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 cutting edge evidence generation and a rapid publication through EHR analysis of ICU patients diagnosed with sepsis to support our client’s monitoring equipment through determination of increased of predicted probability of clinical outcomes with exposure
  • 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. Presented as Apps, these provided simple and flexible tools for representatives to engage stakeholders on topics of interest within the available time
  • Authored two poster abstracts for high impact meetings and three publications accepted on fluid therapy in patients with Systemic Inflammatory Response Syndrome (SIRS); led HER study and authored a Critical Care meeting abstract for a cardiac medical device which one ‘best in show’
  • 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. The studies resulted in a publication and two poster abstracts presented at major international meetings

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, and enjoys triathlons.