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D I T E P 2 0 1 8 01 Gustave Roussy is one of the largest phase - PDF document

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D I T E P 2 0 1 8 01 Gustave Roussy is one of the largest phase 1 centre, with more than 450 patients included per year in phase 1 trials. The mission of the DITEP is to accelerate the development of new anticancer drugs, to build

  1. D I T E P 2 0 1 8 01

  2. � Gustave Roussy is one of the largest phase 1 centre, with more than 450 patients included per year in phase 1 trials. The mission of the DITEP is to accelerate the development of new anticancer drugs, to build an ambitious cancer research program (precision medicine, immunotherapy and new targets), and also to give a new hope to patients facing cancer battles. � Dr. Christophe Massard Head of DITEP 3

  3. Created on September 1 st , 2013 to strengthen the therapeutic innovation and the early clinical trials at Gustave Roussy. In 2018, this medical department carries the ambition to be one of the top international players in early drug development, precision medicine and immunotherapy.

  4. OUR STRATEGIC VISION AND MISSIONS

  5. Oncology has become in the last decade an exciting therapeutic area bridging new scientifjc concepts and major clinical breakthroughs for the patients and their families. Our ambition is to foster a new era of cancer care and treatments by: Promoting innovation and multidiscipli- Continuously developing the medico- nary collaborations to achieve higher scientifjc expertise of our investigators rates of treatment effjcacy based on team and the skills and performance streamlined molecular analyses and of our clinical operations staff through predictive tools generated from our fruitful collaborations and partnerships precision medicine programs, as well with pharma and biotech companies. as innovative imaging methods. Pursuing our quality assurance Facilitating patients’ inclusion in phase management in the context of ISO- I/II studies at an earlier stage of the 9001 certifjcation. disease to acknowledge the early clinical trial as a true therapeutic opportunity within an integrated cancer care management structure. Positioning cancer immunotherapy and the novel immunomodulators as early as possible as potential backbone therapies for combinations with other approaches.

  6. OVERALL ORGANIZATION OF THE DITEP

  7. DITEP KEY STEPS September 2006 Early drug development and clinical trials identifjed as a strategic orientation of Gustave Roussy. Prof Soria appointed as the leader of a working group for therapeutic innovation and early clinical trials expansion. September 2007 Establishment of the early clinical trial pluridisciplinary committee (RCP-150) September 2008 Creation of the « SITEP » (Service des Innovations Thérapeutiques et Essais Précoces), fjrst hospitalization unit in France fully dedicated to early clinical trials in oncology (fjrst-in-human administration, phase I trials, phase October 2010 I/II extension cohorts) with 8 beds and 6 out- Recognition granted by the french patient seats. National Cancer Institute (INCA, 4 years) of SITEP as an early trials center (CLIP²) July 2011 Certifjcation of the french Health Regional Agency (ARS, 5 years) for fjrst-in-human trials September 2013 Creation of the DITEP as a full medical DITEP department of Gustave Roussy , headed Drug Development Department by Prof. Soria. February 2015 Renewal of the CLIP² label by INCA (4 years) May 2015 New premises gathering all the DITEP teams on one fmoor (4th) September 2016 Renewal of the ARS certifjcation for fjrst-in-human trials November 2016 ISO 9001 accreditation N°2016/72604.1 September 2017 Dr Massard appointed as Head of the DITEP

