Knopf: Nuances among oncologists, w/15-20 pt visits/day, how to access that data to make informed decisions? #PMLS2016
5:21pm August 11th 2016 via Hootsuite
Barlow: Complementary diagnostics and data collection can point to new options. Data has to support the education... #PMLS2016
5:18pm August 11th 2016 via Hootsuite
Barlow: Trad path 'slows innovation'. The 'system doesn't learn when you narrow the box'. Shouldn't prevent collecting data #PMLS2016
5:15pm August 11th 2016 via Hootsuite
Mazumder: cobas ctDNA test - due to lower sensitivity, need to reflex to the tissue. What was 1-2w is now 6. Real world: cost #PMLS2016
5:07pm August 11th 2016 via Hootsuite
Knopf: In one clinic there will be several economic scenarios at work, given their situation. Clinician - may not even be aware #PMLS2016
5:05pm August 11th 2016 via Hootsuite
Phillips: Elephant: what about ACO's? (Accountable Care Orgs) For Precision Med, may help facilitate but also make it harder #PMLS2016
5:04pm August 11th 2016 via Hootsuite
Raymond: About 25% of pts w/tissue biopsy don't get useful results, due to poor quality of their sample. #PMLS2016
5:03pm August 11th 2016 via Hootsuite
Knopf: Prostate ca, BRCA-pos: a great option, lower tox. But all physicians won't all get up to speed quickly #PMLS2016
5:01pm August 11th 2016 via Hootsuite
Carter: Going back and forth w/multiple sequencing - Dx, then for a clinical trial. Barlow: Trial designs are changing, adapting #PMLS2016
4:58pm August 11th 2016 via Hootsuite
Mazumder: What's pragmatic? Need to get many pts on a clinical trials. ALK-EML4 is only 5% prevalent; at $5k/pt, what about cost? #PMLS2016
4:57pm August 11th 2016 via Hootsuite
Barlow: But 'not everyone can sequence to the same level of quality' - what are they paying for? #PMLS2016
4:55pm August 11th 2016 via Hootsuite
Barlow: Feels that for NSCLC, need to sequence up-front, collect data due to the existing unmet needs. Upfront = cheaper #PMLS2016
Barlow: From Medicare's perspective, only 3 biomarkers have Rx. But if held to that, a learning gap to overcome. #PMLS2016
4:54pm August 11th 2016 via Hootsuite
Phillips: Payers are not covering tumor sequencing (WES, WGS). Sees big push for a tech 'arms race' to sequence more genes. #PMLS2016
4:53pm August 11th 2016 via Hootsuite
Knopf: At Sutter, sophisticated pts will ask for complex tests w/o not a lot helpful data. #PMLS2016
4:52pm August 11th 2016 via Hootsuite
Knopf: 2nd Lung ca pt, went to ctDNA, never smoker doing well. Getting through efficiently; can talk pts out of getting tests #PMLS2016
4:51pm August 11th 2016 via Hootsuite
Knopf: Could be palliative; graded on RVU's (pt satisfaction) rather than pt outcomes. Two lung ca pts: 1 stg IV pt, died too soon #PMLS2016
4:50pm August 11th 2016 via Hootsuite
Carter: Focus on panel will be Oncology. Community hosp setting? Sutter: 'Depends on the pt'. Like quantum mechanics; a percentage #PMLS2016
4:48pm August 11th 2016 via Hootsuite
Barlow: 5y later: the role that Dx can play, and how a rep of Medicare can get the best 'bang for the buck' #PMLS2016
4:47pm August 11th 2016 via Hootsuite
Barlow: Helped create MolDx, to better understand the nature of these tests; found that all payers stuggled w/stds, utility #PMLS2016
4:46pm August 11th 2016 via Hootsuite
"2016 - A Diagnostics Odyssey' Panelists con't: Victoria Raymond (Trovagene); Mike Barlow (Palmetto GBA) #PMLS2016
4:44pm August 11th 2016 via Hootsuite
Jennifer Carter (N-of-One) Moderator; Ron Mazumder (Janssen Diagnostics); Kevin Knopf (Sutter Health); Kathryn Phillips (UCSF) #PMLS2016
4:43pm August 11th 2016 via Hootsuite
Howard: May come out in non-FDA approved manner before (machine learning) becomes a submission #PMLS2016
3:36pm August 11th 2016 via Hootsuite
Q when will first machine-learning algorithm be approved? Howard: Vast data, complex methods. Guidances touch on it, but evidence? #PMLS2016
Q about Zika, and how the Hill looks at it. Howard: even with Ebola, needed some rigor around evidence. #PMLS2016
3:34pm August 11th 2016 via Hootsuite
