Leaders in Pharmaceutical Business Intelligence Group, LLC, Doing Business As LPBI Group, Newton, MA

9:20-9:50

Studies are showing that genetic tests are being ordered at a sufficient rate however it appears there are problems in interpretation and developing treatment plans based on omics testing results

• 30 % of patients in past and now currently half of all patients are not being given the proper treatment based on genomic testing results (ASCO)
• E.g. only 1.5% with NTRK fusions received a NTRK based therapy (this was > 4000 patients receiving wrong therapy)
• A lung oncologist may only see one patient with NTRK fusion in three years

Precision Medicine Practice Gaps

48% of oncologist surveyed  agreed pathologist needs to be more informed and relevant in the decision making process with regard to tests needing to be ordered

95% said need to flip cost issues ; what does it cost not to get a test … i.e. what is the cost of the wrong therapy

We need a new commercialization model for therapeutic development for this new era of “n of one” patient

9:50-10:15

There are some tumor markers approved by FDA that cant just be measured by NGS and are correlated with a pathologic complete response

• Many point mutations will have no actionable drug
• Many alterations are post-genomic meaning there is a post translational component to many prognostic biomarkers
• Prevalence of point mutation with no actionable mutation is a limit of NGS
• It is important to look at phospho protein spectrum as a potential biomarker

Reverse phase protein proteomic analysis

• Made into CLIA based array
• They trained centers around the US on the technology and analysis
• Basing proteomics or protein markers by traditional IHC requires much antibody validation so if the mass spectrometry field can catch up it would be very powerful
• With multiple MRM.MS there is too low abundance of phosphoproteins to allow for good detection

They  conducted the I-SPY2 trial for breast cancer and determining if phosphoproteins could be a good biomarker panel

• They found they could predict a HER2 response better than NGS
• There were patients who were predicted HER2 negative that actually had an activated HER2 signaling pathway by proteomics so NGS must have had a series of false negatives
• HER2 co phosphorylation predicts pathologic complete response and predicts therapy by herceptin
• They found patients classified as HER2 negative by FISH were HER2 positive by proteomics and had HER2 activation

10:15-11:10