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Laurence Van Bree


SENIOR PROJECT MANAGER, GLOBAL PROJECT MANAGEMENT,
HEMATOLOGY/ONCOLOGY
Laurence Van Bree, PhD

EDUCATION

Doctor of Biological Sciences, 1997
University of ULB, Brussels, Belgium
               
                Degree - Zoology, Molecular Biology, 1992
University of ULB, Brussels, Belgium


THERAPEUTIC EXPERIENCE

Cardiovascular:  Heart Failure, Coronary Artery Disease
Hematology / Oncology: Chronic Myeloid Leukemia, Melanoma, Solid Tumors, Breast Cancer, Head
& Neck Cancer, Liver Cancer, Colorectal Cancer, Lung Cancer, Prostate Cancer
Infectious diseases: AIDS, Chronic Hepatitis, Tuberculosis


PROFESSIONAL EXPERIENCE

PPD, Brussels, Belgium                                                                    Senior Global Project Manager 2009 - Present

With full support from Franchise Director/Associate Director:
SPM
"                As Global or EMEA PM, plan and implement, to achieve, anticipated and unexpected project deliverables.
"                Analyze and oversee cost, personnel hours and project needs to determine the most cost effective and efficient means to run and complete projects successfully on time, to agreed quality standards and within budget while meeting the Customer's needs and adhering to the contract.
"                Delegate assigned responsibilities to project team members.
"                Have regular and proactive liaisons with Department Heads to optimize performance and utilization of the project team members.
"                Anticipate potential issues and escalate appropriately/pro-actively to their Franchise Director/Associate Director.
"                Act as primary contact with Customer throughout study until delivery of final project product(s).


Bristol - Myers Squibb :               
                                                               
Building and leading the observational study
capability in the Outcomes Research Department                  2006 - 2008
Protocol Manager                                                                                2003 - 2006
CRO Alliance Site Manager                                                                2003 - 2003
Hub Site Manager                                                                                          2002 - 2003
European Lead Clinical Scientist                                                                          1999 - 2002

Lead for the observational study execution capability in the outcomes Research department  2006 - 2008

"                Successfully managed 2 observational pan EU studies as a protocol manager;
"                Cross sectional, 8 countries, 110 sites,  1750 patients (orphan disease : CML)- completed 
"                Cross sectional, retrospective design, 7 countries, 90 sites, 1000 patients, Advanced Breast Cancer - completed
"                Functional manager for 4 additional EU studies (oncology, infectious diseases) - developed strategies and program tools to streamline processes for 4 Project Managers
"                Building the study execution capability in the GEOR department
"                Prepared and executed presentation of project specific training to the observational study team
"                Line manager (4 protocol managers, 3 assistants)
"                Challenged CROs during bid defenses (all studies were outsourced) and involved in CRO selection process
"                Developed specific position profiles, and training curriculum for Observational Study positions
"                Developed a RACI for positions involved in Observational Study Execution
"                Acted as GCP/Q&A/regulatory first point of contact (new capability)
"                Ensured the team completed adequate trainings
      Protocol Manager 2003 - 2006

"Drives the successful execution of a protocol using strong management and organizational skills.  Monitors protocol progress and addresses and manages obstacles, serves as primary contact for the protocol. Coordinates the development of protocol level documents and plans. Effectively leads a global team of individuals assigned to the protocol."

"                Successfully managed 3 phase I , 2 phase II and 1 phase III clinical trials
"                Delegation of assigned responsibilities to project team members (project management chart)
"                Anticipate potential issues and escalate appropriately/pro-actively
"                Tracked and managed budgetary issues for projects.
"                Lead Project Team Meetings to communicate progress of studies, quality issues, budgetary issues,    and operational concerns

                                                                CRO Alliance Site Manager 2003 - 2003

"                EU support for the protocol manager (US based)  for the coordination of the EU start up activities of a phase IIIb cardiovascular, outsourced study (Icon); this included a feasibility study and the CRO selection process.
"                Selection of sites and countries in Europe , in agreement with marketing,
"                Selection of CRO
"                Follow on with the CRO on submission processes in Europe

