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 FH.RI.Research@AdventHealth.com 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!