MMS

How do you move an oncology program forward when the evidence is still evolving?

Early-phase oncology development requires some of the most critical decisions in drug development to be made long before the complete picture is available. Sponsors must balance speed, risk, and scientific rigor while interpreting emerging data, refining development strategies, and determining where to invest next.

In our new eBook, we explore how structured decision-making frameworks, integrated evidence strategies, and cross-functional alignment can help sponsors navigate uncertainty with greater confidence. From dose escalation and cohort expansion to biomarker-driven development and modeling and simulation, discover practical approaches for making better decisions when the data is still incomplete.

Download the eBook to learn how stronger decision architecture can help accelerate development while maintaining scientific and regulatory confidence: https://hubs.li/Q04pBRry0

Interim overall survival (OS) analyses can influence critical clinical and regulatory decisions, despite often being based on immature data. How can sponsors and regulators better interpret these results and assess potential treatment-related harm?

Join Friends of Cancer Research on Wednesday, July 15 for Interpreting Interim Overall Survival (OS) for Decision-Making, a webinar exploring a simulation-informed framework designed to support more informed interpretation of interim OS findings in oncology trials.

We're pleased that Andrew Mills, Strategic Principal Statistician at MMS, will join a panel of experts to discuss practical considerations for applying this framework in trial design, data interpretation, and regulatory decision-making.

Register here: https://hubs.li/Q04pk7nx0

In her latest blog, Somya Dunn, Senior Medical Director, Safety Risk Management and former FDA Risk Management Analyst, addresses how FDA REMS programs could shape every stage of the patient journey, from where treatment is delivered and who can provide it, to how patients are monitored and supported throughout care.

Click here to read the blog: REMS and Psychedelic Therapies: https://hubs.li/Q04nB6PC0

AI, RWE, and real-time data are reshaping drug development, but success isn't about chasing every new innovation. It's about knowing what matters, applying it strategically, and maintaining a clear regulatory path forward.

In our latest MMS blog, our CEO Uma Sharma explores how sponsors can balance innovation with sound decision-making as the FDA advances initiatives around real-time clinical trials, AI-enabled technologies, and real-world evidence.

Read Uma's latest perspective: https://hubs.li/Q04nJJFk0