CENTRE FOR INNOVATION IN REGULATORY SCIENCE - Key Persons
Job Titles:
- Member of the CIRS Team
- Senior Research Analyst
Adem is responsible for the operation of the Emerging Markets Industry Metrics Programme and provides analytical support for the OpERA programme and other regulatory projects. Prior to joining CIRS in June 2021, Adem was Senior Research Executive at Ipsos MORI and Senior Research Analyst at the Centre for Medicines Research (CMR) International, a subsidiary of Clarivate.
Job Titles:
- Member of the HTA Steering Committee
- Vice President for HTA Policy, Johnson & Johnson
Job Titles:
- Member of the HTA Steering Committee
Job Titles:
- Head
- Member of the CIRS Team
- Member of the HTA Steering Committee
Anna is currently Head of CIRS and is responsible for leading the team in its mission to maintain a leadership role in identifying and applying scientific principles for the purpose of advancing regulatory and HTA policies and processes. Before joining CIRS in July 2021, Anna was International Operations Lead (Associate Director) at Guidehouse, where she oversaw the European team of regulatory consultants working for small to medium sized pharmaceutical and biotechnology companies.
Belen supports core HTA projects, such as the annual HTA agency and industry benchmarking studies, as well as other research projects and meetings/workshops. Prior to joining CIRS in May 2021, Belen was at University College London completing her PhD in Drug Delivery.
Job Titles:
- Member of the HTA Steering Committee
- Senior Director, Patient and Health Impact Innovation Centre, Pfizer
Job Titles:
- Member of the HTA Steering Committee
- Special Adviser, Lead Methodologist in Regulatory and Pharmacoeconomic Statistics, Norwegian Medicines Agency ( NoMA ) Vice - Chair JSC ( EUnetHTA21 )
Job Titles:
- Vice President, Global Regulatory Affairs, Eli Lilly
Job Titles:
- Head of Sector Marketing Authorisation, Swissmedic
Job Titles:
- Senior Vice President, Head of Global Regulatory, Eisai Europe
Job Titles:
- Member of the HTA Steering Committee
Job Titles:
- Global Head International Regulatory Policy, Roche
Job Titles:
- Chairman, European Medicines Agency ( EMA ) Committee for Medicinal Products for Human Use ( CHMP )
Job Titles:
- Senior Advisor, Integrated Development, Global Health, Bill and Melinda Gates Foundation, UK
Job Titles:
- Member of the HTA Steering Committee
- Global Head, Pricing & Market Access, GSK
Job Titles:
- Senior Vice President, Oncology Regulatory Science, Strategy and Excellence, AstraZeneca
Job Titles:
- Member of the CIRS Team
- Senior Scientific Writer
Jenny writes, reviews and tracks outputs from CIRS activities including journal publications, R&D Briefings and workshop/fora reports. She is also responsible for managing online communication channels such as the CIRS website and LinkedIn page. Before joining CIRS in 2019, Jenny worked as Research Communications Manager for a rare disease patient organisation for four years, and so has an interest in patient involvement in drug development and regulatory and HTA processes.
Job Titles:
- Office Director, Office of International Program, Pharmaceuticals and Medical Devices Agency ( PMDA ), Japan
Larry advises on the CIRS strategy for Latin America and works closely with regulatory agencies in the region to understand the issues they are facing and to help strengthen their review processes. He is also currently Adjunct Research Professor at the Temple University School of Pharmacy Regulatory Affairs and Quality Assurance. Prior to this , Larry was at CIRS for over 13 years as Executive Director (2008-2019) and Head of Regulatory Collaborations (2019-2021).
Job Titles:
- Member of the CIRS Team
- Senior Manager, Regulatory Programme and Strategic Partnerships
Magda oversees the Regulatory side of the Regulatory and Access Programme for CIRS member companies as well as the Optimising Efficiencies in Regulatory Agencies (OpERA) programme for regulatory agencies. She is also responsible for managing special research projects with CIRS stakeholders. Magda's doctoral work focused on the development of a framework for decision making during the development, regulatory review and reimbursement of medicines.
Mario supports CIRS activities in Latin America and works closely with regulatory agencies in the region to understand the issues they are facing and to help them strengthen their processes. Prior to being a consultant, Mario was Director General of International Regulatory Affairs at the Mexican regulatory agency, COFEPRIS.
