Press Releases
Research Presentation Strategies Announces New System Enabling the First-Ever Full Day Virtual FDA Drug Approval AdComm Presentation
Research Presentation Strategies (RPS), the leader in FDA advisory committee (AdComm) presentation support, announced the use of their technology platform for a successful virtual Cardio-Renal Drug Advisory Committee (CRDAC) meeting that took place on July 15, 2020. The RPS platform was utilized by a sponsor last week for the first fully virtual, day-long drug approval AdComm presentation.
Anticipating a need for this capability, RPS developed and tested their virtual system extensively at mock rehearsals over the past year. All features and benefits of RPS’ live Q&A response technology have been incorporated into their virtual platform. RPS worked with the FDA to test the system and ensure a seamless integration with the FDA’s meeting platform. The RPS virtual platform enables a drug sponsor to preview any of thousands of data slides, instantly displaying it to the panel in response to panel member questions.
“This is the culmination of over 25 years experience assisting with in-person AdComm presentations,” said RPS CEO Robert Befus. “Designed last year to support virtual mock rehearsals, the platform enabled us to support our customer with confidence in this unexpected completely virtual environment.”
Although this was a needed innovation to support presentations across the globe, the COVID-19 pandemic has made it imperative to find a way for sponsors, remotely and in real time, to provide the data and responses that panel members need in order to inform their discussions and make decisions.
“We helped present the first electronic sponsor presentation in 1996 and have been innovating more effective technologies and strategies for FDA advisory committee meetings since,” said Befus. “We’re looking forward to developing new solutions that make the process even more efficient, intuitive, and reliable for both the FDA and sponsors.”
About Research Presentation
Strategies
Research Presentation Strategies, a leader
in the design and development of pharmaceutical presentations for regulatory,
clinical and medical affairs. RPS is also the owner of SlideSource.com, a
subscription slide and presentation management system that enables users to
work individually or collaboratively to quickly build or modify presentations
from existing libraries. Since 1996, RPS has specialized in providing expert
support services and technologies to pharma teams preparing for FDA and EMA
regulatory presentations.