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June 2024
smjStrategies is thrilled to announce original research on the participation of drug development professionals as clinical trial subjects. Pharma companies spend millions each year asking third parties to explain and predict the patient journey, when in fact all drug development professionals are free to learn first hand what participating in a clinical trial is like. Those that have participated have reported high impact insights and learnings that are directly related to their job performance and company missions. Pharma as Patients, a collaboration with Brenner Insights, seeks to establish a baseline metric of drug development professional participation in clinical trials. This is the first of its kind. We believe direct participation in clinical trials, by the professionals who are empowered to design them, could be a significant innovation accelerator in clinical research and the pharmaceutical industry. |
November 2023
This final PHUSE and ASA webinar on Interdisciplinary Safety Evaluation for Learning and Decision Making: Education for Executives summarized the four prior in the series, specifically to help executives hear it all fast, because executives don’t have an extra six hours to learn the nitty gritty like transitioning from SAS to R, understanding how best to prepare for FMQs (FDA Medical Queries) and SMQs (Standardized MedDRA Queries), and how industry is learning how to stop analyzing safety data using efficacy-oriented statistical methodologies. In this executive summary, smjStrategies addressed the other item that is of great interest to executives: impact to revenue stream. Yes, the primary value of safety data is to protect patients. However what this Working Group has shown is that using non-efficacy statistical methods for safety data, earlier in the program, can and does have a positive impact on revenue. Check it out here! |