Webinar: Advancing Development of New Oncology Therapies: Aligning with FDA’s Project FrontRunner

Thursday, April 4 | 11am EDT | 1 hour | Hosted by: Clinical Leader

In November 2022, FDA Oncology Center of Excellence (OCE) introduced Project FrontRunner to emphasize the need for new cancer drugs to be accessible to patients with early advanced metastatic cancer in an earlier clinical setting. The aim is to provide an alternative development pathway for faster approval of new treatments that does not follow the existing paradigm in which most treatments are developed for patients who have already received multiple prior lines of therapy or have failed available treatment options. Eligible development programs should have the potential to provide clinically meaningful treatment effects and/or have better safety profiles than the current “standards of care.”  

With a significant number of newly diagnosed cancer patients each year, this initiative may benefit a larger patient population from these treatments. 

When planning the development of a new cancer drug, Sponsors should collaborate with FDA on the design of a clinical development program intended to achieve accelerated approval with efficient conversion to full approval. One key aspect of the development program is to initiate a randomized trial earlier in the oncology treatment setting among patients who have received fewer treatment lines to demonstrate improved treatment effect and/or safety profiles in comparison to standard care. Factors driving decisions should be based on early clinical and scientific evidence, as well as factors such as the level of risk the Sponsor and regulatory bodies are willing to accept, the length of time to regulatory approval, the demographics of the patient population, and the relevance of the target used for accelerated approval in the earlier setting.  

Earlier interactions between Sponsors and the FDA are strongly recommended to discuss and confirm the overall development plan, as the Project FrontRunner paradigm may not be appropriate for all oncologic development scenarios. 

Ultimately, advancing novel cancer treatments to patients earlier brings with it both risks and rewards to patients, investigators, and drug developers. We intend to discuss these in this webinar. 

Thursday, April 4 | 11am EDT | 1 hour | Hosted by: Clinical Leader

Robin Bliss, Ph.D.

Vice President, Consulting, Veristat

Robin oversees and executes Strategic Clinical Development Consulting, collaborating with Regulatory Consulting, Clinical and Medical Consulting and Statistical Consulting. A statistician with 15+ years’ experience, Robin is skilled in planning and implementing complex study protocols, planning and executing study analysis, marketing applications, and providing statistical and strategy representation at regulatory agency meetings.

John Kirk, Sc.D.

Principal Regulatory Strategist, Veristat

John has over 30 years of experience in Regulatory Affairs for both developmental and approved products, and has worked for both large and small pharma companies, including Parke-Davis, Pfizer, Esperion Therapeutics and Amicus Therapeutics. His passion is in the rare disease space, where the unmet medical needs are high. John has also participated on joint operating committees with strategic partners and has provided business development support of due diligence efforts.

Patricia Rodriguez

Project Director, Veristat

Patricia brings over 15 years of experience in project management, specializing in oncology and CNS projects. She is skilled in managing global multinational studies and programs in the CRO space, including roles at Labcorp, Syneos Health, and IQVIA.