The clinical trial industry is witnessing a swift integration of artificial intelligence (AI) and data science technologies. This shift aims to enhance efficiency and minimize the high failure rates that plague drug development.
Scheduled for 12-14 May, Biomed Israel will feature a session led by Ittai Harel, managing partner at Pitango Venture Capital, titled “Reinventing clinical trials: new models, technologies, and companies.”
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This session will examine how innovations in clinical trial design and implementation, including digital platforms, decentralized trials, adaptive methodologies, and data-driven patient recruitment, are increasingly challenging traditional methods of clinical development.
Keynote speaker Dikla Shpangental, Senior Vice President and General Manager for Switzerland, Israel, and South Asia at IQVIA, will be joined by representatives from companies such as PhaseV, ImmunAI, QuantHealth, NucleAI, Leal Health, and Yonalink/Veeva.
This interview has been edited for brevity and clarity.
Abigail Beaney (AB): What are some of the main innovations you are seeing in the clinical trial space?
Ittai Harel (IH): Various sectors within pharma have evolved significantly over the years, while others have remained stagnant. Clinical development, a field with over $100 billion invested annually, suffers from notable failure rates, highlighting the potential for improvement. Recent years have unveiled innovations poised to create substantial impact.
Pharmaceutical companies typically adopt a cautious approach. With substantial investments at stake, there is understandable resistance to drastic changes until new methods have demonstrated their effectiveness.
However, with the rise of patient data collection through smart watches and wearables, alongside advancements in genetic analysis and AI, we find ourselves on the brink of transformative changes in clinical trials.
AB: Which companies are currently showing the most promise?
IH: One notable company is QuantHealth, specializing in data science. Another high-potential start-up is PhaseV, which is growing quickly. Several innovative companies in Israel are harnessing AI and data science, each with unique perspectives.
QuantHealth tackles one of the most complex challenges in data science—accurately modeling and predicting patient reactions to various drugs based on factors such as dosage, patient selection, and trial design parameters.
They utilize extensive datasets to understand drug behavior and leverage insights from prior clinical trials and de-identified patient records. Their goal is to accurately predict responses at both group and individual levels. After applying their platform across numerous clinical trials, their predictive accuracy continues to grow, leading to increased adoption by pharma and biotech firms seeking higher success rates and efficient market entry for new therapies.
Immune AI is another promising organization, specializing in unique biomarker data, exploring single-cell analysis combined with AI capabilities. This approach offers pharmaceutical companies enhanced insights into patient dosing and immune responses.
NeuraLight also stands out for its innovative diagnostics based on ocular biomarkers. Focused on developing their platform as a critical tool for neurological drug trials, they can provide early patient response identification and continuous analytical feedback, leading to more accurate data-driven outcomes.
Companies like these are effectively addressing the core challenges of drug market entry. If they succeed, the drug development landscape could become significantly more efficient, resulting in lower costs and therapies tailored to individual patients.
AB: Beyond AI and technology, what are some effective strategies for tackling challenges in clinical trials?
IH: Issues such as the diversity of patient populations pose significant challenges in drug development. While having comprehensive biological and behavioral data is valuable for ensuring optimal patient-therapy matches, achieving this remains complex. In Israel, considerable discourse is ongoing regarding the necessary infrastructural and governmental support to attract more global players in clinical development.
Economic strategies, such as Australia’s successful incentive programs, illustrate the potential for enhancing clinical trial business models and operational efficiency in other regions.
Regulatory challenges also require attention, as agencies like the FDA may lag behind the rapid technological advancements, necessitating a more agile response to emerging methodologies.
Modern capabilities enable more accessible patient recruitment for clinical trials, facilitating remote operations that utilize advanced monitoring and diagnostics tools. This evolving landscape promises even greater advancements driven by the innovative companies entering the field.
Despite the industry’s high levels of professionalism, many senior trial managers express skepticism toward new innovations. The belief persists that past methods are sufficient due to their extensive experience. However, this traditional mindset may hinder necessary progress.
Remarkably, the industry may soon face a transformative shift, akin to a dam reaching a breaking point. Whether this occurs in two or five years, the sense of impending change is palpable.
With early adopters leading the way, it falls on innovators to provide data that builds trust in new systems. The increasing interest from investors such as Pitango HealthTech underscores the anticipated substantial changes and opportunities in the coming decade.
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