8:00 – 10:00 | WORKSHOP A
Exploring Toxicity & Risk Issues when Delivering to the Eye
- Quan Dong Nguyen Professor of Ophthalmology, Medicine, and Pediatrics, Stanford Medicine
Ocular immune privilege has made it abundantly difficult to achieve localized sustained drug delivery due to the result of ocular inflammation. Immune responses may vary according to the mode of administration (subretinal vs. intravitreal vs. suprachoroidal) however, the eye is a sensitive organ that tends to severely reject foreign objects. The field struggles to find the optimum method to reduce, and eventually eliminate, inflammation.
Join this workshop to:
- Understanding the different modes of ophthalmic drug delivery; subconjunctival, intravitreal, peri-orbital, and subretinal
- Examining current ophthalmic drug delivery devices and chances of inflammation
- Overcoming the eye’s low tolerance for foreign substances to be able to cross its barriers and allow the drug to be safely administered to the retina with minimal ocular damage
- Reviewing recent high-profile device candidates in the clinic that failed due to toxicity issues
- Decreasing the risk of infections and retinal detachment caused by repeated injections into the retina when locally delivering into the retina
8:00 – 10:00 | WORKSHOP B
Dosage & Half-Life Extension: Finding the Balance Between Dosage & Less Frequent Administration of Drugs
- Paulina Jakubiak Senior Scientist, Genentech
- Emily Ross Technical Development Scientist, Genentech
- Cameron Lee Associate Director, Novartis
Over the years, the focal point when developing drugs for the eye has been to achieve sustained release to reduce the frequency of drug administration for better patient care. The field has struggled with finding the ideal dose that doesn’t cause inflammation and is sustained within the eye for a prolonged period of time to decrease the frequency of injections.
Attend this workshop to learn how you can:
- Achieve slow-release and durable formulation drugs to avoid increasing dosage that could result in inflammation
- Understand the ideal dose to reduce the frequency of injections to one every 6-9 months for better patient
- Examine different routes of administration represent different dosage forms, therefore, it is crucial to understand the complexity of delivering to the eye i.e. testing the system, drug product, methodology, device
- Explore how to extend half-life of large molecule drugs to limit redosing via intravitreal injection, to once every 6-9 months, to reduce patient burden and concerns
10:00 | MORNING NETWORKING BREAK
10:30 – 12:30 | WORKSHOP C
Advances with Subretinal Delivery Route
- Arun Upadhyay Chief Scientific Officer, Head of R&D and Medical, Ocugen
- Stephen Poor Global Program Clinical Head, Novartis
Subretinal surgery has been around as a route of delivering drugs into the eye. An invasive yet effective mechanism of reaching the retina. Unfortunately, it remains an unrealistic method when delivering drugs every once every month. With elderly patients, there are several other health concerns to consider. Frequent ocular surgery could result in a higher risk of irreversible damage to the retina and vitreous space.
Here’s what you can learn by joining this workshop:
- Get an overview of ocular drug delivery via the subretinal route
- Conceptualizing the streamlining of subretinal procedures to reduce ocular damage and inflammation
- Understanding of how to improve subretinal injections for cell therapies to avoid cell death as they undergo high sheer force due to the small cannula of the subretinal injection
10:30 – 12:30 | WORKSHOP D
Designing Clinical Studies for Sustained Release Implants
- Jie Shen Director - Digital Science, AbbVie
With Genentech’s PDS receiving FDA approval back in 2021, the ophthalmic drug delivery space has been moving into the direction of developing sustained release ocular implants for prolonged drug delivery, reduced frequency of administration, and reduced patient burden.
Attend this workshop and get answers to your burning questions regarding clinical trials for implants, such as:
- How do we design a clinical trial that is small & efficient to warrant additional investments into the development of implants?
- What are the necessary FDA guidelines that need to be implemented for successful INDs?
12:30 | LUNCH & NETWORKING
1:30 – 3:30 | WORKSHOP E
Exploring the Latest Developments with Suprachoroidal Delivery
- Viral Kansara Vice President, Preclinical Development, Clearside Biomedical
Suprachoroidal delivery is an emerging delivery route that exploits the suprachoroidal space for less invasive administration and increases the durability of various ophthalmic treatment. With the ongoing preclinical and clinical developments surrounding the use of suprachoroidal delivery for a variety of ophthalmic modalities.
Join this workshop to hear the latest developments in this exciting area such as:
- Update on clinical trials related to suprachoroidal delivery for gene therapies
- Understanding the principle behind suprachoroidal delivery – the ‘what’ and ‘why’?
- Is safety and efficacy maintained in patients, post-approval?
1:30 – 3:30 | WORKSHOP F
Evolution of Gene Therapy for Ocular Diseases as Long-Acting Treatment
- Ashwath Jayagopal Chief Scientific Officer, Opus Genetics
Gene therapies provide a lot of promise as long-acting treatment for ophthalmic diseases. Providing the retinal cells with the genetic information to reproduce the drug within the eye, gene therapies create a bio-factory, meaning that the drugs can last many years with a single injection. However, the field is still evolving and requires its bolts to be tightened and made foolproof.
Join this workshop to hear from leading experts in gene therapies for more insights on:
- Updates on clinical trials
- Are gene therapies the answer to achieving sustained release drug delivery?
- Where do gene therapy vectors transduce when they are injected into the suprachoroidal space?