As neuroscience trials grow in complexity, a tailored approach to decentralized clinical trial (DCT) elements is essential. This session explores how innovations such as remote assessments, home nursing, and digital recruitment are being selectively applied across diverse neurological conditions—including Alzheimer’s, MS, Parkinson’s, and rare diseases. Drawing on real-world examples, we’ll examine which tactics are delivering true value for patients and sites, and which remain unproven. Attendees will gain practical insights into balancing patient-centricity, scientific rigor, and operational feasibility—learning why “one size fits all” doesn’t work, and how early, systematic assessment drives success in a rapidly evolving landscape.

This presentation explores the value of doing a “mock patient” protocol walkthrough as a tool for uncovering hidden operational burdens that traditional feasibility reviews often miss. By stepping through visits, procedures, and logistics from the patient’s perspective, the team identified unexpected pain points and redesigned assessments to reduce friction. Attendees will gain practical guidance on conducting trial walkthroughs, interpreting findings, and using them to streamline visits to hopefully minimize burden on both patients and research sites.

This talk explores the unique challenges of psychedelic and mental-health studies, where patient mindset, setting, and the support of the clinical study team play a critical role in both participant well-being and data quality. It highlights practical approaches to improving comfort and engagement—such as thoughtful environment design and extended visit support—while emphasizing that informed consent is an ongoing process rather than a one-time event. The session also demonstrates how small protocol refinements and closer coordination with study sites can foster trust, reduce anxiety, and create more ethical, sustainable, and human-centered trial experiences.

Offering a frontline view from psychiatric research sites, this session highlights the unique challenges of recruitment and retention in mental health clinical trials and approaches site can incorporate to overcome them.  From protocol development to trail execution, understand what a truly patient-centric trial looks like. Explore communication frameworks and trust-building practices. Learn where sites encounter constraints and what sponsors can do differently to improve trial continuity and participant satisfaction.

This session explores how meaningful patient and caregiver engagement can reshape study design in neurology and mental health trials. It covers tools and approaches—such as simplified visit guides, scheduling aids, digital reminders, and caretaker-support resources—that reduce burden and strengthen adherence. Drawing on lessons from ALS, CNS, and complex progressive-disease studies, it demonstrates how early input and structured engagement can improve feasibility, reduce attrition, and support the realities of daily life for participants and caregivers.

Organizations with complementary capabilities can, when aligned in the right context, create synergies that advance clinical research. Achieving this, however, requires thoughtful planning, intentional collaboration, humility, and a shared commitment to the mission. DCRI and IQVIA have initiated a prospective collaboration to accelerate the advancement of obesity-related clinical research that emphasizes synthesis of scientific, operational, and data-informed decision making, unique site-relationships, and impactful dissemination of insights.

Point-of-Care Testing (POCT) is rapidly gaining traction in clinical trials due to its speed, portability, convenience, and ease of use. Nowhere is this more evident than in obesity and metabolic programs, which leverage POCT to improve patient experience, reduce screen failures, and expedite operations. This talk will cover the history of POCT as well as specific examples of its use case in MASH/MASLD trials, which have seen significant activity over the past few years.

Learnings from the UK’s first clinical trial delivery accelerator—the UK Vaccine Innovation Pathway—are being translated to accelerate obesity trials in the UK. This trailblazing programme has created a new blueprint for delivery of large-scale, community-based trials. This session explores how clinical expertise, operational leadership, enhanced inclusivity, and optimized research delivery facilities, services, and settings emerged as the key components for delivering efficient obesity trials.

As digital capabilities evolve and AI matures, it is critical to understand how to maximize value from the wide array of tools available. We will discuss some of the areas in clinical development where AI can bring value, and how to achieve that value.

Oncology clinical trials remain among the most complex research endeavors, requiring rigorous oversight of ethical, regulatory, and operational processes. Despite advances in study design, regulatory workflows often lag behind, resulting in delays in Institutional Review Board (IRB) approvals, incomplete submissions, and protocol deviations. These inefficiencies extend trial timelines and restrict patient access to innovative therapies. There is a critical need to explore emerging technologies—particularly artificial intelligence (AI)—to streamline compliance and improve accuracy.

