Emmanuel PANIZZI

May 2010 to June 2010: Managing of 1 protocol Melanoma
Protocol Title: “A Phase II Multicenter, Open-Label Study of XXX Plus XXX in Subjects with Stage III (Unresectable) or Stage IV Melanoma”
• Pre-study visits
• Site status reports
• Contract management

January 2010 to present: Managing of 1 protocol in Breast Cancer
Protocol Title: “A Phase II, Multicenter, Open-Label, Randomized Study of XXX Plus XXX as First-Line Treatment in Subjects with HER2 Negative Metastatic Breast Cancer”
• Pre-study visits
• Initiation visits
• Site status reports
• Contract management

February 2010 to June 2010: Managing of 1 protocol in Lymphoma Cancer
Protocol Title: “A Phase II Multicenter, Open-Label Study of XXX Plus XXX in Subjects with With CD20-Positive B Cell Non-Hodgkin’s Lymphoma Who Are Ineligible For Or Have Previously Received An Autologous Stem Cell Transplant”
• Pre-study visits
• Initiation visits
• Site status reports
• Contract management

August 2009 to January 2010: Managing of 1 protocol in Melanoma
Protocol Title: GM307 “A multicenter, randomized, double-blind study of XXX with or without XXX inchemotherapy-naïve subjects with advanced melanoma and low LDH – The AGENDA Trial
• Monitoring visits
• materials management
• Site status reports

June 2008 to August 2009: Managing of 1 protocol in Lung Cancer
Protocol Title: A randomized, double-blind, parallel, three arm, multicenter, phase II trial evaluating the efficacy and safety of XXX in combination with XXX/XXX compared to XXX/XXX alone in previously untreated subjects with lung cancer.
• Monitoring visits
• Study drug’s accountability and materials management
• Site status reports
• Investigator fees management

February 2008 to May 2008: Managing of 1 protocol in Myeloma
Protocol Title: : A phase III, randomised, open-label, 3-arm study to determine the efficacy and the safety of XXX plus low-dose XXX when given until progressive disease or for 18 four-week cycles versus the combination of XXX, XXX and XXX given for 12 six-week cycles in patients with previously untreated multiple myeloma who are either 65 years of age or older or not candidates for stem cell transplantation.
• Pre-study visits
• Site status reports

Mi-August 2007 to June 2008: Managing of 1 protocol in Hepatitis B
Protocol Title: A phase II, double-blind, multi-centre, randomised study comparing XXX, XXX plus XXX and XXX in the treatment of Chronic Hepatitis B subjects with Decompensated Liver Disease and in the prevention of Hepatitis B recurrence post transplantation.
• Monitoring visits
• Close-out visits
• Study drug’s accountability and materials management
• Site status reports
• Investigator fees management

Mi-August 2006 to present: Managing of 2 protocols in Hepatitis B
Protocol Title 1: A Randomized, Double-Blind, Controlled Evaluation of XXX versus XXX for the Treatment of HBeAg Positive Chronic Hepatitis B.
Protocol Title 2: A Randomized, Double-Blind, Controlled Evaluation of XXX versus XXX for the Treatment of Presumed Precore Mutant Chronic Hepatitis B.
• Monitoring visits
• Close-out visits
• Study drug’s accountability and materials management
• Site status reports
• Investigator fees management

Mar. 2006 - Mi-Aug. 2006:Managing of a protocol in Breast cancer
Protocol Title: A phase III Trial of XXX in Patients with Advanced Breast Cancer Previously Treated with XXX.
• Monitoring visits
• Study drug’s accountability and materials management
• Site status reports
• Investigator fees management

Clinical Trial phase III on the LLC with CD20+
• Visits of installation
• Monitoring
• Management and order of the pharmaceutical products
• Administrative management of the protocol

Clinical trial phase I on the colorectal cancer
• adaptation of the Monitoring Plan
• adaptation of the Study Reference Manual
• creation of the Guide Nurse
• management of a TMF for the closure of a clinical trial

Management of a clinical trial of phase II/III on the lung cancer not to small cells of stage IIIA
Co-administration of a clinical trial of phase II on the lung cancer not to small cells of stage I/II
• Visits of installation / Monitoring
• Management of the SAE
• Design and management of the data base
• Seizure of the data/coding and emissions of the corrections
• Involved in the design of CRF following the protocol
• Involved in the drafting of information patient and assent for 2 protocols
• involved in the design and the drafting of the newsletter of the IFCT as well as plates for the investigators
• involved in the drafting of the administrative file addressed to AFSSAPS and with the CCPPRB
• Management and order of the pharmaceutical products
• involved the update of Internet site of IFCT

Clinical trials on the HIV (15 tests in progress)
• CRFs completion
• preparation of the visits of the patients (planning, kits blood...)
• preparation of the monitoring visits of laboratory
• involved in the preparation of a scientific publication (screening of patients)