Job Titles:
- Senior Vice President, Head of Regulatory Affairs, Bayer
Job Titles:
- Member of the HTA Steering Committee
- Medical Advisor, Technology Access and Assessment Division, Commonwealth Department of Health, Australia
Job Titles:
- Member of the HTA Steering Committee
- Senior Director HTA, International Markets, Eli Lilly and Co
Job Titles:
- Deputy Director, Integrated Development, and Lead for Global Regulatory Systems Initiatives, Bill and Melinda Gates Foundation
Job Titles:
- Director
- Member of the CIRS Team
- Member of the HTA Steering Committee
Neil oversees the development and delivery of CIRS' research programme, which includes international multi-stakeholder workshops, fora and research projects to advance regulatory and HTA policies and processes. Neil has worked at CIRS and its previous form under the Centre for Medicines Research (CMR) International for over 30 years and has initiated to a number of key projects in the area of regulatory strategy and R&D performance.
Job Titles:
- Member of the HTA Steering Committee
- Programme Director, Scientific Affairs, National Institute for Health and Care Excellence ( NICE ), UK
Job Titles:
- Chief Medical Officer and Senior Vice President, Global Medical, Regulatory & Quality, GlaxoSmithKline
Job Titles:
- Member of the HTA Steering Committee
- Principal, Rubix Health
Job Titles:
- Chief Medical Officer, EMA
Job Titles:
- Director, Office of Strategic Programs, US Food and Drug Administration ( FDA ) Center for Drug Evaluation and Research ( CDER )
Job Titles:
- Independent Strategy Advisor, PharmaExec Consulting Filial SE, Sweden, and Former Executive Director, EMA
Job Titles:
- Member of the CIRS Team
- Member of the HTA Steering Committee
- Senior Manager, HTA Programme and Strategic Partnerships
Tina oversees the HTA research and activities of the CIRS Regulatory and Access Programme and is responsible for strategic partnership with agencies, companies, academics and professional societies for HTA. Tina is currently undertaking a PhD with Utrecht University entitled ‘Ensuring equitable access to new medicine through quality company, regulatory and HTA decision making'. Her main field of interest is international HTA policy and intelligence.
Job Titles:
- Partner, Consilium Salmonson & Hemmings and Former Chair, CHMP / EMA
Job Titles:
- Member of the HTA Steering Committee
- Global Access Chapter Lead for Evidence, Roche
Job Titles:
- Member of the HTA Steering Committee
- Professor HTA, Utrecht University and Special Advisor HTA, National Health Care Institute ( ZIN ), the Netherlands
Job Titles:
- Deputy Director of Clinical Department Center for Drug Evaluation, National Medical Products Administration ( NMPA ), China
Job Titles:
- Administrator
- Member of the CIRS Team
Gill has been with CIRS for a number of years and manages the administrative details of the organisation including arranging its workshops and meetings. She also liaises with the member companies and collaborating agencies and is the first point of contact for CIRS. Gill has a broad experience of CIRS and the day-to-day activities of the organisation.
Job Titles:
- Vice President, Global Regulatory Policy and Intelligence, Pfizer
Job Titles:
- Member of the CIRS Team
- Research Analyst
Juan supports the delivery of regulatory research projects as well as the OpERA programme. Prior to joining CIRS in June 2021, Juan was Consulting Analyst at IQVIA and before that, worked at the Mexican regulatory agency COFEPRIS.
Job Titles:
- Director General, Pharmaceutical Drugs Directorate, Health Canada
Job Titles:
- Vice President, Regulatory Affairs ( Regulatory International, Regulatory Policy & Intelligence ), Abbvie
Job Titles:
- Member of the HTA Steering Committee
- Chief Pharmacist, Dental and Pharmaceutical Benefits Agency ( TLV ), Sweden
Job Titles:
- Member of the HTA Steering Committee
- Professor of Health Services Research
Professor of Health Services Research and HTA, Faculty of Health Sciences, University of Southern Denmark and Former Director and Chair of EUnetHTA Executive Committee
Job Titles:
- Member of the HTA Steering Committee
- Vice - Chair
- Consulting Physician of the Association of Austrian Social Insurance Institutions
Job Titles:
- Executive Director of Centre of Regulatory Excellence ( CoRE ), Duke - NUS Medical School and Chairman, Consortium for Clinical Research & Innovation, Singapore
Job Titles:
- Professor, Pharmaceutical Medicine, Kitasato University Graduate School of Pharmaceutical Sciences, Japan
Job Titles:
- Member of the HTA Steering Committee
- Global HTA & Access Policy Lead - Global Market Access
Job Titles:
- Member of the HTA Steering Committee
- CEO and President, CADTH, Canada
Job Titles:
- Executive Director, Global Regulatory and R & D Policy, Amgen