Dr. Dennis Merkle is the Director of In Vitro Diagnostic (IVD) Strategy in the Global Oncology Business Franchise at Merck Biopharma. In this role he is responsible for heading the IVD program and strategy for the marketed oncology products, managing alliances between Merck and di­agnostics partners, as well as working closely with business development on oncology pipeline products and future companion diagnostics (CDx). Dennis joined Merck at their headquarters in Darmstadt, Germany in September of 2014. Prior to that he worked as a Marketing Manager in Abbott Molecular’s EMEA division, in Wiesbaden, Germany from 2011- 2014, focusing mainly on companion diagnostics products with pharma partners, namely the ALK FISH CDx for Pfizer’s Xalkori compound. From 2006 to 2010 he worked as a senior research scientist for Philips Re­search in Eindhoven, The Netherlands as part of the develop team for a random access, fully automated PCR platform that recently has been introduced to the market by Biocartis. Dennis received his PhD in Chem­istry from the University of Calgary, Canada in 2004, worked as an Alex­ander von Humboldt Post-doctoral fellow at the Technical University of Dresden, Germany from 2004-2006, and obtained his MBA degree from the Durham University Business School in the UK in 2014.

Dr. Nigel Ten Fleming is a serial entrepreneur, who founded Athena Di­agnostics (Worcester, Massachusetts, USA), the first neurology focused reference laboratory, which was sold for $740 million to Quest. He has served on both public and private company boards. He received his PhD in Clinical Biochemistry from Cambridge University, did postdoctoral studies at Boston University School of Medicine and Harvard Medical School, and was a Lecturer in biochemistry and physiology at Harvard Medical School.

Dr. Guido Schuette is Senior Project manager for Roche Molecular Diag­nostics in EMEA-LATAM at Roche Diagnostics. In this role he is respon­sible for the strategic marketing and sales activities in Europe, Middle East, Africa and Latin America. He is a medical doctor and studied econo­mies as well and has worked in the diagnostics industry for the last 15 years. Over the last years his focus was on personalized medicine and companion diagnostic within Roche and he worked on cooperation’s with other pharmaceutical companies. He has experiences in market access and business development and in implementing new diagnostic tests and tools in different indication areas. In his different senior manage­ment positions he gained experiences in Clinical Chemistry, Immunology, Molecular Diagnostics and on Biomarkers.

Dr. Holt is the Biomarker Services Manager at Hologic. He has over 20 years’ experience of genomics research and has spent the last 10 years working in biomarker based contract research. Bobs current focus is on personalised medicine and the development of companion diagnostic products for pharmaceutical clients. Dr. Holt has considerable experi­ence of diagnostic product development, from early biomarker discov­ery through to the development of diagnostic products, his primary re­sponsibilities include companion diagnostic development, discovery and validation of biomarkers and assays in support of personalised medi­cine studies. Bob has an undergraduate degree from the University of Dundee and a PhD. from the University of Liverpool. Additionally, he has authored several key biomarker publications in peer-reviewed journals as is an inventor on a number of biomarker patents.

Erwin Sablon joined Biocartis as Director of Diagnostics Development and Alliance Management in 2010. In 2012, he took on the role of Head of R&D and Alliance Management. He is responsible for all Biocartis in­ternal and external assay development R&D activities related to the Idyl­laTM platform, and for managing the relationships with the company’s major development and research partners. Prior to joining Biocartis, Erwin held the position of Director Project Management at Ablynx N.V. (Gent, Belgium) from 2008-2010. He gained extensive experience in in vitro diagnostics (IVD) development of molecular diagnostic assays dur­ing his 18 years at Innogenetics NV (Gent, Belgium), where he held various R&D management positions, including at the departments of infectious diseases, virology and microbiology. Erwin holds a PhD in Mo­lecular Biology from the University of Ghent and an Executive MBA from the Vlerick Leuven-Gent Management School. He is (co-)author of more than 80 peer-reviewed publications and inventor on more than 20 patent families in the IVD space.

