Josie Hayes 3/10/26 Josie Hayes 3/10/26 Your colleague mentions an interesting biomarker in a team meeting. Someone says "we should look into that." Read More Josie Hayes 3/5/26 Josie Hayes 3/5/26 Your surrogate endpoint biomarker could take nearly 4 years to qualify under the FDA's Biomarker Qualification Program—if it even makes it through. Read More Josie Hayes 3/1/26 Josie Hayes 3/1/26 Accelerated approval is getting tougher to secure. Read More Josie Hayes 2/24/26 Josie Hayes 2/24/26 Many biomarker strategies fail before a single sample is tested. Read More Josie Hayes 2/20/26 Josie Hayes 2/20/26 When should you collect ctDNA in your clinical trials to best predict survival? Read More Josie Hayes 2/17/26 Josie Hayes 2/17/26 "M10 excludes biomarkers." I hear this constantly from biopharma teams. Read More Josie Hayes 2/13/26 Josie Hayes 2/13/26 Your startup pivots at light speed. Your CRO moves like molasses. Read More Josie Hayes 2/9/26 Josie Hayes 2/9/26 Fresh biopsy collection isn't just about the science—it's about strategic timing. Read More 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 Older Posts
Josie Hayes 3/10/26 Josie Hayes 3/10/26 Your colleague mentions an interesting biomarker in a team meeting. Someone says "we should look into that." Read More
Josie Hayes 3/5/26 Josie Hayes 3/5/26 Your surrogate endpoint biomarker could take nearly 4 years to qualify under the FDA's Biomarker Qualification Program—if it even makes it through. Read More
Josie Hayes 2/24/26 Josie Hayes 2/24/26 Many biomarker strategies fail before a single sample is tested. Read More
Josie Hayes 2/20/26 Josie Hayes 2/20/26 When should you collect ctDNA in your clinical trials to best predict survival? Read More
Josie Hayes 2/17/26 Josie Hayes 2/17/26 "M10 excludes biomarkers." I hear this constantly from biopharma teams. Read More
Josie Hayes 2/13/26 Josie Hayes 2/13/26 Your startup pivots at light speed. Your CRO moves like molasses. Read More
Josie Hayes 2/9/26 Josie Hayes 2/9/26 Fresh biopsy collection isn't just about the science—it's about strategic timing. Read More
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
