Manfred Dietel is currently the medical director of the Institute of Pathology and the former head of the board of directors at the Charité University Hospital in Berlin, Germany. He previously served as dean of the Medical Faculty at Charité. Before this, Professor Dietel was the director of the Institute of Pathology at the University of Kiel, Germany. He received his medical education from the University of Hamburg, Germany, where he was promoted to assistant professor and served as a full professor of anatomical and surgical pathology. Professor Dietel’s scientific interests include in vitro cell growth of benign and malignant tumours of gastro-intestinal, breast/ ovarian, mesenchymal origin, the prognosis of ovarian tumours, and molecular mechanisms of cytostatic drug resistance. In the diagnostic field of surgical pathology, he works on molecular tumour pathology, predictive biomarkers, and telepathology. Methods of interest are cell culture, immunohistochemistry, in-situ hybridisation, PCR, multi-gene assays, next generation sequencing, and telecommunication in diagnostic and scientific pathology. Professor Dietel is on the editorial board of several scientific journals and the editorial board of the WHO Classification of Tumours series: Pathology and Genetics of Gynaecological Tumours. He was the president of several congresses, including the European Society of Pathology, and head of the annual meeting of the German Society of Senology (2001). He is a member of several national and international scientific societies including the American Association of Cancer Research (AACR), the European Society of Pathology (ESP), and the German Society of Pathology (DGP), where he is a former president. He is a member of the Leopoldina German National Academy of Science.

Ralph received his PhD in biochemistry from the University of Basel for his thesis on malarial CDK-like kinases. He continued to work on CDK-like kinases as a postdoc at the Imperial Cancer Research Fund (ICRF) in the lab of Nobel laureate Prof. Tim Hunt. Following his interest in protein kinases, he then joined ProQinase GmbH to support drug discovery and translational fee-for-service projects in Oncology. Applying his experience in Oncology drug discovery/early development, he subsequently moved to Janssen and later to Böhringer Ingelheim to support the translation of Oncology programs to the clinic, now with a focus on Immune Oncology.

Christopher Levis is responsible for the identification and development of strategic partnerships with pharmaceutical companies for companion diagnostic products using immunoassay technologies. This includes relationship development with global pharma partners to bring IVD assays to market to support drug launch.

David Chafin, Principal Scientist at Roche Tissue Diagnostics located in Tucson Arizona; received a B.S. degree in biochemistry from Purdue University and a PhD in biochemistry from the University of Iowa. David was both a Cancer Center and NIH postdoctoral fellow at the University of Rochester. David is the technical lead for pre-analytics. This project aims to provide standardization of routine tissue collection. Efforts have focused on ways to optimize tissue fixation providing high quality with exceptional turn-around time and higher medical content. David holds several patents on automated immunohistochemistry as well as novel fixation protocols. His group is doing at RTD in the field of tissue preservation of solid tumours and the preanalytical variables that need to be improved. His team is working for 9 1/2 years in this area, developing technologies to help standardize the collection of cancer tumours and understanding scientifically how these preanalytical variables play a role in FFPE tissues.

Frédéric (Fred) Baribaud is a scientific director at Janssen R&D in the early development immunology biomarker department where he leads the rheumatology biomarker group. Fred has over 10 years work experience on personalized medicine approaches in several immunological diseases such as UC, CD, asthma, COPD, RA, Lupus, and PsO. His group’s work is focused on establishing pharmacodynamic assays, patient segmentation for response prediction, and characterize disease driving pathways. He joined Janssen R&D in 2006 after spending four years at Incyte Corporation in Wilmington working on target validation and co-leading SMI compound development teams. Prior to this, he was a post-doctoral fellow at the University of Pennsylvania working on HIV entry. Fred holds a BS and an MS in biochemistry from the University of Geneva, Switzerland and a PhD in biology from the University of Lausanne, Switzerland.

