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Pfizer Clinical Research Unit – Brussels Pfizer Confidential │ 1 Erasme Hospital One–day Clinic Since 2005 The unit is located in the two upper floors (3 & 4) of the one-day clinic Pfizer Confidential │ 2 DRUG DEVELOPMENT – VALUE OF PHASE I RESEARCH Who are we? • Dedicated group of very experienced staff – Most experienced phase 1 nursing staff in the industry – 4 full time MDs – Never a major medical event – Never a major quality issue that has forfeited study • Seen as « Benchmark » by competent authorities (FAHMP) and other phase one units in Belgium Pfizer Confidential │ 4 Drug Discovery Pfizer Confidential │ 5 Cost of a drug Pfizer Confidential │ 6 Early Development Research • Healthy volunteers • Pharmacokinetics • Pharmacodynamics • …… ? Pfizer Confidential │ 7 Early Development Research • Healthy volunteers • Pharmacokinetics • Pharmacodynamics • …… ? Pfizer Confidential │ 8 Who are these volunteers? • The majority (+ 49%) is employed (nurse, police, military, firemen, independent workers) – Very little (less than 20%) unemployed • Reliable and trustworthy! • Are reimbursed for their time and uncomfortable nature of study (not for risk!!!) – i.e. several blood samples, number of nights in the unit etc – Average per 24hrs = 110 euro Pfizer Confidential │ 9 Healthy volunteers What is “Healthy”? • No disease • No modification of drug absorption or elimination (kidney, liver, gut etc) • No concomitant medication • Conclusion: No confounding factors!!! Pfizer Confidential │ 10 Volunteer types Volunteering types in the PCRU-BR: • Healthy Subjects • Patients • Specific populations Pfizer Confidential │ 11 Specific populations Not « Healthy » but no « Patient » Characteristics - according to study protocol: • Elderly • Lactating women • Overweight • Elevated LDL • ... Pfizer Confidential │ 12 Patients • PCRU-BR has experience in studies with patients since 2004 – Phase1/methodology studies in patients • Characteristics; according to the study protocol • Since 2011 patient studies are specifically run to assess an early sign of efficacy => avoid needless (later-phase) studies Pfizer Confidential │ 13 Recruitment Methods Are chosen upon protocol requirements Newspaper Advertisements PfizerPro Newsmail (Patient) Associations (e.g. La Third Party Vendors (Clariness, leche league) BBK Worldwide) Student Associations Pfizer Corporate Social Media Accounts (Blog, Facebook, Twitter) Pharmacies (e.g. Multipharma) PCRU Newsmail GP/SP (Close collaboration) Word of Mouth Pfizer Confidential │ 14 Recruitment Methods Recruitment Methods 7% 9% 6% 34% 15% 29% Word of mouth Pfizer Website Banner/Clariness Medical Referral Metro Other Pfizer Confidential │ 15 Recruitment Process First Contact Call Center First Panel Visit Selection (Query) Proposition of a Study Inscription in a Study Study Specific Screening Pfizer Confidential │ 16 What are our « safety nets » ? MEDICAL REGULATORY / ETHICS • 1st contact: Telephone call • FAMHP • First visit/screen phone (general) • Ethics Committee approval • AAHRPP Accreditation • Screening visit (study) • Admission (just prior to 1st drug dosing) Pfizer Confidential │ 17 What happens to the volunteers in the unit? • Admission: (Day 0) afternoon before dosing – Drug test; lab safety : BS, urine; physical exam – Explanation of the « schedule » – Overnight stay • Next day (Day 1) – ECG, BP, BS (PK), Empty bladder, No breakfast unless food interaction studied – Dosing – No toilet or water 1 hour after dosing – Stay in room for first 4 hours, semi-recumbent – Up to 5 ECG, BP, BS (PK), other tests – Cardiac Monitoring in case of FIH – Urine collection – ……………. • Day 2 In house (idem day 1) ECG, BP, BS (PK), lab safety : BS, urine • Day 3 ECG, BP, BS (PK), lab safety : BS, urine, physical exam and discharge Pfizer Confidential │ 18 S A F E T Y What happens to the volunteers in the unit? Pfizer