Dr Lestter Cruz Serrano, Head of Global Medical Affairs at Cognizant, joined Muhammad Younis for a thought-provoking session on the transformative role of AI and cloud-based technologies in healthcare. Dr Lestter discussed breakthrough innovations that are reshaping clinical research, highlighting both their promise and the persistent challenges surrounding adoption, interoperability, and regulatory compliance. He shed light on Cognizant’s open, SaaS-based clinical ecosystem and its unique ability to streamline trials by connecting sponsors, sites, and tech partners. Reflecting on impactful collaborations led by the medical affairs team, he emphasised how these efforts bridge the gap between research and real-world application, enhancing patient outcomes. Dr Lestter also underscored the importance of industry events like the London Biotechnology Show in driving innovation, fostering collaboration, and shaping the future of global biotechnology.

#LBS: AI is revolutionising healthcare in unprecedented ways—what breakthrough innovations have had the most significant impact recently, and what challenges still need to be addressed for wider adoption?

Dr Lestter Cruz Serrano: AI is rapidly transforming all industries, across the globe. 70% of CEOs expect AI to significantly change the way their company creates value in the next three years. The impact of AI is not just limited to productivity gains as each passing month seems to bring a new AI-powered breakthrough, positively impacting one or more process areas.

We are anticipating AI to potentially revolutionize all aspects of the life sciences industry starting from accelerated drug discovery and development, optimizing clinical trials design, AI-driven recruitment, screening and even subsequently facilitating personalized medicine and precision healthcare to patients. And we are glad to see theoretical use cases being brought to fruition in the form of practical applications.

Some of the real-world examples of AI, in the recent past, which have caught our attention and can be called out as breakthrough innovations are:

• AI-designed drug, ISM5411, for IBD which Insilico Medicine announced in early 2024 – which is a potentially first-in-class candidate for the treatment of IBD via oral medication. Insilico leveraged their generative AI-powered drug design platform, Chemistry42, which synthesized and screened approximately 115 molecules. 

The great news is, as recently as January 2025, they published the results of Phase 1 of first-in-human study, conducted in Australia & China, which combined 120+ patients, and demonstrated that ISM5411 was generally safe and well tolerated across all dose groups, with no reports of serious adverse events (AEs) or treatment-related AEs leading to discontinuation.

• Novo Nordisk reportedly claimed that their efforts in drafting a clinical study report were reduced from 12 weeks to just 10 minutes using a next-generation AI assistant tool. This represents a significant gain in expediting study closure-related processes.
• IBM Watson’s clinical trial matching system utilizes AI technology to identify potential matches between patients and clinical trials based on medical history and other relevant criteria. This AI-driven approach led to an impressive 80% increase in breast cancer trial enrollment over 11 months, showcasing the power of AI to revolutionize patient recruitment and accelerate medical research.

However, a lot of work still needs to be done. Data privacy, security risks, and navigating complex regulatory landscapes pose obstacles to adoption of AI models on a large scale. Additionally, the human touchpoints of these technologies—including how researchers, providers, and patients will work with and alongside AI-advancements will become more critical. 

Even though we are hearing very positive outcomes with some of the examples I just said, we must ensure results' reproducibility and clinical validity of any AI-powered solution – which will require AI-based models to be evaluated and validated with a “human in the loop” model. Orienting clinical research on this aspect could promote further adoption of AI in clinical trials, giving researchers and clinicians a wide range of possible interpretations for future uses at all levels of the health care system. 

Also, we must remember that healthcare data is highly sensitive and given these are still early days for advanced AI like Generative AI models, there are concerns about the privacy and security of patient information when it is used to train AI algorithms. Then, we also have to understand if there is any algorithmic bias, as any AI algorithm can perpetuate and potentially amplify existing biases in healthcare data, leading to disparities in care.   

Additionally, there is the question of explainability and trust. Many AI algorithms are "black boxes," meaning that it is difficult to understand how they arrive at their conclusions. This can make it difficult for clinicians to trust AI-powered recommendations.   

In summary, AI has the potential to revolutionize healthcare and life sciences, but it is important to address these challenges to ensure that AI is used safely, effectively, and equitably.

#LBS: Cognizant’s open, SaaS-based clinical ecosystem aims to streamline trials by connecting sponsors, sites, and technology partners. What unique advantages does this platform offer in addressing long-standing challenges such as interoperability, regulatory compliance, and trial efficiency?

Dr Lestter Cruz Serrano: For years, multiple pharmaceutical companies noted that clinical trial sites were heavily burdened by using many different platforms, each requiring unique login credentials, unique technology training to perform clinical trial responsibilities and communicate with their sponsors. In addition to the high costs and redundant efforts involved in developing and maintaining individual sponsor portals, the existence of disparate processes and tools within these portals increased both risk of error and support needed for site users. 

