PhaseV, under the leadership of CEO Raviv Pryluk, stands at the forefront of this transformation. In this interview, Pryluk shares his journey, insights, and innovative approaches that are revolutionizing clinical trials to enhance efficiency, effectiveness, and patient outcomes.
Outsourcing Pharma (OSP): Could you start by giving us a bit of your background and how you came to work for PhaseV?
Raviv Pryluk (RP): I’m an engineer by training with a Bachelor's and Master's in engineering and a PhD in computational neuroscience. My transition from engineering to biology occurred during my PhD, where I learned that biology’s outcomes can be unpredictable. I spent years in defense and tech industries before moving into biotech, working with Big Pharma. I realized that no matter how innovative your biology is, without properly designed, conducted, and analyzed clinical trials, success is uncertain. This realization led to founding PhaseV, a technology company headquartered in Boston, aimed at bringing innovative technologies from other domains into clinical trials to improve their design, conduct, and analysis. We’re a multidisciplinary team with expertise ranging from software engineering to biology and medicine.
OSP: What makes PhaseV stand out in the field of clinical trials?
RP: We differentiate ourselves in several key ways. Firstly, we bring tools from other tech domains, ensuring our algorithms are innovative while tailored to the unique regulatory environment of clinical trials. Secondly, we focus on making our technology intuitive and user-friendly. Clinical trials involve various stakeholders, including physicians, data scientists, and commercial teams. We ensure our tools are accessible and understandable to foster broader adoption. Lastly, we integrate design and execution, streamlining the process and removing silos that typically hinder clinical trial efficiency.
OSP: Can you tell us about the platforms you’ve developed at PhaseV?
RP: We’ve built two main platforms. The first supports the design and execution of adaptive clinical trials, which use accumulating data to make predefined adaptations, such as adjusting doses or patient populations. This approach makes trials more efficient, effective, and ethical, though it’s complex. Our platform simplifies this process, making it more intuitive and accurate, thereby increasing the adoption of adaptive trials. The second platform focuses on reanalyzing clinical trials using tools from causal inference and machine learning to detect heterogenous treatment effects. This helps in precision medicine by understanding how different patients respond to treatments and tailoring approaches accordingly.
OSP: How do you ensure that your platforms are user-friendly and intuitive?
RP: We spend a lot of time on making our tools interactive and understandable. Machine learning and adaptive trials are inherently complex, and trial teams are multidisciplinary. By making our technology accessible, we empower stakeholders to make informed decisions based on data and technology, rather than replacing them. Our goal is to enhance and augment their work, not to create black-box solutions.
OSP: How has the feedback been from your clients?
RP: The feedback has been very positive. Initially, there’s some hesitation when we talk about machine learning and AI. But once clients see that our solutions are intuitive, speak their language, and come with statistical guarantees, their concerns are alleviated. We work with a range of clients from small biotechs to big pharma companies, and the response has been enthusiastic across the board.
OSP: What are your thoughts on the role of AI and machine learning in the future of clinical trials?
RP: AI and machine learning have immense potential, but it’s crucial to address challenges openly. The FDA and other regulators are keen to understand and adopt these technologies, provided they are explainable and reliable. For instance, our platform’s transparency and interpretability have been key in gaining regulatory trust. The aim is to use technology to enhance regulatory science, not replace it.
OSP: How do you tackle data privacy and security concerns?
RP: Data privacy and security are paramount. We leverage the capabilities of major cloud providers like AWS, Google, and Azure to ensure scalable, secure, and encrypted solutions. Compliance with regulations such as GDPR and HIPAA is integral to our operations. We work hard to maintain data integrity and privacy without compromising the efficiency and accuracy of clinical trials.
OSP: What are the major benefits of adaptive trials for patient retention?
RP: Adaptive trials significantly increase the likelihood that patients will receive effective treatments rather than placebos. This enhances patient retention as participants are more likely to stay engaged in a trial if they believe they are receiving beneficial treatment. Additionally, adaptive trials make the process more ethical by reducing the number of patients receiving ineffective drugs.
OSP: How do you see technology addressing the challenge of patient diversity in clinical trials?
RP: Diversity in clinical trials is critical for generalizable and effective treatments. Technology can play a significant role by ensuring diverse patient recruitment and optimizing for health equity. By incorporating diverse data sets and enforcing inclusive algorithms, we can turn the challenge of diversity into an opportunity for more representative and effective trials.
OSP: What are your final thoughts on the impact of technology on the pharmaceutical industry?
RP: The pharmaceutical industry is traditionally slow to adopt new technologies, and for good reasons related to safety and compliance. However, recent changes driven by the pandemic, regulatory shifts, and competitive pressures are accelerating this adoption. By providing clear, explainable, and beneficial technological solutions, we can help the industry move forward, ultimately benefiting patients through faster, more accurate drug development.
PhaseV say its innovative approaches are setting a new standard in clinical trial design and execution, paving the way for a future where advanced technologies ensure faster, safer, and more effective drug development processes.
