DevotionA Time of Great Hope, Change and Collaboration

Susan Dempsey-Walls, MN, CNS Cancer Research

Every Standard of Care Therapy is Available Because of a Past Successful Clinical Trial

The Power & Promise of Cancer Research

“A Time of Great Hope and Optimism”

ASCO 2018 Keynote Address

Key to Success During Future Changes

If everyone is moving forward together, then success takes care of itself.

Coming together is a beginning,

staying together is progress,

and working together is success.

- Henry Ford

NCI Strategy Project Clinical Research Celebration

Cancer Clinical Research Director Cancer Research Sr. Director

Translational Research Center

Investigational Drug Services

Clinical Research Nurses/Coordinators

Research Compliance/Regulatory

Research Assistants

Data Management

David Moorhead, M.D.Chief Clinical Officer

Better TogetherOffice of Research Integrity

Risk ManagementInterpreter Services

Informed Consent and Non-English Speaking Subjects Guidance

• Ivette Leka - ORI• Michelle McKinney - IRB• Felipe Valerio - Qualified Bilingual Staff• Jessy Castillo - Interpreter Services

• IRB• ORI• Research Departments• Interpreter Services• Risk Management

Collaboration

• IRB policies and SOPs related to informed consent and documentation

• FH policies and procedures for Language and Communication

• Research Department response to Short-Form Survey

• Guidance for interpreter services

ORI and IRB Review

Why Changes Were Needed?

• Lack of guidance of Short-Form use• Confusion of Short-Form use• Non-English population in Florida has

increased in 2017/2018• Low enrollment of non-English speaking

subjects - promote diversity

Better Together

• Identified gaps, reviewed policies, and developed guidance.

• Providing clarity and guidance on use.

• Treating all subjects with fairness and respect.

• Making sure researchers are doing the process correctly.

Keep Me Safe Love Me

Own ItMake It Easy

• HRP-802 Investigator Guidance- Informed Consent

• HRP-803 Investigator Guidance- Documentation of Informed Consent

• Short-Form Consent Templates

Changes to Current Guidance’s and Documents

Effective on 8/01/2018

Added References • New Short-Form Guidance- HRP-804 • HRP-001- Definitions policy• FH SOP 010.024- Language access and

communication assistance

HRP-802 Investigator GuidanceInformed Consent

HRP-803 Investigator Guidance Documentation of Informed Consent

Signatures• Short-form –

Subject and witness• Summary (Long

Form) - Personnel obtaining consent and witness

References• New Short-Form Guidance -

HRP-804 • HRP-001 - Definitions policy• FH SOP 010.024 - Language

access and communication assistance

• Discontinue use of WIRB Short-Form consent templates

• Now using template with our FH IRB logo• Revised Short Form templates in 5 most

common FH languages• Spanish, Creole, Portuguese, Arabic and

Vietnamese• Available in IRBNet 8/1/18

Revised Short-Form Template

Short-Form Consent Templates

Note: Interpreter cannot serve as witness

New Guidance Documents/Templates

• HRP-804 Investigator Guidance- Short Form Consent Process in Research

• Quick Guidance - Short-Form Consent use in Research• Quick Guidance - Informed Consent Process for Non-

English Speaking Subjects in Research • Template - Informed Consent Checklist• Interpreter services guide for researchers

HRP-804 Investigator GuidanceShort-Form Consent Process in Research

How many times can I use it?• No more than 3 times in the same language • After 3 times of use, it must be translated in that

languagePlease note that prior to starting a study, the enrollment of non-English subjects must be detailed in the protocol / supplement formIRB can request the ICF to be translated due to the complexity of study or at their discretion

• What it takes to become a QBS?• How long it takes?• Benefits of becoming a QBS

Felipe ValerioQualified Bilingual Staff

Contact: • ORI- FH.ORI@FLhosp.org, 407-303-8793• IRB- FH.IRB@FLhosp.org, 407-303-5581• Interpreter Services-

FH.Interpreter.Services.Dept@flhosp.orgo Manager Office: 407-303-8768o In-Person Interpreter Same Day Appointment: 407-303-3025o Interpreter Services Office: Ext. 110-6707 or 110-6670

(Monday - Friday, 6AM - 4PM)

Questions

Cancer ResearchSue Coakley, BS, MHA, CCRP

Florida Hospital Cancer Institute Clinical Research

Vision Statement: National recognition as a Cancer Institute that provides patients access to value-based, personalized care through highly specialized, comprehensive, and innovative destination programs.

