Blog Post by Admin
Publication
Apr 10, 2021
Can Synthetic Data Be A Proxy For Real Clinical Trial Data? A Validation Study
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Blog
Apr 8, 2021
Research spotlight: Using RWE to assess molecular insights, published in Science
Earlier this year, Aetion co-authored a study published in Science that demonstrates how ...
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Blog
Mar 25, 2021
Leveraging RWE in regulatory submissions of medical devices: Three takeaways for medical device and diagnostic companies
The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological ...
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Blog
Mar 18, 2021
Research spotlight: Using RWD to evaluate risk of COVID-19 reinfection
To date, approximately 66 million patients have recovered from COVID-19, globally. As the ...
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FDA Decision Alert
Mar 16, 2021
CDER-Approved NDA for VEKLURY® (remdesivir)
On October 22, 2020, the FDA approved Gilead Sciences’s VEKLURY® (remdesivir) for the ...
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Blog
Mar 11, 2021
Research spotlight: Understanding and correcting bias in RWE studies
Real-world evidence (RWE) studies are often criticized for their susceptibility to ...
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Blog
Mar 4, 2021
How RWE can support drug development during COVID-19 and beyond: Q&A with Dr. Diana Brainard of Gilead Sciences
The COVID-19 pandemic introduced novel challenges for global biopharma organizations, as ...
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Blog
Feb 25, 2021
How RWE can advance understanding of—and boost public confidence in—COVID-19 vaccine safety
After nearly one year of suffering, isolation, and economic downturn on an unprecedented ...
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Blog
Feb 18, 2021
Opportunities to advance RWE in Europe: Assessing today’s landscape and priorities for future guidance
Real-world evidence (RWE) has emerged as an important tool for global regulators, health ...
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Blog
Feb 11, 2021
How medical device companies can use RWE to drive impact for patients: Q&A with Christian Howell, Aetion’s VP/GM of Medical Devices and Diagnostics
For medical device manufacturers, real-world data (RWD) and real-world evidence (RWE) are ...
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Blog
Feb 4, 2021
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 ...
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Blog
Jan 21, 2021
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 ...
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Blog
Jan 14, 2021
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, ...
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FDA Decision Alert
Jan 8, 2021
EMA-Approved application for ZOLGENSMA® (onasemnogene abeparvovec-xioi)
On March 26, 2020, the European Medicines Agency (EMA) approved AveXis’s ZOLGENSMA® ...
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Blog
Jan 7, 2021
Research spotlight: Using RWE to evaluate complications of COVID-19
While COVID-19 is primarily a respiratory disease, its impact has also been associated ...
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Blog
Dec 17, 2020
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 ...
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FDA Decision Alert
Dec 17, 2020
CDER-Approved NDA for EVRYSDI™ (risdiplam)
On August 7, 2020, the FDA approved Genentech’s EVRYSDI™ (risdiplam) “for the treatment ...
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FDA Decision Alert
Dec 14, 2020
CDER-Approved NDA for BLENREP (belantamab mafodotin-blmf)
On August 5, 2020, the FDA approved GlaxoSmithKline (GSK)’s BLENREP (belantamab ...
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FDA Decision Alert
Dec 14, 2020
CDER-Approved NDA for VILTEPSO® (viltolarsen)
On August 12, 2020, the FDA approved Nippon Shinyaku’s VILTEPSO® (viltolarsen) for ...
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Blog
Dec 10, 2020
RWE Guidance Watch: NICE updates methods for health technology evaluations
With real-world evidence (RWE) growing in influence across health care, regulatory and ...
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Presentation
Dec 9, 2020
Synthetic Clinical Trial Data: Use Cases, Methods, and Experiences
Stephen Bamford, Head of Clinical Data Standards & Transparency; IDAR, Global ...
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Blog
Nov 24, 2020
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 ...
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Blog
Nov 12, 2020
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 ...
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Blog
Nov 5, 2020
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 ...
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