Archives: Agenda

• Moving studies forward on unknown territory: Funding clinical trials amidst recent research policy changes and abrupt NIH cuts
• Shining light on the changing scope of the FDA: Discussion of the latest changes under the new administration including years of critical DEI work
• Technological developments into 2026 and beyond: what changes can we expect to see in the next 3-5 years?
• Navigating the constantly evolving vendor and CRO landscape as a small to mid-sized sponsor company

Moderator: Robert Loll, SVP, Business Development & Strategic Planning, Praxis

• Organizational Updates
• Nationalized Entry Review
• Pharmaceuticals import and entry transmission compliance requirements
• Biologics import and entry transmission compliance requirements

• Integrating central lab expertise early in trial design to avoid fragmented workflows and costly delays
• Enhancing trial efficiency and biomarker strategy through proactive collaboration with laboratory partners
• Positioning lab providers as co-authors of research success, offering insights on biomarkers, assays, sample logistics, and data flow
• Ensuring protocols are both scientifically robust and operationally feasible by embedding lab considerations from the outset

• Today’s clinical trials are becoming more complex, trending towards patient-centric approaches and biomarker-driven designs
• Higher burdens are put on sites and patients to adhere to the protocols
• We present a comprehensive site support model that reduces burdens on investigators, site clinical research staff and patients, increasing protocol compliance and data quality.

• Overcoming financial constraints when budgets are limited and resources tight
• Fierce site competition: How start-ups can compete with established companies for sites
• Utilizing effective planning to improve study and program efficiency without compromising patient safety
• Agile and adaptable: Being prepared to adjust your strategy and approach as needed

• Understand what often goes unseen in site networks, including turnover, burnout, and uneven site support, and how these issues impact delivery
• Learn how to evaluate CRO and network partners beyond surface-level metrics like site count and start-up timelines
• Explore why sustainable site relationships depend on consistency, communication, and shared goals rather than financial incentives alone
• Hear real-world insights into the operational strain sites face and how sponsors can better align with what sites truly need to succeed
• Gain a more realistic, strategic framework for assessing site networks before outsourcing decisions are made

• How do we look at data transparency issues when scaling AI?
• Case study on AI rights and a look at recently released survey discussing where things need to change
• Without GDPR, what can be done to protect patients regarding data sovereignty?
• Delving into the unique and amplified challenges for AI risk assessment
• How can we effectively leverage AI in our heavily regulated environment?

• Current biotech funding and pipeline trends shaping early and late phase development
• How market dynamics are influencing trial initiation and program design in 2025
• Shifts in CRO selection and strategic approaches among emerging biotechs