PRE-CONFERENCE WORKSHOP DAY

8:00 am Check-In & Coffee

Synopsis

Light Breakfast Served

WORKSHOP A – 09.00

9:05 am Demonstrating the Value of the Patient Engagement Function to Receive Internal Buy-In & Enhance Job Role Stability

Synopsis

  • Exploring metrics that drive value recognition to build internal allies
  • Overcoming executive focus on product-only investments and strategies for promoting broader patient advocacy adoption
  • Analysing the challenges of demonstrating the necessity of the patient engagement function in a smaller biotech company when budgets are tight
  • Setting up effective patient advocacy practices without direct product or scientific ties
  • Translating the value of patient advocacy in commercially focused environments

12:00 pm Morning Break & Networking

Synopsis

Hot Lunch Served

WORKSHOP B – 12:00

Standardizing Patient Engagement Metrics for Regulatory Submissions

  • Maria Marano Associate Program Director, PFMD
  • Karin Mitchell Director, Advocacy & Patient Reimbursement Services, Omeros Corporation
  • Paula Hines Senior Director, Regulatory Affairs, Teva Pharmaceuticals
  • Giulia Ghibellini Patient Focused Medical Engagement, Lead Global Medical Affairs, Teva Pharmaceuticals

Synopsis

  • Understanding the FDA’s requirements for patient experience data in NDAs
  • Defining key metrics that satisfy both regulatory and commercial needs
  • Demonstrating the financial and clinical ROI of patient engagement activities
  • Exploring case studies on how pharma companies are securing regulatory approvals with patient data

Discussing questions such as:

  • How can we measure PE to add value to regulatory submissions, what should we be measuring, are we measuring the wrong things, how do we innovate the way we are quantify the input from patient community in a way that regulatory bodies will accept, and are there any roles that have been put out about engaging with patient advocacy stakeholders?

4:00 pm End of Pre-Conference Workshop Day