Our program cares for more newly diagnosed cancer patients than any other

hospital system in Florida.*

More than 1,000 patients enrolled onto clinical trials

annually

Research affiliations with the National Cancer Institute (NCI), Children’s Oncology Group, and

University of Central Florida (UCF) College of Medicine

Accredited as an Academic Comprehensive Cancer

Program by the American College of Surgeons

Commission on Cancer

One of the most experienced radiation oncology programs in Florida and accredited by the

American College of Radiology (ACR) for quality

Performing more than 130 adult bone marrow transplants annually, and accredited by the Foundation for Accreditation of

Cellular Therapy (FACT) for quality

The world leader in robotic prostatectomy, utilizing Central Florida’s first da Vinci® Surgical

System

More than 10,000 cancer surgeries performed annually

Certified by the American Society of Clinical Oncology’s

(ASCO) Quality Oncology Practice Initiative for quality in

medical oncology

Accredited by the National Accreditation Program for Breast Centers (NAPBC) for

excellence in breast cancer care

Medical Director Goals

Participate in clinical trials that will serve our patient population

Perform scientifically sound clinical trials that have the potential to change or complement the treatment of patients with cancer

Perform and report research data in an organized and systematic manner with the highest quality possible

Providing our research leaders the opportunity to publish and participate in National scientific and research forums

Carlos Alemany, MD

Senior Director (1) Director (1)

Nurse Manager (1)

Disease Specific-Focus Nursing Team (8.5)

Administrative Specialist(1)

Regulatory Team (4)

Peds Onc Team (2)Rad Onc Coordinator (1)

BMT Team (1.5)Urology Practice (1.5)

Research Assistants (2)

Core Lab

Data Team (4)

Clinical ResearchMedical Director (1)

Contract/Budget Analyst (1)

Last First Florida Hospital Position Higher Education

Degrees FL Dept of Health Licensure Research Certification IATA Year Started in Research Year started at FH

Year Started in Research at FH

Acker Ingrid Research Nurse BS, BSNRN

1 2016 2012 2016

Clise Lauren Research Nurse BSN RN 1 2016 2016 2016

Coakley Susan Director BS, MHA CCRP 1 1992 2012 2012

DiosomitoGyongyi Budget Specialist BS CCRP

20032003

2006

Fogg-Smith Stacy Research Nurse BSN RN 12016 2016 2016

Guyler SaraRegulatory Coordinator II

BS, MHA 0 CCRP2016 2016 2016

HardyKabreina

Clinical Research Assistant

RMA

1 2015 2015 2015

Hartley Kim Study Coordinator CMA1 2016 2005 2016

LeBlancJane

Research Nurse BS RN1

2000 1998 2000

MattixCorina

Research Nurse AS RN CCRC 1 2000 2010 2010

PortillaLilia

Clinical Research Coordinator MS 0 1981 2009 2009

Reinhart Barbara Clinical Research Assistant AA 0 1 2001 2001 2001

SamuelCini

Research Nurse BSN RN 1 2015 2006 2015

SellersKaren

Research Nurse BSN RN1

2012 2012 2012

Smith Jenni Research Nurse BSN RN 12016 2007 2016

Smith Jamie

Research Nurse BSN RN1

2015 2013 2015

SolerLourdes

Clinical Research Coordinator LPN CCRC 2006 2011 2011

StaffordDanyell

Clinical Research Assistant AS 2016 2016 2016

ThomasAndrea Research Nurse BSN RN 1 2017 2013 2017

Valerio

Felipe New Study Acquisition

DHA CCRC, CCRA 1 2007 2005 2007

WhaleyMorgan

Regulatory Coordinator II BS 2016 2016 2016

WhiteKaren

Clinical Research Coordinator CCRP 2000 2011 2011

Dempsey-Walls

Susan

Research Nurse Manager

MN, CNS, CNS, AOCNS

1 2018 2014 2018

Iorio

Rebecca

Regulatory Coordinator I

BS, MS

2018 2018 2018

GordonJasmine

Regulatory Coordinator IIBS

2015 2015 2015

PercyMelanie

Study Coordinator BS

1 2004 2018 2018

CrimminsCathy

Research NurseBSN RN; CPN

1 2018 2013 2018

FHCI Offers Broad Portfolio of Novel Clinical Trials Across All Disease SitesBone Marrow

TransplantBreast CancerHead and Neck CancerGastrointestinal

Malignancies (GI)Genitourinary

Malignancies (GU)Gynecology Oncology

(Gyn Onc)Hematological

Malignancies

MelanomaNeuro-oncologyPediatric OncologyThoracicUrological (Early

Stage/Prevention)

