Thank to the 13 speakers who have shared their expertise and experience during this biomarker training. Here are their short biographies.
Jan Bogaerts earned his degree in mathematics (1986) and his PhD in mathematics (1993) at the Free University of Brussels (Belgium).
In 1988 he also earned a degree in management at the Free University in Brussels.
From 1986 to 1993 he worked as an assistant in mathematics and statistics at the faculties of Economic, Social and Political Sciences and of Science at Free University of Brussels.
In 1993 he joined BMS as statistician, and was later promoted Associate Director Statistics. In this position he worked on the development of several drugs in oncology, including several FDA and EMEA submissions.
In 2004 he joined the EORTC as statistician of the EORTC Breast Cancer Group, and in 2006 he was appointed senior statistician. In 2010 he became Head of the Statistics department, and in 2012 he was appointed Methodology Vice Director. He was a contributor to the development of version 1.1 of RECIST and is on the RECIST Steering Committee. He represents EORTC as course director of the Flims workshop. Another key role is as the statistician of the MINDACT trial EORTC 10041 – BIG 3-04 (Microarray In Node-negative and 1 to 3 positive lymph node Disease may Avoid ChemoTherapy: A prospective, randomized study comparing the 70-gene signature with the common clinical-pathological criteria in selecting patients for adjuvant chemotherapy in breast cancer with 0 to 3 positive nodes) which recently closed accrual.
Current statistical interests include the use of and methodological issues around Progression Free Survival, alternative ways to use changes in tumor measurements as predictive markers, and the correct evaluation of the contribution of new markers to existing prognostic risk evaluation.
Marc Buyse holds a ScD in biostatistics from the Harvard School of Public Health (Boston, MA). He worked at the EORTC in Brussels and at the Dana Farber Cancer Institute in Boston. He is the founder of the International Drug Development Institute (IDDI) and of CluePoints, two biostatistical service organizations based in the US and Europe. Marc currently lives in the Bay Area. His research interests include clinical trial design, validation of biomarkers and surrogate endpoints, statistical methods in oncology, statistical detection of errors and meta-analysis (http://publicationslist.org/marc.buyse).
MD, Specialised in Dermatology and Immunology. PhD in Immunology.
Degrees in infectious diseases, pharmacology, allergology and toxicology.
From 1996 to 2001 Assistant professor at Lyon hospital.
2001 to 2008 : head of proteomic research at bioMérieux. Settlement of the proteomic lab and program. Set-up of a new discovery project for colon protein markers identification: proteomic in tissue and blood. MS, 2D gels, differential and quantitative proteomic. Secretomic analysis.
The project aimed mainly to discover markers for colorectal cancer mass-screening and monitoring.
From 2008: settlement of new technology in the proteomic lab for proteins quantification: multiple reaction monitoring (MRM) and MRM3. Aiming to shorten the validation process of biomarkers.
2008-2010 : Oncology program director at bioMérieux. Scientific and medical lead of over 15 oncology research projects (colon, breast, prostate, liver), using various technologies (transcriptomics, molecular biology, proteomics, immunoassay, miRNA studies...).
From discovery to validation phases. In blood, tissue, stool, urine.
Settlement of the biomarker validation process.
2011-2012 : Scientific and medical advisor at bioMérieux.
From 2013: ALATEA Biomarkers. Process of start-up creation, dedicated to protein dosages development, using MRM and MRM3. Prestation of bioanalyse, multiplex assays development and biomarkers clinical validation.
Currently in the incubator of innovative companies Crealys (Lyon, France).
Dominique Demolle, CEO, Company co-founder, Aepoida, Demolle has over 20 years of experience in Pharmaceutical Development. She received her PhD degree in Applied Biomedical Sciences from the Free University of Brussels (ULB, Belgium). In 1989, Dr. Demolle joined the Clinical Research group of GD Searle Belgium, where she managed efficacy trials, mainly in inflammatory diseases. In 1993, she joined Eli Lilly, and in 1996 she was promoted to Research Scientist in Clinical Pharmacology. Since 1999, Dr. Demolle has held positions with increasing leadership responsibilities (from Local to Global). In 2003, she became in charge of the US Indianapolis Lilly CRU (Clinical Research Unit), in addition to the European Operational staff. In 2004, she was promoted to Associate Director of Global Early Phase Operations (with the Global Early Phase Lilly operational staff and the Lilly CRU reporting to her). Dr. Demolle has excellent knowledge of Drug Development in different therapeutic areas, as well as strong managerial skills. Because of her scientific background and understanding of compound development requirements, she reconciles "science" with operational constraints in the most efficient way. In 2007, Dr. Demolle left Lilly to become a cofounder of Aepodia with Denis Gossen and former colleagues/peers.
