Index

One Standard, Many Markets: What FDA, EMA, and PMDA Actually Agree On

Eri Tajima, Country Lead Flatiron Health Japan — Thu, 16 Jul 2026 13:57:25 GMT

As precision medicine accelerates and oncology care becomes more complex, the importance of real-world data in regulatory decision‑making is growing globally. Eri Tajima leads Flatiron’s work in Japan, where she has spent years helping sponsors and regulators work through what high-quality real-world data looks like in practice. Lockwood Taylor leads global regulatory strategy for Flatiron, with experience spanning FDA, EMA, and other health authorities. Over the past several years, they have sat in different rooms, in different countries, hearing essentially the same conversation, and they have watched sponsors repeatedly run into the same misunderstanding about what it takes to get real-world evidence across the regulatory finish line.

The new frontier of academic research

Mariana Hernandez, Head of Health Systems Partnerships — Tue, 14 Jul 2026 13:03:08 GMT

The studies that stick with me after a conference are the ones that answer a question clinicians are already asking, or surface a problem the field hasn't quite named yet. By that measure, this year's ASCO had a lot to offer.

Across ASCO 2026, academic researchers presented 18+ studies powered by Flatiron’s real-world data (RWD) that spans treatment selection, biomarker adoption, end-of-life care, and historically underrepresented patient populations. What connected these studies was more fundamental than subject matter—each one answered a question that clinical trials, by design, aren't built to ask. Trials, which are constructed around specific hypotheses, in defined patient populations, with endpoints that close at a fixed point in time, are oftentimes not reflective of day-to-day clinical care. Real-world data, drawn from actual clinical settings, longitudinally, and at scale, fills in what sits beyond that frame.

Here are four studies that stood out.

A conversation with Dr. Ronac Mamtani on the evidence that moves oncology forward

Mariana Hernandez, Head of Health Systems Partnerships — Mon, 22 Jun 2026 18:43:04 GMT

I had the pleasure of sitting down with Ronac Mamtani, MD, MSCE, section chief for genitourinary cancers and researcher at the University of Pennsylvania and Penn’s Perelman School of Medicine atReuters Digital Health 2026. In the last decade of partnership with Flatiron, Dr. Mamtani has been asking some of oncology's most important questions, mentoring the next generation of physician-scientists at Penn Medicine, and pushing the boundaries of what real-world evidence can tell us about how patients actually fare in the clinic, not just in clinical trials. He has a gift for making complex research feel urgent and deeply human, and he is one of the most thoughtful voices I know on what meaningful research and mentorship look like in practice.

ASCO 2026: Translating oncology innovation into real-world impact

Emily Castellanos, MD, MPH, Head of Research Oncology — Wed, 17 Jun 2026 21:10:26 GMT

ASCO 2026 delivered no shortage of headline-making data, positive trials and new strategies across tumor types, much of it genuinely practice-changing. But treatment efficacy in a trial is only the first thing worth knowing. What comes after matters just as much: who will benefit most, when it should be used, how it fits into an evolving landscape, and whether those results hold up to the patient sitting across from you.

That challenge was reflected in ASCO's 2026 theme, "The science and practice of translation: improving cancer outcomes worldwide." The meeting showcased important scientific advances. But as an oncologist, I know that whether a treatment works in a trial is rarely where the questions end. Many of the most consequential conversations centered on implementation: how physicians, researchers, and health systems will turn promising clinical evidence into better decisions and outcomes for patients.

Three developments stood out to me - not only for their scientific significance, but for the questions I expect they’ll raise as they move from the trial setting into real-world care.

Rewriting the real-world evidence playbook for clinical development

Mark Guinter, PhD, Director of Research Sciences — Mon, 08 Jun 2026 15:58:30 GMT

I've spent my career as an epidemiologist working at the intersection of real-world data and oncology—first studying cancer etiology and outcomes, and now at Flatiron Health, where I collaborate with biopharma clinical development teams to build the evidence strategies that underpin some of the most consequential decisions in drug development.

ISPOR 2026 reflections: AI, access, and the evolving role of RWE in oncology

Flatiron Health — Fri, 29 May 2026 21:54:11 GMT

ISPOR Annual 2026 — the annual meeting of the Professional Society for Health Economics and Outcomes Research — recently concluded in Philadelphia, and our Flatiron team left energized by the breadth, rigor, and real-world impact of health economics and outcomes research (HEOR) work currently taking place.

From innovation to strategic insight: making sense of rapid advances in bladder cancer care

Khilna Patel, Clinical Director, Flatiron Health — Mon, 11 May 2026 15:39:48 GMT

The bladder cancer landscape is evolving rapidly. The emergence of immune checkpoint inhibitors (ICIs) has fundamentally reshaped treatment, especially for muscle-invasive (MIBC) and advanced disease cases, and antibody-drug conjugates (ADCs) have introduced a new level of precision by targeting proteins like Nectin-4 commonly found on bladder cancer cells. The combination of these novel modalities is now producing much better outcomes — even in the perioperative setting for MIBC patients where chemotherapy used to be the main option, as we recently learned at the 2026 ASCO Genitourinary Cancers Symposium in San Francisco.

Unlocking the next level of RWD: Flatiron’s Scientific Vision

Jonathan Kish, VP, Research Sciences — Tue, 05 May 2026 14:14:48 GMT

Imagine a world where every treatment decision in cancer care—from the design of the trial to a patient’s course of therapy—is informed by comprehensive intelligence.

The real-world perspective: Why global RWE matters in modern oncology

Arun Sujenthiran, MD — Tue, 28 Apr 2026 14:26:06 GMT

In my work as a clinician, I've spent nearly two decades watching the same pattern repeat itself: the treatments that earn approval through randomised controlled trials, our gold standard for evidence, are often tested on populations that don't look like the patients sitting in my clinic. The gap between what clinical trials demonstrate and what I observe in clinical practice isn't merely theoretical—it's reflected in patients sitting in our clinics—and this is precisely where real-world evidence becomes not just valuable but essential.

High-quality, validated AI-enabled research: Insights from recent prostate cancer research

Eunice Hankinson, MSN, FNP-C, Clinical Director — Wed, 22 Apr 2026 13:00:32 GMT

If there’s a question I hear most often from researchers it’s: How can we trust real-world data extracted by AI?