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Date Time 11:00 - 12:00
Location Webinar Timezone EDT - America/New York
Overview
The past decade has seen significant advancements for cell and gene therapies (CGTs). There are now more than 40 FDA approved CGTs. With the promising treatment effect brought by the currently approved CGTs, there are noticeable limitations, such as manufacturing and durability of response, that encourage continued development in this field. New CGTs can potentially benefit patients by enhancing efficacy or addressing the limitations of currently available therapies. However, the development of new CGTs faces unique challenges as approved first-generation products could be potentially established as the standard of care (SOC). Given that approved CGT products are likely to be chosen as the comparator in a randomized control studies under the traditional drug development paradigm, the feasibility of head-to-head comparisons arises. What options exist to demonstrate the effectiveness of new CGT products?
In this webinar, we introduce the challenges of developing new CGTs in conventional randomized control trials (RCT) and single arm trials (SAT), as well as discuss some possible strategies for pivotal trials. Our first speaker will review the history of SAT and RCT for previously approved products and introduce some limitations of these designs as they apply to new product approval.
Our second speaker will continue with practical implementation challenges of these designs from the industry perspective. Our final speaker will add value by sharing insights from the regulatory perspective. The webinar will conclude with an audience Q & A session. We believe that more dialogue about this topic among all stakeholders involved in drug development is crucial and hope that this webinar will contribute towards such a dialogue.
Speakers
Patricia Anderson, ICON plc
Evgeny Degtyarev, Novartis Pharma
Zhenzhen Xu, Center for Biologics Evaluation and Research, FDA
Moderator: Daniel Li, Bristol Myers Squibb