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Quintiles Site Management Kim Davis, SSRM June 17, 2014 Copyright © 2013 Quintiles 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 2 QUINTILES FACTS Founded in 1982 25,000 professionals in 62 countries Range of services from Drug development to commercialization Of the top best-selling drugs Quintiles has helped develop or commercialize everyone. 3 4 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” Quintiles Confidential 5 Clinical Trial Challenges Site Challenges Include: • 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 Goals • • • • • • • • • 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 6 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 Quintiles Confidential 7 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. Quintiles Confidential 8 Site Continuum From Tactical to Strategic to Transformative Prime Sites Partner Sites Standard Sites Relationship re-invented with every study; little consistency or value for either party Tactical (<1 studies/yr) Relationship actively managed; Relationship actively exploration of process of managed; exploration alignmentalignment for efficiency; process for pipeline comparison to site efficiency; pipeline capabilities for planning of comparison to site future study placement capabilities for planning of future study placement Strategic (1-8 studies/yr) 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 Transformative (8-20+ studies/yr) Therapeutic Alliances 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 - Focused patient population - High level of oversight - Volume based on current study mix Transformative - Beyond the Traditional Site Relationship Quintiles Confidential 9 Benefits of Partner Site Status Why do Good Sites Participate? 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 Quintiles Confidential 10 Right Sites Globally Partner Site recruitment rates are, on average, 50% higher Partner Site Outperformance Enrollment Rate 22% 86% Emerging Mkts USA/Canada Avg Partner Enr Rate 50% 52% Western Europe Global Avg Non Partner Enr Rate *Analysis included standard trials with enrollment closed between 2009-2011 and a minimum level of partner site participation. 11 Partner Site Expectations What does success look like? Streamline Site Identification process Faster Study Start Up Best in Class Recruitment Improved Overall Trial Performance QUALITY Quintiles Confidential 12 Current Pipeline Pipeline by Therapeutic Area - USA Cardiovascular 5% Allergy/Immunology 1% Dermatology 3% Rheumatology 12% Endocrinology 9% Respiratory 10% Gastrointestinal 5% Other 12% Orthopedics 3% Ophthalmology 1% Hematology/Oncology/ Transplantation 19% Neurology 10% Infectious Disease 9% Nephrology 1% Quintiles Confidential 13 Opportunities Won Primary Indication Therapeutic Indication Phase Other Not applicable Phase 1 Allergy/Immunology Respiratory Hematology/Oncology/Transplantation Hematology/Oncology/Transplantation Neurology Hematology/Oncology/Transplantation Endocrinology Endocrinology Endocrinology Gastrointestinal Endocrinology Cardiovascular Infectious Disease Hematology/Oncology/Transplantation Rheumatology Allergy COPD Non-small cell lung cancer Solid tumor configuration Multiple sclerosis Chronic lymphocytic leukemia Diabetes mellitus type 2 Diabetes mellitus type 2 Diabetes mellitus type 2 Ulcerative colitis Acromegaly Cardiovascular Disease RSV Sickle cell disease Rheumatoid arthritis Phase 3b Phase 2 Phase 2 Phase 1 N/A Phase 3b Phase 3b Phase 3b Phase 3b Phase 2 Phase 3 Phase 2 Phase 1 Phase 