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Research MattersApril 25, 2019
WelcomeRob Herzog
VP Research Operations
DevotionAnne Epley
Transplant Research
Devotion
Celebrating 30 Years of Service!Congratulations Anne!
Genomics Message
Neil Finkler, M.D.
Thank You
The Genomics Strategy
The Inflection Point
A 50/50 PREDICTION – IN 2030 EVERYONE WILL BE SEQUENCED
Examples at Other Health Systems
➢ Kaiser - Biobank Initiative: Goal of 500,000 patients
➢ Intermountain - Genomic analysis for all pts with metastatic CA
➢ Banner – Part of All of US study. Goal is to recruit 100,000 patients.
➢ Aurora – Member of IGNITE Research Network (Implementing Genomics)
➢ Northwell – Multiple partnerships to create Precision Med Cancer Biobank
➢ CHI & Dignity – Launched Precision Medicine Alliance to serve 150 hospitals
➢ MedStar – Both implementing genomics strategy. It has proven to be a market differentiator.
➢ Numerous other non-AMC and AMC Genomics/Precision Med initiatives
2019 – Two Workstreams
Build the Foundation- PwC & The Roadmap to 2025
- Begin creating Operating Structure
Conduct Early Learning Pilot(s)
The Path
How can you integrate and layer genomics into existing monitoring, prevention, and care paths to improve outcomes and reduce costs?
How can a genomics offering help you identify patient needs before they even walk in the door?
What are the right genomics capabilities to invest in to maximize value or return on investment and how do you prioritize across your short and long-term roadmap?
Data gathering
Getting a lay of the land at AdventHealth through interviews and overlaying our point of view and research on the genomic health market
Alignment workshop
Align team around the goals and future state vision for the the Center for Genomic Health
Roadmap development
Translate potential use cases into a defined, practical path of investments and partnerships for success
In the remaining time, we will deep dive & workshop:
● IT infrastructure and data governance
● Further capability assessments
● Functional org design
● Governance model review (to drive program success)
And begin solidifying the vision, refining the roadmap, and answering the big questions
Answer the big questions
Center for Genomic Health roadmap construction
Piloting Improve clinical experience Expand the market Drive whole health Develop new channels
Discrete, time bound pilots with potential partners to test/build capabilities
Prove the clinical feasibility of genomics and operationalize to better treat our existing populations, improving the patient experience
Deliver consumer facing genomics services to expand the population AH serves, improving the consumer experience
Leverage in data sets to generate insights into the determinants of health, enabling greater predictive power and best in class clinical practices
Evolve business models to use data for contracting (VBC), population health, and commercial opportunities (e.g. Pharma research)
The Center for Genomic Health roadmap and use cases are defined across phases, building clinical utility by standing up capabilities and demonstrating value, while continuing to make investments to prepare for future phases
RoadmapOverview of how each clinical use case matures across the
phases
Capability MappingSet of capabilities required to support each use case across
the roadmap phases
Value DriversDefined set of value drivers that
can be realized across each phase of the use case
Investment ConsiderationsCost/investment considerations
to enable the use case and cabilites across phase
Phase 1 Phase 2 Phase 3 Phase 4time
inv
est
me
nt
Phase 0
Consumer entertainment genomics
Cardiovascular risk screening
Inherited disease carrier screening
NICU and peds rare disease diagnosis
Opioid dependence and pain management
Systemwide pharmacogenomics
Market AdventHealth branded, at home kit for “entertainment genomics,” offering non-diagnostic health related traits through consumer facing channels
Identify and cross-screen patients with common CV comorbidities for risk of inherited CV disease to stratify patients across different care plans
