DIA 2024 Global Annual Meeting

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-588-L04-P; CME 1.00; RN 1.00

Increasingly, biopharmas are integrating patient engagement across their corporations in ways that address shared priorities with patient communities. Additionally, they are also increasing the transparency related to delivering on these commitments, including but not limited to, the percent of clinical trials that are informed by patients. This workshop will discuss approaches taken by various companies, the role of advocates, and their perspectives on the importance of achieving meaningful patient engagement, along with the steps necessary to achieve the goals.

Learning Objectives

Describe how to bring together key stakeholders to evaluate how, and where, patient engagement can be fully integrated to address what matters most to patients; Describe how to move beyond patients informing select clinical trials to 100% of a portfolio; Identify how to align resources, capabilities and change management needs to deliver on the vision; Discuss how to communicate and monitor the impact of engagement strategies.

Chair

Victoria DiBiaso, BSN, MPH, RN

Speaker

Implementable Approaches to Fully Integrating Patient Engagement Across an Entire Company: Including all Clinical Trials
Tracey Robertson, MBA

Patient Perspective
Hollie Schmidt, MS

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-600-L04-P; CME 1.00; RN 1.00

This workshop will assist attendees with ways to properly accommodate medically complex and/or rare disease patients through providing accessibility tools and solutions. Soft skills and “person first” language will be discussed.

Learning Objectives

Identify how to expand the definition of diversity; Describe how to have conversations with patients about disabilities; Explore solutions and recommendations for no/low-cost actions you can take to make your facility as accessible as possible for a variety of disabilities; Define resources for support and training for site staff.

Chair

Stacy Hurt, MBA, MHA

Speaker

Facilitator
Carlos Orantes, MBA

Facilitator
Cecile Gonzalez-Cerimele

Facilitator
Mindy Cameron

Component Type: Workshop
Level: Intermediate

Clinical trial simulations are a valuable and insightful methodology in understanding the patient experience during a clinical trial. Discussion will focus on strategies in operationalizing clinical trial simulations to inform clinical trial design.

Learning Objectives

Discuss how to derive and operationalize insights from patients and caregivers from clinical trial simulations; Explain strategies on how insights can impact clinical trial design and operation.

Chair

Wesley D Peters, MS

Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-24-651-L04-P; CME 1.00; RN 1.00

Challenge areas for developing patient-centered sensor-based outcomes (SBOs) will be identified, along with solutions and key considerations using real-world examples of SBO development.

Learning Objectives

Describe key challenges to leveraging the patient-focused drug development (PFDD) guidance series to develop fit-for-purpose, patient-centered sensor-based outcomes (SBOs, eg, wearables) to support medical product development and decision making; Identify potential solutions to inform development of fit-for-purpose, patient-centered SBOs.

Chair

Katelyn R Keyloun, PharmD, MS

Speaker

Sensor-Based Outcome Measure Development: Challenge Areas for Concept Elicitation and Interpretation of Endpoints
Bill Byrom, PhD

FDA Update
Michelle Campbell, PhD

EMA Update
Steffen Thirstrup, MD, PhD