Archives: Agenda

RT 1: AI and Vendor Proposals: Hype or Help?
Silvana Giro, Senior Management, Global Medical & Regulatory Affairs, Bracco Imaging

RT 2: Patient Engagement Tools That Actually Work
Behtash Bahador, Senior Director, Community Engagement & Partnerships, CISCRP

RT 3: Key Takeaways of Project Optimus
Karin Nordbladh, Director, Clinical Operation, Immune Oncology, Alligator Bioscience

• Why the oversight of CROs need an evolution
• Elevating the Strategic Role of the CRO: from oversight to influence
• Align: integrating risks across the organization
• Accelerate, enabling speed with confidence
• Governance design in practice

• Asthma is characterised by chronic airway inflammation and bronchial hyperreactivity. Despite treatment with inhaled corticosteroids and bronchodilators, a proportion of patients do not achieve adequate asthma control.
• Several cytokines and growth factors involved in asthma-related inflammation interact with Janus Kinase 1 (JAK1). Londamocitinib is a potent and selective inhaled JAK1 inhibitor designed for the treatment of asthma.
• In this FIH study, oral inhalation of Londamocitinib had an acceptable safety and tolerability profile in healthy volunteers and asthmatic patients.
• A 50% reduction in mean FeNO was seen in asthmatic patients after 3 days, which persisted until the last dose.
• This preliminary data demonstrates anti-inflammatory effects in the lungs with minimal systemic exposure of Londamocitinib, supporting the rationale for further studies to investigate the clinical efficacy of londamocitinib in patients with asthma.

With the increasing complexity of clinical trials, we are seeing a heightened responsibility and burden placed on both patients and sites. In this session, we will:

• Explore the latest insights on participant challenges and preferences, drawing on the latest CISCRP Perceptions & Insights Study
• Share what research sites are calling out as top priorities in supporting their patients and studies
• Showcase how patient- and site-centric solutions can reduce workload, enhance visibility, and streamline the clinical trial journey

What Patients and the Public Think: Insights on AI and Tech in Trials

As AI and emerging technologies reshape the clinical research landscape, understanding the perceptions and experiences of trial participants, patients, and the public is critical to building trust and improving trial success when these tools are used. Drawing on the latest CISCRP Perceptions & Insights bi-annual survey of over 12,000 respondents globally, this session explores concerns, expectations, and trial experiences on the use of AI and decentralized trial technologies. Practical approaches to the planning and use of these tools in research will also be shared, aligned with emerging patient-centric regulatory and good practice expectations.

• Defining what do we do well & what could be improved – EU vs US focus
• Planning & preparation within clinical trials – focus on phase 2/3
• Choosing the right trial designs for new inpatient studies
• How to achieve successful launch by building appropriate phase 3 program

Protocol amendments, slow enrolment, and late feasibility surprises aren’t failures of science, they’re failures of execution. In this session, we’ll show how Aika, Biorce’s AI-driven clinical trials assistant, applies real-world operational evidence to trial design decisions before problems surface. The session includes a live demo of Aika, illustrating how teams can identify execution risk early and design more predictable, scalable trials.