What operators need from interiors across safety, accessibility, durability, cleaning and maintenance.
- Turning passenger and operational needs into measurable requirements
- Avoiding design decisions that create maintenance or compliance problems
- Building whole-life value into procurement
For sponsors and biotechs, momentum is everything but data privacy gaps have a way of surfacing at the worst possible moment in extremely costly ways. This session walks through three checkpoints where privacy oversights can bring progress to a halt: regulatory submission, site-level execution, and the eventual sale or licensing of trial IP.
- Submission: the privacy documentation and registration gaps that can delay or derail regulatory filings
- Site: where data protection responsibilities between sponsor, CRO and site most often break down
- Sale: why buyers and licensing partners are scrutinising data provenance and privacy compliance more closely, and how gaps can devalue or derail a deal
Participants will learn how to evaluate and optimize pediatric biomarker sampling strategies, apply a practical blood volume review framework, identify opportunities to reduce patient burden while preserving scientific value, and explore future innovations that enable more insight from less blood.
Workshop objectives:
- Recognize the impact of blood volume burden in pediatric clinical trials
- Evaluate protocol sampling requirements through a patient-centered lens
- Apply strategic biomarker sampling principles to balance scientific objectives with patient feasibility and operational considerations
- Identify opportunities to reduce blood volume without compromising study objectives
- Explore emerging innovations in sample collection and biomarker science
In this session will explore how the next generation of AI can move clinical development beyond search, dashboards, and isolated use cases toward intelligent workflows that help teams synthesize complex information, surface relevant insights, and act with greater speed and confidence.
Key Discussion Points:
- Move beyond AI experimentation to practical clinical impact, exploring where AI can meaningfully improve decisions across study design, feasibility, and site selection.
- Learn why AI is only as effective as the data and clinical context behind it and why fragmented inputs can limit even the most sophisticated models.
- Explore the shift from searching for information to working with intelligent clinical workflows that can synthesize complex data, surface insights, and help teams determine what to do next.
- Understand where AI should augment, not replace, human expertise, particularly for complex decisions involving investigators, sites, countries, and trial strategy.
- See what the next generation of clinical intelligence could look like when connected data, AI, and workflows come together to support faster, more confident decision-making.
This session will explore whether the FDA’s Real-Time Clinical Trials (RTCT) program is an aspirational vision for the future or a near-term reality that biotech companies should begin preparing for today. This session will discuss what sponsors can do now to position themselves for participation in this emerging real-time development model.
- Separate hype from reality: Examine FDA’s stated goals for RTCTs, the scope of the pilot program, and its potential opportunities and limitations.
- Understand the broad operational and technology requirements: Identify the critical capabilities needed for participation in the pilot program.
- Develop your biotech readiness roadmap: Discuss practical actions sponsors can take today to assess their organizational readiness and engage with FDA as the RTCT model evolves.
Hybrid operating models offer flexibility in how sponsors and CROs divide responsibilities, but success depends on how effectively those responsibilities are integrated across the study lifecycle. Drawing on lessons learned from a complex oncology clinical trial with an accelerated start-up timeline and sites selected before CRO engagement, this session explores practical strategies for establishing clear governance, coordinating sponsor- and CRO-managed functions, and creating a unified operational approach that accelerated site activation, supported first patient in, and sustained enrollment momentum despite a highly distributed delivery model.
The session will explore:
- Defining clear sponsor and CRO roles, governance structures, shared timelines, ownership, and decision-making frameworks to drive accountability and enable seamless execution within a hybrid operating model.
- Managing cross-functional vendors, technology integrations, and operational dependencies to proactively identify and mitigate execution risks.
- Building a unified sponsor-CRO approach for site engagement through aligned communication, coordinated oversight, and shared expectations to strengthen collaboration and enhance the site experience.
- Applying cross-functional readiness planning and proactive risk management strategies to accelerate study start-up, support first patient in, and drive enrollment success.
The “One, Big Beautiful Bill” introduces statutory changes that affect healthcare coverage and funding, with implications for patient access and participation in clinical research.
This session examines:
- Key provisions of the law from Medicaid and Tax reform to Orphan Drug Exclusion expansion
- Projected and potential impacts on patients and patient access, community based care settings, and equitable trial enrollment
- Practical perspectives on adapting to policy driven change and maintaining clinical research infrastructure