Araceli Diez-Fraile, DVM, PhD, is Biobank Manager at the Belgian Cancer Registry in Brussels focusing on the operation of the Belgian Virtual Tumourbank (BVT), a tumour tissue-banking web application for biospecimen annotation by the partner biobanks, and data query and traceability by researchers. She received a DVM from Zaragoza University and earned her PhD in Veterinary Sciences from Ghent University. After a 15 year career as scientist in various fields (cancer, inflammation, apoptosis…) at Ghent and Leuven Universities resulting in more than 20 scientific publications, Araceli Diez-Fraile decided it was time for a change of scenery and moved to the Belgian Cancer Registry in Brussels, where she was offered the Biobank Manager position. In addition to running the BVT, Araceli Diez-Fraile participates at the Belgian coordination office for the pan-European Biobanking and Biomolecular Resources Research Infrastructure (BBMRI), a project that will enable researchers to access different types of biological samples stored in biobanks located across Europe. More information about the BVT can be found at the web page http://virtualtumourbank.kankerregister.be Araceli Diez-Fraile can be contacted by e-mail at firstname.lastname@example.org or by telephone +32 (0) 250 10 10.
Education and training
• MD - Doctor in Genees-, Heel- en Verloskunde (K U Leuven – 1983) ; Specialty certification - Pathology (K U Leuven – 1990) (Department of Pathology, The University of Leeds, Algernon Firth Institute, Leeds LS2 9JT, England - United Kingdom - 9/1/1984-31/7/1986 ; PhD - Geaggregeerde voor het Hoger Onderwijs (K U Leuven – 1994
• K U Leuven - 1998 Hospital governance and management
• K U Leuven – 2002 Quality management / coordination
• University Foundation UB Virtual, Universitat De Barcelona – 2003 Diploma of Continuing Education : International On-Line Tissue Banking Course
• Professor (deeltijds hoogleraar) - Faculty of Medicine - K U Leuven – courses histology, pathology (teaching since 1996)
• Professor - Faculty of Medicine - K U Leuven (permanent education) Quality management : multidisciplinary approach in biomedical, biotechnological and pharmaceutical setting and clinical research (teaching since 2008)
• Staff member – Department of pathology - University Hospitals Leuven – gastro-intestinal pathology (1994-2007)
• Director Cell and tissue banks - University Hospitals Leuven (since 2001-2011)
• Coordinator Activity Center Biobanking (therapeutical, scientific, diagnostic tissue banking) - University Hospitals Leuven (since 2011)
• Representative / member various scientific and other organisations ( NIHDI - National Institute for Health and Disability Insurance (RIZIV – INAMI) ; Superior health council – working group : Cells, tissues and organs of human and animal origin - member (since 2001) ; Royal Academy for Medicine in Belgium – member (since 2009) )
Dr. Forsyth, MD, PhD, MBA, IFCAP, is CEO of Pathlicon and its leading pathologist.
Dr. Forsyth received his MD and PhD from the Ghent University, Belgium and his MBA from the Vlerick Leuven-Ghent Business School, Belgium. Following his completion as an internship in pathology in the University Hospital Ghent and the Leiden University Medical Center, The Netherlands, Dr. Forsyth served as a resident and later as a Head of Clinics in sarcoma and molecular pathology at the N. Goormaghtigh Institute of Pathology, University Hospital Ghent. During this period, he was involved in main international scientific collaborations with focus on molecular mechanisms of bone diseases. He published over more than 40 internationally peer-reviewed articles in this domain. Nowadays, Dr. Forsyth is one of the international key-opinion leaders concerning bone and molecular pathology and is board member of the European Musculoskeletal Oncology Society. Recently, he has been announced as a World Health Organization-Expert and as an international fellow of the College of American Pathologists.
