Copyright © 2013 Quintiles Quintiles Site Management Kim Davis, SSRM June 17, 2014

Copyright © 2013 Quintiles

Quintiles Site Management

Kim Davis, SSRM

June 17, 2014

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Quintiles Mission:Quintiles helps to improve healthcare worldwide by providing a broad range of professional services, information and partnering solutions to the pharmaceutical, biotechnology and healthcare industries.

Our Passion:Improving patient treatment options by helping our customers deliver new medicines

Quintiles Confidential

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QUINTILES FACTS

Founded in 198225,000 professionals in 62 countriesRange of services from Drug development to commercializationOf the top best-selling drugs Quintiles has helped develop or

commercialize everyone.

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Clinical Trial Challenges

Experienced research sites are saturated with opportunities

50% of sites enroll 90% of the patients in any given trial

30% of sites selected and initiated NEVER enroll 1 single patient

80% of Clinical Trials fail to meet initial enrollment quotas creating

potential losses between $600,000 to $8M Daily*


* Source: Cutting Edge Information, “Web-Based Patient Recruitment”

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Clinical Trial Challenges

• Study Opportunities• Patient enrollment focus• Facilitate site selection• Site motivation / focus• Resolution of site issues• Site communication• Patient retention• Improved site quality• Regular performance review

• Study Timelines• Decrease Overall Cost

• Competition for studies• Lack of focus on enrollment• Challenges with particular

patient population• Competition for patients to participate in

studies• Lack of adequate staffing• Limited knowledge or training• Complex drug/device protocol• Data collection challenges• Protocol errors• Patient retention

Partnership GoalsSite Challenges Include:

Quintiles Partner Program – A worldwide network of top Investigative sites who conduct their studies to the

highest quality standards who have a strategic alliances and acquisitions in order to enhance timely enrolment of patients on global studies:

• Program initiated in 2004

• Over 1500 worldwide Partner Investigators

• Relationships Matter

• Proven improved site performance

• Improved investigator satisfaction

7Quintiles Confidential

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Program Goals

>Explore avenues to expand the current investigative site pool

>Develop creative patient recruitment strategies

> Identify high performing investigative sites using qualitative and quantitative data – eliminate non-performing sites

> Improve relationships with quality sites and gain greater efficiencies from start up to close out.


Site Continuum

Long term strategy - developmental not prescriptive Class based on results not ambitions Support against milestones Mutual collaboration and aligned goals allows a new type of relationship

From Tactical to Strategic to Transformative

Tactical(<1 studies/yr)

Strategic(1-8 studies/yr) Transformative

Relationship re-invented with every study; little

consistency or value for either party

(8-20+ studies/yr)

Relationship actively managed; exploration of process

alignment for efficiency; pipeline comparison to site capabilities

for planning of future study placement

Partner Sites

Relationship actively managed; exploration of

process alignment for efficiency; pipeline comparison to site

capabilities for planning of future study placement

Partner SitesPrime Sites

Mutual commitment at senior levels to collaborate on all

appropriate studies; operational/functional

alignment; long-term planning and goal-setting; dedicated alliance manager assigned;

joint corporate governance of relationship

Standard Sites

Transformative - Beyond the Traditional Site Relationship

Therapeutic Alliances

- Focused patient population- High level of oversight- Volume based on current study mix

9Quintiles Confidential

Benefits of Partner Site Status

Quintiles High Study Volume Increased number of trials Increased access for patients to new medications Differentiation from other physician practices

Quintiles Operational Expertise Advice and tools to improve site’s recruitment Sharing best practices to streamline processes at the site Sharing of metrics to compare performance to others

Quintiles Commitment Work together on feasibility of relevant protocols Insight into industry pipeline for key indications Relationship manager to provide high quality customer

service around the clock An advocate for the site within Quintiles

Why do Good Sites Participate?

Quintiles Confidential 10

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Right Sites Globally Partner Site recruitment rates are, on average, 50% higher

*Analysis included standard trials with enrollment closed between 2009-2011 and a minimum level of partner site participation.

