TUCSON, Ariz. and AMSTERDAM, September 20, 2022 — Critical Path Institute’s (C-Path) European nonprofit today announced the appointment of Cécile Ollivier M.S. as Managing Director – Europe and Robert Hemmings, M.S., to its Board of Directors.
“We are pleased to appoint Cécile Ollivier as the Managing Director for our European activities, along with welcoming Robert Hemmings to C-Path’s European Board of Directors,” said C-Path Chairman of the Board Wainwright Fishburn. “Their wealth of knowledge and experience in the regulatory sector, plus Hemmings’ clinical trial methodology expertise, will be invaluable as we look toward the future and continue to accelerate drug development across the world.”
Ollivier is a senior health engineer with more than 15 years’ experience in global drug development and regulatory science, particularly for pediatric and rare diseases. Prior to joining C-Path, she was with a medical technology company developing digital endpoints, and for 11 years served as a scientific officer at the European Medicines Agency (EMA) where she provided technical and regulatory expert guidance on pediatric developments across multiple therapeutic areas.
Ollivier has been recognized for her work leading the EMA pediatric extrapolation global strategy and other global activities including the EMA/FDA harmonization for Gaucher disease for which she received an FDA award and the global harmonization of criteria for development in pediatric pulmonary arterial hypertension (PAH) with FDA and Health Canada. She was also an expert in the E11 R(1) working group and the pediatric standing group for the International Conference of Harmonization (ICH).
Hemmings is currently partner at Consilium Salmonson & Hemmings and has deep expertise in global clinical trial design, critical appraisal of clinical trial data and regulatory affairs. He was head of the group of statisticians and pharmacokineticists at the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK for nearly 20 years. He has been a member of the Committee for Medicinal Products for Human Use (CHMP) at the EMA for 11 years, has chaired EMA’s Scientific Advice Working Party 8 years, and chaired and served on EMA’s groups for biostatistics, modelling and simulation and extrapolation. Hemmings also represented the EU and was the Rapporteur for the revision of the ICH guideline E9 (R)1 addendum on estimands and sensitivity analysis in clinical trials, to the guideline on statistical principles for clinical trials. Additionally, he has involvement in multiple initiatives related to innovation in clinical trial design and regulatory strategy including, EMA’s Priority Medicines (PRIME) scheme for unmet medical needs, adaptable pathways, and accelerated access pathways in the UK.
About Critical Path Institute
Critical Path Institute (C-Path) is an independent, nonprofit organization established in 2005 as a public and private partnership. C-Path’s mission is to catalyze the development of new approaches that advance medical innovation and regulatory science, accelerating the path to a healthier world. An international leader in forming collaborations, C-Path has established numerous global consortia that currently include more than 1,600 scientists from government and regulatory agencies, academia, patient organizations, disease foundations, and hundreds of pharmaceutical and biotech companies. C-Path U.S. is headquartered in Tucson, Arizona, C-Path in Europe is headquartered in Amsterdam, Netherlands with additional staff in multiple other locations. For more information, visit c-path.org.