Archives: Agenda

• 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

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: 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
2. Balancing innovation, speed, and risk in modern clinical development
   Hosted by George Naumov, Chief Operating Officer, RS Oncology
3. 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
   
4. Roundtable 4: The use of AI in cross-functional data review
   Hosted by Kevin Stephenson, Executive Director, Data Management, Karyopharm Therapeutics

To be in with a chance of winning our LinkedIn prize draw, post your most engaging and/or funniest photo from Day 1 of the conference on LinkedIn by 8:00pm on June 30^th.

Please include the hashtag #CTO and tag both:

• Clinical Trials in Oncology Event Series
• Arena International Events Group

We will shortlist three finalists, and the audience will vote for the winner during the Chairpersons’ Opening Remarks on Day 2.

Please note. You must be present in the room at 8:45am to claim the prize. If the winner is not present, the prize will be awarded to the next finalist in attendance.

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?

• Identifying the key decision points that shape an oncology program’s trajectory
• Making faster, more informed go/no-go decisions through cross-functional insights
• Recognizing differentiation opportunities and reducing development uncertainty early
• Accelerating development and strengthening competitive positioning in a crowded market

LinkedIn Prize Draw

To be in with a chance of winning our LinkedIn prize draw on day 2, post your most engaging and/or funniest photo from Day 1 of the conference on LinkedIn by 8:00pm on June 30^th.

Please include the hashtag #CTO and tag both:

• Clinical Trials in Oncology Event Series
• Arena International Events Group

We will shortlist three finalists, and the audience will vote for the winner during the Chairpersons’ Opening Remarks on Day 2.

Please note. You must be present in the room at 8:45am to claim the prize. If the winner is not present, the prize will be awarded to the next finalist in attendance.

• Changing how researchers select potential patients for better success rates
• How has regulation 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

• Integrating the right biomarker to narrow relevant patient groups and optimize and personalize disease management
• Engaging with the oncology community and advocacy groups to grow involvement of well-informed patients
• Leveraging investigator expertise for pragmatic trial designs and patient identification
• Building the evidence, from natural history to endpoint development, to support informed decisions by health authorities
• Modernizing criteria: Moving beyond traditional cut-offs to include underrepresented populations safely

Moderator: Nekia Clark, Director of Community Engagement & Outreach, Ellie Fund