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Simulation and Prediction for Adaptive Licensing Decision-Making

Bust of Janus, Vatican MuseumJanus was the Roman God of transitions, a deity with two faces, one looking towards the past and the other the future. It was only a matter of time therefore, that clinical trial simulators, and other purveyors of predictive analytics would adopt him as an embodiment of their core initiatives. The aptly named Janus Initiative aims to model decision pathways in clinical development, using powerful simulations to help inform multiple stakeholders on adaptive licensing decisions. The objective is to give every stakeholder in the process a sense of what consequences his or her decision-making will have on other stakeholders involved.

Adaptive licensing is a relatively new concept in the world of pharmaceutical regulation. It advocates for “iterative phases of evidence gathering to reduce uncertainties,” in order to “maximize the positive impact of new drugs on public health.” [1] In other words, it provides a way to resolve the standard tradeoff between taking the necessary time to evaluate new drugs properly, and ensuring that those patients who need new drugs receive them as quickly as possible.

Janus teamed up with Cytel to create powerful simulation software that provides multiple stakeholders with detailed predictions about their ability to meet their goals, based on an evolving set of information provided by all parties. Patients receive predictions on accessibility to new therapeutics. Providers obtain detailed predictions about prescription numbers and financing. Sponsors are provided with up to the minute expected investment calculations. Regulators receive information about the benefit, harm and uncertainty of new therapeutics based on patient and provider behavior.

According to a recent paper in The Journal of Health Policy and Technology, Janus is able to make such predictions by first determining the connections between each stakeholder during pre-trial deliberations. “Janus elucidates the connections among stakeholders and the decisions they make. It especially emphasizes how stakeholder requests for evidence to make those decisions impact the ability of all to meet their individual goals and the overall goal of improving patient outcomes.” A link to the paper, co-authored with Cytel CTO Nitin Patel, can be found below. You will need access to the Journal of Health Policy and Technology in order to view it. 

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[1] Trusheim, Mark R., et al. "The Janus initiative: A multi-stakeholder process and tool set for facilitating and quantifying Adaptive Licensing discussions."Health Policy and Technology 3.4 (2014): 241-247.
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