John Massarelli

Company: myTomorrows

Job title: Pre-Approval Access Specialist

Seminars:

Expanded Access in Practice: Turning Demand into Strategic Opportunity 11:30 am

Discuss the role of Expanded Access (EA) in the treatment journey and its strategic importance for early-stage biopharma companies Analyze key regulatory frameworks and ethical considerations shaping EA, including recent legislation and expectations for transparency and accountability Assess internal capabilities and stakeholder dynamics required to manage EA effectively, including governance, resource planning, and external pressures…Read more

day: Pre-Conference Workshop Day

Presented by myTomorrows: Motivations for Pursuing Expanded Access: Strategic Value and Drivers for Stakeholders 2:00 pm

Explain the strategic benefits of initiating Expanded Access Programs (EAPs) early in drug development, including their role in generating real-world insights, informing clinical and commercial strategies, and supporting global access planning Identify key stakeholder engagement opportunities, including with KOLs, patient advocacy groups, regulators, payers, and internal teams, and describe how Expanded Access fosters collaboration, trust,…Read more

day: Conf Day One