Writing on biobank data access, Safe Harbor de-identification practice, cohort sourcing timelines, consent chain documentation, and the infrastructure gaps between biorepositories and the programs that depend on them.
Drug discovery programs spend months sourcing cohort data before a single assay runs. We examine the structural reasons biobank data remains locked — and what a licensing-first model changes.
Consent documentation is often the last-mile barrier in data room reviews. We break down what broad consent, re-consent protocols, and IRB documentation requirements mean in practice for licensing transactions.
Not all biobank data arrives in licensable condition. We define five criteria — de-identification, consent chain, phenotypic completeness, format standardization, and longitudinal follow-up — that separate research-grade datasets from raw biorepository exports.
A look at how long biopharma teams typically spend sourcing cohort data by therapeutic area, modality, and data type — based on conversations with research operations teams. The numbers are worse than most expect.
The two HIPAA-recognized de-identification methods — Safe Harbor and Expert Determination — have different practical implications for biobank data licensing. We compare their requirements, audit trail implications, and buyer acceptance rates.
We're excited to announce a $2M angel investment to expand our biobank dataset curation capacity, deepen our de-identification pipeline, and grow the team. A note on what this means for our work.