邀请函 I 比利时林堡省生物制药生态系统的发展

SPEAKER INFORMATION

Xiaomin Chen

Ms. Xiaomin Chen, an expert in clinical development with over 13 years’ experience within global Biopharmaceutical industry, including 6 years in global clinical trial management in Novartis USA and over 5 years as a clinical pharmacologist in AstraZeneca and Exelixis. In Novartis, Xiaomin successfully led 50 cross-functional team members in over 14 countries to execute complex Phase 3 oncology clinical trials which led to a global regulatory approval for oncology products.
Xiaomin received her MBA from a New York University. She also holds both Bachelor of Science, Double Major in Pharmaceutics and Biomedical Pharmacology and Master of Science degree in Pharmaceutical Science.

Sunny Chapel

Dr. Chapel is recognized as a leading expert in pharmacometrics from preclinical development through registration to post-marketing across a wide variety of therapeutic areas. She is also a leading expert in facilitating regulatory submissions using pharmacometrics to agencies worldwide.
Dr. Chapel works as an adjunct professor in the University of Michigan College of Pharmacy. She received her Ph.D. in Pharmacokinetics from the University of Iowa in 2001. In her professional career she has worked for some of the leading pharmaceutical and biotech firms in the world, including Pfizer and Aventis.

Bing Wang

Dr. Wang is a renowned expert in clinical pharmacology and pharmacometrics with over 20 years of industry experience at leading biopharmaceutical companies. He is a cofounder, CEO and Board Chairman of Amador Bioscience. Dr. Wang had led multidisciplinary project teams in hematology, oncology, pulmonary disease and RIA, and contributed to dozens of global IND and CTD filings. He is a well-known speaker and instructor and has approximately 100 publications and is a co-inventor of 12 patents.
Dr. Wang graduated from University of Science and Technology of China in 1994 and received his PhD in Pharmaceutical Sciences in 1999 from University of Nebraska Medical Center under the mentorship of Dr. Thomas M Ludden, former OCP Director of the FDA.

Nidal Huniti

Nidal Huniti is an Executive Director and Head of Quantitative Pharmacology at Regeneron. Nidal is a registered pharmacist, did his master’s degree training in clinical hospital pharmacy and his PhD in PK/PD modeling at the University of Iowa. After completing his masters he worked for both the Pharsight Corporation and Icon Development Solutions, before joining Astra Zeneca’s Clinical Pharmacology/DMPK group in 2010.
Most recently Nidal was Executive Director in Quantitative Clinical Pharmacology, where he has led standardization of processes, workflows, and knowledge management to improve the quality, consistency, and speed of Quantitative Pharmacology deliverables. Nidal is an author of more than 70 peer reviewed papers and more than 150 published abstracts.

Harry Yang

Harry Yang, Ph.D., is Vice President and Head of Biometrics at Fate Therapeutics. Prior to Fate Therapeutics, he worked as Head of AI and Analytics Research at AstraZeneca, and before that Global Head of Statistical Sciences at MedImmune. He has 25 years of experience across all aspects of drug research and development, from early target discovery, through pre-clinical, clinical, translational science, and CMC programs to regulatory approval and post-approval lifecycle management. He has published nearly 100 peer-reviewed papers, 27 book chapters, and 8 books including Data Science, AI and Machine Learning in Pharma and Real-World Evidence in Drug Development and Evaluation. He is the inventor of 2 patented AI-algorithms and a frequent invited speaker at national and international conferences. He has also developed statistical courses and conducted training at the FDA and USP.

Olivier Thas

Olivier first studied bio-engineering with a major in molecular biology, before he obtained his master degree in biostatistics from Hasselt university and his PhD from Ghent University. His research is focused on developing statistical methods for the analysis of data generated with high throughput technologies such as digital PCR, flow cytometry and sequencing, with applications in e.g. gene expression and microbiome studies and in biomarker discovery. In another line of research he develops informative nonparametric rank-based methods.
For many years he has been involved in collaborative research and consulting projects with the pharma and biotech industries. Oliver has published more than 130 papers and 2 monographs. He is currently also the chair of the Master of Statistics and Data Science, and it is particularly in that capacity that he will present here today.