From Protocol Design to Partnerships
Earlier this month, I had the privilege of chairing the Clinical Trials in Oncology East Coast conference in Boston. With over 280 professionals in attendance—from clinical operations leaders and medical affairs experts to regulatory specialists and vendor partners—the event was a powerful reminder of how aligned our community is in its mission to improve outcomes in oncology.
I also had the opportunity to facilitate five sessions, including a fireside chat with Dora Ferrari of Curis on “Solving challenges for operational excellence in early-phase oncology trials.” The energy, collaboration, and shared commitment to innovation were palpable throughout the two-day event.
Panel and roundtable highlights
The conference featured a dynamic mix of panel sessions and roundtable discussions, both of which surfaced some of the most pressing challenges and promising strategies in oncology clinical trials.
Panel sessions
Our panels brought together thought leaders from across the industry to explore how regulatory shifts—particularly around dose optimization—are reshaping trial design and execution. These conversations emphasized the need for:
- Adaptive trial designs that enable faster, data-driven decisions
- Operational flexibility in response to evolving regulatory demands
- Global trial strategies that account for geopolitical instability and patient access
These sessions reinforced the importance of designing trials that are not only scientifically sound but also operationally feasible and patient-centered.
Roundtable discussions
The roundtable sessions on Day 2 were a standout. These rotating, expert-led discussions allowed attendees to engage in candid, cross-functional conversations on five key topics:
- Trial design strategies
- Budget optimization
- AI adoption in clinical research
- Imaging in oncology trials
- Decentralized and hybrid trial models
These sessions were rich with insight and sparked meaningful dialogue across sponsor, CRO, and technology perspectives.
Smarter Protocol Design
A recurring theme throughout the conference was the evolution of protocol design in response to regulatory and operational complexity. Several sessions focused on how dose optimization is influencing trial structure and execution.
Key takeaways included:
Neoadjuvant vs. adjuvant settings: Understanding which trial designs are best positioned to deliver meaningful outcomes
Sample size considerations: Smaller sample sizes in early-phase trials can still yield robust data, especially in today’s funding environment
Adaptive designs: Embracing flexibility to support quicker decision-making and early efficacy signals
Global trial design: Navigating geopolitical hurdles to ensure trials reach patients in underserved regions
The consensus was clear: protocols must be strategically designed to balance innovation, feasibility, and patient access.
Strengthening sponsor and CRO partnerships
Another major focus was how to build more effective and transparent sponsor-CRO relationships—especially in today’s financially constrained environment.
RFP best practices
We heard from companies like Karyopharm about how they approach vendor selection using objective scoring models that prioritize:
- Indication-specific expertise
- Responsiveness and flexibility
- Transparency in budgeting, including assumptions, rate changes, and inflation calculations
This structured approach helps ensure alignment from the outset and sets the tone for a successful partnership.
Budget fluency and communication
One of the most consistent themes I heard was the need for greater budget fluency. From my perspective—and echoed by many attendees—understanding how a CRO budget is built is foundational to building trust.
Too often, sponsors are left trying to decipher inconsistent budget formats or unexplained cost variations. This lack of clarity can create unnecessary tension, slow down decision-making, and—according to many sponsors—erode trust through inconsistent assumptions that make it difficult to compare bids or plan effectively.
There was also a lively debate around unit-based vs. milestone-based budgeting models. In today’s environment—where regulatory delays and patient access challenges are increasingly common—many questioned whether traditional models still make sense. Personally, I believe there’s no one-size-fits-all solution, but transparency and adaptability must be at the core of any financial partnership.
Ultimately, open communication from the outset is what sets successful collaborations apart. When both sides understand the financial framework and feel confident in the process, it creates the space to focus on what really matters: delivering high-quality, patient-centered oncology trials.
Culture as a catalyst
One of the most impactful sessions came from Dr. Giovanni Abbadessa, CMO at Modex Therapeutics, who spoke about the role of culture in biotech success. He shared stories of promising assets that failed—not because of science, but due to poor planning, unclear objectives, and weak internal alignment.
His message resonated deeply with me. At Catalyst Oncology, we believe that a strong, mission-driven culture is just as critical as scientific rigor. It shapes how we collaborate, how we deliver, and ultimately, how we support our clients and their patients. I’m proud to lead a team that lives this every day.
This year’s conference reaffirmed what I’ve long believed: while oncology research is complex, our community is more aligned than ever in its pursuit of smarter, faster, and more inclusive trials.
I left Boston energized by the conversations, inspired by the collaboration, and proud to be part of a team at Catalyst that’s committed to moving science forward—through innovation, transparency, and a relentless focus on patients.
