CAR-T Data Solution to integrate biomarkers, manufacturing, logistics and clinical dataSITUATION
- Client is a leading service provider to CAR-T pharma; provide plant logistics and manufacturing setup services
- Client engaged us to better understand they can improve efficiency of CAR-T workflow through data solutions.
- Unmet needs to be addressed: each patient sample producing several terabytes of data incl. biomarkers (flowcytometry, RNASeq), manufacturing (transduction. qPCR, bioreactor, flow cytometry etc), clinical outcomes and logistics data which are fragmented; difficult to understand why certain mfg runs fail
- What was the key problem statement and the underlying root cause of why certain manufacturing runs failed
- Can we unify ALL data produced in each autologous run to enable one click access to this data into a unified product
- Can we apply advanced analysis including deep learning to predict failures or provide an early view of problem statement
- What does a winning solution look like? What partners? What business case?
- Conducted interviews KOLs in CAR-T manufacturing including academics and pharma (including UPENN)
- Highlighted and quantified the need and possible solutions
- Recruited two partners
- Led the process to develop a pilot solution
- Led several workshops with participation from client and their biopharma customers to refine value proposition and opportunity
- Applied advanced algorithms to predict failures
- Successfully secured board approval to initiate this effort on a global basis
