Pre-Conference Workshops - Tuesday, April 13
Developing Preclinical Models to More Accurately Predict Safety & Efficacy of Novel Wet AMD & DME therapies
10.00 - 13.00 EST | 7.00 - 10.00 PST
10:00 am Opening remarks from chair
- William Schubert Principal Scientist, Bayer
10:10 am Mouse Models of Experimental Choroidal Neovascularization
- Eric Ng Assistant Scientist, Schepens Eye Research Institute of Mass Eye and Ear; Assistant Professor of Ophthalmology, Department of Ophthalmology, Harvard Medical School
- Developing a reproductible mouse model of laser-induced choroidal neovascularization (CNV).
- A mouse model of spontaneous CNV for therapeutic target discovery and drug development.
- Validation of CCR3 as a potential therapeutic target for CNV using mouse models of CNV.
10:40 am Open Discussion – Interactive Session Where Attendees Can Share Audio/Video
11:00 am 3D Tissue Engineered Models of wet-AMD and DME Derived from Patient-specific Stem Cells
- Kapil Bharti Senior Investigator – Ocular and Stem Cell Translational Research Section, National Institute of Health Sciences
– Derivation of 3D tissue engineered eye tissues derived from patient’s specific stem cells.
– Use of these tissues for in vitro disease modeling for wet-AMD and DME
– Development and testing of drugs in these disease models
11:30 am Open Discussion – Interactive Session Where Attendees Can Share Audio/Video
12:00 pm Unraveling Age-related Macular Degeneration
- Claudio Punzo Associate Professor, Dept. of Ophthalmology, University of Massachusetts Medical School
12:30 pm Ocular Biomarkers: Tools for Discovery of Pathological Pathways and Validation of New Therapeutic Agents
- Faryan Tayyari Research Scholar, University of Waterloo
– Invasive and non-invasive ocular biomarkers
– Biomarkers can help with better understanding of pathological pathway
– Biomarkers can increase the drug development success rate
1:00 pm Close of Pre-Workshop
Clinical Biomarkers for Assessing Wet AMD & DME Therapeutics
14.00 - 17.00 EST | 11.00 - 14.00 PST
1:40 pm 1-to-1 Networking Session
1:55 pm Opening Remarks from Chair
2:00 pm Data Needed to Support Biomarker Qualification and Validation
- Adnan Tufail Professor - Ophthalmology , Moorfields Eye Hospital
– Drawing on the experience of the MACUSTAR study and other clinical assessments.
– How to make technical evaluations using observed data.
– Optimize and standardize most relevant existing and/or rapidly available clinical endpoints in: Visual functional outcomes measures; Structural outcomes measures and Patient reported outcomes measures (PROMs).
2:30 pm Retinal Fluid Volume as a Biomarker in NV-AMD
- Anat Loewenstein Director Department of Ophthalmology, Tel Aviv Medical Center, Vice dean Sackler Faculty of Medicine, Tel Aviv University
– Rational for compartmental analysis of retinal fluid volume
– Disease dynamics and treatment response revealed by fluid thickness maps and fluid volume trajectories from daily home SD-OCT self-imaging by NV-AMD patients
– Cumulative fluid exposure as potential predictor for visual acuity outcomes
3:00 pm Biomarkers in Wet AMD
- Marion Munk Professor, Managing Director, Bern Photographic Reading Center, University Hospital Bern; Adjunct Faculty, Dept of Ophthalmology, Northwestern University; Chief Medical Officer, Isarna Therapeutics
– Biomarker to predict disease activity and recurrence in wet AMD patients
– Using machine learning to predict high and low treatment need in wet AMD patients
3:30 pm Discovering Biomarkers for AMD Using Deep Learning
- Aaron Lee Assistant Professor, Ophthalmology, University of Washington School of Medicine
– Novel deep learning framework for agnostic discovery of biomarkers is presented
– Careful selection of training targets can lead to new imaging makers
– Anatomic alignment was critical for achieving this result
4:00 pm Non-Enzymatic Glycation of Albumin May Induce Diabetic Retinopathy: Evidence for a Therapeutic Intervention
- Michael Miller Member of Scientific Advisory Board, Glycadia
– Glycadia, Inc: History, Mission and the breakthrough work of Margo Cohen, MD
– Biomarker evidence supports retinopathy attenuation by inhibiting Glycated Albumin formation and function; pharmacological blockade of pathogenic activity in animal models
– New studies that elucidate the pathogenic role and pathways of Glycated Albumin and Amadori Glucose Adducts in animals and man
4:30 pm How Biomarker Research Can Improve Our Understanding of the Pathology of These Conditions
- SriniVas Sadda President & Chief Scientific Officer , Doheny Eye Institute
– Longitudinal studies to assess the prognostic power of changes in retinal sensitivity (as measured by microperimetry) for progression from iAMD to late AMD (nAMD and GA).
– Utilizing OCT and OCT-A biomarkers that predict the progression of AMD.
5:00 pm Roundtable Discussion – What Evidence Needs to be Generated to Support Biomarker Qualification and Drug Approval by Regulatory Authorities and Payers?
– Technically evaluating the functional and structural outcome measures to support a biomarker qualification.
– Expectations of regulatory authorities, payers and clinicians.
Interactive session to enable the audience to pose questions and discuss points raised during the session and what this means for drug development efforts.