Heather Gustafson

Owner/Consultant @CDx InSight

ScientistMBAPostGraduate🎓 Student🧮 Education💸 Marketing🧨 ConsultingBusiness AnalystAdvisorCustomer ResearcherAssociate

As a consultant in Clinical Biomarker and Companion Diagnostic Development, my role revolves around driving the development of diagnostic tools that make a meaningful impact on patient care. I work closely with teams to develop diagnostic strategies that seamlessly align with clinical milestones. This isn't just about paperwork (while there is lots of that!); it's about ensuring that diagnostic tools serve a real purpose in the journey of patient treatment and is positioned for market adoption. My work involves bridging the gap between translational research and clinical development. I help companies formulate IVD and CDx strategies in line with objectives, lead efforts to generate critical data, and help shape the global product roadmap. Passionate about the transformative power of diagnostics, I am committed to driving innovations that enhance patient outcomes. If you're looking for expertise in this field, let's connect and explore how we can work together to make a difference.

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Work Background

CDx InSightIndependent Consultant

Jul. 2023Providing strategic and technical planning guidance for LDT, IVD and CDx development for pharmaceutical and biotech companies.

Guardant HealthDirector, Clinical Diagnostics

Jan. 2022 - Jul. 2023Generated CDx and CTA proposals including budget, resources, timelines, and analytical validation and clinical validation strategies. Reviewed contracts. Provided regulatory and clinical trial design support to pharma partners to maximize data generation or support product portfolio. Served as clinical science SME and JSC/JPT member and clinical lead for global CDx programs from initial partner interactions to design transfer. Supported regulatory interactions including IDE submissions, pre-sub, sPMA interactive reviews, and 100-day meetings.

MerckDirector, Companion Diagnostics

Jul. 2020 - Jan. 2022Managed cross-functional teams in development of diagnostic strategy. Advanced internal efforts to utilize ctDNA in clinical studies. Supported clinical development teams from early-stage clinical trial design to global CDx.

HTG Molecular DiagnosticsSenior Manager, Research & Product Development

Jul. 2019 - Jul. 2020Tucson, Arizona Managed direct reports and cross-functional product development teams, including CDx programs, for molecular profiling technologies. Drove product development standardization and best practices development. Oversaw product development documentation, customer communication, and participation in regulatory submissions.