Emerging Mkts USA/Canada Western Europe Global

Avg Partner Enr Rate Avg Non Partner Enr Rate

22%

86% 52%50%

Partner Site OutperformanceEnrollment Rate

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Partner Site ExpectationsWhat does success look like?

Streamline Site Identification process

Faster Study Start Up

Best in Class Recruitment

Improved Overall Trial Performance


QUALITY

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Current Pipeline


Allergy/Immunology1%

Cardiovascular5% Dermatology

3%

Endocrinology9%

Gastrointestinal5%

Hematology/Oncology/Transplanta-

tion19%

Infectious Disease9%

Nephrology1%

Neurology10%Ophthalmology

1%

Orthopedics3%

Other12%

Respiratory10%

Rheumatology12%

Pipeline by Therapeutic Area - USA

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Opportunities Won


Primary Indication Therapeutic Indication PhaseFirst Patient Entered

DatePopulation Age Group

Other Not applicable Phase 1 5/22/2014 Adult – 17+ Years

Allergy/Immunology Allergy Phase 3b 5/29/2014Adolescents – 12 Years to 16 Years; Adult – 17+ Years

Respiratory COPD Phase 2 7/1/2014 Adult – 17+ YearsHematology/Oncology/Transplantation Non-small cell lung cancer Phase 2 7/1/2014 Adult – 17+ YearsHematology/Oncology/Transplantation Solid tumor configuration Phase 1 7/1/2014 Adult – 17+ YearsNeurology Multiple sclerosis N/A 7/1/2014 Adult – 17+ YearsHematology/Oncology/Transplantation Chronic lymphocytic leukemia Phase 3b 8/1/2014 Adult – 17+ YearsEndocrinology Diabetes mellitus type 2 Phase 3b 9/1/2014 Adult – 17+ YearsEndocrinology Diabetes mellitus type 2 Phase 3b 9/1/2014 Adult – 17+ YearsEndocrinology Diabetes mellitus type 2 Phase 3b 9/1/2014 Adult – 17+ YearsGastrointestinal Ulcerative colitis Phase 2 9/30/2014 Adult – 17+ YearsEndocrinology Acromegaly Phase 3 12/1/2014 Adult – 17+ YearsCardiovascular Cardiovascular Disease Phase 2 12/31/2014 Adult – 17+ YearsInfectious Disease RSV Phase 1 1/12/2015 Adult – 17+ Years; Geriatrics – 75+ YearsHematology/Oncology/Transplantation Sickle cell disease Phase 1 3/27/2015 Adult – 17+ YearsRheumatology Rheumatoid arthritis Phase 1 6/30/2015 Adult – 17+ Years

Neurology Epilepsy Phase 1 11/1/2016Children – 2 Years to 12 Years; Adolescents – 12 Years to 16 Years

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Monthly Site Review


Enrollment

Zero Enrollers – If site does not enroll a patient within 100 days of site initiation

Protocol Number Sponsor Name

Primary Indication

Current Study Site Status Account Name

Investigator First Name

Investigator Last Name

Site Startup Date

No. of Days Open for Enrollment (x = No. of Days)