1 Phase 1 Neurology Epilepsy Phase 1 Quintiles Confidential First Patient Entered Population Age Group Date 5/22/2014 Adult – 17+ Years Adolescents – 12 Years to 16 Years; Adult – 5/29/2014 17+ Years 7/1/2014 Adult – 17+ Years 7/1/2014 Adult – 17+ Years 7/1/2014 Adult – 17+ Years 7/1/2014 Adult – 17+ Years 8/1/2014 Adult – 17+ Years 9/1/2014 Adult – 17+ Years 9/1/2014 Adult – 17+ Years 9/1/2014 Adult – 17+ Years 9/30/2014 Adult – 17+ Years 12/1/2014 Adult – 17+ Years 12/31/2014 Adult – 17+ Years 1/12/2015 Adult – 17+ Years; Geriatrics – 75+ Years 3/27/2015 Adult – 17+ Years 6/30/2015 Adult – 17+ Years Children – 2 Years to 12 Years; Adolescents – 11/1/2016 12 Years to 16 Years 14 Monthly Site Review Enrollment Protocol Primary Current Study Site Number Sponsor Name Indication Status WA21092 Hoffmann-La Roche Multiple sclerosis Enrollment Closed H8A-MC-LZAX Eli Lilly and Company Alzheimer's diseaseEnrollment Open BAN2401-G000-201 Eisai Limited Alzheimer's diseaseEnrollment Open S187.3.005 Solvay Pharmaceuticals Parkinson's diseaseEnrollment Closed 101MS326 Biogen Idec Multiple sclerosis Enrollment Closed I1F-MC-RHAP Eli Lilly and Company Arthritis Enrollment Open H8A-MC-LZAO Eli Lilly and Company Alzheimer's diseaseEnrollment Closed MK-8237-001 Merck Sharp & Dohme AllergicCorp. rhinitis Enrollment Open WA21093 Hoffmann-La Roche Multiple sclerosis Enrollment Closed ACP-103-015 ACADIA Pharmaceuticals Parkinson's diseaseEnrollment Closed NV20234 Hoffmann-La Roche Influenza Enrollment Open D1050325 Sunovion Pharmaceuticals Schizophrenia Enrollment Open NV20234_ext Hoffmann-La Roche Influenza Enrollment Open No. of Days Open for SUBJECT SUBJECT Investiga Investiga Enrollment S SUBJECT SUBJECTS SUBJECTS S MED_EN tor First tor Last Site Startup (x = No. of SCREENE SCREEN SUBJECTS ENROLLMEN RANDOMIZ DISCONTI RL_FACT Account Name Name Name Date Days) D FAILURES ENROLLED T FAILURE ED NUED OR University of South Florida Derrick Robertson 2-Nov-11 500 < x 16 6 10 0 10 3 360% University of South Florida Balebail Physicians Raj Group 9-Aug-13 300 < x ≤ 500 3 0 3 0 3 0 100% USF Suncoast Gerontology Amanda Center Smith 7-Mar-13 300 < x ≤ 500 6 3 3 0 3 0 111% University Of South Florida RobertMedical Hauser Center 8-Apr-10 500 < x 3 0 3 0 3 2 74% University of South Florida Derrick Robertson 27-Feb-12 500 < x 2 1 1 0 1 0 75% University of South Florida John Carter 26-Nov-13 200 < x ≤ 300 0 0 0 0 0 0 0% USF Health Byrd Institute Balebail Raj 15-Jun-11 500 < x 4 0 4 0 4 1 70% University of South Florida DennisAsthma, Ledford Allergy & Immunology 27-Jun-13 300 < x ≤ 500 2 0 1 1 0 0 20% University of South Florida Derrick Robertson 9-Jul-11 500 < x 2 0 2 0 2 1 43% USF Health Byrd Institute Robert Hauser 22-May-09 500 < x 3 0 3 0 3 1 100% University of South Florida Michael - All Children's Nieder Hospital 16-Feb-10 500 < x 0 0 0 0 0 0 0% University of South Florida Tanya Murphy 18-Feb-14 100 < x ≤ 200 0 0 0 0 0 0 0% University of South Florida Sally Alrabaa 23-Oct-13 200 < x ≤ 300 0 0 0 0 0 0 0% Zero Enrollers – If site does not enroll a patient within 100 days of site initiation Greater Than 100 Days Protocol Primary Number Sponsor Name Indication I1F-MC-RHAP Eli Lilly and Company Arthritis D1050325 Sunovion Pharmaceuticals Schizophrenia Current Study Site Status Enrollment Open Enrollment Open Account Name USF USF SITE_INITIA TION_VISIT _LATEST_D ATE_BEFOR Investiga Investiga E_FIRST_SU tor First tor Last SITE BJECT_SCRE Name Name INITIATED ENED John Carter 26-Nov-13 26-Nov-13 Tanya Murphy 18-Feb-14 18-Feb-14 Quintiles Confidential No. of