Biomarker Strategy for Drug Development
Process design, implementation & analysis for therapeutics.
That's where I come in.
I work with therapeutic companies preparing for or already in clinical trials who need expert biomarker guidance to avoid costly missteps and maximize their chances of success.
Two types of clients reach out to me:
The Strategic Planners: They contact me 6–12 months before their trial, wanting a partner to design a tailored biomarker plan that fits their timeline, budget, and regulatory goals.
The Crisis Managers: They call mid-trial when things aren't going to plan—samples were mishandled, data is incomplete, and the readouts aren't telling the story investors or the FDA want to hear.
Whether you're being proactive or you're in crisis mode, I help you transform biomarker uncertainty into strategic advantage.
Most early-stage biotech companies don't need a full biomarker team—they need the right biomarker strategy.
How I help you succeed:
✓ Identify and validate biomarkers that actually matter for your drug and patient population
✓ Align biomarker strategy with clinical and business milestones so readouts come when you need them
✓ Execute on a lean budget with the right partners—no bloated teams, no wasted resources
✓ Translate complex data into compelling clinical stories that resonate with investors and regulators
✓ Avoid common pitfalls that derail programs and burn through funding
My focus is precision medicine—using biomarkers to select the right patients, optimize dosing, and boost the chances your drug becomes First or Best in Class.
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‘Dr. Hayes is ready to take that extra mile to make sure that data is analyzed and best conclusions are put forth.’
Juhi Ojha, Director, Clinical Research Translation Oncology, Merck
Why work with me?
I've spent over 20 years in biomarker development across academia, industry, and as a clinical scientist. I've seen every angle of this work, from assay design to regulatory submissions.
My clients don't get a cookie-cutter plan. They get the benefit of a 360° view, tailored to their drug, their timeline, and their mission.
I built my consulting business around one goal: helping small companies avoid the pitfalls I've seen time and time again.
Ready to get your biomarker strategy right?
If you're in drug development and want a clear, efficient, and customized path forward—especially when every dollar and day counts—let's talk.
“Dr. Hayes is an expert in genomics and translational drug development but is also always open to hearing different ideas from others. She asks fantastic questions and is a pleasure to work with!”
—Medical/Scientific Affairs Leader, Guardant Health.