  8. Headed by Dr. Christophe Massard, in 2018 the DITEP encompasses 150 full-time equivalents dedicated to early clinical trials, translational research and precision medicine programs. Since November 2016, the DITEP has obtained the ISO 9001v2015 certifjcation (Quality Management System) for its activities of access to therapeutic innovations, management of early clinical trials, and scientifjc outreach. MEDICAL AND CLINICAL OPERATION TEAMS • Principal investigators and sub-investigators: 6 MD-PhD, 7 MDs (see CV p.28-40) • Medical and academic assistants & Managers: 13 • Clinical research nurses & Managers: 40 • Head of clinical operation unit: 1 • CRA managers: 2 • Project managers: 7 • Study coordinators: 26 • Clinical research technicians & sample managers: 17 • Schedulers: 3 • Medical research assistants & helpers: 7 • Quality assurance: 1 • Administrative & contracting: 3 • Chief scientifjc offjcer: 1 PLURIDISCIPLINARY CLINICAL RESEARCH AND DECISION-MAKING COMMITTEES • The early clinical trial multi-disciplinary tumor board (RCP-150), headed by Dr Vincent Ribrag, encompasses all DITEP experts in medical oncology, radiotherapy, hematology, immunotherapy, as well as experts in biopathology and imaging. This weekly committee is in charge of the validation of all patients’ referral to our phase I programs, and for the review of all on-going trials and medical decisions regarding any complex situations of safety or experimental treatment decisions. • The molecular pluridisciplinary committee (RCPM-150), dedicated to the weekly review of the molecular tumor profjles performed within our precision medicine programs aims at including each phase I-eligible patient in the most adapted clinical trial based on actionable molecular abnormalities. • A monthly Protocol Review Committee (PRC) to address the scientifjc value and feasibility of new trials proposals. CARE WARDS & FACILITIES • A conventional week-hospitalization unit (4th fmoor) headed by Dr Antoine Hollebecque: 13 single-patient beds. This unit receives patients who require full-time hospitalization as per protocol or for safety surveillance due to side effects over the week. • An out-patient care unit (4th fmoor) headed by Dr Andrea Varga: 16 armchairs (whose 2 dedicated to PK). This outpatient unit is operational every day from Monday to Friday from 7:00 am to 7:00 pm (including PK sampling on Saturdays). This unit also receives patients who require nursing and related cares. • A consultation platform facility • An early phase clinical operations unit (4th fmoor) headed by Mrs Guylène Chartier gathering all staff in the same new premises that host all MDs offjces, a local laboratory dedicated to the processing of biological samples, as well as confjdential monitoring spaces dedicated to the trials sponsors. 09 09

  9. multidisciplinary tumor board the Cancer Immunotherapy Program CRA : Clinical Research Associate CR : Clinical Research EP : Early Phase QA : Quality Assurance MA : Medical Assistant Abbreviations ORGANIZATION CHART Dr A. Marabelle - Clinical Director of Head of Department functional link Dr E.Angevin - Industrial Partnerships Alliance Manager. Dr. C. Massard Dr J.P.Armand - Senior scientific consultant. Pr E.Deutsch - Head of Radiotherapy Department. Dr V.Ribrag - Head of Early Drug Development Dr S. Postel-Vinay - Physician Senior Scientist (UMR 981) functional link Principal Academic External consultant functional link assistant B.Thuillier J.Florance 2 academic assistants Clinical care Head of early phase Executive Head of medic al Head of Head of outpatient Clinical care coordinator clinical operations unit Assistant secretary hospit alization unit care unit coordinator QA officer Manager P. Dielenseger G. Bernal- G. Chartier D. Aubry K. Willinger Dr A. Hollebecque Dr A. Varga Trinel E. Netzer 1 Head nurse (day) 26 study-co Dr A.Gazzah 1 principal MA 1 Head Dr R.Bahleda S. Orange Dr J.M.Michot S.Rodrigues 2 CRA managers nurse 10 data-managers Dr C. Baldini Dr S. Champiat (night) M.Houssaini 5 MA H. Zouhri 5 Sample managers N. Meunier + 25 nurses 2 Medical 1 assistant Administrative 1 Contract and Secretaries 4 Nurse 7 nurses Finance manager 1 Finance coordinator + helpers (night) L. Daley 1 professional 1 Contract coordinator training contract 4 Medical clinical 1 Operations research assistants coordinator + 3 helpers AMR S. Lancereau 3 schedulers 2 project managers in personalized 2 Data Managers medecine M. Ngo Camus C. Nicotra 1 project manager in Immunotherapy S. Fahrane 5 industrial partnerships project managers F.Colame N. Imam E. Toubiwou E. Zedouard H. Pousse 1 Chief Scientific Officer N. Hainault

  10. DITEP KEY FIGURES

  11. 2017 KEY FIGURES 3.946 stays (Conventional Hospital and Day Hospital) 3.504 medical consultations 34 publications on early clinical trials results and precision medicine programs 11,2 as the average journal Impact Factor 2.080 patient’s referrals for inclusion in early clinical trials 104 early clinical trials opened for inclusions 460 patients recruited in early clinical trials 806 patients recruited in precision medicine programs

  12. MAIN ACTIVITY INDICATORS Yearly number of ongoing early clinical trials 104 96 100 91 88 90 80 70 68 70 60 55 50 41 40 30 20 10 0 2010 2011 2012 2013 2014 2015 2016 2017 Early clinical trials, as of January 2018 (in dose escalation and in organ-oriented extension cohorts) 8 3 Other Cell cycle & Apoptosis 6 Epigenetic & metabolic Inhibitors 86 41 Immune Checkpoints 10 & Immunomodulators Antibody Drug Conjugates EARLY CLINICAL & Bispecifjc Monoclonal TRIALS Antibodies 18 Tyrosine Kinase Inhibitors 13

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