DAY TWO

Workshop Day

Tuesday - July 15, 2025

8:00 am Registration & Light Breakfast

8:50 am Chair’s Opening Remarks

Cultivating Opportunities for Drug-Device Combination Approaches for the Advancement of Combination Treatments for the Inner Ear

9:00 am Panel Discussion: Exploring the Potential of Combination Treatments with Device-Based Pharmacological Therapies

  • Simon Chandler Chief Executive Officer, Rinri Therapeutics
  • Dan Giles Business Development Manager, Lineage Cell Therapeutics
  • Benson Jung Director of R&D, Spiral Therapeutics

Synopsis

  • Discussing the integration of device-based therapies and pharmacological treatments to treat medical conditions
  • How device-based therapies and pharmacological treatments can complement each other to maximize therapeutic effects
  • Ensuring the combined therapies do not interfere with each other or result in adverse interactions

9:45 am Round Table: Discussing the Advancements Drug/Device Combination Strategies for Targeted Drug Delivery and Hearing Preservation with Cochlear Implants

Synopsis

  • Exploring combining cochlear implants with therapeutic agents enhances the overall patient experience, offering a more complete solution for auditory restoration by addressing both hearing loss and related issues
  • Exploring clinical studies are critical for demonstrating the clinical benefits of drug/device combinations, with a focus on sustained release mechanisms

10:15 am Morning Break & Networking

Optimizing Preclinical Models & Endpoints to Accelerate Progress in Hearing Disorder Research & Therapeutic Development

11:00 am Harnessing Organoids, Explant Models, Cell Lines and Zebrafish to Advance Therapeutic Innovation

  • Brandon Cox Professor, Department of Pharmacology Southern Illinois, University School of Medicine

Synopsis

  • Exploring the potential and limitations of organoids, explant models and cell lines for preclinical testing and drug/viral screening
  • Using zebrafish for high throughput drug screening
  • How to use these innovative models to accelerate the development of targeted therapies for hearing loss

11:30 am Identifying What Makes for a Great Preclinical Audiology Program to allow for a Smooth Translational Process

Synopsis

  • How to create a robust research program for inner ear research
  • Creating reliable and suitable models for and inner ear preclinical program to ensure ease of transition into clinical work
  • How to make a watertight preclinical program that ensures reliability and drives investment  

12:00 pm Speaking Position Reserved for Turner Scientific

12:10 pm Lunch & Networking

Navigating the Complexities of Clinical Trials in Hearing Research to Improve Trial Design & Accelerate Therapy Development

1:00 pm Developing a Unique Patient Population for Clinical Studies of Hearing Loss and Tinnitus

  • Jianxin Bao Co-Founder & Chief Executive Officer, Gateway Biotechnology

Synopsis

  • Identifying a new patient group for use in audiology clinical trials
  • Using studies of populations that have hearing loss as a side effect of drilling treatment
  • Uncovering current research into new patient groups

1:30 pm Advancing Patient Monitoring to Expand the Radius of Treatment and Allow for Easier Recruitment

  • Masato Fujioka Professor and Chair, Department of Molecular Genetics, Kitasato University School of Medicine

Synopsis

  • How advancing technology has allowed for app technology to record progress in audiology trials
  • Overcoming Frequent in-person visits can be burdensome, especially for patients with mobility issues or busy schedules
  • Advancing direct communication channels between patients and the research team

2:00 pm Afternoon Break & Networking

Advancing from Preclinical Early Stages to Phase III & Beyond to Unlock New Treatment Options

2:30 pm Round Table: Advancing into Late-Phase Clinical Trials to Drive Breakthroughs in Gene Therapy Hearing Loss Treatment

Synopsis

  • Discuss regulatory considerations, safety monitoring, and efficacy endpoints critical for advancing gene therapy for hearing loss
  • Outline the strategies for success in late-stage trials to improve clinical outcome
  • What will the future look like after successful completion of a phase III trial 

3:00 pm Defining and Optimizing Clinical Endpoints to Drive Success in Hearing Disorder Trials

  • Colleen Le Prell Professor, Hearing Science & Department Chair, University of Texas at Dallas

Synopsis

  • Discussing endpoints measured using state-of-the-art technology and standard clinical test measures
  • Selecting outcomes that are meaningful to patients, clinicians, and researchers
  • Striving to come to consensus on clinical trial end points to avoid disparity in trial outcomes
  • Demystifying regulations, what do governing bodies want to see?

3:30 pm Chair’s Closing Remarks

3:40 pm End of Conference Day Two

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