YOUR NAME



|Katja Bierau |

|Via Colle San Francesco 7, 00049 Velletri, Italy |

|E-mail katja@ |

|TELEPHONE: ++39 3929066003 |

|NATIONALITY: GERMAN |

|PERSONAL PROFILE |

| |MSC IN BIOTECHNOLOGY AND PHD IN CANCER STUDIES |

| |Over 12 years experience in the biotech, clinical and pharmaceutical industries and two years as freelance|

| |translator |

| |Experienced in general and clinical project management |

| |Comprehensive understanding of the drug development process, IVD, and Medical devices |

| |Fluent in five languages (English, French, German, Italian, and Dutch) and good understanding of Russian |

| |Multinational experience (Germany, UK, USA, Belgium, Netherlands, Italy) |

|Employment History and Accomplishments |

|2010 - present |Pilotality, Bergharen, NL |

| |Principle consultant and Translator |

| |Current Assignments: |

| |Engagement Manager at 10EQS |

| |Project monitoring and validations for the European Commission |

| |Regulatory, Clinical & Medical advisory and project management (IVD and Medical devices) |

| |Medical, Scientific and technical translations |

|2011 - 2012 |Catalent Pharma Solutions, Aprilia, Italy |

| |R&D Director, interim |

| |Accomplishments |

| |New product proposals, improvements and adjustments for all 4 business lines (pharmaceutical products, |

| |food supplements, medical devices as well as cosmetics) for the Italian and foreign markets. |

| |Regulatory aspects for Medical devices and translations thereof |

|2003 – 2010 |Oncomethylome Sciences (now MDx Health), Liège, Belgium |

| |Program manager and later VP lab Operations |

| |Accomplishments |

| |Developed gene methylation tests, IVD and Medical device products |

| |Managed relationships with international KOLs and organized scientific & clinical advisory board meetings |

| |Directed clinical research and product development projects |

| |Established protocols for several large clinical trials (bladder & prostate cancer) |

| |Set up ISO 9001 certified laboratories in two locations (Liège & Amsterdam) |

| |Hired, trained and coached scientific personnel for GMP/GCP compliant environments |

| |Established workflows for the routine testing of customer clinical trial samples |

| |Successfully implemented and supervised clinical sample testing services for major pharmaceutical |

| |companies |

|2002 – 2003 |PamGene International, Den Bosch, The Netherlands |

| |Senior Scientist / Group Leader ADMET |

| |Accomplishments |

| |Established a laboratory for R&D and service testing |

| |Transferred research partners’ content onto a proprietary in-house platform |

| |Successfully performed predictive gene expression studies for major pharmaceutical companies (toxicity |

| |testing) |

|2000 – 2002 |Phase-1 BioResearch, Gent-Zwijnaarde, Belgium and Santa Fe , New Mexico, USA |

| |R&D Manager Europe (2001 – 2002) |

| |Scientist (2000 – 2001) |

| |Accomplishments |

| |As R&D Manager Europe: Directed R&D activities and acted as key account manager maintaining customer |

| |collaborations (incl. microarray analysis and data mining using advanced bioinformatics tools) |

| |As Scientist: Planned, organized and conducted research in the field of molecular toxicology |

| |Coordinated projects with customers (incl. analyzing results, writing scientific reports and presenting |

| |results to customers) |

|Education |

|1997 – 2000 |PhD in Cancer Studies, The University of Birmingham, UK, Institute for Cancer Studies |

| |Thesis title: “Sub-cellular localization and role of Apoptosis Specific Proteins in mammalian cells” |

| |Post-Doctoral project: “Analysis of telomerase activity in adenovirus transformed fibroblasts, development|

| |of quantitative methods to analyze telomere length and its application in cancer” |

|1993 – 1997 |Diplom-Ingenieur Biotechnology, Fachhochschule Bingen (Germany), Department of Chemical Process |

