Advisory Board

Michael Doherty

Mr Michael Doherty is Chair of Advisory Board at Luminance Health. Mr. Doherty was Head of Product Development at Foundation Medicine from the 2016 to 2019. In this role, he led a team dedicated to the introduction of clinical and data products in the field of cancer genomics based on Next-Generation Sequencing, introducing the groundbreaking F1CDx assay as the first FDA approved and CMS reimbursed large oncology panel. Prior to this he was Head of Global Regulatory Affairs at Roche Pharmaceuticals and Genentech for a period of 14 years from 2002 to 2016, overseeing the approvals of products in the field of oncology, immunology, hematology and bone disease. In addition, he spent 2 years at Genentech building a new organization called Strategic Innovation which was charged with identifying and deploying disruptive concepts in the field of drug development. During his career, he has worked in Regulatory Affairs in Pharmaceutical Companies based in the UK, France, Switzerland and the US. Today, He is a consultant and board member of a number of early-stage companies in both the biotech and diagnostics fields and is chief regulatory officer at Launch therapeutics, an Abingworth/Carlisle clinical co-development company. Prior to working in the Pharmaceutical Industry, Michael worked at the University of Manchester, UK, and Christie Hospital in the Regional Endocrinology Laboratory. He has a BSc in Biochemistry (University of Reading, UK) and a fellowship of the Institute of Medical Sciences, UK, and a Diploma in Management Studies from the University of Portsmouth, UK.

Claus Bolte

Dr. Claus Bolte was Chief Medical Officer at Swissmedic. As a public servant for more than 12 years Dr. Bolte helped to shape Swissmedic’s role as a respected “first-wave” agency. as their Chief Medical Officer, previously Head of Marketing Authorization and Clinical Assessment as well as deputy Chief Executive. Swissmedic is a founding member of the Access Consortium (Australia's TGA, Health Canada, Singapore's HSA, the UK’s MHRA), also a Project Orbis Partner for the concurrent review of Oncology products coordinated by the US FDA. Prior to that, Dr. Bolte had roles of increasing responsibilities with research-based international pharmaceutical, biotech and medical device organisations (UK, USA, CH). Today Dr. Bolte serves as the Vice-Chair of the Board of Directors at the University Hospital Basel (USB), one of the world’s leading hospitals embedded in Europe’s eminent life-sciences hub; he is a member of the “Digitalization” as well as the “Research & Education” committee. Dr. Bolte trained as a General Surgeon and had international clinical and academic appointments in Trauma, Transplant and Oncologic Surgery.

Marisa Papaluca

Dr. Marisa Papaluca worked more than 25 years as former Senior Scientific Advisor at European Medicines Agency (EMA) and played key role supporting EMA decision making committees (CHMP, CAT, COMP) including the re-organisation of the scientific working parties, the pilot EMA Regulatory Science Observatory (RSO) and the EMA regulatory Science Strategy to 2025. Dr. Papaluca was also Founder and Head of the Office for multidisciplinary sciences departments including clinical trials methodology, toxicology, clinical pharmacology, environmental risk assessment. She was Scientific Secretary of the Biotech/Biologicals working party, Deputy Head of Sectors supporting the EMA centralised assessment (including Biologicals sector, and Safety and Efficacy of medicine sector. Prior to this Dr. Papaluca was Medical Director at the Pharmaceutical Department at the Italian Ministry of Health. Today, she is a consultant providing strategic regulatory advice in life sciences field. Dr. Papaluca is Honorary Professor Faculty of Medicines at Imperial College in London. Dr. Papaluca studied medicines at University Rom, Italy with specialization in internal medicines and endocrinology.

Thomas Metcalfe

Mr. Thomas (Tom) Metcalfe is a globally recognized expert in Personalized Healthcare and held leadership roles at Roche Pharma as well as Roche Diagnostics. Mr Metcalfe held various roles at Roche including leading the IMI Health Outcomes Observatories (H2O) project where he continues to advise the pan-European Observatory, Data Policy Lead within Roche Pharma Personalized Healthcare (PHC), Strategic Innovation Leader with a focus on Digital Health, Innovative Development Pathways and the use of comprehensive genomics profiling technologies in the development of cancer medicines, Global Head of the Biomarker Program and Head of the PHC Portfolio as well as business development roles. Tom represented Roche for 10 years at the European Federation of Pharma Industry Associations (EFPIA) board sponsoring Innovation Committee. Mr Metcalfe also acted as Managing Director of Oncotest, a preclinical CRO focused on oncology models. Today he is consultant and works as a strategic advisor on topics related to late-stage medicines development, particularly Real-Word Data (RWD) and Real-World Evidence (RWE), Digital Health, medicines development in rare diseases, European public private partnerships and value-based healthcare. Tom studied Biochemistry at King's College, London University and has an MBA from the Open University, UK.

Franziskus Kath

Dr. Franziskus Kath is an experienced senior executive with an international track record in the Pharmaceutical and Consumer Health industry. He was Vice President Emerging Technologies and Product Quality Management at Johnson & Johnson, the world-largest Healthcare Company. His leadership roles included internal and external production, Quality Assurance, R&D, M&A, sourcing, and supply chain. He worked at various subsidiaries globally at site, sector, and corporate levels. As an inclusive change agent, he drove multiple transformations, and led large organizations through complex changes, built trusted partnerships, and has vast experience in developing external partners. In both operations and quality management, he has significantly contributed to the development and implementation of new strategies, processes, and new organizations. As a pioneer in digital Quality management, he enabled significant cross-functional value through improvements in efficiency and effectiveness, leveraging latest digital technologies. His achievements include simplifications, reductions in waste and human errors, as well as significant cost reductions and capacity increases. Today he is consultant and acts as sparring partner for board and C-level of startups and midsized companies to enhance the collaboration between multinational Life Science companies and their tech-partners. Franziskus holds a PHD in Chemistry from the University of Hamburg and a Dual Degree Executive MBA from INSEAD, Singapore/France and the Tsinghua University, Beijing-China.
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