PhaseV, under the leadership of CEO Raviv Pryluk, is at the forefront of this transformation. In this interview, Pryluk shares his journey, insights, and innovative approach to revolutionizing clinical trials to improve efficiency, effectiveness, and patient outcomes.
Outsourcing Pharma (OSP): First, can you tell us a bit about your background and how you ended up working at PhaseV?
Raviv Pryluk (RP): I am an engineer by training, with a bachelor's and master's in engineering and a PhD in computational neuroscience. I switched from engineering to biology during my PhD, where I learned that biology results can be unpredictable. After years in the defense and high-tech industries, I moved into the biotechnology field, working for a large pharmaceutical company. I realized that no matter how innovative biology is, if clinical trials are not properly designed, conducted, and analyzed, success is uncertain. This realization led me to found PhaseV, a technology company based in Boston. The company aims to bring innovative technologies from other fields into clinical trials and improve their design, conduct, and analysis. We are a multidisciplinary team with a wide range of expertise, from software engineering to biology to medicine.
OSP: What makes PhaseV unique in the clinical trials space?
RP: We differentiate ourselves in several key ways. First, we adopt tools from other technology domains and innovatively tailor our algorithms to the unique regulatory environment of clinical trials. Second, we focus on making our technology intuitive and easy to use. Clinical trials involve many different stakeholders, including physicians, data scientists, and sales teams. We make our tools accessible and easy to understand to drive broader adoption. Finally, we integrate design and execution, streamlining the process and eliminating silos that impede clinical trial efficiency.
Raviv Pryluk CEO and Co-Founder PhaseV
OSP: Please tell us about the platform you developed with PhaseV.
RP: We have built two main platforms. The first supports the design and execution of adaptive clinical trials, which use accumulated data to make predefined adaptations such as adjusting dosage or patient demographics. This approach makes trials more efficient, effective and ethical, but it is 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 causal inference and machine learning tools to detect heterogeneous treatment effects. This can aid in precision medicine by understanding how different patients respond to treatments and tailoring approaches accordingly.
OSP: How do you ensure that your platform is user-friendly and intuitive?
RP: We spend a lot of time making our tools interactive and easy to understand. Machine learning and adaptive testing are inherently complex, and testing teams span multiple disciplines. By making our technology available, stakeholders can make informed decisions with their data and technology, not replace them. Our goal is to enhance and extend their work, not create a black box solution.
OSP: What kind of feedback have you received from customers?
RP: The feedback has been very positive. Initially, there was some hesitation when talking about machine learning and AI. But once clients see that our solutions are intuitive, understandable in their language, and come with statistical guarantees, their concerns are alleviated. We work with a wide range of clients, from small biotech companies to large pharmaceutical companies, and the response has been enthusiastic across the board.
OSP: What do you think about the role of AI and machine learning in the future of clinical trials?
RP: AI and machine learning have enormous potential, but it's important to be open to the challenges. The FDA and other regulators are eager to understand and adopt these technologies, provided they are explainable and trustworthy. For example, the transparency and interpretability of our platform has played a key role in gaining regulators' trust. The aim is to leverage technology to enhance regulatory science, not replace it.
OSP: How do you address concerns about data privacy and security?
RP: Data privacy and security are of paramount importance. We leverage the capabilities of major cloud providers such as AWS, Google, and Azure to ensure scalable and secure encryption solutions. Compliance with regulations such as GDPR and HIPAA is essential 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 main benefits of adaptive testing for patient retention?
RP: Adaptive trials significantly increase the chances that patients receive an effective treatment rather than a placebo. Participants are more likely to stay in the trial if they believe they are receiving a beneficial treatment, thus improving patient retention. Additionally, adaptive trials make the trial process more ethical by reducing the number of patients receiving an ineffective drug.
OSP: How do you think technology can address the challenge of patient diversity in clinical trials?
RP: Diversity in clinical trials is critical for generalizable and effective treatments. Technology can play a key role by ensuring diverse patient recruitment and optimizing health equity. By incorporating diverse datasets and implementing inclusive algorithms, we can transform diversity challenges into opportunities 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 has traditionally been slow to adopt new technologies, for good reasons related to safety and compliance. However, recent changes driven by the pandemic, regulatory changes and competitive pressures have accelerated this adoption. By providing clear, explainable and informative technological solutions, we can help move the industry forward, ultimately benefiting patients through faster and more accurate drug development.
PhaseV says its innovative approach is establishing new standards in clinical trial design and execution, paving the way for a future where advanced technologies enable a faster, safer and more effective drug development process.