New Study Activation Process CDA

New Study Tracking Sheet & Reg Excel Master List Updated

Multidisciplinary Review; PI & Medical Director Protocol Review

Feasibility Questionnaire / Feedback Pharmacy/Infusion Room

Pre-Site Selection Visit

Cursory Budget Review Required to Complete PRC Submission Form

PRC Submission / Approval

Secure Study Manuals

Central Lab; Imaging; & Pharmacy

Coverage Analysis

Contract & ICF for Legal Approval

OSP Budget Review & Pre- Approval

Budget Negotiations with Sponsor

OSP Post-Review/Approval

Clinical Trial Agreement Executed

Regulatory Documents

IRB Submission (Central/Local)

Research Team Portal Access/Training

Site Initiation Visit

Sponsor Activation

Study-specific Tool Development

Treatment orders

Infusion Room Up/Down Sheets

Invoice Tracking Sheet

Coordinator NSC Log Sheet

Collaborative Review of our New Study Activation Process

Thank you, OSP!

Shout out to Michelle Kilponen’songoing

support & guidance

Screening/Enrollment Initiatives

• Multidisciplinary tumor boards

• Ongoing updates & educational slides to all investigators

• Open Protocol Study Listing by Disease Site (Fast Facts)

Team

• Disease Specific Protocol Review meetings

• Daily review of physician schedules

• Morning huddle or direct communication from provider

Protocol Champion • Phone

inquires/Referrals• FHCI Nurse Cancer

Care Coordinators (Navigators)

• Clinicaltrials.gov• FHCI Quarterly

Physician Newsletter

• Via Oncology

Awareness

VIA: Promoting Clinical Research

Clinical Trials Presented on Pathways

Clinical Research Reporting

All locally open trials appear BEFORE the pathway treatment recommendation

If treating On Pathway, cannot bypass trial without indicating why trial will not be selected

Internal or external linksfor easy access to studydetails

• Trial selections by disease, presentation, physician and/or site

• Patient specific characteristic data to assist in pre-screening activities

• Patient counts by disease / presentation as well as physician / site (typically used to assess where to open trials)

Clinical Trial View to End UsersOpen Trial – appears as first selectable option

Thank You, Study Builders! Complication of oncology study designElements and events do not occur on same

dayRoutine care vs Non-Routine care can vary

by timepointClinical Validation Financial Validation Loading of back data Proactive use of CTMS once “go live” Supportive and open-minded teamIssue: multiple MRN#s for one patient

Collaboration with suggestions & questions

Building for future upgrades (“wish list”)

Infusion Room & IDS Pharmacy Partnering

Create a scheduling appointment spreadsheet (duration of appointments for specific treatment days)

Clinical trial specific education: Creation of “Protocol Pointers” to provide education for infusion room staff

Infusion Staff Research “Basic Clinical Research” education

Infusion -related study deviations: incorporate deviation minimizing strategies

Ongoing Collaborative Initiativesfor Success

CTMS

Infusion/IDSEducation

Via

FHMG

Collaboration

Phase 1b Study of Oncolytic Vaccinia Virus GL-ONC1 in Recurrent Ovarian Cancer

Robert W. Holloway1, James E. Kendrick1, Amanda J. Stephens1, Jessica A. Kennard1, Jeremy Burt2, Jane LeBlanc3, Karen Sellers3, Jamie Smith3,

Susan Coakley3

1Gynecologic Oncology Program, Florida Hospital Cancer Institute; 2Department of Radiologic Services, Florida Hospital;

3Office of Clinical Research, Florida Hospital Cancer Institute, Orlando, FL 32804

ASCO Annual Meeting, June 1-5, 2018 – Chicago, IL

Protocol #: GL-ONC1-015; ClinicalTrials.gov Identifier: NCT02759588

Abstract Brief Summary Background: Immunotherapy can trigger immune activation including tumor-infiltrating CD8+ T cells, leading to anti-tumor response and survival benefits. Immunotherapeutic GL-ONC1 (modified vaccinia virus (VACV)) causes oncolysis, immune activation and durable anti-cancer memory.

Methods: Intraperitoneal (i.pe.) infusion of GL-ONC1 monotherapy was given at high repeated doses in patients (pts) with platinum refractory/resistant disease.

Conclusions: Promising safety data, anti-tumor activity, and immune activation mechanisms were documented in this Phase 1b trial, and a Phase 2 trial (VIRO-15) is currently enrolling. Future studies combining GL-ONC1 and other immune therapies and/or chemotherapy are under consideration.

Tumor Infiltrating Lymphocytes (TILs) Exemplary IHC analysis - pt. # 15A-06, with PFS of 71 weeks:Significant infiltration of CD8+ cytotoxic T cells into tumors after virus treatment indicates activation of immunosurveillance

baseline Week 36

CD3 CD8Baseline 2.94 0.58

Week 36 5.06 3.54

0

1

2

3

4

5

6

Cell

Coun

ts P

er 8

0x F

ield

Immune Cell Counts in Tumor biopsies

p<0.001

CD3+

CD8+

p<0.001

Immune Modulation

Strong PD-L1 staining at the tumor-stromal interface

Baseline

GL-ONC1 Upregulates Immunomodulatory Target Proteins, such as PD-L1

20 days post-Tx

Acute inflammatory responses and PD-L1 upregulationin tumors by oncolytic virus GL-ONC1 can sensitize

tumors to PD-1/PD-L1 blockade.

