Explore the Agenda
7:30 am Check In, Coffee & Light Breakfast
8:20 am Chair’s Opening Remarks
Advancing Retinal Gene Therapies Through Improved Delivery & Clinical Translation
8:30 am Selecting Optimal Gene Therapy Delivery Strategy to Maximise Efficacy, Safety & Patient Reach
- Compare intravitreal AAV delivery for secreted proteins versus subretinal surgery for intracellular targets, understanding which retinal cell populations each route can effectively transduce
- Explore emerging suprachoroidal gene therapy delivery that may offer a middle ground between surgical complexity and transduction efficiency for RPE and photoreceptor targets
- Evaluate novel capsid engineering strategies that enable efficient transduction from the vitreous while minimizing dose-dependent inflammation
9:00 am Bridging the Translation Gap in Retinal Gene & Cell Therapy: Delivery Strategies, Biomarkers, & Predictive Development Models
- Accelerating translation from preclinical research to clinical success with more predictive development strategies
- Optimizing retinal delivery strategies
- Building commercially viable retinal gene and cell therapies
- Reducing development risk through improved translational science
9:30 am Morning Break & Networking
Optimizing Clinical Development Through Better Endpoints, Physician Insights & Patient Engagement
10:30 am Did the Drug Get There, & Did It Work? Verifying Target Access, Drug Engagement & Clinical Translation in Ophthalmic Drug Delivery
- Showcase proving placement with the Near-Real Surgical Specimens (NRSS), a reperfused human ocular tissue platform, as the true human analog for testing delivery devices, with real-time OCT and contrast visualization of suprachoroidal access (inter-specimen CV 6.8% vs 17.7% in cadaveric eyes; TVST 2025)
- Demonstrate accelerated from bench to investigator translation and how the same platform trains and certifies trial PIs on suprachoroidal gene-therapy injection (ICG confirmation of the space) and de-risks first-in-human studies across multiple sponsor programs
- Introduce TEMPO tear proteomics from a Schirmer strip as a non-invasive pharmacodynamic readout, ~3,000 proteins, quantified receptor-pathway inhibition and washout after an IGF-1R biologic in thyroid eye disease, and what this means for precision dosing and payer evidence
11:00 am Panel Discussion: How Can We Improve Clinical Translation by Bridging the Gap Between Preclinical & Human Studies
- Discuss common causes of translational disconnect in efficacy, durability, safety, and immunogenicity from preclnical studies to humans
- Compare the strengths and limitations of rodent, rabbit, minipig, and nonhuman primate models for disease modeling, PK/PD characterization, biodistribution, and safety assessment.
- Discuss the potential of organoids, microphysiological systems, ex vivo human ocular tissues, and computational modeling to complement or replace traditional animal studies.
- Discuss common deficiencies, evidence gaps, or study design limitations that lead to regulatory questions, delays, or clinical holds for preclinical IND packages
11:45 am Lunch & Networking Break
Strengthening Clinical Confidence Through Translational Science & Preclinical Strategy
12:45 pm Selecting & Validating Animal Models for Ophthalmic Drug Delivery
- Discuss how to select the most predictive animal models for your delivery route, formulation, and indication by understanding the strengths and limitations of rabbit, non-human primate, and minipig studies
- Determine when disease models provide meaningful pharmacodynamic insights
- Reduce development timelines, costs, and regulatory risk through strategic non-GLP and GLP study planning that supports stronger IND submissions
1:15 pm Roundtable Discussion: Proving Long-Term Therapeutic Value Through Endpoint Selection & Clinical Trial Design
Join breakout roundtables led by expert moderators to debate key questions, capture consensus and differing views, then reconvene as moderators share insights and spark wider audience debate.
- Discuss how the field should evolve beyond traditional visual acuity measures by identifying functional endpoints that better reflect real-world patient experience, including contrast sensitivity, low-light vision, and other measures of meaningful visual function
- Share experiences validating novel endpoints with regulatory agencies, exploring the evidence packages, study designs, and clinical data required to support acceptance of new outcome measures in future retinal trials
- Explore how predictive biomarkers, advanced imaging analytics, and emerging endpoint strategies can improve patient selection, accelerate development timelines, and generate stronger evidence for regulatory approval and long-term therapeutic value
- Debate which functional endpoints should be prioritised in future retinal studies, how they should be implemented within clinical trials, and what level of change represents a clinically meaningful benefit for patients
2:00 pm Afternoon Break & Networking
Defining the Future of Ophthalmic Drug Delivery With Novel Technology
2:30 pm Advancing Topical Retinal Drug Delivery to Reduce Treatment Burden & Expand Global Access
- Understand how to overcome the biological barriers that have historically limited topical drug delivery to the retina and unlock new opportunities for non-invasive treatment
- Explore formulation strategies that improve retinal penetration and therapeutic activity while maintaining ocular safety and tolerability, and enable convenient dosing to enhance adherence and long-term treatment success
- Learn how next-generation topical therapies could reduce reliance on intravitreal injections while expanding access to retinal disease treatment for underserved patient populations worldwide
3:00 pm Lifecycle Extension Through Ophthalmic Drug Delivery Innovation via Reformulation & Repurposing of drug molecules
- Development of a novel swollen micelle microemulsion (SMM) technology to enhance solubility and room-temperature stability of latanoprost
- Elimination of high benzalkonium chloride (BAK) dependency, reducing potential ocular surface safety concerns associated with chronic therapy
- Improved patient convenience through removal of cold-chain storage requirements and enhanced formulation tolerability.
- Successful progression from formulation concept through clinical development, regulatory approval, and commercialization, illustrating the value of drug delivery-driven lifecycle management
3:30 pm Looking Ahead to The Future of Ophthalmic Drug Delivery
- The Next Generation of Long-Acting Ocular Delivery: Next-generation targeted and minimally invasive delivery systems beyond Intravitreal Injections to extend ocular exposure and reduce treatment burden
- Precision and Repeatable Office-Based Therapy: Advancing non-viral vectors, ASOs, siRNA, and other platforms for precise, durable, and potentially repeatable ocular therapies
- Engineering Exposure, Not Just Dose: Integrating tissue targeting, PK/PD, biomarkers, and digital twins to optimize ocular exposure, therapeutic windows, and patient selection
- AI-Powered Drug Delivery: Leveraging AI to design delivery systems, predict tissue exposure, optimize formulations, and enable more personalized ocular therapies