Jan Hellemans has a Master in Biotechnology (2000, UGent) and a PhD in Medical Genetics (2007, UGent). He is author of more than 100 scientific articles in international journals, including some pioneering publications in the domain of real-time PCR. Together with Jo Vandesompele, he is active in the development of new concepts and algorithms for improved qPCR data analysis, and one of the founders of the RDML consortium. Jan Hellemans supervised a core facility for automated DNA-isolation, (next generation) sequencing and high-throughput real-time PCR at Ghent university. He is a founder of Biogazelle, active as a teacher in qPCR courses and responsible for qPCR assay development in Biogazelle.
Stefan Michiels, PhD, is Head of the Methodology Team in the Department of Biostatistics and Epidemiology at Gustave Roussy (Villejuif, France). His areas of expertise are statistical analysis of biomarker and genomic data, prognostic models, clinical trials, Independent Data Monitoring Committees and meta-analyses in oncology.
Stefan holds a PhD in Biostatistics from the School of Public Health at the Paris XI University and Master Degrees in Statistics and in Applied Mathematics from the University of Leuven. His previous positions include the Université Libre de Bruxelles- Institut Jules Bordet (FNRS researcher), the National Cancer Institute (France) and the University of Leuven. He has authored above 90 peer-reviewed publications (tiny.cc/stefanmichiels or http://publicationslist.org/stefan.michiels) in journals such as Lancet, JAMA, Lancet Oncology, NEJM, Journal of Clinical Oncology, Journal of Clinical Epidemiology, Statistics in Medicine, Bioinformatics and Statistical Methods in Medical Research. He is member of the editorial board of Cancer Prevention Research and The Breast and does regular statistical reviews for The Lancet journals.
MD – CEO - Prior to joining Multiplicom upon successful conclusion of its Series A financing on April 15th 2011, Dirk Pollet was Chief Business Officer at Cellectis since November 2008. Prior to Cellectis, he was Senior Vice President Licensing & IP at Galapagos NV in Belgium and member of the Executive Team. Prior to joining Galapagos NV in 2000, Dr. Pollet was Director Molecular Diagnostics at Glaxo Welcome in Stevenage UK. Prior to Glaxo Welcome he started and build the diagnostics group at Innogenetics NV where he stayed for fourteen years.
Dirk Stynen has a Ph. D. in Biology and Postgraduate Degree in Enterprise Economics (both form University of Leuven, Belgium).
Fifteen years of research and development experience in both academic (University of Leuven, University of Pennsylvania) and industrial settings and in different scientific fields. This includes a 7 year period as head of an R&D laboratory at Sanofi Diagnostics Pasteur, developing immunoassays for clinical microbiology.
At Innogenetics, he was Head of the Department including Quality Assurance, Quality Control, Regulatory Affairs and Labeling (40 collaborators) during 7 years.
Since July 2000 : founder and president of Qarad b.v.b.a., assisting IVD and MD companies worldwide in achieving compliance with European Regulations and Quality System requirements.
MARIANNE VAN BRUSSEL
Marianne Van Brussel, has 15 years of experience in the molecular diagnostic Industry. After her PhD in molecular Virology she started in 1998 at Innogenetics where she developed several molecular diagnostic IVD products from design definition until launch, among them the VersantTM HCV genotyping test. In 2008 she moved to Oncomethylome Sciences, later MDxHealth, where she had various responsibilities (kit development, industrialization, service lab). Since 2010 she is responsible for IVD assay development at Biocartis. Key areas of expertise are design control, verification and validation strategies for CE marking and FDA registration.
Els Vanheusden, MD, holds a Medical Doctor degree from the University of Leuven (Belgium) and 2 Master's Degrees in Hospital Management and Aeronautical & Space Medicine.
In 1991 she started a typical marketing career at Procter & Gamble where she was involved in the set-up of the pharmaceutical division and the creation of the Benelux osteoporosis markets.
In 1997 she became responsible for European marketing at Biosense Webster, a Johnson & Johnson company leading the electrophysiology market.
December 2000, Els co-founded PharmaDM, a bio-informatics spin-off of KULeuven, which she joined as CEO.
In September 2004, she took on the challenge of starting FlandersBio, the cluster of life sciences actors performing R&D activities in Flanders. Late 2008, she co-founded the Capricorn Health-tech Fund, a €42M venture capital fund investing in life sciences companies.
Today Els is managing operations at the Foundation Fournier Majoie.