Confidential │ 19 Adverse Events on 400 Phase 1 protocols: 20 most frequent AE’s 11% 20% 1-6% Pfizer Confidential │ 20 SAEs in Belgian Phase I Units Overview period 2009 - 2012 2009 2010 2011 2012 Healthy volunteers (male & female): 3138 3695 2507 2457 Special populations/patients: 92 197 165 250 • Renal 10 24 10 12 • Hepatic 15 32 44 15 • Hypertensive 17 24 39 69 • Migraine 7 0 4 44 • Overweight & obese 16 52 0 0 • Diabetics 0 4 22 5 • CHF 11 15 0 0 • COPD 0 14 0 32 • Schizophrenic 16 32 32 0 • Asthmatic 0 0 14 0 • Depression 0 0 0 13 • Ligated males 0 0 0 11 • Menopausal women 0 0 0 8 • Cystic fibrosis 0 0 0 3 • Gastroparesis 0 0 0 5 • Osteoarthritis 0 0 0 30 • Hemophilia 0 0 0 2 • Ulcero-hemorrhagic rectolitis 0 0 0 2 Grand total of all subjects: 3230 3892 2672 2707 SAEs or SUSAR: 7 12 12 14 • Related 0 2(0,05%) 0 0 • Not related 7 10 12 14 • Fatalities 0 0 0 0 0,22% 0,31% 0,45% 0,52% % SAEs relative to grand total : Pfizer Confidential │ 21 SAE in GENERAL POPULATION vs Phase 1 population • 3% of all deaths in the general population due to fatal adverse drug reaction (Br J Clin Pharmacol 2008 April) • 0.3% of phase 1 population suffer from serious adverse event • 0.05% of phase 1 population suffer from DRUG RELATED serious adverse event Pfizer Confidential │ 22 Early Development Research • Healthy volunteers • Pharmacokinetics • Pharmacodynamics • …… ? Pfizer Confidential │ 23 Pharmacokinetics MTD Therap. Pfizer Confidential │ 24 Pharmacokinetics – controlled release Pfizer Confidential │ 25 Early Development Research • Healthy volunteers • Pharmacokinetics • Pharmacodynamics • …… ? Pfizer Confidential │ 26 Pharmacodynamics • BP • Temperature • ECG – QT interval Pfizer Confidential │ 27 PCRUS : PFIZER’S INTERNAL UNITS Pfizer’s 2 Clinical Research Units act as « 1 Unit » State of the art internal facilities to conduct Early Development Clinical Trials New Haven Pfizer Clinical Research Units Brussels Pfizer has over 20 years of experience with internal CRUs Pfizer Confidential │ 29 Pfizer’s Clinical Research Units (PCRUs) New Haven CRU (CRU-NH) Established 2005; 52 beds 64,000 Sq ft; Adjacent to Yale Medical Center Brussels CRU (CRU-BR) Established 1992; 60 beds 32,000 Sq ft; Located in ULB Erasme Hospital Pfizer Confidential │ 30 Competitive Advantage in Quality • AAHRPP Accredited since 2009 – Pfizer as a company is AAHRPP accredited for all clinical trials Phase I-IV since 2013 • State-of-the-art facilities with global span that provide exceptional data quality as evidenced by 24 hour database release • Highly experienced clinical research staff partner with study teams in high risk/complex studies • Two locations working to common SOPs and standards Pfizer Confidential │ 31 31 Competitive Advantage in Speed CRU studies are 35% faster than competition Pfizer Clinical Study Report delivery is Industry Best-In-Class 100 2009 Cycle Time Metrics Calendar Days 80 60 CRU External 40 20 57 88 44 72 0 FAP-FSD* LSLV-DBR** * Final Approved Protocol to First Subject Dosed ** Last Subject Last Visit to Database Release Pfizer Confidential │ 32 Phase I Management System (PIMS) PIMS is not only an EDC tool!! PIMS is designed to: • • • • Assist CRU staff in review of safety data Assure quality data collection Comply with regulatory authorities Includes subject (volunteer) database & sample management Pfizer Confidential │ 33 Inside PCRU Brussels Pfizer Confidential │ 34 Inside PCRU Brussels Pfizer Confidential │ 35 Conclusion Speed – Cost – Quality triangle optimal used Quick timelines for Ethics and Regulatory Quick database creation and lock Ability to recruit quickly and with high quality: database, including patients Reliable subject population, low drop out Physicians with significant experience, including specialised experience in dermatology Experienced staff over all 25 Years experience in conducting early development trials in Brussels / Belgium Pfizer Confidential │ 36