Esther Abels, MSc, is the director of Regulatory, Clinical, and Medical Affairs at Philips Digital Pathology Solutions. She graduated in Biomedical Health Science, specialising in toxicology. Esther has experience in clinical validation studies used for regulatory purposes in the USA, Europe, and Asia. She also has a background in bridging R&D, Proof of Concept, and socio-economics studies. She was also a clinical research scientist and the global clinical trial manager for pivotal regulatory studies in pharmaceuticals. She worked in the Netherlands as well as in the USA prior to joining Digital Pathology Solutions in 2011. She played a crucial role in the Digital Pathology Association (DPA) Regulatory and Standards Taskforce and in FDA collaborations. The successful outcome was that WSI was recommended to become a class II instead of a class III device in the United States for primary diagnosis. She also played an integral role and led the entire regulatory, clinical, and medical affairs trajectory within Philips Digital Pathology Solutions (DPS) for Whole Slide Imaging devices to be marketed for “Primary Diagnosis” in the USA, the EU, Canada, Singapore, and parts of APAC. Esther is currently the Chair of the DPA Regulatory and Standards Taskforce.

Maria Orr graduated from Trinity College, Dublin and completed a Ph.D. in molecular genetics at Sheffield University. Following a brief period in academia, Maria moved into the pharmaceutical industry in 1994 where she has been actively involved in the application of genetics to drive drug discovery & development. Maria joined the oncology therapeutic area of AstraZeneca in 2005 where she championed the use of biomarkers to aid clinical drug development, focusing primarily on the use of biomarkers to drive patient segmentation. In 2010, she joined the newly formed Personalised Healthcare & Biomarkers (PHB) function of AZ where she successfully led the team in delivering the companion diagnostic for the PARP inhibitor Lynparza (olaparib). In April 2016, Maria moved to a franchise leader position in PHB where she currently oversees the delivery of companion diagnostics for the DNA Damage Response and EGFR portfolios for oncology, including the companion diagnostics for Lynparza (olaparib), Tagrisso (osimertinib), and Iressa (gefitinib).

Jorge Villacian is the chief medical officer at Janssen Diagnostics, a division of Janssen Pharmaceuticals, dedicated to developing diagnostic solutions spanning across companion diagnostics as well as novel diagnostics technologies in the areas of focus for Johnson & Johnson including; infectious, metabolic, immunologic, neurologic, oncologic diseases, and global public health. Previously, Jorge worked for Tibotec-Virco, where he developed solutions to suppress HIV and other infectious diseases. He established the medical department at Virco, including a diagnostic biostatistics and clinical virology group as well as managing a diagnostic laboratory performing collaborative work with multiple pharmaceutical companies for clinical development of compounds in hepatitis C and HIV. Before this, Jorge lead international clinical development studies of a new protease inhibitor for treatment of HIV with Boehringer Ingelheim. Before joining the pharmaceutical industry, Jorge worked in the clinical setting in Asia in the areas of infectious diseases and public health. He also set up clinical research programs in the fields of HIV, Tuberculosis, and other infectious diseases as well as establishing outpatient antibiotic units and teaching at the National University of Singapore. Jorge has served on multiple committees addressing issues such as HIV research in the Asian setting with the TREAT Asia initiative and currently serves as an advisor to the Global Antimicrobial Resistance Initiative Fund sponsored by the UK Department of Health. He coordinated the RAPP-ID project (an Innovative Medicines Initiative-funded project to develop rapid tests in infectious diseases). He obtained his MD degree in Mexico, trained in internal medicine at Mount Sinai Medical Center, Miami, Florida, and specialised in infectious diseases at the Mayo Clinic, Rochester, Minnesota. He is certified by the American Board of Internal Medicine in internal medicine and infectious diseases.

Darren is the senior principal translational scientist of Oncology iMED at AstraZeneca, having previously had positions in global medicine development, academia, biotechnology, and diagnostics sectors. Darren has over 7 years’ experience as a core member of a multi-functional global product team and has been responsible for strategy, internal and external assay development, clinical deployment, and regulatory representation for biomarkers used as primary, secondary, and exploratory objectives of clinical studies in all stages of drug development. Most recently, Darren was the translational science lead for Lynparza, which is AstraZeneca’s first in class PARP inhibitor approved in 2014. This was used for ovarian cancer indications in Europe and the US, which is defined by loss of function mutations in tumour suppressor genes. Darren is the author of numerous reviews, original patents and papers, journal editor, the chairman of the Manchester Consumer Healthcare Ethics committee, and lectures at the Universities of Manchester and Leeds.

Nis Glavind Kruse has led more than 10 pharmaceutical product releases and $bn brands line extensions, including the recent global launches of Agilent’s high profile, novel PD-L1 assays – managing Agilent’s alliance with our pharma partners in the process. He worked 10+ years in Local, Regional and Global Commercial roles in the pharmaceutical industry before joining Agilent’s Companion Diagnostics Division in 2013 – now holding the position of Director, Global Commercial Alliances. Nis Glavind Kruse holds a Master’s degree in Economics and Business Management (Cand. Oecon) from Aarhus University, Denmark and a number of diplomas in People Management and Sales and Marketing.