Francesca Rossi is currently acting as global regulatory lead and European regulatory lead for Pfizer Oncology pipeline. In this role, she works within Asset teams to help ensure the development and execution of robust registration development strategies and effective Health Authority negotiations for molecularly-targeted therapeutics in clinical development with associated companion diagnostics, along with cancer therapy programs. Before joining Pfizer 10 years ago, Francesca held regulatory affairs positions at GE Healthcare S.r.l. /Amersham Health S.r.l. managing regulatory submission in the EU/ROW area for radiopharmaceutical and contrast media. Previously, Francesca worked as a clinical supply coordinator at MonteResearch S.r.l managing and coordinating the production, packaging, and labelling of products for clinical trial use. Francesca began her industry career at Pharmacia S.r.l. within the Regulatory Affairs International Department. She has a degree in pharmaceutical chemistry and technologies and a postgraduate fellowship at the Laboratory of Chemistry from University of Genova, Italy.

Kai Wilkens completed his Biology studies and PhD thesis in Molecular Biology in Bochum working in the field of Gene Expression Control. He worked in clinical research for a couple of years and after that held different positions in several Life Science companies pioneering innovative technologies, mainly enabling new approaches in translational and clinical research. These included MWG Biotech, Panomics/Affymetrix, Mesoscale Discovery and lately Advanced Cell Diagnostics (ACD). Within building the commercial business for ACD in Europe he supported Bayer Healthcare to develop a novel CDx test based on ACD’s technology.

After obtaining a BSc in Physiology at King’s College London, and a Ph. D. in Cell Biology and Biophysics at the University of Connecticut, Dr. Paul Turner was a Postdoctoral fellow at UC Berkeley and then UCSF, before becoming an Assistant Research Endocrinologist at UCSF. Research was always on focused on signal transduction pathways with an emphasis on disease.

Dr. Paul Turner returned to the UK to join the new wave of proteomics research at Oxford Glycosciences UK Ltd, as a group leader in Drug Discovery. This was followed by several years of work focused on multiplex gene and protein expression in major diseases, at Panomics, a bay area biotech company, which was eventually acquired by the microarray company Affymetrix. Dr. Paul Turner left to join Abcam last year, and now he is working with protein and nucleic acid multiplex assays, with a focus on identifying biomarkers for a variety of disease indications.

George Lee received his PhD in biomedical engineering at Rutgers University and has over 10 years of expertise in the areas of digital pathology, machine learning, and clinical oncology. He has authored over 30 peer-reviewed manuscripts and abstracts and holds several patents for image-based companion diagnostics. Currently, at Bristol-Myers Squibb, he is partnering with image analysis vendors to develop and validate pathology image-based pipelines for the purpose of exploratory hypothesis generation and companion diagnostics. Previous to working at BMS, he worked as a research assistant professor at Case Western Reserve University developing machine learning and image-analysis methodologies for predicting the progression of prostate cancer.

Dr. Svetlana Mukhina is leading global CDx regulatory activities for several oncology development programs at Merck KGaA. In this role, she closely works with companion diagnostic development manufacturers and internal stakeholders in the EU, US, and Asian countries to develop regulatory strategies enabling drug/CDx co-development and registration. Svetlana holds a PhD in Biology and a MSc in Regulatory Affairs, with a focus on regulation of in vitro companion diagnostic devices. Overall, she has over 17 years’ experience in molecular oncology, drug discovery, and assay development.

In his role, Jonathan works closely with a broad range of European, North American and EMEA oncology-focussed companies & quality assurance schemes with the goal of driving the standardization and normalization of molecular assays across the globe. One question he is keen to explore is whether it is possible to replace patient samples in clinical trials with contrived samples in the next 10 – 20 years? Jonathan holds a PhD from the University of Sussex in genomic DNA damage and stability and has extensive business development and product development experience through previous roles including Cambridge-based antibody company Abcam.