SUBJECTS

SCREENED

SUBJECT SCREEN

FAILURESSUBJECTS ENROLLED

SUBJECTS ENROLLMEN

T FAILURE

SUBJECTS RANDOMIZ

ED

SUBJECTS

DISCONTINUED

MED_ENRL_FACTOR

WA21092 Hoffmann-La RocheMultiple sclerosis Enrollment Closed University of South FloridaDerrick Robertson 2-Nov-11 500 < x 16 6 10 0 10 3 360%H8A-MC-LZAX Eli Lilly and CompanyAlzheimer's diseaseEnrollment Open University of South Florida Physicians GroupBalebail Raj 9-Aug-13 300 < x ≤ 500 3 0 3 0 3 0 100%BAN2401-G000-201Eisai Limited Alzheimer's diseaseEnrollment Open USF Suncoast Gerontology CenterAmanda Smith 7-Mar-13 300 < x ≤ 500 6 3 3 0 3 0 111%S187.3.005 Solvay PharmaceuticalsParkinson's diseaseEnrollment Closed University Of South Florida Medical CenterRobert Hauser 8-Apr-10 500 < x 3 0 3 0 3 2 74%101MS326 Biogen Idec Multiple sclerosis Enrollment Closed University of South FloridaDerrick Robertson 27-Feb-12 500 < x 2 1 1 0 1 0 75%I1F-MC-RHAP Eli Lilly and CompanyArthritis Enrollment Open University of South FloridaJohn Carter 26-Nov-13 200 < x ≤ 300 0 0 0 0 0 0 0%H8A-MC-LZAO Eli Lilly and CompanyAlzheimer's diseaseEnrollment Closed USF Health Byrd InstituteBalebail Raj 15-Jun-11 500 < x 4 0 4 0 4 1 70%MK-8237-001 Merck Sharp & Dohme Corp.Allergic rhinitis Enrollment Open University of South Florida Asthma, Allergy & ImmunologyDennis Ledford 27-Jun-13 300 < x ≤ 500 2 0 1 1 0 0 20%WA21093 Hoffmann-La RocheMultiple sclerosis Enrollment Closed University of South FloridaDerrick Robertson 9-Jul-11 500 < x 2 0 2 0 2 1 43%ACP-103-015 ACADIA PharmaceuticalsParkinson's diseaseEnrollment Closed USF Health Byrd InstituteRobert Hauser 22-May-09 500 < x 3 0 3 0 3 1 100%NV20234 Hoffmann-La RocheInfluenza Enrollment Open University of South Florida - All Children's HospitalMichael Nieder 16-Feb-10 500 < x 0 0 0 0 0 0 0%D1050325 Sunovion PharmaceuticalsSchizophrenia Enrollment Open University of South FloridaTanya Murphy 18-Feb-14 100 < x ≤ 200 0 0 0 0 0 0 0%NV20234_ext Hoffmann-La RocheInfluenza Enrollment Open University of South FloridaSally Alrabaa 23-Oct-13 200 < x ≤ 300 0 0 0 0 0 0 0%

Protocol Number Sponsor Name

Primary Indication

Current Study Site Status

Account Name



SITE INITIATED

SITE_INITIATION_VISIT_LATEST_DATE_BEFORE_FIRST_SUBJECT_SCREENED


SUBJECTS SCREENED

SUBJECT SCREEN


SUBJECTS ENROLLME

NT FAILURE

SUBJECTS

RANDOMIZED

SUBJECTS

DISCONTINUED

MED_ENRL_FACT

ORI1F-MC-RHAP Eli Lilly and CompanyArthritis Enrollment Open USF John Carter 26-Nov-13 26-Nov-13 200 < x ≤ 300 0 0 0 0 0 0 0%D1050325 Sunovion PharmaceuticalsSchizophrenia Enrollment Open USF Tanya Murphy 18-Feb-14 18-Feb-14 100 < x ≤ 200 0 0 0 0 0 0 0%

Greater Than 100 Days

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Monthly Site Review

Zero Enrollers

Less Than 100 Days – new studies awarded in last 100 days

Protocol Number

Sponsor Name Phase

Primary Indication Current Study Site Status

Account Name


Investigator Last Name SITE INITIATED


SUBJECTS SCREENED

SUBJECT SCREEN


SUBJECTS

ENROLLMENT

FAILURE

SUBJECTS

RANDOMIZED

SUBJECTS

DISCONTINUED

Enrollment Rate

MED_ENRL_FACT

OROMS824-HTD-002Omeros Phase 2 Alzheimer's diseaseEssential Documents in placeUSF Juan Sanchez-Ramos31-Mar-14 70 < x ≤ 100 0 0 0 0 0 0ECU-MG-301Alexion PharmaceuticalsPhase 3 Disorder of nervous systemEnrollment Open USF Tuan Vu 28-Mar-14 70 < x ≤ 100 0 0 0 0 0 0 0 0%D1050325 Sunovion PharmaceuticalsPhase 3 SchizophreniaEnrollment Open USF Daniel Fallon 21-Mar-14 70 < x ≤ 100 1 1 0 0 0 0 0 0%

