Conference Day 2
CANCELLED
9:25 am Chair’s Opening Remarks
Advancing Bioelectric Medicine Development & Adoption by Mitigating Against Reimbursement Barriers
9:30 am Tackling & Assessing Coverage
Synopsis
- Understand customer’s needs: What do doctors need to see?
- Determining the data required to demonstrate to insurers
- Navigating the future landscape for coverage following the move towards efficiency
10:00 am Step by Step Approach to Position Bioelectric for Optimum Fundraising
Synopsis
- De-risking bioelectric to be better suited for capital investment from real investors
- What is the clinical, regulatory, and commercial strategy so bioelectric medicines are more recognized?
- Comparing and contrasting implantable Vs non-implantable
10:30 am Morning Break & Networking
11:30 am Roundtable Discussion: Reflecting on Experiences with Insurers to Establish Solutions
Synopsis
- What is the process and reimbursement strategy for devices that don’t qualify as breakthrough?
- Delving into devices which improve procedural workflow and enhance profitability but lack strong reimbursement qualifications
- Payments out of DRGs Vs insurance companies
Reimagining Clinical Trial Design & Determining the Role of RWE to Maximize Device Development & Increase Likelihood of Approvals
12:00 pm Maximizing Impact of Data by Leveraging Clinical Studies & Real-World Evidence
Synopsis
- Understanding nuances in different devices, mechanisms of action and intended use cases
- Evaluating optimal dosing
- Reviewing previous data and identifying lessons learned
12:30 pm Lunch Break & Networking
1:30 pm Lessons from the Front: Use of RWE in Indication Expansion for Devices
Synopsis
- Reviewing FDA checklists for RWE
- Determining the role of RWE for bioelectric medicine
- Challenges in outcome selection: Comparator Group
- Delving into the regulatory learnings using reflections and current processes
2:00 pm Roundtable Discussion: Optimizing Clinical Trials to Reduce Costs & Reduce Time Taken
Synopsis
- Modifying trials for faster approval
- Maintaining the integrity of the devices by not altering the parameters
- Demonstrating robust models that could be leaned into to demonstrate proof of the clinical aspects
2:30 pm Afternoon Break & Networking
3:00 pm Approach Towards Designing Non-Invasive Bioelectric Medicine Studies for Alzheimer’s Disease
Synopsis
- Discussing the combination of clinical and biomarker outcomes to demonstrate efficacy and proof of biology
- Demonstrating target engagement
- Highlighting the results of early human studies that helped establish elements of a larger pivotal trial
3:30 pm Roundtable Discussion: Clearly Defining the Disease Indication for Each Neuromodulation Device
Synopsis
- Specifying the category within the ICD that the device fits under
- How to approach the CDC to establish a new category?