Christophe Le Tourneau is senior medical oncologist at the Institut Curie and professor of medicine at the Versailles-Saint-Quentin-en-Yvelines University. He is heading the Department of Drug Development and Innovation as well as the Head and Neck Clinic. Christophe Le Tourneau was certified in medical oncology in 2005 and got his PhD in clinical epidemiology in 2007. He did a 2-year clinical research fellowship at Princess Margaret Hospital in Toronto, Canada, in the Drug Development Program. His main interests are precision medicine, phase I clinical trials with a special attention to the methodology to conduct these trials, as well as head and neck oncology. Christophe Le Tourneau is the principal investigator of numerous phase I and II trials, as well as of clinical trials in head and neck oncology. He ran the first randomized precision medicine trial (SHIVA01) that compared the efficacy of matched targeted therapy versus conventional chemotherapy in patients with advanced cancer. He has published 120+ peerreviewed papers in international journals.

Franziska Vogl, PhD (project manager at Biobank Graz) is responsible for project development at Biobank Graz. She has studied molecular biology and biochemistry and obtained her PhD from Graz University of Technology in 2014. She has expertise in biomedical research with focus on cardiovascular diseases and cancer research.

After finishing her PhD, she joined the Medical University of Graz. At Biobank Graz she is responsible for project development including communication with international partners, selecting of patient cohorts and samples for studies, as well as cost calculation and offer preparation. Franziska Vogl is lecturer of the Master’s programme “MSc in Biobanking” at the Medical University of Graz and author of several professional articles and book chapters.

Christa Noehammer currently works as Senior Scientist at the Austrian Institute of Technology where she has been heading the Molecular Medicine research unit for several years. Holding a master degree in Microbiology and a PhD in Biochemistry she has been working in the microarray field since 1999 being involved in the design, production and data analysis of various microarray types thereby mainly focusing on minimally invasive biomarker discovery for cancer diagnostics. The last couple of years Dr. Noehammer has been very much involved in the setup of sampling - and biomarker isolation protocols as well as high throughput biomarker technologies for saliva diagnostics. Most recently she also started to work on saliva- and serum-derived exosomes aiming among others for the discovery of exosomal epigenetic biomarkers for early diagnosis of type 2 diabetes.

Thomas Hach, MD, is Director Healthcare Systems for Novartis. He is a member of Novartis‘ Corporate Strategy Group. His passion and expertise are in clinical development, patient outcomes and precision medicine. He joined Novartis from Boehringer Ingelheim, where he was Global Senior Medical Director, Therapeutic Area Metabolism. Prior to that, he was an associate principal at McKinsey & Company, serving as a leader in the pharmaceuticals and healthcare practice. Dr. Hach conducted several years of research and clinical practice in diabetes/microcirculation at Karolinska Institutet, Sweden. At the beginning of his clinical career, he worked in orthopedic surgery in Sweden and Germany. He received his medical degree from the University of Mainz, Germany.

Peter Bogaert is managing partner of the Brussels office of Covington & Burling, and has a broad European life sciences practice. He has detailed regulatory expertise under EC and national laws, handles legislative and other policy assignments and provides strategic advice. He also represents life sciences companies before the European Courts in Luxembourg and in local litigation in Belgium. Mr. Bogaert’s practice covers pharmaceuticals, biotechnology, medical devices, special foods and feed, cosmetics and other consumer products and he represents numerous innovative life sciences companies, including start-ups, as well as several industry associations. Chambers Global notes that a client said “He is an extremely experienced professional with broad expertise and provides sensible and well-balanced solutions.” He is consistently ranked by PLC as one of the leading life sciences lawyers globally and Legal 500 EMEA and Chambers Europe note Mr. Bogaert’s prominent regulatory pharmaceutical and environmental practice. Legal 500 EMEA (2011) noted that he is “a superb lawyer who is very pleasant to work with.” Mr. Bogaert regularly writes and speaks on life sciences issues. He is a founding member of the Brussels Pharma Law Group.