Sibyl Munson, PhD

Principal

View Sibyl Munson's profile on LinkedIn
Sibyl has led 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

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

Health Economics and 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

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 16 peer-reviewed publications and is Regulatory Affairs Certified. In her free time, Sibyl volunteers in Denver Public Schools and for area robotics and Irish dance competitions.