Regulatory and Reimbursement Obstacles Clinical Update of Molecular Diagnostics ASU

Transcription

1 Regulatory and Reimbursement Obstacles Clinical Update of Molecular Diagnostics ASU Bruce Quinn MD PhD Bruce. faegrebd. com mobile April 8, 2016 Sky Song / Scottsdale

2 Digital Health & Genomics Deck and White Paper Available Deck is available by White Paper is available by 2

3 Up To Date: Y E S T E R D A Y (April 7) 3

4 Overview: The Impact of Dhealth on Genomics Digital Health: $5B invested in CY2015 7% of all Venture Capital investment Emerging Trends We Can Identify Now: 1) Genomic labs form networks with hospital centers 2) New generation electronic networks connection patient, doctor, EHR, genomics, clinical decision support 3) EHR becomes smart in use of genomic data 4) Mathematics, bioinformatics, modeling channel the utility of genomic data 4

5 What does DHealth mean? Digital Health Positively encompasses electronic health records, clinical decision support, remote monitoring, telemedicine, and big data We can just say DHealth instead of 20 words and phrases 5

6 What does DHealth mean? Digital Health Positively encompasses electronic health records, clinical decision support, remote monitoring, telemedicine, and big data We can just say DHealth instead of 20 words and phrases Negatively so broad a term as to be meaningless 6

7 ONE Genomic Labs Form Networks with Providers Foundation Medicine Publicly held laboratory in Cambridge, MA $500 Investment from Roche in 2015 Precision Medicine Exchange Consortium Vanderbilt, Northwestern, Cleveland Clinic, Others Caris Life Sciences Privately held laboratory here in Phoenix, AZ Well capitalized Caris Centers of Excellence Fox Chase Cancer Center, Carolinas Health System, Wayne State, Others 7

8 ONE Genomic Labs Form Networks with Providers WHY? Heavy investment required in training, familiarity, IT systems integration (LIMS, EHR) Create new consortia of cancer centers that can easily collaborate (clinical trials, etc) Market Lock In Like frequent flier points, owning books on an Amazon Kindle Less head to head competition with other labs IN RETURN FOR smaller market of networked participants OBSTACLES TO MANAGE Compete with in house services at large medical centers Still have to get paid by payers 8

9 TWO New complexity of active electronic interfaces Syapse Palo Alto Startup $25M new investment (Ascension Ventures) Syapse Precision Medicine Platform Not lab specific but has collaboration with Caris Cloud based software platform genomics, clinical data, pharmacy data, decision support. Supports TAPUR trial at ASCO. Flatiron Health $130M from Google Health + $175M from Roche Physician office support, dedicated to oncology, from payment systems to (some) genomics support, the new standard for oncology technology 9

10 THREE EHR becomes SMART with Genomic Data AssureX, Genomind Drug/gene analysis for psychiatry NOT just a lab report of gene findings Rather, provides drug specific reports Genelex Both services initially targeted neuropsychiatric drugs: Difficult patients. Lots of drugs. Many choices. Many generic drugs. Seattle Laboratory (> 10 years) Remodeling itself; YouScript offering, API to interface with health records and e Charts NantHealth Los Angeles, $200M from Allscripts ($2B valuation) EHR plus Genomics and Transformation of Care 10

11 Physician Orders Genetics Report; Integrated Bioinformatics Databases Ordering Physician Genetics 11

12 The Cutting Edge is Rapidly Moving Genetics Integrated with Health System (YouScript) Databases Ordering Physician Networked Physicians Pharmacist Genetics EHR Pharma Compliance Drug Orders 12

13 FOUR Very sophisticated virtual genomics IN SILICO ANALYSIS & THE FDA This is a big deal for the FDA National Workshop in November 2015 Next generation sequencing is not (generally) FDA approved now Future pathways may piggyback on variant databases which incorporate sophisticated software for variant calls 13

14 FOUR Very sophisticated virtual genomics Cellworks Silicon Valley startup, VC funded Predict likely effects of drug libraries on virtual cells by using very sophisticated mathematical modeling Genepeeks Virtual genetic software added on top of parental or in vitro fertilization genomic test (e.g. screen collections of sperm donors) Massive Bio NYC Startup Virtual Tumor Board Precision Medicine Democratized Telemedicine meets information management meets genomics IBM Watson and Pathway Genomics Pathway has collectively had $130M investments Most recent investor = IBM Watson Genomics & Wellness See also: Google Verily & Dexcom 14

15 CONCLUSIONS A LOT IS GOING ON A LOT OF MONEY IS ENTERING THE SPACE THESE AND MORE COMPANIES ARE IN THIS SPACE IF YOU RE STUCK ON NEW CPT CODES YOU LL MISS THIS 15

16 IMPLICATIONS Changing industry structure, changing the boundaries of what it means to be a genetics lab Most of health system and payers will play catch up Quantifying the healthcare value remains to be determined Don t ask: Does your lab have a medical app? The important changes will be more like sea changes 16

17 Digital Health & Genomics Deck and White Paper Available Deck is available by White Paper is available by Separate: Transcript of FDA Workshop on Tumor Gene Panels February