Helping to Bring Cancer Therapies to Patients. Catalyst Oncology is a niche oncology CRO devoting time, energy, and capital to supporting biotechs in bringing next-generation therapies to patients in need.

The new era of early-phase oncology development requires a solid understanding of the requirements and potential challenges, along with a strong command of the strategies to mitigate risks and ensure success. 

Oncology drug development continues to increase in complexity. Large CROs are well-suited for less complex therapeutic areas but weren’t established to operate in the current paradigm. A specialty oncology CRO has the expertise to understand and proactively manage the growing challenges.

Network models for large CROs tend to focus on high volume and big data. Catalyst Oncology’s early-phase site network disrupts the status quo and focuses on dedicated relationships with sites and sponsors, site advocacy, and reducing the site burden.

Imagine a world where cancer treatments are more effective while also being safer for patients. This vision is quickly becoming a reality with Project Optimus, the FDA’s groundbreaking initiative from its Oncology Center of Excellence. 

The FDA’s Project Optimus initiative recommends oncology drug developers move away from traditional approaches of determining the maximum tolerated dose to building dose optimization strategies into clinical development plans that balance safety, tolerability and efficacy.

The early-phase oncology clinical trial landscape is evolving, influenced by shifts in regulatory guidance such as Project Optimus and multiregional clinical development programs. This event provides valuable insights into overcoming the common hurdles faced in these trials and offers strategies to enhance efficiency and effectiveness.

Funding for a Phase I trial is much more demanding to secure than it was a few years ago, and with the introduction of Project Optimus, costs and complexities have increased as well. Small biotechs must be well-prepared to navigate these challenges effectively. 

Oncology trials are becoming more global with obvious advantages from faster patient recruitment and expedited regulatory approvals to reduced operational costs. In response to this shift, the FDA has issued draft guidance on conducting multiregional oncology trials.