Offer carrier screening for parents during family planning or during pregnancy (e.g. NIPT), beginning with well validated variants before expanding to WGS and potential variant of unknown significance
Conduct rapid WGS for NICU and pediatric patients with undiagnosed conditions to aid diagnosis of rare diseases
Prior to surgery, screen patients for risk of opioid dependency and efficacy/response to available pain medication to create a personalized pain management plan
Perform proactive pharmacogenomic screening to support the prescription of drugs with pharmacogenomic labeling, starting in cardiovascular before expanding across other service lines
Consumer-facing use case Primarily research focused use case until more clinically established
Clinical use case Will likely remain as a research focused use case
Initial PGx component can be clinical, but dependency risk score will be research until more clinically established
Clinical use case
Exec owner:
Dr. Finkler & Marketing
Exec owner:
Dr. Smith (research)
Dr. Schoch/Davis (clinical)
Exec owner:
Dr. Wadhawan
Exec owner:
Dr. Smith (research)
Dr. Wadhawan
Exec owner:
Dr. Finkler (inpatient)
Dr. Schoch (outpatient)
Exec owner:
Dr. Finkler (inpatient)
Dr. Schoch (outpatient)
Physician lead:
Dr. Walker
Physician lead:
Per Dr. Smith initially
Dr. Guerrero
Physician lead:
Dr. Rachel Humphrey or other
– Per Dr Wadhawan
Physician lead:
Dr. Wadhawan or Dagli (per Dr.
Wad. Recommendation)
Physician lead:
Likely start inpatient.
Dr Stewart? (or other anes)
Physician lead: Per Inpt-Outpt
Exec owners recom.
Initial use-case dependent
Overview of potential clinical use cases Lifestyle and ancestry
genomicsHealth risk and
polygenic risk scoresCarrier screening and
family planningDiagnosis
Pharmacogenomicefficacy
Pharmacogenomicdosing
Provide survivorship programs
Produce research / publications
Provide patient access to genetic testing info
Drive reimbursement opportunities
Continuous improvement of clinical workflows
Provide lifestyle management and prevention programs
Calculating health and financial ROI
Stratify risk based on multiple determinants of health
Monitor patients remotely
Testing and sequencing
Tracking and management
Intervention and counseling
Implementation of learnings
Provide genetic counseling
Provide epigenetics profiling
Provide imaging services Provide proteomics testing
Provide metabolomics profiling
Provide whole genome/ exome sequencing
Provide expression profiling
Manage / communicate secondary findings
Manage variant call dataProvide integrated counselor/
navigator/ physician portal
Provide carrier screening Provide polygenic risk scoring Provide ancestry testing & info
Generate and collect PROCollect HEOR Track health via wearable
Provide panel sequencing
Manage biobanking
Collect longitudinal data & outcomes
Secure and govern genomic data
Create and manage data partnerships
Continuing physician education
Clinical trials matchingProvide molecular ‘board’ for
complex cases
Manage and govern bioethics
Capabilities Across All Use Cases and Roadmap Phases
Predicting,Preventing
Detecting
Intervening
Curing, Managing
Genomics & Precision
Medicine ContinuumAggregate and explore complex
data sets
Enable secondary use of specimens
and data
Identify at Risk Populations
Leverage demographic data Establish RWE program
Leverage social determinant data
Collect pedigree/ family history
Manage individual treatment plans
Longitudinal case management
Obtain informed consent
Provide telemedicine access
Treat and Manage Disease
Care coordination / integration
Clinical decision support
Multilingual services
Integrate into clinical workflows
Secure preauthorization
Manage informed consent
Phase 1
Phase 2
Phase 3
Phase 4
1
2
3
4
Provide lifestyle management and prevention programs
Stratify risk based on multiple determinants of health
Provide genetic counseling
Provide polygenic risk scoring
Provide panel sequencing
Collect longitudinal data & outcomes
Secure and govern genomic data
Manage and govern bioethics
Collect pedigree/ family history
Manage individual treatment plans
Longitudinal case management
Obtain informed consentClinical decision
support
Integrate into clinical workflows
Provide genetic counseling
Provide carrier screening
