Josie Hayes 2/3/26 Josie Hayes 2/3/26 "We're halfway through Phase I and our biomarker isn't working like we thought." Read More Josie Hayes 1/31/26 Josie Hayes 1/31/26 Where did 47 patients go? Read More Josie Hayes 1/27/26 Josie Hayes 1/27/26 Your biomarker team shouldn't be an afterthought in trial design. Read More Josie Hayes 1/22/26 Josie Hayes 1/22/26 Want to enter phase 2 with an optimal dose and a clear predictive biomarker? Then set your phase 1 biomarker strategy up for success! Read More Josie Hayes 1/19/26 Josie Hayes 1/19/26 If you're running trials with predictive markers, PD endpoints, or potential companion diagnostics, here's what changed: Read More Josie Hayes 1/14/26 Josie Hayes 1/14/26 What's the biggest biomarker budget surprise you've encountered? Read More Josie Hayes 1/10/26 Josie Hayes 1/10/26 Is your team stress-testing biomarkers before clinical translation? Read More Lauren Gourley 1/6/26 Lauren Gourley 1/6/26 How much biomarker data are you collecting in your Phase I? Read More Josie Hayes 12/29/25 Josie Hayes 12/29/25 If your biomarker Kaplan-Meier plot only shows two curves, you're missing the real story. Read More Josie Hayes 12/22/25 Josie Hayes 12/22/25 The missing melanoma sample taught me everything about biomarker strategy. Read More Josie Hayes 12/19/25 Josie Hayes 12/19/25 The best consulting relationship is one that eventually ends. Read More Lauren Gourley 12/14/25 Lauren Gourley 12/14/25 The best biomarker strategy isn't always the most sophisticated one. Read More Josie Hayes 12/10/25 Josie Hayes 12/10/25 Your biomarker strategy should be your competitive advantage—not a straightjacket. Read More Josie Hayes 12/5/25 Josie Hayes 12/5/25 Most Phase 1 biomarker plans cost north of $1M. Read More Josie Hayes 12/1/25 Josie Hayes 12/1/25 Planning a clinical trial budget for biomarkers? Read More Lauren Gourley 11/27/25 Lauren Gourley 11/27/25 Is your team treating QC as a checkbox—or as the foundation of reliable biomarker discovery? Read More Lauren Gourley 11/24/25 Lauren Gourley 11/24/25 Your drug doesn't need to be first in class to win. Read More Josie Hayes 11/19/25 Josie Hayes 11/19/25 The diagnostic partner's proposal looked perfect. Read More Josie Hayes 5/9/25 Josie Hayes 5/9/25 Bolster your biomarker data in phase 1 using backfill Read More Josie Hayes 8/23/24 Josie Hayes 8/23/24 👇 Deploy a biomarker at your peril! Read More Older Posts
Josie Hayes 2/3/26 Josie Hayes 2/3/26 "We're halfway through Phase I and our biomarker isn't working like we thought." Read More
Josie Hayes 1/27/26 Josie Hayes 1/27/26 Your biomarker team shouldn't be an afterthought in trial design. Read More
Josie Hayes 1/22/26 Josie Hayes 1/22/26 Want to enter phase 2 with an optimal dose and a clear predictive biomarker? Then set your phase 1 biomarker strategy up for success! Read More
Josie Hayes 1/19/26 Josie Hayes 1/19/26 If you're running trials with predictive markers, PD endpoints, or potential companion diagnostics, here's what changed: Read More
Josie Hayes 1/14/26 Josie Hayes 1/14/26 What's the biggest biomarker budget surprise you've encountered? Read More
Josie Hayes 1/10/26 Josie Hayes 1/10/26 Is your team stress-testing biomarkers before clinical translation? Read More
Lauren Gourley 1/6/26 Lauren Gourley 1/6/26 How much biomarker data are you collecting in your Phase I? Read More
Josie Hayes 12/29/25 Josie Hayes 12/29/25 If your biomarker Kaplan-Meier plot only shows two curves, you're missing the real story. Read More
Josie Hayes 12/22/25 Josie Hayes 12/22/25 The missing melanoma sample taught me everything about biomarker strategy. Read More
Josie Hayes 12/19/25 Josie Hayes 12/19/25 The best consulting relationship is one that eventually ends. Read More
Lauren Gourley 12/14/25 Lauren Gourley 12/14/25 The best biomarker strategy isn't always the most sophisticated one. Read More
Josie Hayes 12/10/25 Josie Hayes 12/10/25 Your biomarker strategy should be your competitive advantage—not a straightjacket. Read More
Lauren Gourley 11/27/25 Lauren Gourley 11/27/25 Is your team treating QC as a checkbox—or as the foundation of reliable biomarker discovery? Read More
Lauren Gourley 11/24/25 Lauren Gourley 11/24/25 Your drug doesn't need to be first in class to win. Read More
Josie Hayes 11/19/25 Josie Hayes 11/19/25 The diagnostic partner's proposal looked perfect. Read More
Josie Hayes 5/9/25 Josie Hayes 5/9/25 Bolster your biomarker data in phase 1 using backfill Read More
