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March 20, 2012
Simulation Modeling for Optimizing Design of Clinical Trials and Registries
Speaker for this event:
  • Badri Rengarajan, MD, Medical Director, Archimedes Inc.  Learn More
  • Simulation Modeling for Optimizing Design of Clinical Trials and Registries               Register Today!

    In this webinar, Badri Rengarajan, MD, will provide an overview of simulation modeling and how it can be used to improve clinical development efforts. Dr. Rengarajan will highlight how simulation modeling helped Orexigen formulate the study design for its pre-approval CV outcomes trial. This study protocol was cleared by the FDA in earlier this month, overcoming a complete response letter issued in early 2011.

    Clinical trial and registry programs can greatly benefit from simulation modeling as they frequently fail to achieve their intended clinical and commercial impact. Failure can be attributed to several reasons, including:

    • Poor prediction of efficacy and safety profile
    • Inadequate powering due to uncertainty in baseline/control arm event rate
    • Slow enrollment
    • Unknown performance in a real-world setting (with comorbidities, less than perfect medication compliance and uncertain adherence to clinical guidelines)
    • Lack of head-to-head or comparative effectiveness data
    • Safety concerns (e.g., increased cardiovascular risk)

    Simulation provides the ability to test trial and registry designs before implementing them. It can estimate eligible population size and baseline event rates, and anticipate trial performance under different variations in inclusion/exclusion criteria, protocols, and patient/physician behaviors. Simulation provides the ability to project years forward in time and to test multiple variations in design before a trial protocol is finalized, thereby reducing risk, time, and cost.

    Participants of this webinar will:

    1. Learn how simulation modeling can enhance pre- and post-approval clinical development
    2. Understand the types of clinical problems that simulation modeling can address
    3. View specific examples
    • Clinical development directors
    • Clinical operations leaders
    • Medical affairs directors
    • Registry program directors
    • Managed care professionals
    • Regulatory professionals

    Register Today!


    Badri Rengarajan, MD, Medical Director, Archimedes Inc.

    Badri Rengarajan, MD, is a medical director at Archimedes. His primary responsibilities include leading consulting engagements, providing clinical input to Model development efforts, and building relationships with clinical research leaders. Dr. Rengarajan has over ten years of healthcare industry experience including roles in product development strategy and new product planning, regulatory affairs, market research, and business development.

    Dr. Rengarajan was previously a director of business development and market research at Nodality (personalized/predictive medicine), regulatory team leader at Genentech, and an engagement manager at McKinsey. Dr. Rengarajan earned an A.B. in biology and public policy from Harvard University and an MD from Yale University.


    Archimedes is a Healthcare Modeling company that has built a large scale simulation model of physiology, disease, interventions, and healthcare systems.

    The Archimedes Model is written at a high level of detail using object-oriented programming and run on a distributed computing network. The core of the Model is a set of ordinary and differential equations that represent the physiological pathways pertinent to diseases and their complications. The Model includes aspects of diseases and healthcare systems needed to analyze downstream clinical events, utilization, and costs including: signs and symptoms; patient behaviors in seeking care; patient encounters with the health care system (e.g. emergency room visits, office visits, and admissions); protocols and guidelines; tests and treatments; provider behaviors and performance; patient adherence to treatment recommendations; and clinical events that affect logistics, utilization, and financial costs. The Model is flexible and helps decision makers understand the likely outcomes of interventions.

    To learn more about the Archimedes Model visit www.archimedesmodel.com

    Register Today!
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