Takeaways from the Clinical Trials in Oncology East Coast
I was thrilled to recently chair the 2024 Clinical Trials in Oncology East Coast (CTOEC) conference in Boston. CTOEC is an intimate, less formal conference that I look forward to attending each year. This year’s conference was well attended and offered great opportunities to network with new colleagues and connect with old. The program featured some of the industry’s leading experts discussing the latest challenges and innovations impacting oncology operations, and I gleaned some invaluable insights and takeaways.
Regulatory guidance for oncology trials
One of the key topics at this year’s CTOEC conference was Project Optimus and some of the new U.S. Food and Drug Administration (FDA) programs. Panelists and participants discussed and debated how to adapt to some the new guidance and study design trends. Many signal novel, innovative ways of thinking about how to make early phase oncology trials successful. At Catalyst Oncology, we’ve been discussing these new regulatory developments and their impact on Phase I and II clinical trial designs for nearly two years, so it was good to hear alignment on these issues.
Diversity in clinical trials
Another hot topic at this year’s conference was the FDA’s guidance on diversity in Phase III clinical studies. In this guidance, the FDA calls for Diversity Action Plans to increase clinical trial enrollment from historically underrepresented populations and improve clinical trial data about the patients who may potentially use new, approved therapies. Conference participants agreed that most of our early phase oncology customers aren’t thinking about this, so we need to guide our sponsors earlier.
Oncology sites and patients
One of the most inspiring moments of the conference for me was a passionate presentation by Dr. Claudia Hesselmann, Founder and CEO of Arsenia Exploratory Medicine, an Eastern European site network. She discussed differentiating an optimal site to identify quality subjects for any oncology trial, particularly in early phase development. Arsenia’s dedication to identifying the best patient and clinical trial site for every protocol has enabled them to perfect their craft. Dr. Hesselmann likened it to being a professional tennis player: the more tennis you play, the greater the chance to go to Wimbledon. This analogy resonated with many attendees.
Biotech financing challenges
Despite the large number of drugs approved in cancer research in 2023, conference participants couldn’t ignore the reality that the biotech funding environment has become extremely challenging. The confluence of inflation, interest rates and increased clinical trial complexity from regulations, including Project Optimus, has resulted in a tight financing market for biotechs, which is only complicated further by a myriad of “me too” assets. According to panelists during a session about financing, new biologics, first-in-human assets, new treatment pathways, and biomarker-driven trials are oncology therapies currently getting attention from the investment community.
Focus on patients
Another highlight from this year’s conference was the new Patient Recruitment and Engagement track. It included a speaker who presented personal experiences as an oncology trial participant. Despite the industry’s efforts to do more to educate the cancer communities about clinical trials, we still fall short in terms of bringing trial opportunities to patients who don’t have other alternative, approved treatment options. During the presentation, the audience was reminded that it can be difficult for patients to get to their visits. Patients are at the heart of everything we do in clinical research, so we must be mindful of their needs and continue to challenge each other to do better—for the patients.
These are a few of the highlights and key takeaways from Clinical Trials in Oncology East Coast 2024. Overall, the conference had good energy and offered great opportunities to network, share best practices, and learn from some of the industry’s best. I am already looking forward to attending Clinical Trials in Oncology West Coast 2025 in the spring.
