Prepping for the Inflation Reduction Act: Why Manufacturers Need a Plan for Rapid RWE Generation
Since the passing of the Inflation Reduction Act (IRA) in August 2022, the healthcare industry has been bracing for the impact of several key provisions. Three of these policies—price negotiations, inflation-adjusted rebates, and the out-of-pocket spending cap—will be at least partially in place by the close of 2023.
How Life Sciences is Leveraging Machine Learning - 5 Use Cases in 5 Minutes
By Mike Munsell, PhD
Insights & Innovators: Is Lab Data the Secret Weapon for More Efficient Clinical Trials?
By Ritupriya Yamujala
Insights & Innovators: Using Machine Learning to Develop Disease Predictability Models
A Q&A with Chao Li, PhD
Insights & Innovators: A Q&A with Greg Norman and Poorva Nemlekar from Dexcom
Greg Norman, PhD is Director of Health Economics and Outcomes Research at Dexcom where he leads studies to assess real-world evidence of the clinical and health economic impact of continuous glucose monitors for people with diabetes. Poorva Nemlekar, MS is the Lead HEOR Specialist within the Global Access team at Dexcom. Poorva works on multiple[…]
Insights & Innovators: A Q&A with Greg Norman and Katia Hannah from Dexcom
Greg Norman, PhD, is Director of Health Economics and Outcomes Research at Dexcom where he leads the generation of real-world evidence to support the clinical and health economic impact of continuous glucose monitors for people with diabetes. Katia Hannah, PhD, MPH, is the Senior Health Economics and Outcomes Research Specialist within Dexcom’s[…]
Building a Real-World Evidence Center of Excellence: Lessons from the Frontlines
A Q&A with Margaret McDonald, Head of Apex Data Consulting, LLC, following a 17+ year career at Pfizer. Margaret McDonald is an accomplished analytic research scientist, healthcare executive and former hospital laboratory administrator with a Ph.D. in epidemiology, specializing in real-world data and analytics (RWD). She has expertise in global[…]
The Importance of Accounting for Time-Related Bias in Single-Arm Trials with Historical Controls (Part 2)
A Q&A with Samy Suissa, PhD In our previous blog post, we sat down with Dr. Samy Suissa, the co-founder and principal investigator of the Canadian Network for Observational Drug Effect Studies, to discuss the main themes from his recent journal article in Epidemiology. Namely, he argues that while single-arm trials with historical controls are[…]
The Importance of Accounting for Time-Related Bias in Single-Arm Trials with Historical Controls (Part 1)
A Q&A with Samy Suissa, PhD Randomized control trials (RCTs) are typically heralded as the gold standard in clinical trial design. However, regulatory agencies are increasingly recognizing the role of single-arm trials that leverage historical controls, especially within the rare disease space. Yet while these single-arm trials could have[…]