Archives: Agenda

• Overview of IO Biotech’s cancer vaccine clinical development strategy and ongoing Phase 2/3 programs across melanoma, lung, and head and neck cancer
• Key clinical milestones, including enrolment completion and efficacy/safety outcomes with vaccine + anti PD 1 combinations
• Operational considerations for executing multi cohort, global vaccine trials with complex neoadjuvant/adjuvant endpoints
• Insights on aligning clinical execution with regulatory strategy and preparing for potential registrational milestones

• The continued development and commercial feasibility of cell and gene therapies require access to the community setting
• With current downward pressures on academic research institutions in the U.S., community sites are ideally primed to help support and drive this clinical development
• Through innovative, strategic positioning of sites, sponsors and vendors, community access to these therapies can accelerate development through increased data collection

• Changing how researchers select potential patients for better success rates
• How has regulatory changed and what to expect?
• How to improve drug efficacy and patient safety before it’s too late
• Back to square one: Differentiating with simpler, patient-centric protocols and optimized study design
• Avoiding disappointing results by implementing the right technology tools to advance your trial
• Lessons learned to mitigate trial failures

Moderator: Keya Watkins, President – Oncology, Worldwide Clinical Trials

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

Roundtable 1: Making RECIST Work for You: Why you should be using RECIST Plus in your clinical trials

Hosted by Dr. Rick Patt, Vice President, Medical & Scientific Affairs, RadMD

Roundtable 2: ClinOps challenges in a digital age

Hosted by George Naumov, Chief Operating Officer, RS Oncology

Roundtable 3: SITE PERSPECTIVE: Working smarter with legal on clinical trial agreements

Faraz Siddiqui will draw on his experience advising pharmaceutical companies to demystify clinical trial agreements for non-attorney leaders. This workshop is designed for business and Clinical Operations professionals who want a clearer, practical understanding of how these agreements work—and how to collaborate more effectively with their legal teams throughout the process by discussing common negotiation points; key areas of risks; and strategies to streamline interactions with counsel. This session is intended for educational purposes only and does not constitute legal advice.

Hosted by Faraz Siddiq, Assistant General Counsel – EDD, Memorial Sloan Kettering Cancer Center

Roundtable 4: The use of AI in cross-functional data review

Hosted by Kevin Stephenson, Executive Director, Data Management, Karyopharm Therapeutics

Best 3 LinkedIn posts from day 1 with hashtag #CTO and @Clinical Trials in Oncology Event Series tagged will win a prize in day 2 morning’s prize draw during chair’s opening remarks. Deadline end of drinks reception day 1. You must be present to win!

This session will explore recent findings from the Tufts Center for the Study of Drug Development (CSDD) on the current landscape of decentralized clinical trial (DCT) solutions, addressing key questions including:

• How are DCT solutions being funded, and to what extent?
• How are resources being deployed for DCT implementation across research site types?
• Which DCT solutions are most heavily funded and supported?
• What are participant and site perspectives on direct-to-participant investigational products – what’s working and what’s challenging?