Archives: Agenda

• What is realistic, what isn’t, and how can you stay ahead of the curve?
• How biotech and pharma differ when it comes to technology and innovation: as a biotech, where should your priorities lie?
• Staying ahead of competitors when funding and resources are limited for technology investment
• Leveraging agility and flexibility to adopt technology quickly
• Balancing innovation with risk management and scalable development

MODERATOR Jay Russak, Former Senior Director, Clinical Operations, Keros Therapeutics

• Uncovering the invisible: a 20-year analysis of medically underrepresented populations in clinical trials
• Benchmarking against the US census reveals structural gaps and needs
• Adopt a six-pillar architecture to embed equity from the ground up

• Streamlining feasibility, site selection and qualification processes to minimize delays
• Leveraging technology to manage documents, workflows and communication
• Identifying common bottlenecks and strategies to overcome them proactively
• Aligning sponsor, CRO and site teams to ensure clarity from day one

• How to build a strong CRO onboarding plan that sets your study up for success
• Making your kickoff meeting count: aligning teams, timelines, and expectations
• Fast-tracking your study start-up — from project plan to site activation
• Anticipating and mitigating early risks to protect your study timelines

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

• 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.