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 Josie Hayes 8/21/24 Josie Hayes 8/21/24 Precision Dosing: More Is Not Always Better Read More Josie Hayes 7/27/24 Josie Hayes 7/27/24 AI algorithm predicts response to checkpoint Inhibitors! Read More Josie Hayes 6/3/24 Josie Hayes 6/3/24 Concurrent Submission of In Vitro Devices and Drug Applications in Multiple Countries Read More Josie Hayes 5/16/24 Josie Hayes 5/16/24 FDA Final Ruling for Lab Developed Tests. What does it mean for Biopharma? Read More Josie Hayes 5/16/24 Josie Hayes 5/16/24 What Clinical Trials Led to the Keytruda Tumor Agnostic FDA Approval in MSI-H tumors? Read More Josie Hayes 5/3/24 Josie Hayes 5/3/24 Should you target a biomarker-positive population in your clinical trial, or simply track it? Read More Josie Hayes 4/15/24 Josie Hayes 4/15/24 Why are biomarker studies important when evaluating RECIST criteria in early clinical trials? Read More Josie Hayes 3/25/24 Josie Hayes 3/25/24 An Introduction to the Use of Pharmacodynamic Biomarkers in Drug Development Read More Josie Hayes 3/18/24 Josie Hayes 3/18/24 Assay Development For The Clinic Read More Older Posts
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
Josie Hayes 7/27/24 Josie Hayes 7/27/24 AI algorithm predicts response to checkpoint Inhibitors! Read More
Josie Hayes 6/3/24 Josie Hayes 6/3/24 Concurrent Submission of In Vitro Devices and Drug Applications in Multiple Countries Read More
Josie Hayes 5/16/24 Josie Hayes 5/16/24 FDA Final Ruling for Lab Developed Tests. What does it mean for Biopharma? Read More
Josie Hayes 5/16/24 Josie Hayes 5/16/24 What Clinical Trials Led to the Keytruda Tumor Agnostic FDA Approval in MSI-H tumors? Read More
Josie Hayes 5/3/24 Josie Hayes 5/3/24 Should you target a biomarker-positive population in your clinical trial, or simply track it? Read More
Josie Hayes 4/15/24 Josie Hayes 4/15/24 Why are biomarker studies important when evaluating RECIST criteria in early clinical trials? Read More
Josie Hayes 3/25/24 Josie Hayes 3/25/24 An Introduction to the Use of Pharmacodynamic Biomarkers in Drug Development Read More
