Archives: Agenda

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 operations. Roundtables will take place in the Stream A conference room.

ROUNDTABLE 1: Navigating biological material regulations

Sean D. Smith, Biological Threat Exclusion Coordinator (BTEC), US Customs and Border Protection

ROUNDTABLE 2: Keeping patients at the heart of your clinical trial

Behtash Bahador, Senior Director, Community Engagement & Partnerships, CISCRP

ROUNDTABLE 3: Fostering a positive relationship with your CRO and vendor partners

Liza Micioni, Director, Clinical Operations, Tris Pharma

ROUNDTABLE 4: Negotiation tips for emerging startups

• 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.

• 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

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.

• 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

• 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