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Study Quality

Sponsor Name Protocol Number Account Name



Right Patients Recruited

Right Patients Consented

Patients without IP Deviations

Patient Data Correctly Captured

Patient SAEs Correctly Reported

Average GCP and Protocol Compliance %

Patients Complete on Completed Studies

No. of Patients

Screened

No. of Patients Enrolled

Solvay Pharmaceuticals S187.3.001 University Of South Florida Medical Center Hauser Robert 0 0Solvay Pharmaceuticals S187.3.005 University Of South Florida Medical Center Hauser Robert 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 3 3AstraZeneca D0490C00005 University of South Florida Hauser Robert 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 8 6AstraZeneca D144AC00001 University Of South Florida IRB Bengtson Michael 100.00% 100.00% 50.00% 100.00% 100.00% 90.00% 75.00% 4 4AstraZeneca Research and DevelopmentD4300C00002 University Of South Florida IRB Carter John 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 0.00% 1 1AstraZeneca Research and DevelopmentD4300C00003 University Of South Florida IRB Carter John 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 1 1AstraZeneca Research and DevelopmentD4300C00005 University Of South Florida IRB Carter John 100.00% 0.00% 100.00% 100.00% 100.00% 80.00% 1 1MedImmune MI-CP147 University of South Florida, College of MedicineLujan-ZilbermannJorge 100.00% 100.00% 100.00% 1 0Biogen Idec 101MS326 University of South Florida Robertson Derrick 100.00% 100.00% 0.00% 100.00% 100.00% 85.70% 2 1Biogen Idec 223AS302 University of South Florida Vu Tuan 60.00% 100.00% 100.00% 100.00% 100.00% 92.60% 60.00% 24 20Biogen Idec 997HA301 University Of South Florida Medical Center Saba Hussain 0 0Not Available 223AS304 University of South Florida Vu Tuan 100.00% 87.50% 100.00% 100.00% 100.00% 97.50% 87.50% 8 8Dainippon Sumitomo Pharma America, Inc.D1050236 University of South Florida Hidalgo Rosario 100.00% 84.00% 83.30% 84.00% 100.00% 88.40% 91.70% 25 12Dainippon Sumitomo Pharma America, Inc.D1050256 University of South Florida Hidalgo Rosario 100.00% 71.40% 50.00% 92.90% 100.00% 82.90% 14 14Sunovion Pharmaceuticals D1050235 University of South Florida Hidalgo Rosario 100.00% 86.70% 100.00% 93.30% 100.00% 92.90% 15 4

Protocol Deviations are tracked and reviewed

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New Study Opportunity Process

• Opportunities>Pre-Award bid defense>Feasibility – if Quintiles were awarded this study would you be interesed

>Post Award – Relationship Mgr places the best sites on a list

• Next Steps> CDA – USF has a Master CDA however some Sponsors do not accept

- Turnaround time on this is very important> Right PI – how does OCR know what PI’s want which studies?> eSIF – to be completed by the PI or Site Director or Study Coordinator

- Turnaround time on this is very important> Site Selection is made by review of MANY parameters and data

- Performance metrics are very important as the Sponsor & Quintiles select the best sites

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How to be a successful Partner Site

> New Study Opportunities- Pipeline- New Opportunities communicated to Master Contact- Quick turnaround on PI interest, CDA Signature &

completion of eSIF

> Site/PI Identification- Right Site, Right PI, Right Patient Population- Start up – efficiency important- PI Capabilities very important

> Measure engagement / commitment- PI interest / capabilities assessment- Timely response- Timely start up process

> Key - Centralized Functions

» Budgets | Contracts | IRB | Regulatory- Training & Staff Education- Core Processes & Procedures- Communication/Relationship with each division/PI

conducting research


Questions

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