Research MattersJanuary 10, 2017

WelcomeRob Herzog, VP Research Operations

DevotionJasmine Jones

Center for CREATION Health Research12 Just as a body, though one, has many parts, but all its many parts form one body, so it is with Christ. 13 For we were all baptized by one Spirit so as to form one body—whether OSP or ReSIS, Jews or Gentiles, Cancer or Orthopedic Research, slave or free, ORI or Research Finance—and we were all given the one Spirit to drink. 14 Even so the body is not made up of one part but of many.15

DevotionJasmine Jones

Center for CREATION Health Research15 Now if the foot should say, “Because I am not a hand, I do not belong to the body,” it would not for that reason stop being part of the body.16 And if the ear should say, “Because I am not an eye, I do not belong to the body,” it would not for that reason stop being part of the body.17 If the whole body were an eye, where would the sense of hearing be? If the whole body were an ear, where would the sense of smell be?18 But in fact God has placed the parts in the body, every one of them, just as he wanted them to be. 19 If they were all one part, where would the body be? 20 As it is, there are many parts, but one body.

DevotionJasmine Jones

Center for CREATION Health Research21 The eye cannot say to the hand, “I don’t need you!” And the head cannot say to the feet, “I don’t need you!” 22 On the contrary, those parts of the body that seem to be weaker are indispensable, 23 and the parts that we think are less honorable we treat with special honor. And the parts that are unpresentable are treated with special modesty,24 while our presentable parts need no special treatment. But God has put the body together, giving greater honor to the parts that lacked it,25 so that there should be no division in the body, but that its parts should have equal concern for each other. 26 If one part suffers, every part suffers with it; if one part is honored, every part rejoices with it.

27 Now you are the body of Christ, and each one of you is a part of it.

1 Corinthians 12:12-27

Leadership MessageState of the FHRI

Steven R. Smith, M.D. Chief Scientific Officer

Thank You!

Laying the Foundation

New StructureNew Leaders

1 Team

E2

Publ

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Clin

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Impa

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Gran

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con

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Volu

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Q & A

About UsCardiovascular Research

• Partnered and aligned with the Cardiovascular Institute to provide state-of-the-art medical care and perform groundbreaking research in the Central Florida area

• As one of the top cardiac centers in the nation, the FH Cardiovascular Institute helps patients gain access to promising, new treatments and technologies before they are available to the general public

• CTMS “1st Wave”

57 Studies (Industry, Non-Industry, and FH Sponsored) • Interventional Cardiology• Cardiac and Vascular Surgery• Structural Heart Disease• Pulmonary Hypertension• Peripheral Vascular Disease• Heart Failure• Electrophysiology and Arrhythmia• Cardiac Imaging• Preventive Cardiology Staff• 11 Research Staff• 57 IRB Credentialed Investigators

About UsCenter for Interventional Endoscopy

CIE Quick Facts• CIE opened in 2011• #1 in Florida by volume• Tertiary Referral Center

• 39 states• 8 countries

• Providers• 5 Endoscopists• 1 Pathologist• 2 Mid-level

CIE Research • Goal: to innovate & attempt to

answer critical questions in the field of gastrointestinal endoscopy

• 43 Studies• 17 Investigator Initiated, Prospective,

Randomized Trials• 14 Retrospective studies• 7 Industry Sponsored• 2 Grant-funded (NIH & VA)• 3 Registries

• Research Staff• 3 FTEs

• Publications (Peer-reviewed journal articles)

• 24 in 2014• 42 in 2015

Research Services Updates

• ORI – Christina Jackson• ORI – Penny Carlson• IRB – Janice Turchin• OSP – Regina Tan• RAS – Michelle Dolske

Research Oversight Committee1st Meeting, January 12, 2017

Rob Herzog• VP Research Operations

Judith Fox• Corporate Responsibility

Fouad Hajjar, MD• IRB Chairman

Janice Turchin• IRB Manager

Troy Kishbaugh, JD• FH Legal

• Scott Silvestry, MD• Physician Investigator

• Jennifer Keehbauch, MD• Physician Investigator

• Esmond Chan• FH Finance Director A/R

Melissa Leonard• Clinical Operations & Nursing

RepresentativeJeff Carrico

• Investigational Drug Services (IDS )Penny Carlson

• ORI Compliance & EducationChristina Jackson

• ORI Compliance & EducationIvette Leka

• ORI Compliance & Education• TBD

• FHMG Representative

ClinicalTrials.govFinal Rule published September, 2016 - Effective, January 18, 2017• Applies to all Applicable Clinical Trials. ClinicalTrials.gov has developed a new

checklist to assist researchers in determining if their trial meets the criteria for an Applicable Clinical Trial (ACT)

https://prsinfo.clinicaltrials.gov/ACT_Checklist.pdf

• Results must be submitted within 12 months after primary completion date• Potential Federal enforcement actions• Label as non-compliant in ClinicalTrials.gov• Civil monetary penalties of up to $10,000/day• NIH Clinical Trials registration policy also updated – Applies to all clinical trials with federal

funding• Includes phase 1, non-FDA regulated, and behavioral research• Potential enforcement actions related to CT.gov non-compliance includes:• Possible suspension or termination of grant or contract funding• Considered in future funding decisions• Label as non-compliant in CT.gov

Research Patientsand FHMG• AthenaHealth initiated 11/1/2016

• Need to differentiate between FHMG and independent PI and sub-I’s.

• How many active studies do you have that involves a PI or sub-I that is FHMG?