| |Engineering |

|References available on request |

|4 Patents (APPENDIX 1) and 10 publications (APPENDIX 2) |

| | |

|APPENDIX 1: patents |

WO/2009/037441: IMPROVED METHYLATION DETECTION

WO/2009/037438: IMPROVED DETECTION OF MAGE-A EXPRESSION

WO/2008/084219: EPIGENETIC CHANGE IN SELECTED GENES AND CANCER

WO/2008/155549: IMPROVED URINE SAMPLE COLLECTING AND PROCESSING

APPENDIX 2: publications

Renard I, Joniau S, van Cleynenbreugel B, Collette C, Naômé C, Vlassenbroeck I, Nicolas H, de Leval J, Straub J, Van Criekinge W, Hamida W, Hellel M, Thomas A, de Leval L, Bierau K, Waltregny D. (2010), Identification and Validation of the Methylated TWIST1 and NID2 Genes through Real-Time Methylation-Specific Polymerase Chain Reaction Assays for the Noninvasive Detection of Primary Bladder Cancer in Urine Samples. Eur Urol. In press.

Troyer DA, Lucia MS, de Bruïne AP, Mendez-Meza R, Baldewijns MM, Dunscomb N, Van Engeland M, McAskill T, Bierau K, Louwagie J, Bigley JW. (2009), Prostate cancer detected by methylated gene markers in histopathologically cancer-negative tissues from men with subsequent positive biopsies. Cancer Epidemiol Biomarkers Prev. 18(10), 2717-22.

Glöckner SC, Dhir M, Yi JM, McGarvey KE, Van Neste L, Louwagie J, Chan TA, Kleeberger W, de Bruïne AP, Smits KM, Khalid-de Bakker CA, Jonkers DM, Stockbrügger RW, Meijer GA, Oort FA, Iacobuzio-Donahue C, Bierau K, Herman JG, Baylin SB, Van Engeland M, Schuebel KE, Ahuja N. (2009), Methylation of TFPI2 in stool DNA: a potential novel biomarker for the detection of colorectal cancer. Cancer Res. 69(11), 4691-9.

Sadones J, Michotte A, Veld P, Chaskis C, Sciot R, Menten J, Joossens EJ, Strauven T, D'Hondt LA, Sartenaer D, Califice SF, Bierau K, Svensson C, De Grève J, Neyns B. (2009), MGMT promoter hypermethylation correlates with a survival benefit from temozolomide in patients with recurrent anaplastic astrocytoma but not glioblastoma. Eur J Cancer, 45(1), 146-53

Vlassenbroeck I, Califice S, Diserens AC, Migliavacca E, Straub J, Di Stefano I, Moreau F, Hamou MF, Renard I, Delorenzi M, Flamion B, DiGuiseppi J, Bierau K, Hegi ME. (2008), Validation of real-time methylation-specific PCR to determine O6-methylguanine-DNA methyltransferase gene promoter methylation in glioma. J Mol Diagn., 10(4), 332-7

Maxwell JA, Johnson SP, Quinn JA, McLendon RE, Ali-Osman F, Friedman AH, Herndon JE, Bierau K, Bigley J, Bigner DD & Friedman HS (2006), Quantitative analysis of O6-alkylguanine-DNA alkyltransferase in malignant glioma. Mol Cancer Ther, 5(10), 2531-9

Grand RJA, Schmeiser K, Gordon EM, Xian Z, Gallimore PH & Turnell AS (2002), Adenovirus E1A is a substrate for caspase-mediated degradation during apoptosis. Virology, 301, 255-271

Schmeiser K, Armstrong SJ, Hammond EM & Grand RJ A (1999), Assignment of yeast APG5 human homologue to chromosome band 6q21 by fluorescence in-situ hybridization. Cytogenetics and Cell Genetics, 87, 213-214

Schmeiser K & Grand RJA (1999), The fate of E- and P-cadherin during the early stages of apoptosis. Cell Death and Differentiation, 6, 377-386

Schmeiser K, Hammond EM, Roberts S & Grand RJA (1998), Specific cleavage of gamma-catenin by caspases during apoptosis. FEBS Letters, 433, 51-57

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