Senior Principal, Strategic Consulting, Cytel
James Matcham joined Cytel in April 2020 as a Senior Principal in the Strategic Consulting team. He began his career with 5 years working as a Research Fellow at the Applied Statistics Research Unit at the University of Kent. He then completed 21 years at Amgen where he worked on the development and regulatory/reimbursement approval of many of their biotechnology products, representing the company at regulatory submissions in the US and the EU and eventually chairing the company’s International Protocol Review Committee. His last few years there were spent working to improve literature review, the use of adaptive and early phase design, network meta-analysis, Bayesian methods and quantitative decision making. More recently he spent 6 years at AstraZeneca as Head of Early Clinical Development Biometrics, responsible for clinical development plans, decision making and the design and analysis of phase 1, 2a and 2b trials. During this time he pioneered the use of quantitative decision making and the use of innovative clinical trial design and advanced analytics.
James has been a member of UK society for Pharmaceutical Statisticians (PSI) for over 30 years, serving on the Scientific and Training Committees as well as the Board of Directors. He has also served on the Professional Affairs Committee of the Royal Statistical Society and contributed to other industry-wide activities. He has been a Chartered Statistician of the Royal Statistical Society for over 25 years and has over 30 publications in refereed scientific journals and two contributed book chapters.
Executive Director of Biostatistics
Michelle Casey has been a practicing biostatistician for over 17 years with 16 years of experience within Oncology drug development across a variety of indication. She is currently an Executive Director of Biostatistics at Pfizer supporting late phase development in Rare Diseases. Michelle is a member of the industry working group for estimands in Oncology which is a special interest group of the European Federation of Statisticians in the Pharmaceutical Industry and a scientific working group of the Biopharmaceutical Section of the American Statistical Association.
Biostatistician, Roche
Kaspar Rufibach is a member of Roche's Methods, Collaboration, and Outreach group and located in Basel. He does methodological research, provides consulting to Roche statisticians and broader project teams, gives biostatistics trainings for statisticians and non-statisticians in- and externally, mentors students, and interacts with external partners in industry, regulators, and the academic community in various working groups and collaborations. He has co-founded and co-leads the European special interest group “Estimands in oncology” (sponsored by PSI and EFSPI, which also has the status as an ASA scientific working group, a subsection of the ASA biopharmaceutical section) that currently has 36 members representing 22 companies and several Health Authorities and works on various topics around estimands in oncology. Kaspar’s research interests are methods to optimize study designs, advanced survival analysis, probability of success, estimands and causal inference, estimation of treatment effects in subgroups, and general nonparametric statistics. Before joining Roche, Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich.
Partner, Consilium and former Chair of CHMP SAWP and head of Statistics at MHRA
- Partner at Consilium, a consultancy partnership between Rob Hemmings and Tomas Salmonson, supporting companies in the development, authorisation and life-cycle management of medicines.
- Previously worked at AstraZeneca and for 19 years at the Medicines and Healthcare products Regulatory Agency, heading the group of medical statisticians and pharmacokineticists.
- Co-opted as a member of EMA’s CHMP for expertise in medical statistics and epidemiology, 2008-2019. Rapporteur for multiple products across therapeutic areas in the EU centralised procedure.
- Chair of CHMP’s Scientific Advice Working Party from 2011-2019, and chair of EMA expert groups on Biostatistics, Modelling and Simulation and Extrapolation.
- Author or Rapporteur for multiple regulatory guidance documents, including E9(R1).
Director, Stone Biostatistics
Andrew Stone (MSc, CStat) is a consultant biostatistician who has 27 years of experience in the pharmaceutical industry. He led the oncology therapeutic area for biostatistics at AstraZeneca in various roles for nearly 10 years. For the last 4 years he has provided consultancy services to various pharmaceutical companies across a variety of therapeutic areas. He has published a number of papers related to trial design and analysis.
Principal, Strategic Consulting, Cytel
Paul Terrill, a member of Cytel’s Strategic Consulting group, is an experienced statistician who has extensive statistical design and analysis skills which he uses to provide valuable statistical consultancy and advice, primarily to support biotech and small pharmaceutical companies who lack in-house statistical expertise. He moved into the pharmaceutical industry in 2005 and has worked for a number of CROs before joining Cytel in 2017. Paul is a Board Member of the PSI and Chair of the PSI Scientific Committee.