Spring House, PA

Thursday, 9th April 2020

Due to the latest developments of COVID-19, the PHUSE Spring House SDE will be a
virtual event and open to all.

Click the link below to register for the webinar.


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RWE: A New Gold Rush Revolutionising Data Collection, Analysis and Submission.



Randomised controlled trials (RCTs) have been the traditional gold standard of drug development. Globally accepted as a rigorous tool to examine evidence of drug safety and efficacy, RCTs have been at the core of drug discovery. Real-world data (RWD) and real-world evidence (RWE) have been around for just as long as RCTs; however, their impact on traditional drug development has been minimal. The FDA has long used data from real life to monitor post-approval safety and surveillance, but New Drug Applications have not veered from RCT insights when seeking regulatory approval.
This data landscape has been slowly but surely changing in the past few years. With digitisation of healthcare and explicit legislative and regulatory support from the agency, RWE is ushering a new era of data insights with the potential to significantly reduce the development life cycle for new products. The FDA has already approved medical devices, procedures and drugs based on RWE data either by itself or as an important supportive source to data from RCTs. A benchmarking survey conducted by Deloitte finds that 90% of global pharma companies are investing in RWE analytical capabilities with applications that cover the entire product life cycle.
While the industry is excitedly flocking to this new gold rush, in some ways it is still unchartered territory. How credible are insights from RWE? What will be the measures of robustness and completeness? Can RWE indeed have an impact on drug formulary positioning or pricing? Can we establish standards for this data? Will RWE insights ever replace the need for RCTs?
Will we have answers to all questions raised? Probably not. But we will have an opportunity to have thought-provoking conversations, share knowledge and, perhaps, a better understanding of RWE and a new perspective on data insights.



Utilise the PHUSE App to connect with other attendees, view the speaker profiles and learn more about the event sponsors.

Registered attendees will receive joining instructions from the App.

Sponsored by:



Time Presentation Speaker(s)
09:05 Attendees join webinar
09:15–09:30 Welcome Sangeeta Bhattacharya,
Janssen Research & Development
09:30–10:00 FDA RWE Regulatory Perspective Rebecca Lipsitz,
Janssen Research & Development
10:00–10:30 Real-world Evidence and Regulatory Submissions David Hood,

Networking Break
Use the PHUSE App to connect with other attendees and discuss the presentations.

10:45–11:15 Use of EHR Data in Drug Development – Applications and Key Considerations Jeremy Snider,
Flatiron Health
11:15–11:45 Innovative Technologies Utilization in 21st Century Novel Clinical Research Programs Towards Generation of Real-world Data and its Articulation for Analysis & Submission Srinivasa Mandava and Cheryl Simon,
11:45–12:15 PHUSE Updates & Closing Remarks Chris Hurley,
PHUSE Americas Director


SDE Chairs:

Ramesh Ayyapath, ICON

Rana Farha, Janssen Research & Development

If you have any questions, or require any information, please contact the SDE Chairs.






If you are interested in sponsoring this event, click here.



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