Archives: Agenda

• Expediting: Fast track, Breakthrough therapy, Accelerated approval, Priority review, RMAT
• Key considerations: Clinical evidence, surrogate endpoints, post-approval requirements
• Major health policy concerns around support for developing new oncology drugs
• Cost, access, regulation, public funding, balancing innovation with long-term care

Interactive roundtable sessions offer a unique opportunity to come together with your peers to share best practice and develop solutions to critical challenges facing the industry as a whole. Each discussion will be led by a table moderator and will focus on a different challenge within oncology clinical trials. Roundtables are an exciting, interactive way to build your personal network and learn from the experience and expertise of others.

After 30 minutes, delegates will have the opportunity to swap and choose a different table, and each roundtable will run twice.

1. Roundtable 1: Measuring success by assessing the effectiveness of your patient enrollment strategy
   Hosted by Irene Soto, Clinical Operations Expert
2. Roundtable 2: Advantages and challenges of conducting multi-regional clinical trials in oncology
   Hosted by Deepa Arora, Director, AJNA Therapeutics
3. Roundtable 3: Fine-tuning the site-sponsor partnership
   Hosted by Cecilia Tran Muchowski, Senior Director, Site Alliances, Genmab
4. Roundtable 4: Bringing innovation to clinical trials
   Hosted by Bobby Asem, Associate Director, ClinOps, Bluejay Therapeutics

• Navigate new regulatory requirements and complex study designs with larger sample sizes and a broader global footprint
• Implement country and site selection strategies that optimize FPI/LPI milestones
• Manage the complexities of enrollment, cohort management, safety review, and trial logistics across multiple regions
• Maintain a patient-centric approach to optimize study coordination and to benefit patients

• Oncology trials are growing in complexity, both in design and execution.
• Precision medicine is leading to hyper-fractionated patient populations in biomarker-driven studies.
• Sponsors and CROs must evolve their operating models to enhance patient centricity in this shifting landscape.
• This session presents a 360° Site Support model that puts patients at the center — with proven success in oncology trials.

• Chronicles of a site whisperer: Unlocking underperforming trials through connection
• Front-loading focus: Proactive engagement for study success
• Partnership greenhouse: Cultivating strong site relationships
• Safety net navigator: Why escalation pathways matter

• Defining what do we do well and what could be improved – EU vs US focus
• Planning and preparation within oncology drug trials – focus on phase 2/3
• Choosing the right trial designs for rare disease studies
• How to achieve a successful launch by building appropriate phase 3