Days Open for Enrollme nt (x = SUBJECT No. of SUBJECTS SCREEN Days) SCREENED FAILURES 200 < x ≤ 300 0 0 100 < x ≤ 200 0 0 SUBJECTS SUBJECT SUBJECT ENROLLME S S MED_EN SUBJECTS NT RANDOM DISCONTI RL_FACT ENROLLED FAILURE IZED NUED OR 0 0 0 0 0% 0 0 0 0 0% 15 Monthly Site Review Zero Enrollers Less Than 100 Days – new studies awarded in last 100 days Primary Protocol Sponsor Indicatio Account Number Name Phase n Current Study Site Status Name OMS824-HTD-002 Omeros Phase 2 Alzheimer'sEssential disease Documents in placeUSF ECU-MG-301 Alexion Pharmaceuticals Phase 3 Disorder ofEnrollment nervous system Open USF D1050325 Sunovion Pharmaceuticals Phase 3 Schizophrenia Enrollment Open USF Investiga tor First Name Juan Tuan Daniel Investiga tor Last Name SITE INITIATED Sanchez-Ramos31-Mar-14 Vu 28-Mar-14 Fallon 21-Mar-14 No. of Days Open for Enrollment (x = No. of Days) 70 < x ≤ 100 70 < x ≤ 100 70 < x ≤ 100 SUBJECTS SCREENED 0 0 1 SUBJECT SCREEN FAILURES 0 0 1 SUBJECTS ENROLLED 0 0 0 SUBJECT S SUBJECT SUBJECT ENROLL S S MED_EN MENT RANDOM DISCONTI Enrollme RL_FACT FAILURE IZED NUED nt Rate OR 0 0 0 0 0 0 0 0% 0 0 0 0 0% 16 Study Quality Protocol Deviations are tracked and reviewed Sponsor Name Protocol Number Solvay Pharmaceuticals S187.3.001 Solvay Pharmaceuticals S187.3.005 AstraZeneca D0490C00005 AstraZeneca D144AC00001 AstraZeneca Research and Development D4300C00002 AstraZeneca Research and Development D4300C00003 AstraZeneca Research and Development D4300C00005 MedImmune MI-CP147 Biogen Idec 101MS326 Biogen Idec 223AS302 Biogen Idec 997HA301 Not Available 223AS304 Dainippon Sumitomo Pharma America, D1050236 Inc. Dainippon Sumitomo Pharma America, D1050256 Inc. Sunovion Pharmaceuticals D1050235 Right Investiga Investiga Right Patients tor Last tor First Patients Consente Account Name Name Name Recruited d University Of South Florida Medical Center Hauser Robert University Of South Florida Medical Center Hauser Robert 100.00% 100.00% University of South Florida Hauser Robert 100.00% 100.00% University Of South Florida IRB Bengtson Michael 100.00% 100.00% University Of South Florida IRB Carter John 100.00% 100.00% University Of South Florida IRB Carter John 100.00% 100.00% University Of South Florida IRB Carter John 100.00% 0.00% University of South Florida, College of Medicine Lujan-Zilbermann Jorge 100.00% University of South Florida Robertson Derrick 100.00% 100.00% University of South Florida Vu Tuan 60.00% 100.00% University Of South Florida Medical Center Saba Hussain University of South Florida Vu Tuan 100.00% 87.50% University of South Florida Hidalgo Rosario 100.00% 84.00% University of South Florida Hidalgo Rosario 100.00% 71.40% University of South Florida Hidalgo Rosario 100.00% 86.70% Patients without IP Deviation s Patient Data Correctly Captured Patient SAEs Correctly Reported 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 0.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 100.00% 50.00% 100.00% 100.00% 100.00% Average GCP and Protocol Complian ce % 100.00% 100.00% 90.00% 100.00% 100.00% 80.00% 100.00% 100.00% 85.70% 100.00% 92.60% 100.00% 100.00% 100.00% 83.30% 84.00% 100.00% 50.00% 92.90% 100.00% 100.00% 93.30% 100.00% 97.50% 88.40% 82.90% 92.90% Patients Complete on No. of No. of Complete Patients Patients d Studies Screened Enrolled 0 0 3 3 8 6 75.00% 4 4 0.00% 1 1 100.00% 1 1 1 1 1 0 2 1 60.00% 24 20 0 0 87.50% 8 8 91.70% 25 12 14 14 15 4 17 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 18 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 Quintiles Confidential 19 Questions 20