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

  • Robert Gay Director Pharmaceutical Approaches, Cochlear

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.

12:30 pm Lunch & Networking Break

ADVANCES IN NON-INVASIVE & PRECISE DELIVERY DEVICES FOR MAXIMUM TARGET EXPOSURE & REDUCED OFF-TARGET EFFECTS

1:30 pm Ensuring Desired Target Exposure in the Cochlea with Novel Sustained Release Drug Formulations for Reduced Injection Frequency & Improved Patient Compliance

  • Hugo Peris Chief Executive Officer, Spiral Therapeutics

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

2:00 pm Uncovering the Therapeutic Power of Gene Therapy/Genome Editing Therapy Technologies for Genetic Hearing Loss in Animal Models

  • Wan Du Physician Scientist, Massachusetts Eye and Ear/Harvard Medical School

Synopsis

  • Preclinical result to demonstrate the rescue of auditory function and hair cell survival by a single administration of AAV-TMPRSS3 gene therapy in aged mice
  • Developing efficient and specific genome editing targeting microRNA mutation with high safety profile preserved long-term hearing

DEVELOPING NOVEL BIOMARKERS & DIAGNOSTIC TOOLS FOR IMPROVED SUB-CATEGORIZATION OF INNER EAR HEARING LOSS

2:30 pm Developing Disease-Specific Biomarkers to Sub-Type Acquired Hearing Disorders for Improved Therapeutic Interventions

  • Jianxin Bao Chief Executive Officer, Gateway Biotechnology Inc.

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

3:00 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

3:45 pm Chair’s Closing Remarks & End of Conference