In this panel at BIO's 2022 International Convention, Dan Riskin from Verantos, and Jiawen Zhu and Herbert Pang from Genentech, spoke about two ongoing FDA demonstration projects. Verantos highlighted our work in the TRUST study, which distills high-validity RWE and compares it with traditional approaches. The demonstration project is intended to inform FDA's RWE guidance development.
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In late 2020, FDA announced that it had awarded four grants to researchers to examine the use of real-world data (RWD) to generate RWE in regulatory decision-making. Through these grants, FDA seeks to further assess potential study designs and analytic methodologies to determine whether observational studies can reliably generate evidence on the safety and effectiveness of drugs to support regulatory decisions. This interactive panel gives a brief introduction to the grantees and their unique projects, explores the impact of different settings, patient populations, and data-gathering approaches, and, most importantly, shares insights gained about whether particular models are more likely to garner acceptance from FDA in the near term.
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Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s.
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s.
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s.
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s.
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s.
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s.
Lorem Ipsum is simply dummy text of the printing and typesetting industry. Lorem Ipsum has been the industry's standard dummy text ever since the 1500s.
Lorem Ipsum is simply dummy text of the printing and typesetting industry.
Lorem Ipsum is simply dummy text of the printing and typesetting industry.
Lorem Ipsum is simply dummy text of the printing and typesetting industry.
Lorem Ipsum is simply dummy text of the printing and typesetting industry.
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