Archives: Agenda

• 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.

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.

• 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

• Evaluating CRO capabilities and experience relevant to your specific therapeutic area and development stage
• Balancing cost, quality and timelines within tight budget constraints
• Negotiating contracts with flexibility to protect your biotech’s goals

• An overview of common challenges and how to overcome these
• Securing initial funding: navigating opportunities available to raise capital
• Overcoming early stage hurdles
• Building strategic partnerships to support your biotech

• Navigating global data restrictions: Lowering concerns and finding solutions regarding the limitations on research imposed by GDPR in the EU
• Sharing best practice for scaling studies across multiple states and countries despite a lack of consistency with regulations
• Looking at the intersection of data privacy and sample ownership regulations with the business imperative to address new questions that may arise during study analysis
• Addressing concerns at the protocol and ICF development phase

• Considerations during EDC vendor selection
• Operational and technical considerations when implementing Patient Reported Outcomes measures
• Outsourced/Hybrid/Insourced EDC development models- cost and operational considerations

• What forced me to think strategically about clinical research training methodology
• Gaps & Risks of ‘check-the-box’ training
• Initial impact of Simulation-Based training on risk mitigation, Site time, Satisfaction, Enrollment and Quality
• Advances in Simulation-Based training that enhance site and patient engagement as well as optimize protocols

• Identifying outsourcing opportunities and pitfalls to avoid that can be addressed through AI driven solutions: timeline standards, document prep and system utilization
• Developing operationally, process and system driven AI models to support clinical operations and outsourcing: what can be streamlined?
• Integrating AI insights into outsourcing strategy to drive speed, quality and cost effectiveness: timelines, project management and reconciliation