Blog
Sourcing global real-world data to support R&D: Q&A with Ian Rentsch, VP of Growth and Strategic Partnerships, Aetion
Biopharma organizations are working to incorporate real-world evidence (RWE) throughout ...
Blog
Real-world data in the era of COVID-19: Expert perspectives on the changing data landscape
The COVID-19 pandemic has brought forth a new era of collaboration between health care ...
Blog
Applying regulatory experience in the technology space: Q&A with Lowell Schiller, Chief Legal and Regulatory Officer at Aetion
Lowell Schiller, J.D., recently joined Aetion as Chief Legal and Regulatory Officer, ...
FDA Decision Alert
EMA-Approved application for ZOLGENSMA® (onasemnogene abeparvovec-xioi)
On March 26, 2020, the European Medicines Agency (EMA) approved AveXis’s ZOLGENSMA® ...
Blog
Research spotlight: Using RWE to evaluate complications of COVID-19
While COVID-19 is primarily a respiratory disease, its impact has also been associated ...
Blog
Interim results of the RCT-DUPLICATE Project: Dr. Jessica Franklin on learnings thus far
The RCT-DUPLICATE project began in 2018 with the goal of informing the use of real-world ...
FDA Decision Alert
CDER-Approved NDA for EVRYSDI™ (risdiplam)
On August 7, 2020, the FDA approved Genentech’s EVRYSDI™ (risdiplam) “for the treatment ...
FDA Decision Alert
CDER-Approved NDA for BLENREP (belantamab mafodotin-blmf)
On August 5, 2020, the FDA approved GlaxoSmithKline (GSK)’s BLENREP (belantamab ...
FDA Decision Alert
CDER-Approved NDA for VILTEPSO® (viltolarsen)
On August 12, 2020, the FDA approved Nippon Shinyaku’s VILTEPSO® (viltolarsen) for ...
Blog
RWE Guidance Watch: NICE updates methods for health technology evaluations
With real-world evidence (RWE) growing in influence across health care, regulatory and ...
Presentation
Synthetic Clinical Trial Data: Use Cases, Methods, and Experiences
Stephen Bamford, Head of Clinical Data Standards & Transparency; IDAR, Global ...
Blog
Data Synthesis Platform Available for the PHUSE Community
By Kayley Phillpott Posted On: December 7th, 2020
Blog
CNIL Recommends Against US Service Providers for Processing Health Data – What Does that Mean?
Organizations processing the personal data of EU citizens, and data from France in ...
Blog
RWE Guidance Watch: MHRA draft guidance on RCTs generating RWE to support regulatory decisions
With real-world evidence (RWE) growing in influence across health care, regulatory and ...
Blog
How can real-world data support opioid addiction research? Q&A with Dr. Jacob “Gus” Crothers of Groups Recover Together
The opioid epidemic is one of the greatest public health challenges this century, and its ...
Blog
ICPE research spotlight: Part III: Standard-setting research to advance the use of RWE
This year at ICPE All Access, Aetion’s scientific research is represented across 15 ...
Presentation
Optimal Synthesis of Clinical Trial Data
Khaled El Emam, SVP & GM, Replica Analytics
Publication
Evaluating Identity Disclosure Risk in Fully Synthetic Health Data
Publication
Optimizing the Synthesis of Clinical Trial Data Using Sequential Trees
Blog
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 ...
FDA Decision Alert
CDER-Approved sNDA for IBRANCE® (palbociclib)
On April 4, 2019, the FDA granted a label expansion to Pfizer’s IBRANCE® (palbociclib) ...
FDA Decision Alert
CDER-Approved NDA for AYVAKIT™ (avapritinib)
On January 9, 2020, the FDA approved Blueprint Medicines Corporation’s AYVAKIT™ ...
Blog
Can synthetic data help organizations respond to 'Schrems II'?
By Mike Hintze, Khaled El Emam Posted On: October 28th, 2020 Can synthetic data help ...
Blog
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) ...