Hub Site Manager 2002 - 2003

"                Work with the protocol manager and responsible for the clinical coordination and training in the Hubs (new structure) in Eastern Europe and Israel region  - for 2 phase III studies and a phase 4 study in Anti infective therapeutic area 

                                                                                                                  European Lead Clinical Scientist 1999-2002

"                Support for the protocol manager and responsible for managing one third of the European sites
"                Responsible for a phase III cardiovascular trial (1999 - 2001) with about 600 sites in Europe and 3000 patients worldwide ; 
"                Responsible for an anti infective trial (July 2002 - January 2003).
"                Investigator meeting organisation
"                Development of study tools
"                Included working in Start up phase, follow on and energizing the recruitment
"                Primary contact for sites issues and questions
"                Successful site management and 'remote management' of monitors based in several EU countries (France, Israel, Sweden, Norway, Finland, Denmark, Russia, Estonia, Latvia, Lithuania, Romania, Czech R, Hungary, Poland, Croatia, Slovenia, Slovakia et Portugal, Italy, the Netherlands, Germany, and Belgium)

BioMerieux, Brussels, Belgium               
                                                                                Technical Assistance and Product Manager 1998 - 1999
(specialised Medical diagnostic kits and devices)

"                Adviser for BioMérieux techniques used for clinical diagnosis (bacteriology, serology)
"                Contact for  clients and opinion leaders (phone, on site visits)
"                management of 2 ranges of products (molecular biology and bacteriology) as a product manager
"                organization of a symposium (molecular biology techniques used for the diagnosis of Tuberculosis)

Laboratoire de Neuropathologie,ULB, Erasme                     
Research Fellow  1992 -  1997
                   
"                Scientific basic research: investigation of the consequences of a minimal cortical lesion on the expression of different classes of genes in the rat brain, by using molecular biology techniques. 
"                Training of  students
"                Management of a project, coordination of the work of technicians and students, enhanced scientific knowledge (in depth)


PROFESSIONAL DEVELOPMENT

Training while employed at PPD is available upon request.

Prior to PPD:

"                Trainer in Clinical coordination - monitoring data collection and data quality and early process control - Serious Adverse Event reporting.
"                Remote trainer for  SOPs via videoconference
"                Trainer of  the observational study team


PUBLICATIONS AND PRESENTATIONS
Publications:

VAN BREE L., DASSESSE D., and SCHIFFMANN S.N (1999): Changes in neuropeptides and glutamic acid decarboxylase (GAD67) expression in the rat striatum following spreading depression induced by a minimal cortical lesion.  Neuroreport, 10, 2993-2997.

ZHANG F., VAN BREE L., ALBALA N., VERSLYPE M. and VANDERHAEGHEN J.J (1996):  NMDA receptor antagonist MK801 down-regulates rat striatal proenkephalin and protachykinin mRNAs.  Neurochemistry international, 28, 189-192,

VAN BREE L., ZHANG F., SCHIFFMANN S.N., MAILLEUX P., HALLEUX P. and VANDERHAEGHEN J.J (1995).: Homolateral cerebrocortical increase in neuropeptide and receptor expression after minimal cortical infarct.  Neuroscience, 69, 847-858.

ZHANG F., HALLEUX P., ARCKENS L., VANDUFFEL W., VAN BREE L., MAILLEUX P., VANDESANDE F., ORBAN G.A., VANDERHAEGHEN J.J (1994).: Distribution of immediate early gene Zif-268, c-fos, c-jun and jun-D mRNAs in the adult cat with special references to brain region related to vision.  Neuroscience Letters, 176: 137-141,

JACOBS O., VAN BREE L., ZHANG F., MAILLEUX P., SCHIFFMANN S.N., HALLEUX P., ALBALA N. and VANDERHAEGHEN J.-J (1994).: Homolateral cerebrocortical increase of immediate early gene and neurotransmitter messenger RNAs after minimal cortical lesion.  Blockade by N-methyl-D-aspartate antagonist. Neuroscience, 59: 827-836. The two first authors contributed equally to this work.               
Abstracts

