Spring House, PA

Thursday, 9th April 2020

Registration will open soon.

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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?
To discuss, learn and brainstorm on such questions and more, you are invited to the PHUSE SDE being hosted at Janssen on 9th April, 2020! 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.



Janssen Research & Development,

1400 McKean Rd,

Spring House,

PA 19477





SDE Chairs:

Ramesh Ayyapath, ICON

Rana Farha, Janssen Research & Development

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




The SDE App is sponsored by Navitas Data Sciences.


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



To follow.


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