We are blessed with a great team….

Thank you to our research patients, friends and families!

Cancer ResearchNathalie McKenzie, MD

What We Are Doing and Where We Are Going?

1. Exciting Clinical trials currently open.2. Trials recently approved.3. Concepts in development.4. What can we be the best at?

Exciting Clinical Trials Currently Open

STUDY NAME CANCER TYPE PRINCIPAL INVESTIGATOR

ANCERS-2 A Prospective, Multicenter, Observational Study Examining the Clinical Utility of CANscript in Routine Clinical Practice

Recurrent Epithelial ovarian cancer (EOC)

Nathalie Mckenzie, MD

Genelux—Phase 1b & 2 Study with GL-ONC1 in Patients with Recurrent OvarianCancer (VIRO-15)

Recurrent Ovarian Cancer Robert Holloway, MD

Xenetic -VX-EC-2-02: A Phase 2, Single Arm, Two Period Study of Sodium Cridanimod in Conjunction with Progestin Therapy in Patients with Endometrial Carcinoma

3rd Line Endometrial Cancer James Kendrick, MD

Clinical Trials Recently Approved

IMMUNOTHERAPY

+

PARP INHIBITOR

Targeted Agents Combined

IMMUNOTHERAPY(Nivolumab)

+

PARP INHIBITOR(Rucaparib)

Concepts In Development

• Using novel treatment strategies to preserve fertility in young women diagnosed with GYN cancers

• New surgical techniques FPRT (Fertility Preserving Radial Trachelectomy)

• Use of neoadjuvant chemotherapy Search for best regimen

• New sophisticated radiation modalities IGBT (Image Guided Brachytherapy)

Cervical Cancer: FPRT

Procedure:• Dividing the uterus

proximal to the cervical isthmus

• Excising the entire cervix and surrounding parametria

• Then suturing the uterus to the vagina

Stretch Break

Stretch Break

Stretch Break

Stand up

Roll your neck

Stretch your arms

Twist your waist

Sit down

Cancer Vision & Strategic Update

Bryan Allinson | Senior Director

Research Services Updates

OSP: Regina TanRAS: Michelle DolskeORI: Christina Jackson

OSP Updates

• Institutional Clearance Requirements Reminder

• Updated Pathology Budget Worksheet• Grants Assignment Update• CTMS Update

Institutional Clearance Required PRIOR to study initiation [HRP-010] Requirements:

Signed Research Review Application (RRA) Current Financial Conflict of Interest training and disclosures IRB approval and IRB-approved informed consent(s) Fully Executed Legal Agreements, as applicable

Clinical Trial Agreement (CTA), Grant award, other types of funding agreements

Material Transfer Agreements (MTA)/Data Use Agreement (DUA) Letter(s) of Agreement Physician Payment Letters for ancillary hospital services

Local MAC Approval Letter or Notification, as applicable Approved Internal Budget, if externally-funded Signed Coverage Analysis(es) or Billing Grid(s), if required

Updated Pathology Budget Worksheet

Grant Assignment Update

Audrey Carr Quilin Mars Leerin ShieldsCardiovascular Nicholson Center Cancer (Clinical) Diabetes Institute

Celebration Ortho Cancer (TRC) Radiology/Rad Onc

CREATION Pharmacy Children’s Research TRI-MD

CIE Thrombosis Surgery/ISA

Global Robotics Transplant

GME Urology

Neuroscience Women’s Health

CTMS Update

Clinical Conductor Release 5.0 available July 17 Release notes coming soon

Departments LIVE Cardiovascular Research Neuroscience ResearchWomen’s and Ped’s Research Center for Interventional Endoscopy Cancer Research

Research Services Updates

OSP: Regina TanRAS: Michelle DolskeORI: Christina Jackson

Research Oversight Committee Update

• Receives report from research team

• Determines serious and/or continuing non-compliance

• Disseminates information

IRB

• May give input r/t CAPA• Communicate summary of

serious and/or continuing non-compliance to ROC quarterly

• Communicate specific cases to ROC as requested on a case-by-case basis

Research Compliance

• Reviews specific cases as requested

• Reviews quarterly summary

• May add to CAPA

Research Oversight Committee

Research Oversight Committee Update

DRAFT

Thank you for attending!

Next meeting will be in September

or October