This presentation explores strategies for embedding patient and advocacy perspectives across the oncology trial lifecycle. We will outline a roadmap for when and how to engage patients in oncology trials and share proven methods for gathering meaningful patient input. Two real-world case studies will highlight cross-functional collaboration in action: the co-creation of a pediatric oncology patient-facing trial brochure, and the use of a patient-centric risk assessment tool to improve study design and execution. Attendees will gain actionable insights into the importance of incorporating patient advocacy and experience data early to enhance trial relevance, feasibility, and patient outcomes.

Drug discovery is becoming slower and more expensive over time, a trend known as Eroom's Law. This presentation will explore how we can reshape the timelines and costs of drug discovery research by leveraging artificial intelligence (AI) and real-world data (RWD). We will discuss how a full-stack AI approach can be used for end-to-end integration, from identifying targets and pathways to clinical trial simulations.

I will also provide a case study on REC-1245, a drug candidate for biomarker-enriched solid tumors and lymphoma, to illustrate how our “ClinTech” efforts using AI and RWD can accelerate the development of high-potential programs. We'll highlight how this approach uses RWD to identify quality sites for faster enrollment and applies causal AI modeling to explore potential additional indications.

Novel clinical trial methods include technology and artificial intelligence-enabled tools and are starting to impact the development and delivery of clinical trials. We will discuss tools and real-world use cases that relate to protocol development, participant recruitment, and endpoint data collection.

This closing panel, moderated by Ariel Bourla, MD, PhD, Executive Director, Head of Solid Tumor Oncology, Data Science and Digital Health at Johnson & Johnson, brings together experts from across the program to synthesize insights on precision medicine, decentralized trial models, and AI-driven innovation. Panelists will reflect on advances in biomarker testing, evolving trial designs, and the transformative role of artificial intelligence in discovery and development. The discussion will highlight opportunities, challenges, and collaborative strategies shaping the future of oncology research and patient care.

Community adoption of cell & gene therapies such as CAR T therapy is critical to expanding patient access beyond academic centers. While CAR T has traditionally been concentrated in large institutions, a significant portion of patients are managed in community settings, creating a misalignment between where general oncology care occurs and where CAR T is administered. The evolution from streamlined referrals to collaborative care models to now enablement of administration in community sites highlights the need to address barriers that have historically limited growth in supporting cell and gene therapy (CGT) in the community channel.

Pharma and biotech companies have gained valuable lessons from CAR T and CGT commercialization, highlighting both opportunities and the growing need to expand into community settings. While academic centers have historically dominated clinical trial enrollment, efforts such as BMS’s OUTREACH trial demonstrate how trials can be successfully conducted in community sites despite challenges such as fragmented patient populations and continued reliance on academic institutions for volume and data. These experiences underscore the importance of strategic planning when designing trials and selecting sites, particularly as the industry evaluates whether investments in community-based trials will translate into commercial success.

Community involvement in CAR T therapy is gaining momentum, with practices beginning to explore how to effectively onboard and adopt these treatments in outpatient settings. Starting this journey requires a clear understanding of what is needed, from infrastructure and clinical training to operational workflows, and learning from best practices already established by early adopters. Successful implementation hinges on building clinical confidence, ensuring access to necessary resources, and fostering collaboration with academic centers and manufacturers. While challenges remain, this growing trend signals a significant opportunity for practices to position themselves as leaders in delivering advanced therapies closer to patients.

Driving CAR T and CGT adoption requires coordinated solutions across various stakeholders involved in the patient journey.  Biopharma companies must deepen engagement with community practices and invest in education and operational support. Third-party entities and accreditation bodies play a critical role in ensuring compliance and quality. Partnerships with apheresis and blood centers are essential to streamline logistics, and consulting organizations guide sites through readiness and workflow optimization. Payer and policy collaboration are key to addressing coverage, reimbursement, and network inclusion challenges. By aligning these efforts, industry can accelerate community integration and create a more sustainable, patient-centric model for advanced therapies.