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Visualize rapid, validated insights through real-world data.
Generating real-world evidence from chargemaster data: Q&A with Myla Maloney of Premier, Inc.
Most real-world data (RWD) sets are based on claims data, which provides useful ...
CDER-Approved sNDA for IBRANCE® (palbociclib)
On April 4, 2019, the FDA granted a label expansion to Pfizer’s IBRANCE® (palbociclib) ...
CDER-Approved NDA for AYVAKIT™ (avapritinib)
On January 9, 2020, the FDA approved Blueprint Medicines Corporation’s AYVAKIT™ ...
Can synthetic data help organizations respond to 'Schrems II'?
By Mike Hintze, Khaled El Emam Posted On: October 28th, 2020 Can synthetic data help ...
How can small- to mid-sized biopharma generate insights from RWD? Q&A with Michael Sanky of Optum Life Sciences
Optum, a new Aetion data collaborator, offers a robust range of real-world data (RWD) ...
CDER-Approved NDA for KOSELUGO™ (selumetinib)
On April 10, 2020, the FDA approved AstraZeneca’s KOSELUGO™ (selumetinib) “for the ...
Unlocking insights in RWD for market access and commercial teams: Q&A with Ki Park of Symphony Health
The integrated solutions of Symphony Health, a new Aetion data partner, extract data from ...
ICPE research spotlight: Part II: Exploring new methods for RWE research
This year at ICPE All Access, Aetion’s scientific research is represented across 15 ...
Ask the Accelerators: Dr. William Morice of Mayo Clinic Laboratories on RWE and COVID-19 diagnostics
Ask the Accelerators is a series highlighting the perspectives and work of organizations ...
PETs and Sharing Clinical Trial Data
Janssen’s Head of Clinical Data Standards & Transparency, Stephen Bamford, recently ...
ICPE research spotlight: Part I: Expanding real-world applications of RWE
This year at ICPE All Access, Aetion’s scientific research is represented across 15 ...
CDER-Approved NDA for NOURIANZ™ (istradefylline)
On August 27, 2019, the FDA approved Kyowa Kirin’s NOURIANZ™ (istradefylline), an adjunct ...
Ask the Accelerators: Dr. Nirosha Lederer on COVID-19’s implications for the future of RWE, and what we’ve learned so far
Ask the Accelerators is a series highlighting the perspectives and work of organizations ...
Three recommendations for generating regulatory-grade RWE: Considerations for the FDA on PDUFA VII
With the passage of the 21st Century Cures Act and the sixth Prescription Drug User Fee ...
Structuring epidemiology teams to maximize impact of RWE: Q&A with Dr. Nicolle Gatto
Nicolle Gatto, Ph.D., is the Senior Vice President of Scientific Research at Aetion, ...
Death to Privacy Shield
PETs to the Rescue in the Wake of the Privacy Shield Verdict Due to contemporary ...
CDER-Approved NDA for TAZVERIK™ (tazemetostat)
On January 23, 2020, the FDA approved Epizyme’s TAZVERIK™ (tazemetostat) for patients “16 ...
How can AI and RWD work together to improve understanding of chronic diseases? Q&A with Kathryn Starzyk, Head of RWE at OM1
OM1, a new Aetion data partner, curates deep clinical real-world data (RWD) from ...
PETs to Manage Emerging Privacy Risks
As the pace of technological innovation continues to grow, new risks to consumer and ...
Real-world evidence and regulatory decision-making: A round-up of readings on progress to date, and what’s to come
In recent years, the U.S. Food and Drug Administration (FDA) and other global regulatory ...
Seven Ways to Evaluate the Utility of Synthetic Data
The article published by IEEE Security & Privacy magazine emphasizes the crucial role ...
Lessons from four recent FDA decisions in infectious disease
The use of real-world evidence (RWE) has proven pivotal to research in infectious ...
The Cures Act’s second act: Six ways to ensure Congress doubles down on its boldest bet
In the article below, originally published in Morning Consult, Carolyn Magill, CEO of ...
CDER-Approved NDA for ONGENTYS® (opicapone)
On April 24, 2020, the FDA approved Neurocrine’s ONGENTYS® (opicapone) “as an adjunctive ...