Blog
Ten Recommendations for Regulating Non-identifiable Data
There is considerable activity today in regulatory development and updates around the ...
Presentation
Synthetic Data
Blog
ICPE Research Spotlight 2021: Part II: Forging methods to advance principled database epidemiology
This year at ICPE All Access, Aetion’s scientific research was represented across ...
Presentation
Practical Mechanisms for Generating Anonymous Data
Presentation
Ten Recommendations For Regulating De-identification
Blog
ICPE Research Spotlight 2021: Part I: Findings from Aetion-FDA research collaboration to advance understanding of COVID-19 with RWE
This year at ICPE All Access, Aetion’s scientific research is represented across ...
Blog
RWE to inform value decision-making: Learnings from ICER’s 24-month reassessment pilot
In its 2020 Value Assessment Framework, the Institute of Clinical and Economic Review ...
Article
Could Synthetic Data be the Future of Data Sharing?
This article in CPO Magazine explores the rise of synthetic data generation (SDG) as a ...
Blog
Patient voice in RWE: Generating evidence that will impact payer and HTA decision-making
With the rise of patient-centered medicine and accelerated approvals, health technology ...
FDA Decision Alert
CDER-Approved NDA for LUMAKRAS™ (sotarasib)
On May 28, 2021, FDA granted Accelerated Approval to Amgen’s LUMAKRAS™ (sotarasib) for ...
FDA Decision Alert
CBER-Approved sBLA for KEDRAB® (rabies immune globulin (human))
On May 17, 2021, FDA approved an sBLA for Kamada’s KEDRAB® (rabies immune globulin ...
Blog
RWE Guidance Watch: IMPACT HTA publishes recommendations on the use of RWE in HTA
As researchers await comprehensive guidance on the use of real-world evidence (RWE)—and ...
Blog
An update on efforts to standardize and democratize RWE: Q&A with Dr. Nirosha Mahendraratnam Lederer
As real-world evidence (RWE) adoption continues to ramp up across health care, ...
Blog
Research spotlight: Gilead Sciences and Aetion use RWE to assess the comparative effectiveness of remdesivir for COVID-19
As COVID-19 continues to evolve, frontline health care workers are eager for real-world ...
FDA Decision Alert
CBER-Approved BLA for ABECMA® (idecabtagene vicleucel)
On March 26, 2021, FDA approved Celgene’s BLA for ABECMA® (idecabtagene vicleucel) for ...
FDA Decision Alert
CDER-Approved sBLA for ERBITUX® (cetuximab)
On April 6, 2021, FDA approved a new biweekly dosing regimen for Eli Lilly’s ERBITUX® ...
Blog
Using RWE to characterize diseases as novel treatments become available: Q&A with Dr. Maria Schneeweiss
As novel therapies come to market, especially in disease areas that aren’t as well ...
Blog
Research spotlight: Using RWD sources to describe the patient burden of a poorly understood rare disease
This month, Aetion and Boehringer Ingelheim published two co-authored papers which ...
CDER-Approved NDA for LAMPIT® (nifurtimox)
On August 6, 2020, FDA granted accelerated approval to Bayer Healthcare’s LAMPIT® ...
Presentation
Implementing the FAIR Data Sharing Principles
Presentation
Experiences Implementing Data Synthesis in a Global Life Sciences Company
Presentation
Data Synthesis: A Tool for Responsible Data Sharing
Blog
Research spotlight: Organized structure of RWE best practices
In the last five to 10 years, stakeholders from around the globe have launched ...
Blog
How NICE is approaching guidelines for RWE generation: Q&A with Dr. Páll Jónsson
In its recently announced five-year strategy, the UK’s National Institute for Health and ...