At Siemens Healthineers, Raimund Martin is responsible for business development, partnership management, and M&A of the unit ‘Molecular Services,’ which was created in 2016 through the acquisition of ‘NEO New Oncology AG’. Previously, Raimund held various positions in the company, including 5 years as Manager Oncology Strategy with the focus on aligning product and service offerings along the clinical workflow in oncology. Before joining the strategy team, he was a VP of portfolio & product management from July 2007 to December 2010. He was the managing director at Siemens Hearing Instruments, from March 2005 to June 2007. He was also the VP of corporate projects at Siemens Audiology from 2003 to February 2005. He has a Dipl-Ing. in electrical engineering from theUniversity of Erlangen.

• Dr. Christoph Borchers, FCAHS
• Director, UVic Genome BC Proteomics Centre
• Professor, Department of Biochemistry and Microbiology, University of Victoria
• CSO, MRM Proteomics Inc.
• Don and Eleanor Rix BC Leadership Chair in Biomedical and Environmental Proteomics
• Research Professor, Department of Oncology, McGill University, Montreal
• Segal McGill Chair in Molecular Oncology

Dr. Borchers’ expertise includes improvement, development, and application of technology for proteomics, focusing on quantitative proteomics for clinical diagnostics. He is a professor at the University of Victoria in the Dept. of Biochemistry and Microbiology, where he holds the Rix BC Leadership Chair, and is the director of the UVic-Genome BC Proteomics Centre. Dr. Borchers is also a Professor in the Dept. of Oncology at McGill University, the director of the McGill/JGH Proteomics Centre, and holds the Segal Chair in Molecular Oncology. Dr. Borchers is also the founder and CSO of MRM Proteomics (MRMP), a spin-off company performing contract research and providing proteomic technologies.

Rachel Skelton, Ph.D., is a business development manager of pharma partnerships at Leica Biosystems, focusing on Companion Diagnostic programs. She joined the company over a year ago to help further develop the CDx business unit by leveraging her experience across the CDx continuum. Rachel began her career in molecular (PCR, NGS) assay development and clinical laboratory at Insight Genetics, Inc., where she first focused on bench science, then moved to quality and regulatory, and finally business development. Following her time focusing on molecular space, Rachel joined Leica, a Danaher company, where as part of the Business Development team, she envisions growing a centre of excellence for CDx among all Danaher operating companies to provide a comprehensive portfolio of technologies to realize multimodality precision medicine capabilities on a global scale.

Romain Lecomte is a senior director of global marketing in the Clinical Diagnostics Division of Thermo Fisher Scientific. Romain has been in the in vitro diagnostics industry for more than 25 years. He served in several roles related to sales & marketing management and was the general manager of the legacy French BRAHMS Diagnostica subsidiary when his company has been acquired by Thermo Fisher Scientific in 2009. Romain earned a MS in biology from Angers University and a master’s degree in Business Administration from Caen University.

Andrea is a scientist at the intersection between technology and its utilization for better patient outcomes. He is currently leading R&D and Innovation at Diatech Pharmacogenetics, which is the leading Italian molecular Dx provider. He oversees CE-IVD product development, both in-vitro assays and software, and he manages the relationships with external quality assessment schemes. Previously, he led the Diagnostic Product Development Team at Horizon Discovery in Cambridge, UK, where he developed several categories of reference standards for the OTS catalogue and managed custom projects for the major sequencing companies and pharmaceuticals. He earned a PhD in Molecular Medicine from the University of Trieste, and he worked as a postdoc with Nobel Laureate Craig Mello at the University of Massachusetts on novel NGS methods, miRNAs and cancer. His objective at the summit is to learn more about CDx and to find opportunities for interaction.

Dr. Sylvie le Gledic is a director at Voisin Consulting Life Sciences (VCLS), France. Sylvie brings over two decades of experience in the regulatory field of in vitro diagnostic (IVD) medical devices, including biochemistry, haematology, immunology, blood gas, and molecular biology products under Annex II List A and List B. At Voisin Consulting, Sylvie is in charge of the design and implementation of global regulatory strategies for the development of IVDs and in particular CDx in co-development with medicinal products. Sylvie helps IVD manufacturers in the creation of CE mark technical files and US regulatory dossiers for FDA approval, advising on the required Quality Management System. Sylvie assists pharmaceutical companies in developing Companion Diagnostics (CDx) in drug and CDx co-development and facilitates liaison between both pharmaceutical and diagnostic developers. Sylvie is actively involved in the evolution of the EU IVD regulation, and closely follow the new rules for regulatory approval of CDx, both in EU and the USA. Dr. Sylvie le Gledic is based in the company’s Paris office.

Walli Van Doren graduated from the Catholic University of Leuven and earned a master’s degree in Public Health (MPH). For many years she worked as a general practitioner in Belgium as well as in several African countries where she also contributed to the development of health insurance systems in countries like Rwanda. Currently, Walli works at the NIHDI of Belgium where she is in charge of personalized medicine and the development of a linked reimbursement procedure for the personalized drug and its companion test. She also focuses on reimbursement of next generation sequencing for targeted therapy in oncology and haematoncology.

Paul Tausch has been with Thermo Fisher Scientific in the Transplant Diagnostics division (TDX) for over 31 years. He began his career in the laboratory, focusing on production and research in Class I serology before moving into the commercial area where he served as a Technical Consultant and focused on internal database development. Paul then assumed oversight of the commercial activity for the organization for the past 22 years before recently transitioning to focus on several new initiatives, one being the development of opportunities to leverage the IVD reagent development experience of TDX into the area of companion diagnostics.