• Standardizing pneumonic: Shortname|IRBNet#|PI name

• Contact: Kate MacNaughton FHMG.revenue.cycle.directors@flhosp.org• Notify:

• when initiating a new study• new patient enrollment

OSP: Office of Sponsored Programs

TBA

Regina Tan

Bianca Maldonado

Leerin Shields

Michelle Kilponen

QuilinMars

Jessica Hyacinthe

OSP

Team A

IIT/IIS Grants and Contracts -Funded Studies

Team B

Industry-Sponsored

Studies

IIT/IIS Internally - Funded Studies

Meghan Brodie

TBA

Research Services Updates

Research Advancement and Support

• Class Schedules posted on Intranet Research Services Website

• Email class RSVPs to FH.RAS@flhosp.org• New FHRI website expected to be released

by end of January www.FHResearch.com

Better TogetherHighlighting a Best Practice,

Collaboration, or Process Improvement

Use of Biospecimens in Research*TRI-MD

• Paul Coen, PhD*• Mandy Jones, BSN, CCRC• Josh Smith• Anna Zago• Chris Davis, PhD

Research Services• Michelle Dolske, PhD, CRCH• Michelle Kilponen, MRA• Janice Turchin, CIP• Michelle McKinney, MS, CIP• Fouad Hajjar, MD

DilemmaAs an institution, we have been on a learning curve. Approved protocols and ICFs have not always been detailed or sophisticated with regard to what could be done with residual or archived biospecimens.

Here is our Story

Scope of Biospecimen Research at FHCancer

Transplant

TRI-MD

Pharmacy Nursing Research

Neuroscience

GME

Global Robotics Institute

CelebrationHealth

Cardiovascular

Ortho

Children’s

InterventionalEndoscopy

Surgery

Winter ParkMemorial Hospital

Radiology

Creation Health

Thrombosis

FH Research Enterprise

TRI-MD Current State (July 2016)

After a study is completed, there are often requests for archived tissue from the study. Three specific problem’s were identified:1. Protocol and Informed

Consent are not always specific about how archived tissue will be handled

2. Protocol and Informed Consent may have conflicting information about how archived tissue will be handled

3. Protocol and Informed Consent may not reflect the PI’s intent of how archived tissue will be handled

We developed a Guidance Document to ensure:

• Delineation of Scientist/Investigator intent for the use of biospecimen in research

• Accurate depiction of this intent in the Protocol and Informed Consent as well as other study documents

Problem & Solution

1. Talked to scientists/investigators to define common “intents”

2. Defined the different intents both graphically and in the written document

3. Mapped the different “intents” to sections of the protocol and Informed Consent to yield “Synchronization”

4. Reviewed Guidance Document with ORA and IRB to insure institutional alignment – multiple iterations to achieve consensus.

Steps We Took to Develop the Guidance Document

• Provided a common language, common ground to discuss Scientist and Investigator intent regarding biospecimen use

• Reduced questions and ambiguities related to use of leftover and archived biospecimens in the protocol and informed consent

• More efficient IRB review and approval of studies• More efficient OSP review of MTA requests

Result

Impact StoryHow We Make a Difference

Anne Epley, BSN, RN, CCRPClinical Research Manager

FH Transplant Institute

Jarvik 2000Ventricular Device SystemPost Auricular Connection

Ventricular Assist Device

• Pulls blood from the left ventricle through a pump

• The pump sends the blood to the aorta and out to the rest of the body

• Battery operated• Power connection

exits out the abdomen

• Destination or bridge

Jarvik 2000

• Implanted directly into the left ventricle

• Battery operated• Power Connection is

post auricular• Can implant via

sternotomy or thoracotomy

• Destination only via clinical trial

Mr. S.

• 71 years old

• Retired auto service supervisor

• Married 49 years

• 2 daughters

• 2 grandchildren

• Referred to FHTI Advance Heart Failure clinic in

September 2013

Mr. S.Initial Presentation• On multiple medications• Using oxygen at night• Increased fatigue• SOB with minimal activity• Decreased functional

status – NYHA class IV• Frequent napping

Medical History• CAD• Ischemic Cardiomyopathy• Atrial Fib• H/O Vtach, • s/p multiple ablations• ICD implanted• HTN• Dyslipidemia• Obstructive Sleep Apnea• Cancer survivor

Mr. S.Current Status• Stable, NYHA class I• Enjoying walking and

water activities• Able to move to West

Coast to be near daughters

• Quality of Life greatly improved

VAD Implant• VAD evaluation completed• Consented for RELIVE trial,

randomized to the Jarvik 2000 device

• Implanted 11/2013• LOS 30 days (non-device related

complications)• Only 2 admissions since, both

related to his defibrillator and rhythm issues

• Recently completed his final 3 year study visit

Mr. S.’s Thoughts on Being a Study Participant

• Grateful for the

option

Ease of use

Shower, swim

No infections

• No regrets

TeamworkRob Herzog

• Assignment• Re-group• Discussion• Re-cap

Small Group DiscussionHow is research making care at FH

•more affordable? (eyes, ears, nose)

•more connected ? (mouth, hands, arms)

•more exceptional? (trunk, leg, feet)

Wrap-UpRecognition

Team Members• Promotions

• Tere Richards (Pediatric)• Jasmine Jones (CREATION

• Graduations• Diane Thomas (BHCA)

Teams• ResIS

• CTMS “Go Live!”• Cardiovascular

• 1st Wave of CTMS• TRI-MD

• Grant Awards• Microbiome• Epigenetics of adipose

tissue• Molecular Transducers of

Physical Activity in Humans (MoTrPAC)

• Industry Partnerships• Sanofi• Pfizer

New Team• Research Analytics

Institute

Closing Remarks

Thank You for Attending!

Our next Research Matters meeting will be in March…

Details will be released soon!