The Cognizant® Shared Investigator Platform (SIP) was built as a SaaS, cloud-based “first-of-its-kind” solution for the global life sciences industry (initially as an initiative from TransCelerate, which is a consortium of 20+ major pharmaceutical companies) designed to address these challenges and ultimately enhance efficiency during clinical trial planning and execution. Pharmaceutical companies chose to adopt SIP to increase engagement with investigative sites and eliminate the need to develop and maintain company-specific portals. 

With multiple global pharmaceutical companies onboarded on the platform, SIP has grown exponentially and supports a huge volume of data & document exchange since its first release in 2016.

Some of the unique advantages which SIP offers are:

• Mutually recognized GCP training for sites, which means GCP training completed once and approved by any sponsor, will be considered approved by all sponsors in SIP.
• Reusable templates to enable faster survey creation and design for sponsors.
• Deep integration with various Sponsor systems, for example, CTMS, LMS, Safety systems etc. to ensure easy interoperability and an end-to-end connected ecosystem
• A single conduit for sites to access all study systems, provided by different vendors, which are used by Sponsors for a given protocol. 
• Centralized investigator profile and site profile with one-time configured details, capabilities and documents (e.g. CV, Lab Normal Ranges etc.) which will be reused automatically for all future studies for all sponsors.
• Audit trail enabled for sponsors to track all updates done in the system, either by a site user or a sponsor user, ensuring necessary regulatory oversight.
• Centralized repository for study documents, including safety documents with the additional features of online acknowledgement & e-signatures.
• Robust delegation framework to support PIs in various process areas in SIP, thereby reducing hard dependency on the PIs and ensuring PI’s time is more focused on patients rather than on technology platforms.

#LBS: Looking ahead, how do you see AI and cloud-based solutions shaping the future of clinical research, and what role do you envision Cognizant playing in driving these innovations forward?

Dr Lestter Cruz Serrano: Most popular AI platforms today are accessible through cloud services, providing scalability, flexibility, and ease of use. Clinical trials generate massive amounts of data and hence having a robust, sustainable infrastructure to handle AI-based platforms is quite critical. Cloud platforms provide the storage and processing power needed to handle this volume. AI algorithms can analyze this data to identify patterns, trends, and insights that would be difficult or impossible to detect with traditional methods. This leads to more accurate and efficient analysis of trial results.

If the latest models of AI and ML truly achieve and mature to what they promise to be, we might see late-stage clinical trials can become early-stage clinical trials, things that used to be early-stage clinical trials can be done in vitro which will be true testament of accelerated drug discovery and development.

We are also anticipating seeing optimized trial design enabled via AI which can help researchers design more efficient and effective trial protocols, selecting appropriate endpoints, and predicting patient responses. A well-defined protocol will address a lot of current pain points which sites & CRAs face on the ground.

Remote patient monitoring is also greatly enhanced by cloud-based solutions. Early detection and intervention, sending safety reports in bulk across sites, across various regions is a key requirement to ensure patient safety and monitoring. AI-powered systems can monitor patients in real-time for adverse events and other safety signals.

Cognizant has been a frontrunner in establishing AI platforms and models which truly help in transforming business & operational processes. Very recently, Cognizant has been named as a Leader in AI and Generative AI Services in Everest Group’s PEAK Matrix® 2024. 

Cognizant’s Neuro® platform offerings have multiple facets of AI, starting from responsible generative AI, simplified gen AI for edge applications, orchestration of various AI & automation technologies, orchestration of operations and even proactively managing cybersecurity risks. Thereby providing an end-to-end offering of cloud-based AI solutions.

A very pertinent example is Cognizant’s AI-enabled Neuro® PV specifically designed for Pharmacovigilance (PV), which utilizes advanced ML algorithms to analyze large volumes of safety data, identify potential adverse drug reactions (ADRs) faster, prioritize and analyze safety signals based on their severity and potential risk, enabling faster and more targeted investigations.

Even as part of our SIP product roadmap, we are evaluating multiple AI enabled use cases, for example an AI enabled chat bot to help with “How to...” queries, pre-fill & suggest responses to research sites while responding to feasibility surveys based on sites capability / previous responses, and few more.

As a more futuristic vision, what we see as the next frontier of efficiency is an ecosystem of Agentic AI which promises more autonomous and goal-oriented AI systems. With prebuilt, reference agent networks, sponsors and sites can achieve a superlative collaboration between a range of cross-functional teams, where desired actions will be orchestrated sequentially to produce desirable outcomes. Cognizant’s Neuro® AI Multi-Agent Accelerator and Cognizant® Multi-Agent Services Suite offers this no-code framework and collaborative agent networks across a given organization or institution. 

