CONFERENCE DAY TWO

Thursday, May 29, 2025

7:30 am Check In & Morning Coffee

8:25 am Chair’s Opening Remarks

  • Mayssa Attar Senior Vice President & Head of Pharmaceutical, Consumer Research & Development, Bausch + Lomb

NAVIGATING THE REGULATORY LANDSCAPE TO OBTAIN APPROVALS FOR NOVEL IMAGING BASED BIOMARKERS

8:30 am Regulatory Strategy for Evolving Retinal Imaging Endpoint to Streamline Approval

Synopsis

  • Exploring the introduction novel retinal imaging biomarkers into regulatory submissions
  • Reviewing functional vs. structural endpoint considerations
  • Analyzing opportunities to support novel retinal imaging endpoints

9:00 am Utilizing VR Guided Multi Luminance Orientation and Mobility Testing for Assessment of Visual Function

  • Ash Jayagopal Chief Scientific & Development Officer, Opus Genetics

Synopsis

  • Exploring how virtual reality stimulators can help connect structural changes in the retina with functional outcomes
  • Leveraging these tests to help define clinically meaningful improvements
  • Discussing how secondary or exploratory functional endpoints can be validated and transitioned into primary endpoints for clinical trials

9:30 am Panel Discussion: Delving into FDA vs EU Perspective on Retinal Imaging Endpoints to Demonstrate Functional Vision

Synopsis

  • Detailing how the FDA and EU approach the adoption of new retinal imaging technologies
  • Discussing the divergent regulatory standards of each organization
  • Highlighting the growing focus on functionality and quality of life improvements for patients

10:00 am Morning Coffee Break & Networking

ENSURING DATA HARMONIZATION ACROSS MULTIPLE IMAGING MODALITIES TO ENSURE VALIDITY OF READOUTS

10:30 am Standardizing Data Across Retinal Imaging Modalities for Better Trial Outcomes

  • Brian Levy Chief Executive Officer, Ocunexus Therapeutics

Synopsis

  • Emphasizing the importance of creating standardized protocols to ensure consistency and accuracy in multi-center trials
  • Creating protocols to ensure harmonization of data
  • Examining the technical barriers involved in aligning measures such as image quality, resolution, and acquisition methods

11:00 am Utilizing Retinal Imaging for Early Detection & Monitoring of Neurological Disorders

  • Tara DeSilva Associate Professor, Cleveland Clinic Taussig Cancer Institute

Synopsis

  • Examining the correlation between OCT and MRI findings to predict neurodegeneration in MS
  • Leveraging visual assessments in preclinical testing to evaluate neuroprotective strategies
  • Investigating the role of visual imaging in the early detection of neurological diseases

11:30 am Panel Discussion: Exploring Emerging Imaging Technologies Capabilities for Higher Magnification of Retinal Neurons

  • Francesca Cordeiro Professor of Glaucoma and Retinal Neurodegeneration Studies, University College London - UCL
  • Shelley Boyd Chief Executive Officer, Translatum Medicus
  • Tara DeSilva Associate Professor, Cleveland Clinic Taussig Cancer Institute

Synopsis

  • Utilizing adaptive optics to enhance cellular-level imaging for early disease detection
  • Exploring DARC Technology for real-time assessment of retinal health and neurodegeneration
  • Considering ultra-wide field retinal imaging for improved disease tracking
  • Microperimetry potential for mapping functional vision loss with precise correlation to structural changes

12:00 pm Lunch & Networking

ENSURING ALIGNMENT WITH RESEARCH & COMMERCIAL TRENDS TO SPEARHEAD DEVELOPMENT

1:00 pm Fireside Chat: Commercial Trends & Opportunities in Retinal Imaging Biomarkers & Endpoints

  • Daniil Gataulin Senior Analyst, Biotech Equity Research, Chardan Capital Markets

Synopsis

  • Examine the evolving landscape of retinal imaging biomarkers in AMD, focusing on advancements in detecting disease progression and treatment efficacy
  • Analyze unmet needs and opportunities for innovation, emphasizing the potential of novel imaging technologies and AI-driven analyses to enhance precision, durability, and patient care
  • Explore collaboration across research and industry to standardize biomarkers and accelerate their clinical utility

1:30 pm Using Ellipsoid Zone Loss in Retinal Imaging to Set a Reliable Endpoint

Synopsis

  • Examining how the loss of the ellipsoid zone correlates with photoreceptor and neuronal damage
  • Discussing the journey of regulatory acceptance
  • Highlighting the opportunities in using ellipsoid zone loss as an anatomical endpoint in clinical trials for faster readouts

2:00 pm Highlighting the Importance of Longitudinal Data for Assessing Retinal Disease Progression

  • Najam Sharif Vice President - Global Research & Development, Nanoscope Therapeutics Inc

Synopsis

  • Addressing the challenges and advantages of incorporating longitudinal data in clinical trials 
  • Emphasizing the critical role of long-term imaging data in accurately evaluating disease progression and treatment efficacy
  • Exploring strategies to optimize data collection and analysis

2:30 pm Chair’s Closing Remarks

  • Mayssa Attar Senior Vice President & Head of Pharmaceutical, Consumer Research & Development, Bausch + Lomb

2:35 pm End of 3rd Retinal Imaging Biomarkers & Endpoints Summit

CONFERENCE DAY ONE
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