Biomarker Strategy for Drug Development
Process design, implementation & analysis for therapeutics.
Precision Medicine development is a bit like building a very expensive watch.
It’s all in the process.
Because if one piece or one part is out of place, you'll end up building a watch that can’t keep time; making it useless. But often you don’t know that until you’ve built it.
I know that with the number of eyes, teams and experts you have working on your biomarker strategy, and the pressure on you to get results; you want to be able to trust that you will get the exact results you need.
That every step, every element of your biomarker testing process is going to work.
That you have the right experts in place to design each part of the process.
Herein lies the problem.
When a biomarker strategy is built with holes, or the wrong prioritization, or incorrect readout endpoints, you fail to build the story of your drug.
You’re answering the wrong questions.
Data is coming at the wrong times.
You’re spending a huge amount of money and not getting the benefit.
But most importantly, you’re slower than the competition.
You’re less efficient than the competition.
And you may miss your chance to be First in Class or Best in Class.
This is why I created Hayes Consulting.
Having spent 20 years studying, researching and working across clinics, academia and industry, in the US and the UK, and with all types of biomarkers and all types of omics data, I have an in-depth knowledge of the entire development and testing process.
And I know that with the right biomarker strategy in place, you absolutely can achieve the results you want to achieve for your program.
If you have that niggling feeling that there are holes in your biomarker strategy or gaps in your Translational team, it’s probably because there are.
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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
Working together, I guide you to ensure you have a plan that
Identifies the best biomarkers
Plans for the optimal regulatory path
Correctly prioritizes the right biomarker types at each phase of the trial
Has a seamless execution strategy with the right partners
Ensure that readouts fit with program strategy and milestones
Generates readouts that create the optimal story for your drug
I help you spot gaps, potential pitfalls, miscommunication and assumptions.
I can work with teams to support them, or alongside you to guide, advise, optimize, and streamline.
I highlight the places where things need to be tighter or more rigid, and those places you can be more relaxed.
I can also support you by managing the entire process from conception and design through to completion.
So if you’re ready to get your biomarker strategy and precision medicine development process running just as efficiently as your watch, then book in for a free discovery call and let’s chat.
“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.
