8:00 am Morning Refreshments & Check In
8:55 am Chair’s Opening Remarks
EXPLORING DRUG/DEVICE COMBINATION THERAPY & SUSTAINED-RELEASE DRUG FORMULATIONS FOR EXTENDED TARGET EXPOSURE & PRECISE DELIVERY TO TARGET CELLS IN THE INNER EAR
9:00 am Combining Cochlear Implants with Therapeutic Agents for Precise Delivery & Extended Release in the Cochlea
Synopsis
- Enhancing patient experience with the combination of cochlear implants and therapeutic agents for a more holistic approach to auditory restoration
- Utilizing combined device/drug approaches for reducing responses to insertion trauma and ensuring precise delivery to target region
- Preclinical and clinical approaches to demonstrate clinical benefit of device/ drug combinations
9:30 am Designing & Developing Novel Platform Technology for Sustained Release of Various Therapeutic Modalities via Cochlear Implant Device
Synopsis
- Developing sustained release drug formulations delivered via implantable pellets embedded into the cochlea, on a cochlear implant electrode or in a hydrogel
- Understanding the FDA’s criteria for successful outcome measures for inner ear drug therapeutics and cochlear implants; device improvement and drug efficacy
- Reviewing regulatory discussions to gain approval for drug/device combination products
10:00 am Exploring Drug/Device Combination for Precise Drug Delivery & Hearing Preservation Using Cochlear Implants
Synopsis
- Discussing hearing preservation using cochlear implantation as a model for therapeutic development for both genetic and acquired hearing loss
- Sharing results from MED-EL DEX-EL phase 1/2 clinical trials for drug-eluding electrode
- Stand-alone device drug delivery based on cochlear implantation for more accurate and complete delivery of gene therapies, cell therapies and small molecules into the inner ear
10:30 am Morning Break
11:30 am Roundtable Discussion
Synopsis
- Discovery Table: Understanding target biology and patient population characteristics, such as genotype-phenotype relations, prevalence and target amenability, for genetic vs acquired hearing disorders
- Preclinical Table: Developing novel in vitro and in vivo preclinical models beyond mice and replicating the underlying biology of the human inner ear structures
- Clinical Table: Discussing strategies to optimize clinical trial design and patient recruitment for varying patient populations with genetic and acquired hearing disorders
Moderator Feedback & Audience Debate: Moderators will be assigned to each roundtable to facilitate discussion and collate the findings. Following the roundtable discussions, they will present back to the entire delegation and open up a wider audience debate.
ADVANCES IN NON-INVASIVE & PRECISE DELIVERY DEVICES FOR MAXIMUM TARGET EXPOSURE & REDUCED OFF-TARGET EFFECTS
12:30 pm Ensuring Desired Target Exposure in the Cochlea with Novel Sustained Release Drug Formulations for Reduced Injection Frequency & Improved Patient Compliance
Synopsis
- Utilizing targeted delivery systems such as nanoparticle-based carriers and intra-tympanic injections for localized delivery to ensure minimal systemic exposure and maximum therapeutic efficacy
- Developing slow-release drug formulations to improve their ability to penetrate barriers within the inner ear, ensuring optimal target exposure
- Optimizing drug dosage to achieve desired target exposure levels by utilizing pharmacokinetic modelling techniques to improve prediction of drug distribution patterns
1:00 pm Lunch & Networking Break
2:00 pm Uncovering New Regenerative Combination Therapeutics for Acquired Hearing Loss & Controlling Therapeutic Exposure to the Target in the Cochlea
Synopsis
- Identifying the drug-like combinations for reprogramming in the mature mammalian inner ear
- Exploring the gene therapy approach for cytotoxic drug-induced hearing loss to regenerate hair cells in the cochlea
- Optimizing the process to achieve the regeneration of healthy functional hair cells for hearing recovery and controlling the ‘on-off’ switch for the gene therapy once inside the cochlea to monitor therapeutic exposure
2:30 pm Exploring Clinically Validated Non-Invasive Oral Therapy to Preserve Residual Hearing After Cochlear Implantation
Synopsis
- Explore first-in-class oral drug candidates for hearing preservation postimplantation with minimal side effects, reduced auditory deficit and improved recovery
- Oral drug concentrations in the perilymph signifies a significant leap in understanding drug distribution dynamics, offering insights crucial for optimizing therapeutic efficacy in inner ear disorders
- Achieving primary endpoints for residual hearing preservation in the perilymph, with orally administered drugs
DEVELOPING NOVEL BIOMARKERS & DIAGNOSTIC TOOLS FOR IMPROVED SUB-CATEGORIZATION OF INNER EAR HEARING LOSS
3:00 pm Developing Disease-Specific Biomarkers to Sub-Type Acquired Hearing Disorders for Improved Therapeutic Interventions
Synopsis
- Identifying specific cochlear damage (i.e. noise-induced and age-related) and the varying scale of synapse damage in sensorineural hearing loss
- Establishing unified and objective categorization of hearing loss subtypes based on damage to specific cell types, beyond observable changes
- Understanding the lack of translational data following preclinical screening for different noise intensity, noise types and varying damage in the cochlea
3:30 pm Afternoon Break
4:00 pm Panel Discussion: Developing Combination Therapy & Utilizing Cochlear Implants as Delivery Devices
Synopsis
- Understanding the limitations of using cochlear implants as the sole treatment
- Managing off-target effects and inflammatory responses by combining implants with drugs
- Discussing the challenges of delivering gene therapies vs cell therapies vs small molecules using implant devices