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New Horizon /  (Page 3)

Solange Corriol-Rohou, a pulmonologist and an immuno-allergist by training, joined AZ R&D in 2004 and is currently Sr. Director of Regulatory Affairs & Policy for Europe. Over the past 20 years, moving from the French Medicines Agency/EMA and a specialist physician position at the Hospital of Versailles to the pharmaceutical industry, she has gained strategic experience in drug development for different therapy areas, such as respiratory, inflammation and oncology. She is currently leading the AZ Paediatric Work Group. Solange, in her role as the chair of the Clinical Development Expert Group at the EFPIA, organized jointly with the EMA several workshops. Dr. Corriol-Rohou has recently been involved in critical issues, such as Complex Clinical Trial Designs, the use of Digital tools...

Chris Copland acts as a patient advocate in memory of his daughter, Bethan. He has been a representative at the National Cancer Research Institute and the ACCELERATE platform, for whom he currently co-chairs the FAIR Trials working group. He is also active in the Euro-Ewing’s Consortium and as a CRUK Campaigns Ambassador. Chris recently retired from the University of York....

S. Y. Amy Cheung, PhD is a Senior Director in Integrated Drug Development with responsibility of Quantitative Sciences lead for the UK. She is a core member of the Pediatric Integrated Practice Area at Certara. She has over a decade of Pharma experience (AstraZeneca).  She obtained her PhD from the University of Manchester. After receiving her PhD, she worked at the Centre for Applied Pharmacokinetic Research (CAPKR) at The University of Manchester. Followed by a postdoc on mechanistic modelling. She has expertise in pediatric drug development, oncology, infection, CNS, vaccine, mAb, MIDD, PBPK, and extrapolation. She is a member of the IQ CPLG pediatric working group and chair of the IQ TALG CPLG Pediatric PBPK group. She is an affiliated...

Dr. Alex Bliu is a senior biostatistician with the Office of Biostatistics, Centre for Regulatory Excellence, Statistics and Trials (CREST) at Biologic and Radiopharmaceutical Drugs Directorate (BRDD), Health Canada. Alex holds a doctorate in Biostatistics from the McGill University. In addition to reviewing and providing statistical expertise in different drug submissions at BRDD, Alex is involved in different policymaking activities both within Health Canada and internationally and contributes to several regulatory guidelines.  Dr. Bliu’s research work and expertise focus on designs and analysis of clinical and epidemiological studies, biostatistics in general, causal inference, missing data methods, and time to event outcomes....

Professor Hannah Batchelor is a pharmaceutical scientist who has worked in academia, the NHS and within pharmaceutical industry. She is currently based at the Strathclyde Institute of Pharmacy and Biomedical Science, in Glasgow. She works on the design and manipulation of medicines to create age-appropriate drug formulations to maximise clinical efficacy in paediatric patients....

Dr. Jeff Barrett is Senior Vice-President at the Critical Path Institute serving as leader of the Rare Disease Cures Accelerator, Data Analytics Platform and a critical liaison between C-Path and the pharmaceutical industry, foundations, and other key stakeholders. He also contributes to C-Path’s model-informed drug development (MIDD) and real-world data (RWD) technologies efforts....

Lynne Yao, M.D., is the Director, Division of Pediatric and Maternal Health (DPMH) in the Office of New Drugs at FDA. DPMH oversees initiatives for the study of medicines in the pediatric population; and improve collection of data to support the safe use of medicines in pregnant and lactating individuals....