Phase I pharmacokinetic profile and early clinical evaluation of the pan-Her inhibitor BMS-599626, JC Soria, J Cortes, JP Armand, A Taleb, L Van Bree, E Lopez, S Song, K Zeradib, F Vazquez, R E Martell, J Baselga;  Abstract of ASCO (2005)

The pan-Her inhibitor BMS-599626 : biological effects, pharmacokinetic profile, and early clinical evaluation of a phase I trial JC Soria, J Cortes, JP Armand, S Ropert, A Taleb, L Van Bree, E Lopez, S Song, A Catteau, F Vazquez, RE Martell, J Baselga; Abstract and oral presentation  at ECCO (2005), Paris
VAN BREE L., ZHANG F., SCHIFFMANN S.N., MAILLEUX P., and VANDERHAEGHENJ.J (1994): A minimal cortical infarct causes diffuse cortical changes in gene expression of several classes of proteins. Abstract of the 3d Annual Meeting UIAP/PAI, Louvain.
VAN BREE L., ZHANG F., SCHIFFMANN S.N., MAILEUX P., ET VANDERHAEGHEN J.-J ( 1994):  Effets d'une lesion cérébro-corticale minimale sur l'expression des gènes précoces, des neurotransmetteurs, de leurs récepteurs, des facteurs de croissance et du cytosquelette.  Société Belge de Neurologie, Fondation médicale Reine Elisabeth.
VAN BREE L., ZHANG F., MAILLEUX P. and VANDERHAEGHEN J.-J (1994).: A minimal cerebro-cortical lesion produces extensive changes in immediate early gene and neurotransmitter gene expression in the homolateral cortical hemisphere.  Abstract of the 17th Annual Meeting of the European Neuroscience Association in association with the 26th Annual Meeting of the European Brain and Behaviour Society and the Meeting of the Austrian Neuroscience Association, Austria Center Vienna, Austria,.
VAN BREE L., ZHANG F., MAILLEUX P.and VANDERHAEGHEN J.-J(1994): NMDA receptors mediate diffuse homolateral cerebrocortical changes in gene expression following a minimal cortical lesion.  Abstract of the XIXth C.I.N.P. Congress, Washington, D.C. Collegium, Internationale Neuro-Psychopharmacologicum.
VAN BREE L., MAILLEUX P. and VANDERHAEGHEN J.-J (1994): Diffuse homolateral cerebrocortical changes in gene expression and down regulation of receptors following minimal cortical lesion.  Abstract of the 14th European Winter Conference on Brain Research, La Plagne, France.
VAN BREE L., MAILLEUX P., ZHANG F., HALLEUX P., ALBALA N. and VANDERHAEGHEN J.J. (1993): Homolateral cerebrocortical increase of protooncogene and neurotransmitter mRNAs after minimal cortical lesion.  Blockade by NMDA antagonist.  Abstract of the 2nd Annual Meeting UIAP/PAI, Louvain.


COMPUTER EXPERIENCE

Windows 2000, Excel, PowerPoint, Word, Word Perfect


LANGUAGES

Mother tongue: French
Fluent English, Dutch, Conversational Russian, Basic knowledge in Spanish, German and Chinese


CLINICAL TRIAL EXPERIENCE

ONCOLOGY
Oncology phase I trials: 
"                Phase I study of an Epothilone in combination with Irinotecan in patients with advanced solid malignancies. 1 site in France, 45 patients, primary objective was to determine the MTD and recommended phase II dose;

"                Phase I study with an Epothilone, given in 2 different schedules, in patients with advanced solid malignancies ; 2 sites (France and Switzerland), 60 patients; primary objective was to determine the MTD and recommended phase II dose; This study was conducted in collaboration with the South Europe New Drug Organization (SENDO) .

