We’re excited to share an important milestone at PurpleLab: we’ve officially submitted our first-ever response to a federal Request for Comment (RFC), and it’s now live on regulations.gov. Ann Phillips, our Senior Director of Regulatory and Standards, pulled together an impressive response to the FDA’s RFC focused on the use of HL7 FHIR (Fast Healthcare…

Healthcare is evolving. We used to focus purely on addressing specific symptoms and treating specific diseases. Our understanding of medicine and medical care was shaped by biology and what goes on inside the body.  But we now know that our health outcomes are also significantly shaped by external factors – everything from our ZIP code…

Generic drugs don’t usually grab headlines. They’re dependable, low-cost and mostly stay in the background. But behind that generic label is a global system that’s far more fragile, and far more important, than it seems. Today, that system is under serious pressure. The United States is facing everything from supply chain disruptions and political instability…

Using non-small cell lung cancer (NSCLC) as an example, PurpleLab and Genentech will explore how to leverage RWD to eliminate blind spots in the patient journey.

Real-world data in life sciences is doing what once seemed impossible: challenging the dominance of traditional clinical trials. For decades, clinical trials have been the gold standard in life sciences research. And it makes sense: they’re rigorously controlled and designed to ensure that the true effects of drugs are being measured. But the real world…

Real-World Data: The Cornerstone of Life Science Consulting Life sciences are at an inflection point. As pressure mounts to develop therapies faster, prove real-world value to payers, and personalize interventions, traditional data sources are hitting their limits. Real-world data (RWD), particularly claims data, has emerged as a critical lever across the product lifecycle. For consultancies,…

Why Real-World Evidence Matters Beyond Clinical Trials Market access has never been more complex than it is right now. In a world where payers are tightening the purse strings and every therapeutic area feels like a battleground, just getting a therapy onto formulary, or getting a diagnostic test approved isn’t enough. You need to prove…

The Old Operating System Is Crashing Let’s be honest: pharma’s old operating system is starting to show its age. The traditional model – built around blockbuster drugs, top-down messaging and rigid pipelines – is crashing under the weight of modern complexity. Shareholder returns are sluggish. CEOs are second-guessing legacy bets. The pressure to demonstrate real…

Digital health solutions are increasingly common in healthcare, with over
300,000 health apps available and more than half of U.S. adults using
digital health tools.