Provide panel sequencing
Secure and govern genomic data
Continuing physician education
Manage and govern bioethics
Obtain informed consent
Integrate into clinical workflows
Provide lifestyle management and prevention programs
Provide genetic counselingManage / communicate
secondary findings
Manage variant call data
Provide panel sequencing
Secure and govern genomic data
Continuing physician education
Manage and govern bioethics
Collect pedigree/ family history
Manage individual treatment plans
Care coordination / integration
Multilingual services
Integrate into clinical workflows
Continuous improvement of clinical workflows
Provide genetic counseling
Manage variant call dataProvide integrated counselor/
navigator/ physician portal
Provide panel sequencing
Secure and govern genomic data
Manage and govern bioethics
Manage individual treatment plans
Obtain informed consentClinical decision
support
Integrate into clinical workflows
Manage informed consent
Provide patient access to genetic testing info
Provide genetic counseling
Provide panel sequencing
Secure and govern genomic data
Continuing physician education
Manage and govern bioethics
Obtain informed consentClinical decision
support
Integrate into clinical workflows
The Whole MeTM Helix Pilot
The Pilot
▪ Offer consumers a free AdventHealth branded App with up to 20 traits + ancestry and screening for Familial Hypercholesterolemia from Admera
▪ Research project under IRB supervision
▪ Enroll up to 10,000 participants with cost sponsored by AdventHealth.
▪ ACMG59 gene panel for clinical research
Helix Pilot – 2 Cohort Research Strategy
‘FIRST TO SIGN UP’ COHORT
• 9250 participants
• Screening for FH
• Link to clinical data
• Prospective
• Begins - 7/24
CVD ENRICHED COHORT
• 750 participants
• Screening for FH
• Link to clinical data
• Retro & Prospective
• Enrollment begins Q3
Helix – The Plan
National DNA Day
April 25*
Beta Launch
May 15
IRB Approval
June 1
Early VIP Launch
June 10
Public Launch
July 24
Leader TalkFirst-of-its-kindFlorida DNA studyWholeMe
Genomics Panel
Dr. Walker | Associate Chief Medical Information Officer
Dr. Essner | Principal Investigator
Dr. Lupu | Genetic Scientist
Dr. Finkler | Executive Sponsor, Genomic Medicine
Genomics Landing Page:
https://www.adventhealth.com/hospital/adventhealth-
orlando/genomics-personalized-health
Florence eRegShelley Watson
Christina Jackson
Florence eReg Coming Soon!
• More efficient, organized and standardized
• eSignature capable
• Centralization of all regulatory documents in one place
• Remote monitoring of all regulatory docs is possible
• Monitors can spend less time on site
• Email threads can be easily saved in Florence
• Aids with coordinating multicenter studies
• Florence has a direct connection to the FDA
• Improved regulatory compliance
• Leads to shorter study start up time
• Online storage saves space and keeps documents safe
• Less paper = more green!
• Documents can be scanned and uploaded only once and be available in eReg and CTMS, as well as duplicated to multiple binders within eReg
• Documents can be tracked, tagged with due and expiry dates, and trigger automated email notifications
Years of Service Recognition
• Melissa Pallone – IRB – 10 Years of Service
• Meghan Brodie – OSP – 10 Years of Service
• Kathleen (Kate) Ewing – OSP – 5 Years of Service
• Kim McManus – Whole Person Research – 5 Years of Service
• Jasmine Jones – Whole Person Research – 5 Years of Service
• Ashley Brower – Whole Person Research – 5 Years of Service
• Patricia Robinson – Senior Leadership – 10 Years of Service
• Anne Epley – Transplant Research – 30 Years of Service
Research Services Topics – After the Break
OSP: ▪ AdobeSign: E-Signature Solution▪ Schedule of Expenditures of Federal
Awards▪ CTMS Modified Workflow (CPA)
ORI: ▪ CPA Updates▪ Obtaining Hospital Pricing & Price Files▪ New CITI Module Available
IRB: ▪ Updated Forms▪ New Guidance for Self-Assessments▪ IRB Annual Departmental Rounding
BREAK
We will be regrouping at 3:35pm for the
Research Services Updates – Please take your seats at this time
Research Services Updates
OSP UpdatesMichelle Kilponen
Steven Truong
AdobeSign: E-Signature SolutionWhat is AdobeSign?
