Tag: Life Sciences

  • Pharma’s Billion-Dollar AI Bets May Be Chasing the Wrong Advantage

    Pharma’s Billion-Dollar AI Bets May Be Chasing the Wrong Advantage

    Pharma's Billion-Dollar AI Bets May Be Chasing the Wrong Advantage
    Shashi Shankar, Co-Founder and CEO, Novellia

    2026 will be remembered as the year pharma went all in on AI.

    Since January, nearly every major pharmaceutical company has announced some version of the same thing. GSK signed a five-year foundation-model deal with Noetik. Eli Lilly built a co-innovation lab with NVIDIA. Merck committed a billion dollars to Google Cloud. This month, Novo Nordisk named Amazon Web Services its preferred AI partner. The dollar figures are staggering. And the messaging has been almost identical across all of them: get access to the right model, the right compute, the right discovery platform, and you’ll win the next decade of drug development.

    Then Q2 earnings calls wrapped, and almost no one could point to a measurable return. A faster trial. A failure caught earlier. A drug that reached folks sooner because of what they’d invested. Executives talked about pilots and roadmaps. The announcements are loud but the silence on results is the real story.

    I get why these deals get announced the way they do. The models are really incredible. But when everyone has access to roughly the same model capability, the model stops being an advantage. It becomes table stakes, like electricity. Nobody wins on having electricity. They win on what they build with it.

    A lot of the conversation this year has moved toward the discovery platform or the algorithm on top of the model as the real differentiator. That’s closer. But I’d push it one level further. The real edge is the data the platform is trained and run on. A world-class algorithm trained on incomplete, fragmented, clinically thin data will still give you incomplete, fragmented, thin answers. That’s the layer none of these mega-deals have actually touched.

    To understand why, think about what it actually looks like when a real person tries to navigate serious illness in this country.

    Take someone managing a rare condition who sees six different specialists over four years. Her rheumatologist is in one system. Her neurologist is in another. Two of her earlier records exist at  community clinics she stopped going to. By the time anyone tries to assemble a complete picture of what’s happened to her, half the story is missing or inaccessible. And she’s one of the simpler cases.

    The US has no unique patient identifier. Providers have little regulatory incentive to share records across systems. A single person’s health history can be scattered across every hospital, lab, specialist, and health system they’ve ever seen. Insurance coverage varies by state and plan. Hospitals and their clinics inside the same health system often run on different EHR platforms that don’t talk to each other. Nobody has a complete picture of the folks these drugs are actually designed to serve.

    Claims-based real-world data, the first data type I ever worked with as an intern at Genentech well over a decade ago, are still the primary input for most pharma real-world evidence work and inherit all of that fragmentation. Claims were designed for billing. They can tell you a treatment happened. They can’t tell you what led to it or why. The clinical context lives in physician notes, which are unstructured, inconsistent, and scattered across decades of care. Basic social factors like housing, income, and smoking status are frequently missing. Seventy-eight percent of health organizations say they can’t even locate social-determinant data in a patient’s record after it’s been collected.

    Clinical trials are rigorous by design, and that rigor is also what limits them. They’re built around selected populations, defined observation windows, and specific endpoints. A person enrolled in a six-month trial doesn’t stop being a patient after month six. They get new conditions. They switch doctors. They move. With many rare diseases, patients might see seven different physicians before anyone lands on the right diagnosis. None of that shows up in a trial dataset. Most of it doesn’t show up cleanly in claims either.

    The folks who are hardest to capture accurately in current datasets are usually the people a drug needs to work for the most. Complex conditions. Multiple diagnoses. Long, difficult care journeys. That’s where the data falls shortest, and that’s where the AI answers will be weakest.

    I spent over a decade inside biopharma. I watched incredibly talented teams work hard with an incomplete picture of the people they were trying to help. That gap was always there. What’s new is the scale of investment now being built on top of it.

    The next real competitive edge in this industry will come from the less glamorous work of actually fixing the data. Connecting fragmented records. Capturing the clinical detail sitting in unstructured notes. Building datasets that reflect the full reality of the folks who will rely on a new medicine to save their lives, including the ones that don’t fit neatly into a trial population.

    That work is harder to announce. It doesn’t generate the same headlines. It’s also what determines whether these AI investments eventually deliver.