Nick has a long history of academic excellence (genomics/biotechnology) in some of the most prestigious Universities (Harvard, USA and Oxford, UK) followed by a commercial focus on technology innovation and imple­mentation at several start-up businesses (Oxagen, UK) and more estab­lished players like ThermoFisher (advisor). Nick has founded scientific businesses such as Novolytics, Arcamis, BioMimox, TCGA as CEO, NED, investor and Chairman. During this time Nick has worked as a mentor, coach and consultant; helped public and private sector organisations in technology transfer; small businesses (scientific and non-scientific) to create business strategies, market analysis, financial modelling, IP protection, and many other areas related to business development. More recently Nick has been working with the NHS on several transformational projects. In particular the establishment of the Molecular Diagnostics Centre at the John Radcliffe hospital (Oxford, UK), part of the Oxford University Hospitals NHS Foundation Trust; building and implementing self-sustainability models; developing international partnerships and col­laborations. Additionally, Nick lectures on Genomics at the University of Manchester (UK) and is reading ‘Strategy and Innovation’ at the Said Business School, Oxford University.

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.

Dr. Clarke has worked in the pharmaceutical and diagnostics industry for the last 31 years occupying senior management positions and Board level appointments. His background is primarily scientific but he is now a commercially focused entrepreneur with multiple corporate appoint­ments. Dr Clarke is a specialist in personalized medicine, companion di­agnostics and the application of novel diagnostics both to central labora­tory and point-of-care utilities. He founded diagnostics company, Lab21, in 2005 and is now operating with a portfolio of new and established companies who have products at various stages of commercialisation. Originally a biochemist with a PhD in Medical Genetics, Dr Clarke also has significant experience in antiviral drug development and human vac­cine programmes. Dr Clarke is currently CEO of Glyconics, Entrepreneur-in-Residence at Cardiff University and Executive Chairman of NALIA Bio­systems and PBD Biotech Limited.

Eddie Blair is Managing Director of Integrated Medicines Ltd (IML), a company he formed in 2003 to enable personalised medicine by combin­ing diagnostic-type testing with new and existing medicines. He is also a non-executive director (Rem Com Chair) of Immunodiagnostic Holdings PLC, and a visiting scholar to the Cambridge University Masters in Biosci­ence Enterprise programme. He lectures on personalised medicines and offers occasional bespoke courses based on his best-selling books. He has published more than 40 primary, peer-reviewed papers, including a series on companion diagnostic valuation, and is editor of two person­alised medicine journals. Finally, he is named inventor on at least one dozen patents.

Davide Zocco PhD, Head of Molecular Diagnostics, Exosomics Siena Spa (EXS). He has 10 year-experience in molecular biology and signaling mechanisms of chronic inflammatory disease and cancer. He obtained his PhD from University College Dublin (Ireland) and he was a postdoc­toral research fellow at Harvard Medical School (USA) where he investi­gated the effects of an anti-inflammatory small molecule and early bio­markers of arthritis progression. In 2013, he joined EXS to accelerate the set-up of protocols and diagnostic assays and to cooperate with clinical partners for evaluating the novel potential of extracellular vesicles (EVs) as carriers of genetic variants for liquid biopsy approaches in cancer patients. He directed the development of three RUO kits for the isola­tion and extraction of EV-derived nucleic acids from body fluids, now marketed by HansaBioMed OU, and he is currently working on low-cost high-performance PCR based kits for actionable mutations in blood. He is an invited speaker and instructor at national and international con­ferences and published in high-impact peer review journals, including Nature Chemical Biology and American Journal of Pathology.

Dr. Rosell worked in biomedicine and biotechnology area for more than 30 years, with a proven track record on diagnostic and therapeutic proj­ects. She is Bachelor of Science, specialized in Biochemistry, Master in Clinical Biochemistry and Molecular Pathology and PhD in Medicine. After working as a researcher in the public sector, Elisabet started his career in the pharmaceutical industry as part of the Bioresearch Laboratory of the multinational Merck KGaA were she led the Department of Molecular Biology working on various projects focusing on the areas of oncology and neuroprotection in preclinical research. After several years in a big pharma, she joined Oryzon Genomics, a company created as a spin-off that has been the fastest growing in the emerging Spanish biotech sec­tor, where I led the growth in the biomedical area. As a Biomedicine Director she coordinates technological platforms, services and research projects. Biomedicine team has successfully completed the development and clinical validation of a diagnostic kit for endometrial cancer (GynEc- Dx). Dr Rosell complements the collaboration with companies with a position of associate professor in University Pompeu Fabra, where co­ordinate a Master in Pharmaceutical and Biotechnology Industry. At the present she is involved in pharmaceutical and biotechnology consulting in pharma industry and personalized medicine projects. She collaborates with the Laboratorio Reig Jofre, involved from the beginning in the de­velopment of GynEc-Dx, which currently has 100% rights on the endo­metrial molecular diagnostic product.