Sibyl Munson, PhD

Sibyl directs engagements within four key practice areas and has experience working with manufacturers of pharmaceuticals, biologics, and medical devices/diagnostics. Her recent projects include:

Business and Clinical Strategy:

• Developed a clinical trial protocol with supporting presentations that articulated trial value, strategy, and rationale to CXO’s for a trial within oncology patients utilizing parenteral nutrition
• Created global launch strategy within rapid molecular infectious disease testing which clearly identified/rated key competitors, determined key value drivers, optimal platform and assay menus, and presented executives with adoption/revenues for key global and emerging markets
• Developed a strategy for the optimal uptake of a non-small cell lung cancer (NSCLC) companion diagnostic and service lab through the development of key marketing messages and an actionable strategy for optimal product offerings to maximize utilization and revenues
• Advised an international healthcare company on a neonatology acquisition that laid out clear benefits and challenges for lead products in the U.S., European, and Chinese markets, the competitive landscape, physician perceptions, and market forecasts

Health Economics & Medical Communications:

• Directed EHR analysis of ICU patients diagnosed with sepsis to support our client’s monitoring equipment through generation of predicted probability of clinical outcomes against exposure; analysis presented at international intensive care meeting
• Created a budget impact model (BIM) within the diabetes space to articulate the value to stakeholders of a diagnostic test with improved accuracy and precision
• Guided development of two economic models to support ready-to-use products with hospital stakeholders which provided simple and flexible tools for representatives to initiate conversations, with flexibility to cover only topics of concern to stakeholders within the time available
• Authored two poster abstracts for high impact meetings and three publications accepted on fluid therapy in patients with Systemic Inflammatory Response Syndrome (SIRS)
• Demonstrated the clinical benefit and value of fluid choice within the cardiac surgical population by developing a 12-yr EHR analysis and a cost-effectiveness model that resulted in two poster abstracts presented at major international meetings and a manuscript

Regulatory Strategy:

• Informed medical software development requirements through evaluation of medical risk associated with a prospective diagnostic medical device
• Informed our client on potential market strategies coincident with a larger business strategy critical to product development and resource allocation decisions by performing an orphan designation regulatory path to market assessment for a stem cell therapeutic
• Executed a multi-national assessment of clinical study regulatory requirements and processes to inform our client’s choice of key study sites

Sibyl worked previously in the biologics industry where she directed pre-clinical cancer studies, clinical phase I/II immunological assay development, and intellectual property engagements. She holds a PhD in Microbiology from the University of Wisconsin, a BS in Microbiology from Indiana University, and she completed a post-doctoral fellowship in Immunology at Stanford University. Her graduate work encompassed infectious disease immunological mechanisms and structural biology; her post-doctoral work comprised type I diabetes research. Sibyl has authored 17 peer-reviewed publications, and is Regulatory Affairs Certified. In her free time, Sibyl volunteers in Denver Public Schools and enjoys triathlete sports