Douglas B. Flora, MD, LSSBB, is the executive medical director of Oncology Services and the Robert and Dell Ann Sathe Endowed Chair in Oncology at St. Elizabeth Healthcare.

Dr Flora on the Potential Role of AI in Clinical Trial Screening and Design for Oncology

"I see the whole [clinical trial] process [improving with the use of AI]. The costs will go down, and the rate of return on investment for these investments in good science will be higher."

Douglas Flora, MD, LSSBB, executive medical director of Oncology Services for the Yung Family Cancer Center at St. Elizabeth Cancer Center, discussed the potential of artificial intelligence (AI) to enhance and accelerate clinical trial design and screening within oncology, per his presentation at the 

Flora identified three primary mechanisms by which AI is transforming oncology practices, all aimed at improving speed and efficiency. The first area is patient screening, where AI significantly accelerates the ability to identify and screen suitable candidates for trials, he stated. This accelerated timeline is achieved by automating the mechanical, rote duties traditionally performed by clinical research nurses or clinical research coordinators.

The second critical application is accelerating early-phase drug development. Flora noted that AI facilitates trials developing new agents 

, meaning in a simulated fashion. This simulation allows researchers to quickly identify the best possible targets for therapeutic intervention or the most effective agents available to attack those targets. This methodology, utilizing 

 development, plays a decisive role in reducing the overall time required for a new drug to reach the market, he noted.

The third area of impact involves optimizing the actual conduct of the clinical trial. Flora detailed that AI improves the logistical challenges of research, specifically enhancing how clinicians reach and enroll the appropriate patients more quickly. Furthermore, AI tools allow for the benefits and the risks associated with treatment to be tracked more appropriately and efficiently throughout the trial duration, he said. Ultimately, Flora concluded that the comprehensive adoption of AI is essential for accelerating timelines and ensuring the entire clinical trial process is faster and more efficient. Integrating these tools streamlines the entire research process, resulting in reduced process costs and ensuring a much higher and faster rate of return on investment for scientific endeavors, he emphasized.

Flora is a speaker for Tempus AI, MiBA, Bristol Myers Squibb, Novartis, Haystack, and Natera; consultant/advisor for Viz AI, VieCure, Total Health Oncology, Patient Point, and Azra AI; executive for the Association of Cancer Care Centers, American Cancer Society, Faith Community Pharmacy, and AI in Precision Oncology; and has ownership interests in Tensor Black, Inc.

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Douglas Flora, MD, LSSBB, discusses how the use of artificial intelligence tools could improve patient screening and drug development in oncology.

Dr Flora on the Implications of Emerging AI Models for Oncology Care

"For providers, the most exciting things this year will be more of us having access to the tools that will record our visits with patients and document the important things that were discussed in [those rooms]. [This will] hopefully [reduce] burnout by saving us from staring at the computer all day and letting us look at our patients once again."

Douglas B. Flora, MD, LSSBB, the executive medical director of Oncology Services and the Robert and Dell Ann Sathe Endowed Chair in Oncology at St. Elizabeth Healthcare, discussed the evolving use of generative pre-trained transformers (GPTs) and their potential effects on cancer care.

The emergence of GPTs has marked a significant inflection point in the evolution of digital health care, with implications for oncology and clinical practice more broadly, Flora began. The widespread availability of several GPT models has catalyzed integration across numerous facets of medicine, including the automation of clinical trial screening processes through electronic health record systems, such as Epic and Cerner, he detailed. These models can rapidly identify patients who meet clinical trial inclusion or exclusion criteria by parsing structured and unstructured clinical data, thereby accelerating trial enrollment and improving patient access to experimental therapies, Flora explained.

In clinical workflows, GPT-based applications are increasingly being explored for treatment selection and clinical decision support, offering the potential to synthesize vast volumes of biomedical literature, guidelines, and patient-specific data into actionable insights, Flora continued. One of the most tangible near-term effects of this technology for health care providers is the use of artificial intelligence–driven tools to automate clinical documentation, he noted. These systems, capable of recording patient encounters and extracting key clinical information, may reduce administrative burden and mitigate physician burnout by enabling providers to re-engage more fully with patient care rather than electronic documentation, Flora said. Responsible integration of GPT tools will depend on ongoing validation, regulatory oversight, and user education to ensure that these systems enhance—not compromise—clinical care, he concluded.

Douglas B. Flora, MD, LSSBB, discusses the potential utility of GPT models for improving clinical trial screening and workflows in oncology.

Dr Flora on the Mechanism of Action of BXQ-350 in Newly Diagnosed CRC

“There are some properties of proliferation of cancer cells that S1P will promote, activating some oncogenic pathways and stimulating immunosuppressor cells. This new product can increase ceramide [levels] and reduce S1P [levels]. Ceramide is pro-apoptotic, so some of that downregulation may stimulate immune effector cells to activate things that raise ceramide levels.”

Douglas B. Flora, MD, LSSBB, the executive medical director of Oncology Services and the Robert and Dell Ann Sathe Endowed Chair in Oncology at St. Elizabeth Healthcare, discusses the mechanism of action of thenovel sphingolipid metabolism modulator BXQ-350 and how this mechanismprovides the rationale for the agent’s investigation in combination with modified FOLFOX7 (mFOLFOX7; leucovorin, fluorouracil, and oxaliplatin) and bevacizumab (Avastin) in patients with newly diagnosed metastatic colorectal cancer (mCRC).

Sphingolipid metabolism plays a critical role in cancer biology, with ceramides and sphingosine-1-phosphate (S1P) exerting opposing effects on tumor progression, Flora begins. Ceramides promote apoptosis and mitigate chemoresistance, whereas S1P facilitates cancer cell proliferation, activates oncogenic pathways, and supports an immunosuppressive tumor microenvironment (TME), he details. As such, targeting sphingolipid metabolism represents a potential therapeutic strategy in CRC, according to Flora.

BXQ-350, a nanovesicle formulation of Saposin C, functions as an allosteric activator of sphingolipid metabolism, reducing systemic S1P levels andincreasing C18 ceramide levels, Flora explains. Preclinical data suggest that BXQ-350 selectively targets tumor cells, sparing normal tissue within the TME, he notes. This agent was initially evaluated in a phase 1 dose-escalation study (NCT02859857) in patients with advanced solid malignancies. BXQ-350 was well tolerated, with no dose-limiting toxicities or maximum tolerated dose identified. The clinical benefit rate with BXQ-350 among evaluable patients and across all 6 gastrointestinal tumor types was 17.8%, and outcomes included partial responses and stable disease. Additionally, BXQ-350 showed signs of alleviating chemotherapy-induced peripheral neuropathy (CIPN), with 1 patient with chronic CIPN at enrollment self-reporting symptomatic improvement.

Currently, the phase 1b/2 ASIST study (NCT05322590) is investigating BXQ-350 in combination with standard mFOLFOX7 plus bevacizumab in the frontline setting in patients with newly diagnosed mCRC.

Douglas B. Flora, MD, LSSBB, discusses the rationale for assessing BXQ-350 plus mFOLFOX7 and bevacizumab in a phase 1/2 trial of patients with mCRC.

Douglas B. Flora, MD, LSSBB

Articles

Dr Flora on the Potential Role of AI in Clinical Trial Screening and Design for Oncology

Dr Flora on the Implications of Emerging AI Models for Oncology Care

Dr Flora on the Mechanism of Action of BXQ-350 in Newly Diagnosed CRC