"                Phase I study in Patients with Her2 or EGFR expressing advanced solid malignancies; 2 sites (France and Spain), 45 patients, primary objective was to determine the MTD and recommended phase II dose for the compound.  Exploratory investigations (Pet scan data, biomarkers)

Oncology phase II trials: 
"                A phase II study of plant cell fermentation derived Paclitaxel in patients with advanced carcinoma of the breast; 5 sites in UK, 75 patients, primary objective : evaluate the response rate of the treatment  given to patients with previously treated breast carcinoma

"                A phase II trial of Neoadjuvant Paclitaxel and Cisplatin in Patients with Locally Advanced Head and Neck Cancer; 6 sites in Korea, 50 patients ; primary objective  : to determine the response rate of the combination therapy in that specific patient population. 

Oncology phase III trials: 
"                A phase III study, of an EGFR targeted therapy in liver cancer; feasibility study in US, Europe and Asia. 

"                A Randomized, Multicenter Phase 3 Study to Compare the Efficacy of a targeted agent in Combination with Chemotherapy to the Efficacy of Chemotherapy Alone in Patients with Previously Treated Metastatic Colorectal Cancer (Russia Ukraine Bulgaria, Romania; 33 sites)

"                A Randomized, Multicenter, Phase 3 Study to Compare the Efficacy of a targeted agent in Combination with Oxaliplatin/ 5-fluorouracil/ leucovorin to the Efficacy of Oxaliplatin/ 5-fluorouracil/ leucovorin alone in Patients with Previously Untreated Metastatic Colorectal Cancer (Argentina, Brazil, Mexico, Chile, Costa Rica, South Africa; 38 sites)

"                A phase 3, Multicenter, Randomized, Placebo-controlled, Double-Blind Trial of a compound in combination with Paclitaxel and Carboplatin for Advanced Non-small Cell Lung Cancer (Latin America, Europe and Asia, 96 sites, 572 patients)

"                AFFIRM: A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral a compound in Patients with Progressive Castration-Resistant Prostate Cancer Previously Treated with Docetaxel-Based Chemotherapy; 12 EU countries, 600 patients; 72 sites

Oncology Observational studies :
"                UNIC : Unmet Needs in CML and Ph+ ALL (UNIC):  A European Cross-sectional study of the epidemiology, treatments patterns and outcomes of chronic myeloid leukemia and Philadelphia chromosome positive acute lymphoblastic leukemia.  1800 patients in 8 countries.  Outsourced to Phimap

"                PEACE : PanEuropean survey on treatment patterns in newly diagnosed metastatic breast cancer; 1000 patients in 7 countries; outsourced to Phimap

"                Targeted Therapy Observational study in Chronic Myeloid Leukemia: 1000 patients 14 EU countries; Oustourced to I3

"                Observational study in Melanoma : treatment patterns and outcomes ; 400 patients in 3 EU countries; Outsourced to Parexel.


CENTRAL NERVOUS SYSTEM:
"                A 3 month observational prospective patient cohort study of the treatment of breakthrough pain in cancer patients with Instanyl

HEMATOLOGY HEMOPHILIA :
"                A Phase I, randomized, double-blind, placebo  controlled, single dose escalation study of FVIIa variant BAY 86-6150 (B0189) in subjects with moderate or severe hemophilia types A or B with or without inhibitors

INFECTIOUS DISEASES :
"                Long term efficacy and safety of atazanavir with stavudine and lamivudine in patients previously treated with nelfinavir or atazanavir. Phase IIIb, multicenter, international, open - label, roll-over/switch study.

"                Long term off-treatment assessment of treatment outcomes with entecavir and lamivudine for chronic hepatitis B infection in patients who have enrolled in phase III entecavir trials.  No treatment administered.  Study is a post- treatment observational study, designed to collect long term safety and efficacy information.

CARDIOVASCULAR:
"                OVERTURE: the Omapatrilat Versus Enalapril Randomized Trial of Utility in Reducing Events.  Disease type: congestive heart failure;  This was a phase III, multicenter, randomized, double blind, active-controlled, parallel group study.

"                Antianginal efficacy of Omapatrilat in Patients with chronic angina pectoris; phase II, randomized, double-blind, placebo controlled parallel study.


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