Howard: These floors for performance may differ - dep on what the risk is for a given test. No clear way for agency to acct for #PMLS2016
3:31pm August 11th 2016 via Hootsuite
Howard: A stds-based approach, in a design-control way, to document impact of changes made. Valid performance stds too. #PMLS2016
3:30pm August 11th 2016 via Hootsuite
Howard: The conundrum: innovation and access to latest discovery; and standards and level of evidence that supports it #PMLS2016
3:29pm August 11th 2016 via Hootsuite
Perez: Agency is conservative by nature; encourages audience to interact more; to work with them. Drug-side is indication-specific #PMLS2016
3:26pm August 11th 2016 via Hootsuite
Perez: Now the validation cycle may never end; needing different req's for lung test, then colon etc. But regulation not there yet #PMLS2016
3:25pm August 11th 2016 via Hootsuite
Perez: It is clear that the Companion Dx paradigm - one marker, one test - is outdated. Now guidance reflects 4-5y of thinking #PMLS2016
3:23pm August 11th 2016 via Hootsuite
Perez: After CDx approval sees 'real-world LDT's performing better than the original' - no mechanism to capture that. #PMLS2016
3:13pm August 11th 2016 via Hootsuite
Perez: Uncertain times w/LDTs, 'but the Agency is willing to listen'. Some facilities have difficulty sharing info #PMLS2016
3:12pm August 11th 2016 via Hootsuite
Perez: Accelerated timeframes also mean no time for design-controlled CDx #PMLS2016
3:11pm August 11th 2016 via Hootsuite
Perez: Reliant on LDTs, as design-controlled for CDx (Xalkori), labs with 100-page vs 2pg reports. Evidence-based approaches #PMLS2016
Howard: Feels that eventually will require some kind of legislation. Who decides when there's enough data to make a claim? #PMLS2016
3:08pm August 11th 2016 via Hootsuite
Howard: Performance characteristics of a particular test 'can be pretty cr*ppy'; and clinical validity/utility? #PMLS2016
3:07pm August 11th 2016 via Hootsuite
Howard: 'Reasonable assurance of safety and efficacy': evidence is randomized clinical trial. But for 100K tests? #PMLS2016
3:02pm August 11th 2016 via Hootsuite
Howard: Did work on the draft LDT guidance. Biggest challenge under enforcement discretion: between 10K-100K genomic tests #PMLS2016
3:01pm August 11th 2016 via Hootsuite
Sally Howard (Human Longevity): formerly of the FDA. Omar Perez (Pfizer); Jon Retzlaff (AACR); Wade Ackerman (FDA Senate Counsel) #PMLS2016
3:00pm August 11th 2016 via Hootsuite
"Assuming LDTs are regulated by the FDA, what does that regulation look like?" #PMLS2016
2:58pm August 11th 2016 via Hootsuite
New panel; "Regulatory Conundrums – Should We Be Left To Our Own Devices?" Moderator: Scott McGoohan (BIO) #PMLS2016
2:54pm August 11th 2016 via Hootsuite
Florez: "It (copays) has to be taken out of the equation" Kurzrock: "This is the front door" #PMLS2016
2:43pm August 11th 2016 via Hootsuite
Lai: Non-responders outside of oncology: pts look at it differently. Anti-depression: willingness all dependent on copay (!) #PMLS2016
2:42pm August 11th 2016 via Hootsuite
Kurzrock: Found that 'front-door screening with a large panel' was needed. Can't be done drug-by-drug. #PMLS2016
2:40pm August 11th 2016 via Hootsuite
Florez: PSKC9, statins useful regardless of genotype. Lai: Game-changing approaches will come from outside Pharma (AssureRx) #PMLS2016
2:38pm August 11th 2016 via Hootsuite
Yale: What does PM mean for Pharma? Lai: 'Pretty depressing'. 7y to get from discovery to on-label. In 10y: same Q's ex-oncology #PMLS2016
2:33pm August 11th 2016 via Hootsuite
Kurzrock: FGFR mutations in cancer vs germline dwarfism: germline has no increased incidence of cancer. Is it immune mechanism? #PMLS2016
2:31pm August 11th 2016 via Hootsuite
Ganz: SNPs haven't been useful for Cardio-vascular risk, but have been great for potential Rx targets (i.e. PSK9) #PMLS2016
2:27pm August 11th 2016 via Hootsuite
Lai: The major problem of Precision Medicine is 'not enough medicines'. We're still talking oncology, not outside of it #PMLS2016
2:26pm August 11th 2016 via Hootsuite
