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Advanced Therapies Congress
Meet Veristat at the Advanced Therapies Congress 2025
Veristat is excited to participate in the Advanced Therapies...
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Are you interested in learning about the latest FDA initiative to accelerate the development of new cancer treatments? Veristat's informative webinar "Advancing Development of New Oncology Therapies, aligning with FDA's Project FrontRunner" is an excellent resource for those interested in developing new oncology treatments.
In this webinar, Veristat's expert team, Robin Bliss, PhD, Vice President of Consulting, John Kirk, Sc.D, Principal Regulatory Strategist, and Patricia Rodriguez, Project Director, delve into the intricacies of Project FrontRunner and its potential impact on the oncology drug development landscape.
Discover how Project FrontRunner encourages biopharmaceutical companies to develop and seek approval for new cancer therapies for advanced or metastatic disease in earlier line settings, making a greater impact on patients' lives. The webinar covers key aspects of implementing Project FrontRunner in clinical trials, including:
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When does offering patients earlier investigational therapy options make sense?
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What are the trial design considerations/implications?
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How does it impact patient safety and site participation?
Robin Bliss emphasizes the importance of considering the Project FrontRunner framework, stating, "We also expect and strongly recommend that you consider the framework, not only because it will likely have been considered by FDA reviewers ahead of any of your meeting and correspondence dates, but also because it does provide an opportunity for an efficient clinical development program for early line treatment."
The webinar also explores the historical context of accelerated approval and its evolution in oncology drug development. John Kirk notes, "Accelerated approval was established several decades ago in response to the outbreak of HIV infection. It's been picked up by other therapeutic areas, including oncology."
Watch the on-demand webinar now and gain valuable insights from Veristat's multidisciplinary team on navigating the complexities of oncology drug development in light of the FDA's Project FrontRunner. This initiative can be leveraged to advance your oncology therapies and make a meaningful impact on patients' lives.
