Archives: Agenda

• Understand the benefits, optimal use cases and best scenarios for master protocols
• Maximize trial operations with improved coordination and more sub-study opportunities
• Enhance data collection and sharing, broadening patient access to new therapies
• Navigate strategic relationships for safe and successful master protocol research

• Identify and eliminate “white space”.  Spot gaps between strategic planning and operational execution and apply techniques to streamline transitions across the clinical development lifecycle.
• Understand how early consulting and clinical pharmacology services work together to enhance strategy and execution. Understand when and how to engage to shape a cohesive development pathway, improve timing, and accelerate decision-making.
• Align scientific, regulatory, and clinical perspectives from the outset. Explore the benefits of integrated teams in a CRO setting to ensure continuity, reduce delays, and support end-to-end development.
• Connect strategic and operational elements across development stages. Gain practical insights into bridging planning, execution, and transition phases for smoother progression and better outcomes.

• Planning for a successful sponsor/CRO relationship
• Defining goals, priorities and metrics
• Considerations when contemplating a CRO transition
• Overview of common challenges and pitfalls in CRO transitions
• Developing a detailed transition plan to minimize disruptions and ensure continuity

• Coping with layoffs and budget cuts
• Are we expecting droughts for research in the biotech space?
• Diversifying funding and partnership strategies to reduce financial risk
• Strengthening operational agility to respond quickly to market and policy disruptions

MODERATOR Rich Polgar, Managing Director, Danforth Health

• Understand the key points of recent FDA guidance aimed at enhancing diversity and equity in clinical trials
• Discuss how recent FDA guidance supports patient optionality in clinical trials, especially for underrepresented populations
• Identify actionable strategies for integrating FDA guidance into clinical trial designs to achieve diversity and innovation goals
• Explore the potential impact of FDA guidance on future clinical trials, with an emphasis on patient-centricity and inclusivity

• Ensuring your trial is both cost-conscious and efficient without compromising on quality
• Techniques, processes and technology to improve forecasting and budgeting
• Avoiding common mistakes to keep your clinical trial budget on track

As with all industries, artificial intelligence is generating significant buzz in the clinical research space. But where does it offer meaningful impact today, and where is there still work to be done? In this session, we’ll explore the practical realities of applying AI tools within the context of electronic clinical outcomes assessment data, from operational efficiencies like study setup and translation to the future promise of patient-facing applications. Join us for an honest look at what’s achievable now, what’s emerging, and how to think strategically about this fast-moving future.