    The only thread that runs through every part of the care journey is the patient. Every physician visit, every lab, every specialist, every prescription. When you stitch the data around that reality, with the patient’s knowledge and consent, the fragmentation starts to resolve itself. That’s a fundamentally different starting point than what most of the industry is working from today.

    There are real people on the other side of this. A father whose daughter just got a life-changing diagnosis that should have come four years earlier, and has to reckon with what those four years might have cost her. A family sitting in a waiting room, wondering whether the new drug their mom just started is actually working. These are the people whose care journeys are scattered across systems. Getting the data piece right is how the industry actually reaches them, in time, with the right answer.

    About Shashi Shankar

    Shashi Shankar is Co-Founder and CEO of Novellia. He spent over a decade at Genentech and Roche in medical affairs, health economics, and digital health innovation.


  • Clinical Trial Site Selection and AI: Look-Alike Modeling Across Real-World Data and Care Delivery Signals

    Clinical Trial Site Selection and AI: Look-Alike Modeling Across Real-World Data and Care Delivery Signals

    Clinical Trial Site Selection and AI: Look-Alike Modeling Across Real-World Data and Care Delivery Signals
    Aaron Cohen, Vice President, Data Strategy at Definitive Healthcare

    Site selection and enrollment failures are persistent challenges for life sciences organizations. A Tufts Center for the Study of Drug Development analysis of nearly 16,000 investigative sites across 151 Phase II and III global trials found that nearly half of all selected sites either failed to enroll a patient or under-enrolled.1 Site-selection decisions commonly draw on historical performance indicators like prior trial participation and past enrollment, typically favoring sites with an established track record over fresh site opportunities. This creates a sampling problem: if the pool of potential sites is largely composed of those selected in previous trials, analyses of that pool will naturally favor characteristics associated with prior selection. When sponsors draw candidates from a pool shaped by prior selection decisions, established sites are more likely to be selected again and trial speed, diversity, and overall quality are potentially impacted.   

    AI can help organizations identify new clinical trial sites by evaluating a broader range of characteristics to inform site selection so that appropriate candidates are not overlooked. Using predictive algorithms to target new research characteristics including suitable patient populations, investigators, and clinical capabilities, among other data points, sponsors can potentially identify sites that are a unique fit, expanding their approach to site selection.

    Basing site selection on trial history

    Sponsors commonly evaluate sites across four broad categories: likely eligible-patient volume, clinical capability, investigator availability, and prior-trial performance. Problematically, these criteria are frequently measured using historical proxies, with past trial participation among the most readily available. As a result, these screens tend to return sites that already have a research history; they also fail to address the highly protocol-specific nature of enrollment.

    By leveraging different data points for site selection, sponsors can identify the next generation of capable clinical trial sites. The key to tapping into new opportunities is broadening sponsors’ traditional searches to include specific characteristics of a particular trial. 

    Further informing a sponsor’s site selection approach, data shows that trial participation varies sharply by care setting. For example, across Commission on Cancer programs from 2013 to 2017, the overall adult cancer treatment trial participation rate was 7.1%.2 

    Participation rates varied significantly by program type:

    • 21.6% at NCI-designated comprehensive cancer centers
    • 4.1% at community programs
    • 5.4% at academic, non-NCI-designated programs
    • 5.7% at integrated network programs

    While these NCI findings reflect data from several years ago, little suggests that site selection practices have changed meaningfully in the interim. This noted variation is impactful because a site with a strong trial participation history is likely to appear more attractive in a selection process than those with little or none. Prior participation is a real signal. The problem is that it is also a filter, and using it as a primary screen ensures the pool never expands.

    Selecting the next generation of sites with AI

    By identifying specific characteristics related to clinical capability, patient population, investigator or site capability, and data visibility, AI-enabled tools can perform a look-alike analysis to find sites that resemble other ones that have successfully conducted a very similar trial, potentially surfacing new sites that are an appropriate match but lack a trial track record.

    Using real-world patient claims data, procedure volumes, investigators’ expertise, and capabilities to perform specific services and procedures, AI can evaluate broader signals unrelated to trial history. This can be particularly important in the rare disease space, where diagnosis codes are often not specific enough to identify the patients who meet a study’s criteria. By incorporating broader clinical and longitudinal signals, AI can estimate which patients are likely affected by the disease of interest and, by extension, where those patients are receiving care. This can help sponsors identify qualified sites that may be overlooked by diagnosis-code- or trial-performance-based approaches alone. 

