7:30 am | MORNING REFRESHMENTS & REGISTRATION
8:25 am Chair’s Opening Remarks
DESIGNING & DEVELOPING BIOCOMPATIBLE OCULAR SUSTAINED RELEASE IMPLANTS FOR PROLONGED DELIVERY
8:30 am Overcoming the Bio-Incompatibility of Chemical Material Used for Sustained Drug Release in the Retina
Synopsis
- Exploring slow eluding polymers that can be used for the implant that are bio-compatible with the eye and the drug inside the reservoir
- Biodegradable implants; what are the best properties for implant technology and drug and how do they work together to avoid proprietary inflammation?
- Examining the prolonged delivery of biologics using a polymer-based sustained-release pellet
9:00 am Achieving Robust Drug Product Safety & Efficacy for Reduced Ocular Inflammation
Synopsis
- Leveraging lessons from case studies to understand PLGA rods, peptides, degradable depos, polymer-based and matrix binding formulations for ophthalmic drug implants
- Running effective toxicology studies – examples of getting past the time frame
- Establishing effective re-dosage to avoid rapid release and reduce inflammatory response
- Setting up for success – how is manufacturing likely to change from research to development – commercial manufacturing / development process
9:30 am Speed Networking Break
Synopsis
An optimal chance to network one-to-one with leading ophthalmic delivery experts across numerous drug delivery mechanisms. Learn how your peers are developing their devices for better patient comfort, non-invasive delivery methods and working towards achieving sustained drug release.
10:15 am | MORNING BREAK
OVERCOMING THE TRANSLATIONAL CHALLENGES OF DETERMINING SUCCESS OF GENE THERAPY DELIVERY TO THE RETINA
11:15 am Engineering Minigenes as a Therapeutic Approach to Deliver Smaller Yet Functional Portion of Large Genes to the Retina that Exceed AAV Limited Cargo Capacity
Synopsis
- Creating minigenes to overcome the challenges of packaging large genes into AAV
- Using minigenes to address unmet need in inherited retinal diseases
- Delaying photoreceptor degeneration in Leber Congenital Amaurosis using a minigene therapy for CEP290
- Developing a minigene therapy for Stargardt disease
11:45 am Bridging the Gap in Knowledge to Understand Safety & Efficacy Profile of In Vivo Models for Retinal Gene Therapy
Synopsis
- Translatability of AAV between animal models and humans
- Distribution of viral vectors across the retina
- Assessing different routes of administration in the retina for gene therapy
12:15 pm | LUNCH & NETWORKING BREAK
INVESTIGATING PRECLINICAL MODELS FOR IMPROVED TRANSLATABILITY OF OPHTHALMIC DELIVERY METHODS
1:45 pm Developing More Realistic Models for Ocular Disease Modalities for Faster Translation into Humans
Synopsis
- Addressing the gap in translation from monkeys to humans
- Establishing a model that accurately replicates the human immune response and safety profile
- Developing stem cell and organoid models to model the age and micro-environment of the human eye
- Overcoming the gap in anatomy and physiology of the eye in different animals vs. human eye
2:15 pm Phasing Appropriate Animal Studies to Effectively Develop Gene Therapy for Glaucoma & Translating it to Humans
Synopsis
- Optimizing expression to obtain target protein levels
- Assessing efficacy in rodent models
- Confirming expression and long-term safety in non-human primates
2:30 pm | AFTERNOON NETWORKING BREAK
3:30 pm Finding the Most Appropriate Ophthalmic Animal Models for Efficient Translation into Humans
Synopsis
- Exploring better translatable in vivo models that can better predict safety concerns in humans
- Tackling the shortage of monkeys by experimenting with mini pigs and understanding the alternative models
- What are the translational models (if any) that we can do to understand how an in vitro model can be represented in vivo?
REGULATORY CHALLENGES & BENEFIT-RISK CONSIDERATIONS FOR NOVEL RETINAL DELIVERY TECHNOLOGY
4:00 pm Panel Discussion: Reviewing Regulatory Requirements for Different Ophthalmic Drug Administration Routes
Synopsis
- Establishing guidelines for drug development for a disease indication for which there are currently no treatments in the market
- Leveraging lessons from the different delivery approaches and for streamlined regulatory guidance
- Understanding the guidelines for combination between drug and device and combination products for intravitreal injections
- Considering timing and biological division to demonstrate that both drug and device are safe and efficacious to use with each other?
- The device must meet all its medical device regulations while the drug has to meet its regulatory requirements and they both have to meet regulatory requirements together but there aren’t any clear regulatory guidelines at the moment
5:00 pm Chair’s Closing Remarks
5:15 pm Scientific Poster Session
Synopsis
Aside from the formal presentations, the sharing and learning doesn’t stop as the Scientific Poster Session takes place. This will serve as the perfect opportunity to share your recent work developing ophthalmic delivery devices and drug formulations with the community.