advancement of oculomics.
- Image-based Oculomics - findings from the AlzEye Study — Pearse Andrew Keane, MD, FRCOphth
- Detection of Diseases and Systemic Biomarkers in Photos of External Eyes — Yun Liu, PhD
- From Research to Product: The Journey of Reti-CVD AI-SaMD — Tyler Hyungtaek Rim, MD, MBA
- Retinal Imaging for Alzheimer’s Disease (AD) Screening — Carol Yim-lui Cheung, PhD
- DeepCHD: A Deep Learning System for Screening Coronary Heart Disease from Fundus Images — Sheng Bin, PhD
11:15 - 11:25am
BREAK
11:25am - 12:40pm
Imaging biomarkers of the ocular surface in clinical practice and research
Organizers: Pedram Hamrah, MD, FACS, FARVO, Edoardo Villani, MD, FEBO and Stephanie M. Cox, OD
Summarizing the current literature on ocular surface biomarkers will provide a framework for the assessment of the current literature in areas outside of the ocular surface. For those investigating ocular surface disease, it will also highlight the current gaps in potential biomarkers. This session will review the current status of several potential imaging biomarkers for the ocular surface and assess the current state for each step in the biomarker development process according to the criteria outlined by the NIH's BEST (Biomarkers, EndpointS, and other Tools) Resource.
- The growing need for validated ocular surface biomarkers: the role of imaging — Edoardo Villani, MD, FEBO
- Tear film assessment: non-invasive tear break-up time and meniscometry — Stephanie M. Cox, OD
- Meibomian gland assessment: Infra-red meibography — Reiko Arita, MD, PhD
- Assessment of ocular surface inflammation and corneal nerve alterations by in vivo confocal microscopy — Pedram Hamrah, MD, FACS, FARVO
- Optical coherence tomography for ocular surface and corneal diseases — Anat Galor, MD
12:40 - 12:50pm
BREAK
12:50 - 2:05pm
Molecular biomarkers in thyroid eye disease (TED)
Organizers: Hans Olav Ueland MD, PhD and Farzad Pakdel, MD
Designing research projects that add to our understanding of the molecular pathways operating in the pathophysiology of thyroid eye disease and identifying molecules that could predict, mirror, and parallel disease activity, disease severity, response to treatment, and prognosis, can be challenging. Through a summary of the current state of research in diabetic retinopathy, discussions of new areas for research inquiry, and examples demonstrating how to incorporate this information into new research aims, this session seeks to address these challenges and enable new researchers to identify and refine their research aims. Attendees will leave the session with the ability to describe molecular biomarkers in thyroid eye disease, interpret TSH receptor antibody reports, and formulate potential treatment and prognostic plans by input of molecular biomarkers.
- Blood Biomarkers in Thyroid Eye Disease — Hans Olav Ueland MD, PhD
- Tissue Biomarkers in TED — Raymond Douglas, MD, PhD
- Tear Biomarkers in TED — Mikael Thomassen Neset
- Translational Researches on Molecular Pathogenesis of Thyroid Eye Disease — Farzad Pakdel, MD
- Questions and Answers — Terry J. Smith, MD, Farzad Pakdel, MD, Hans Olav Ueland MD, PhD, Raymond Douglas, MD, PhD, and Mikael Thomassen Neset
OCT-based quantification of anterior chamber inflammation: what next?
Organizers: Ameenat Lola Solebo MBBS, PhD, FRCOphth and Edmund Tsui, MD
The imprecision and insensitivity of the current slit lamp based metrics of disease activity complicate the use of inflammation as a monitoring biomarker in anterior uveitis, or as a surrogate endpoint for visual disability, whilst the long duration of follow-up necessary to capture uveitic visual loss in anterior disease, and the irreversibility of uveitic visual loss, make visual function a challenging endpoint for interventional research. Whilst AS-OCT is an emerging modality able to provide objective and sensitive metrics, we have yet to address the issues around acquisition, analysis, and clinical validity to the degree needed for clinical adoption. This session includes presentations about the current state of research in imaging-based disease quantification, discussions of new areas for research inquiry, and a review of attempts to address the challenges around clinical implementation.
- Clinical grading of anterior chamber inflammation — the Standardization of Uveitis Nomenclature (SUN) experience — Douglas A. Jabs, MD, MBA
- Objective imaging biomarkers in childhood uveitis: current landscape — Sheila T. Angeles-Han, MD, MSc
- AS-OCT quantification - the foundations — SriniVas R. Sadda, MD, FARVO
- Integrating AS-OCT into clinical care — Edmund Tsui, MD
- Adventures in implementation — Ameenat Lola Solebo MBBS, PhD, FRCOphth
New generation imaging biomarkers in retinal diseases
Organizers: Alessandro Arrigo, MD, Enrico Borrelli, MD, PhD, FEBO and Riccardo Sacconi, MD
The metrics now available from advanced imaging biomarkers provide much more detail regarding the morphological and functional status of the retina in healthy and pathological conditions. The proper use, interpretation, and application of these metrics in different pathological contexts, either considering neovascular, degenerative, or inflammatory phenomena, are often challenging since highly technical skills are required. In this session, recognized experts will provide a complete, feasible, and detailed description of the new generation imaging metrics, regarding different pathological conditions, including age-related macular degeneration, vascular diseases, inherited retinal dystrophies, vitreoretinal disorders, and uveitis.
- New generation imaging biomarkers in age-related macular degeneration — Riccardo Sacconi, MD
- New generation imaging biomarkers in retinal vascular diseases — Enrico Borrelli, MD, PhD, FEBO (prerecorded)
- New generation imaging biomarkers in inherited retinal dystrophies — Alessandro Arrigo, MD
- New generation imaging biomarkers in vitreoretinal disorders — Rodolfo Mastropasqua
- New generation imaging biomarkers in uveitis — Alessandro Invernizzi, MD
Artificial intelligence to define the prognosis in age-related macular degeneration
Organizers: Enrico Borrelli, MD, PhD, FEBO and Rosa Dolz-Marco, MD, PhD, FEBO
The application of artificial intelligence on innovative retinal imaging technologies allows us to detect biomarkers that may predict the progression of Age-related macular degeneration (AMD). In this session, we illustrate the application of artificial intelligence to detect and quantify biomarkers in AMD eyes and, more importantly, we will discuss its role in early diagnosis and prognostication of AMD.
- Imaging biomarkers in AMD — Rosa Dolz-Marco, MD, PhD, FEBO
- AI to define and detect biomarkers associated with the progression from early/intermediate to late AMD — Maximilian Pfau, MD, PhD
- AI to detect biomarkers associated with the prognosis and progression in eyes with GA — Gregor Sebastian Reiter, MD, PhD
- AI to detect biomarkers associated with the prognosis and progression in eyes with neovascular AMD — Enrico Borrelli, MD, PhD, FEBO
2:05 - 2:15pm
BREAK
2:15 - 3:30pm
Closing Keynote: Imaging biomarkers in ophthalmology
Imaging-derived biomarkers are essential for ophthalmic research by providing objective criteria for subject selection and outcome measures. This applies not only to eye diseases but also systemic diseases with eye findings. However, relatively few quantitative metrics that we can measure from images have been sufficiently validated and trusted to become useful. This presentation will review the development of these successful biomarkers and discuss how new and improved biomarkers can be developed to overcome current limitations.
David Huang, MD, PhD
Wold Family Endowed Chair in Ophthalmic Imaging
Professor of Ophthalmology & Biomedical Engineering
Associate Director & Director of Research, Casey Eye Institute
Oregon Health & Science University
*Program is subject to change without notice.