▪ A cloud based, enterprise-class e-signature service
▪ Fully automated electronic signature workflows
Why use AdobeSign?
▪ Easily request signatures, sign documents, and track and manage process electronically
▪ Sign documents from any location, at any time of day, using a browser or mobile device
How is OSP using AdobeSign?
▪ Research Agreements (when accepted by CROs/Sponsors)
▪ Internal Forms
▪ Coverage Analysis / Billing Grids
Schedule of Expenditures of Federal Awards
SEFA Audit Period▪ February 18, 2019 – April 18, 2019
Results▪ No Material Findings
Shout Outs▪ Research Finance for managing the audit process▪ Research Units for timely completion and submission
of requested supporting documentation
Clinical Conductor Modified WorkflowOverview
▪ Current system used for patient billing for the hospital, SunPort/SunCare, is being replaced with Cerner Patient Accounting (CPA)
▪ CPA Go Live date is scheduled for May 1, 2019
PowerTrial Requirement
▪ All patients enrolled* into clinical trials must be entered and updated in PowerTrials
▪ Directly OR via Clinical Conductor
Clinical Conductor Modified Workflow Training AVAILABLE
▪ If Research Unit is NOT fully implemented in Clinical Conductor
▪ If Clinical Trial is not built in Clinical Conductor prior to patient enrollment
IRB UpdatesJanice Turchin
IRB Updates
Minor revisions• Protocol / Protocol Supplement• External IRB Application• 400.071 SOP Utilization of External IRB
New Guidance for Self-Assessments
IRB Updates
Protocol / Supplement Templates
• Non-English Speaking Subjects• Reduced to one section
• WHY? Less confusing
IRB Updates
External IRB Application
• Those Unable to Consent• Confirm team will follow HRP-021
• WHY? Less confusing
IRB Updates
400.071 SOP Utilization of External IRB
”Inform OSP” section• Content added
• WHY? Maintain compliance
IRB Updates
New Guidance for Self-Assessments
ORI UpdatesChristina Jackson
ORI Updates-Cerner Patient Accounting (CPA)
• Go Live! May 1, 2019• Lisa Ambrosini, Research Revenue Cycle Compliance Specialist
• Patient Accounting/Claims information will no longer be entered into SunCare/SunPort as of May 1st
• Other activities, not related to patient accounting, will remain active in SunPort
• PowerTrials Requirement• Memo detailing requirement until Research Billing Compliance Policy is approved
• Accompanying document to determine which studies need to be entered into PowerTrials
• Compliance deadline within 90 days from receipt of memo
• Continue with current processes into Q3• ORI to conduct auditing/monitoring of new processes after Go Live
ORI Updates-Obtaining Hospital Pricing/Price Files
• Contact [email protected] to obtain hospital Pricing/Price Files
• Carolyn Acevedo, Revenue Management Clinical Liaison, Retiring July, 2019
• Revenue Integrity Department is currently reviewing and transitioning her responsibilities
• We will keep you posted as we learn of new processes
ORI Updates-Continued Professional Development R/T Research Billing Compliance
• AHRI will continue to strive in providing Education and Training opportunities related to research billing in a variety of formats.
• Continuing with Research Billing Departmental Rounding
• CITI-Clinical Trials Billing Compliance module NOW available in our suite of CITI modules
• CITI-New Webinar Coming Soon
• “The Challenge of Medicare Advantage Plans and Local Coverage Determinations”
Thank you for attending!