Head of Strategic Innovation, F. Hoffmann-La Roche Ltd. and Genentech; Executive Adviser, Regulatory and Product Strategy, Foundation Medicine Inc.
Michael Doherty is currently working 50% for Roche/Genentech and 50% for Foundation Medicine in 2 related and synergistic roles. He leads the strategic innovation team in Roche Pharma Development, which is focused on the transformation of the drug development process to ensure the future sustainability of drug development. In addition, he is working as an executive adviser to Foundation Medicine to build a capability to sustain the product portfolio through the transformation from CLIA regulation to an FDA oversight.
He started his career in 1986 in Regulatory Affairs in the Cyanamid Company (Lederle), based in the UK, working primarily in the field of antibiotics registration with the UK Health Authority. He then joined Sandoz, where he led the Regulatory Group in the UK, undertaking the first European filings under the mutual recognition and centralised procedures with the European Commission.
In 1992, Michael joined Rhone Poulenc Rorer (RPR) based in Paris, and took on Global Regulatory responsibility for the respiratory and endocrinology portfolios. He later joined Astra (to become AstraZeneca), where he was first the Head of the Respiratory and Inflammation Regulatory Team and then became Global Head of Drug Development Regulatory Affairs. In 2002, he joined F. Hoffman-La Roche Ltd as Global Head, Regulatory Affairs based in Basel, Switzerland. In 2009, he relocated to Genentech, San Francisco to oversee the integration of the 2 regulatory functions following the full acquisition of Genentech by Roche, and continued in the role of global head of regulatory affairs until the end of 2015.
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 and a fellowship of the Institute of Medical Sciences, UK, and a Diploma in Management Studies from the University of Portsmouth, UK.
Personalized or ‘precision’ medicine is on the rise, due to advancements in, and the emerging integration of, biology, biotechnology, DNA sequencing, IT, and IoT. How do government agencies and businesses envision personalized medicine? How do we address ever-increasing the costs of care? What are regulatory challenges? What happens to health insurance? This panel discussion will […]