Archives: Agenda

• Discuss how patient insurance in the United States can impact a clinical trial patient’s experience in accessing therapies (i.e. SOC, comparators)
• Discuss how companies are currently addressing improving Diversity Equity and Inclusion (DEI) in clinical trials and how appropriate medication access can support DEI
• Supply chain considerations and optimizing the patient experience
• FDA guidance on DEI plans for clinical trials

• What are the latest technological advances and innovative systems adopted by the industry that can enhance cold chain distribution: What should be on your radar?
• Hot topic in cold chain logistics: Sustainability – Aligning market growth with responsible practices to ensure businesses are making smarter decisions regarding the planet
• Efficiently and effectively outsourcing management of temperature-sensitive materials to ensure your cold chain is never compromised
• Expanding capacity on cold chain resources and enhancing end-to-end management to keep up with increasing demand and limited supplies

Increasingly pharmaceutical companies are committing to reduce their carbon footprints in the execution of clinical trials. This session will cover how implementing innovative clinical trial supply technologies and sustainable processes can:

• result in a more efficient use of human resources
• reduce the number of logistical resources required
• reduce waste
• save money
• lower the carbon footprint impact

• Correcting common errors when importing drugs and devices into the United States.
• How to communicate with FDA when your shipments are on hold?
• Understanding the complexity of filing an FDA electronic entry.
• Getting to know your FDA management staff when importing through the West Coast.

During the roundtable discussion session, the conference hall will be divided into four ‘zones’. Delegates can choose which zone they would like to join. Each zone will be led by a table moderator and will focus on a different challenge within clinical data management. After 45 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

ROUNDTABLE 1
Overcoming challenges in patient identification for ultra rare diseases
Kenneth Harvey, Director Clinical Operations, Epic Bio

ROUNDTABLE 2
Exploring strategies for building greater DE&I in rare disease trials
Aditi Kantipuly, MD, MS, Physician, Visiting Scholar University of New Mexico

ROUNDTABLE 3
Crafting recruitment strategies for rare disease trials
Patrick Shores, Senior Director of Sales, Leapcure

• Where rare disease trial sponsors can step in to fill scientific advice gap and teach patients about their condition
• The importance of making patients feel cared for throughout and beyond trial participation
• How rare disease trials differ from other clinical trials when it comes to supporting patients in understanding and managing their disease long term

• Understanding successful protocol design trends and competitive activity in the rare disease space
• Utilizing data analytics and benchmark models for assessing geographic feasibility, timelines, enrollment, and trials cost forecasting
• Improving subject accrual and the site selection process
• Execution phase and beyond – tracking investigators and competitive trials, mitigating potential complications

• Involving patients in trial design to ensure that trial outcomes are relevant and meaningful to patients
• Patient-centric approach: integrating patient feedback and needs into research
• Building a collaborative network