    Although these models rely on prior data, they can use care-delivery and patient-level signals to estimate future suitability without requiring prior performance in a similar trial. AI is not a shortcut around the limitations of the underlying data, but rather a tool that can evaluate more data at scale. The opportunity comes from evaluating different signals, such as patient populations, care-delivery patterns, investigator expertise, and protocol-specific capabilities that can help identify qualified sites traditional approaches may overlook.  

    The foundation of any analysis is and always will be the quality of the input data. AI makes it possible to evaluate larger and more complex datasets. Where data capture can be reliably estimated, it may also help differentiate genuinely low patient volume from limited data visibility.

    It can be effective at extracting variables from clinical text where appropriately governed data are available to supplement site validation. AI can also be used for modeling across full feature sets at scale, beyond manual feasibility capabilities, to screen large numbers of sites that lack prior trial experience.

    While AI cannot fully resolve trial eligibility from claims data, determine site selection, or directly recruit appropriate patients, it can quickly provide valuable estimates, helping sponsors better understand the patient population that is likely to meet treatment criteria. Of course, sponsors will still need to thoroughly assess the capabilities of sites and investigators, and consider the primary factors for managing and running the trial.

    A practical way to evaluate these approaches is through a controlled exploration cohort. Sponsors could reserve a defined percentage of candidate sites for model-identified, trial-naïve organizations and subject them to the same readiness assessments and operational reviews as traditional candidates. Enrollment and study performance could then be measured against established benchmarks. This allows organizations to test whether expanding the candidate pool improves recruitment and site performance without abandoning proven site-selection practices.

    Life sciences organizations don’t need to abandon their current site-selection approach entirely, but they should recognize that relying too heavily on past enrollment performance can create a self-reinforcing system in which the sites selected yesterday become the sites considered tomorrow. This approach comes at a cost: a smaller and less diverse enrollment pool, limited geographic and demographic representation, overlooked patient populations, slower recruitment, and higher costs. By incorporating AI-enabled approaches into site selection, sponsors can base decisions on capabilities and patient populations in addition to prior trial experience, broadening the candidate pool, expanding potential matches, and reaching more patients.


    References

    1. Getz, K. “Enrollment Performance: Weighing the ‘Facts’.” Applied Clinical Trials, May 2012, Vol. 21, Issue 5. Tufts CSDD study of nearly 16,000 investigative sites across 151 Phase II and III global trials conducted 2008–2010, with performance data supplied by 10 pharmaceutical companies and two CROs; typical trial ran in 11 countries among adult patients. Enrollment activation rate is defined as the percentage of sites ready to enroll that enroll at least one patient. Findings: 11 percent of ready-to-recruit sites enrolled no patient; 41 percent of activated sites did not achieve the target enrollment number, defined as a band from sites enrolling only one patient through those missing target by 10 percent or more; 40 percent hit target and 15 percent exceeded it; sites enrolling at least one patient reached 85 percent of target on average; and 48 percent of all selected sites enrolled nobody or under-enrolled.
    2. National Estimates of the Participation of Patients With Cancer in Clinical Research Studies Based on Commission on Cancer Accreditation Data,’ Journal of Clinical Oncology, 2024, doi:10.1200/JCO.23.01030 (covering 2013-2017).

    About Aaron Cohenthe Author: 

    Aaron Cohen is Director of Life Sciences Solutions Consulting at Definitive Healthcare. He specializes in healthcare claims data and real-world data, with deep expertise in claims analytics, provider reference data, patient tokenization and linkage, and cloud analytics. In his more than seven years at Definitive, Aaron has worked in Customer Success, Solutions Consulting, and leadership roles. He leads a team of subject matter experts supporting biopharma, diagnostics, and medical device customers, and is a co-author on a conference poster analyzing Medicare claims data.

    Prior to joining Definitive, Aaron focused on patients’ access to novel medical devices at a reimbursement consulting firm, where he was a Definitive Healthcare customer. Aaron is completing an MS in Data Science at the University of Colorado Boulder.