In summary, Cognizant’s goal is to be the industry leader in AI and our preferred approach is not automate smaller business processes in silos, but to orchestrate different business processes, across various stakeholders, to provide a truly meaning impact to the entire ecosystem.

#LBS: Could you share insights into the impactful collaborations led by Cognizant’s medical affairs team? How have these initiatives effectively bridged the gap between cutting-edge research and practical clinical application, ultimately advancing patient care?

Dr Lestter Cruz Serrano: In general, when anyone talks about Medical Affairs, we traditionally recognize activities like developing insights based on HCP interactions, scientific communication & education for HCPs to enhance their understanding about a pharma company’s products. There is also gathering of real-world evidence in product efficacy, utilization in clinical practice, KOL engagement which includes identification & relationship building, dissemination of medical information, like, responding to queries from HCPs & patients, publication planning with scientific community on research findings etc. One of our critical tasks is better understanding how the HCP and scientific communities are responding and integrating new tools and technologies. Our technology Medical Affairs group operates in a similar way aligning to these same core principles, however in our case the product is a technology platform, instead of being an investigational product (IP). 

Our first assignment has been related to the Cognizant Shared Investigator Platform. SIP was predominantly developed with sponsor provided requirements with very little input from sites & investigators, hence we faced a lot of challenges with sites’ adoption of SIP. One of the key decisions that I took was to invest in nurturing site relationships globally and be a strategic partner to sites and build a team which has a regional presence across the globe. Today this team is called a Global Medical Affairs team, and I currently lead this team. Collectively, we focus on deepening our understanding of the needs of SIP users and continue to evolve and refine technology in response.

Cognizant’s Global Medical Affairs team is composed of both industry experts, who are BCMAS certified as well as process & product specialists who are extremely knowledgeable about the platform & the research ecosystem. This team ensures that site discussions are impactful and meaningful by communicating in the language understood by KOLs & thoughtful leaders, investigators, and research directors. 

Our objective is to better facilitate intelligent technology and innovation exchange with high level Investigators, HCPs & other stakeholders, advising them on the right technology product & platform to adopt and providing necessary training & guidance – eventually to improve user experience & acceptance. 

In the process, we derive human-centered necessary insights & real-world evidence from the Investigators, HCPs and KOLs and become a voice for them – sharing their suggestions & feedback back with pharma & MedTech companies. These Medical Affairs insights allow biopharmaceutical and medical devices companies to reach a higher level of understanding of challenges at clinical research sites, thus helping them to adapt and upgrade their technology platforms to meet the objectives of sites & investigators.

Our Global Medical Affairs team bridges the gap between clinical researchers and technology platforms, so that all site personnel understand how best they can use the platform and why they should use those technologies. For example, in the case of SIP, to ensure efficient dissemination of information among global research sites and optimal usage of the technology platform, without compromising on patient care, the Cognizant Global Medical Affairs team used a multi-channel engagement model with regional focus. The key channels of engagement were 

• KOL Engagement at regional and global levels on multiple initiatives, which include collaborative presentations at industry events & conferences, testimonials to bring SIP closer to new sites for easier adoption, joint podcasts etc.
• Regional Site Advocacy Groups: where all users of our product can take part and have a seat at the table
• Strategic partnerships with site networks and organizations (such as SCRS Global Impact Partnership and AACI partnership)
• Collaborative presentations and panel discussions at industry conferences and events, with a focus on Investigators, academic medical centers & research sites (e.g., AACI Annual Conference, SCOPE, SCRS Global Site Solutions Summit)
• Customized workshops and webinars tailored to specific needs, where best practices & lessons learnt can be shared with research sites with respect to adoption of technology product
• Focused Site Advocacy Groups with SCRS (Society for Clinical Research Sites) & AACI (Association of American Cancer Institutes) members who are using our products

#LBS: Industry events like the London Biotechnology Show bring together key stakeholders to shape the future of biotechnology. In your view, how do such gatherings influence innovation, collaboration, and the overall direction of the industry?

Dr Lestter Cruz Serrano: Industry events like these provide great networking and learning opportunities. We get a podium to validate our approaches, assumptions and potentially unlearn a lot of things. I would say the best part is the opportunity to forge meaningful relationships and explore potential collaborations. These events also enable companies like us to demonstrate our capabilities, obtain feedback from our end users and also discuss with our potential clients.

We truly appreciate the hard work being put behind the scenes for these events. And I wish you the best for your upcoming event.