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Archive

New Horizon /  (Page 2)

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October 2, 2022

Lauren Price, PharmD, is a Clinical Pharmacology Reviewer in the Office of Cancer Pharmacology II, Office of Clinical Pharmacology, US Food & Drug Administration. She obtained a PharmD from the University of Washington School of Pharmacy and subsequently completed an oncology fellowship at the University of North Carolina Eshelman School of Pharmacy. Lauren joined the FDA in 2018 where she reviews and provides regulatory and scientific advice on IND, NDA, and BLA submissions for oncology products....

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October 2, 2022

Robert “Skip” Nelson, M.D., Ph.D. is Senior Director, Pediatric Drug Development at Johnson & Johnson. Previously (2006-2017), Dr. Nelson was Deputy Director and Senior Pediatric Ethicist in the Office of Pediatric Therapeutics at the U.S. Food and Drug Administration. Before joining FDA full-time, Dr. Nelson was Professor of Anesthesiology, Critical Care and Pediatrics at The Children’s Hospital of Philadelphia and University of Pennsylvania School of Medicine. Dr. Nelson is a member of the Secretary’s Advisory Committee on Human Research Protections and serves as the Industry Representative to the FDA Pediatric Advisory Committee....

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October 2, 2022

Subject matter expert in digital health and currently International Regulatory Policy Lead for Digital Health and Data Policy at Roche, Switzerland. From 2017-2022 I led large cross-functional teams at Roche in developing digital health technologies to support drug development for neurodevelopmental disorders. I co-lead the regulatory and dissemination work package of IMI consortium IDEA-FAST and am a member of the EFPIA Digital Medicine subgroup. Before joining Roche I managed the development of wearable technology at a fitness startup in Germany. I have an MSc and PhD in Cognitive Neuroscience from University College London and an MSc in Philosophy from the University of Edinburgh....

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October 2, 2022

Flora Musuamba holds a Ph.D. in Pharmacy and biomedical sciences from Université Catholique de Louvain, in Belgium. She is currently the vice-chair of the European medicines agency modelling and simulation working Party), a member of the EMA scientific advice and methodology working parties and a Pharmacometrics and Pharmacovigilance expert at the Belgian federal medicines agency. She is also an associate professor of Clinical Pharmacology at University of Namur....

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October 2, 2022

David Y. Mitchell, PhD, has over 30 years experience in clinical development, strategic drug development, and project leadership. Dr. Mitchell earned his PhD in pharmaceutical sciences from the University of Colorado and completed a postdoctoral fellowship in the Department of Pharmacology, Toxicology, and Therapeutics at the University of Kansas School of Medicine. Dr. Mitchell has led clinical pharmacology programs at Pfizer and Procter & Gamble Pharmaceuticals in the areas of oncology, neuroscience, and bone disease while serving as the clinical pharmacokineticist, and has served as a global team leader at Pfizer, OSI Pharmaceuticals, and Array Biopharma in the areas of oncology and neuroscience. Since 2009, Dr. Mitchell has been a consultant in clinical pharmacology for small and large pharma and biotech...

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October 2, 2022

Brian is a Principal Scientist in the Quantitative Pharmacology and Pharmacometrics group at MSD. Here he has served as the clinical pharmacology and pharmacometrics lead for several antiviral programs, including MSD’s molnupiravir. Brian holds a PharmD from the University of Florida, where he conducted research on evaluating the bioequivalence of inhaled drug products. He then completed a fellowship in pharmacometrics at the University of North Carolina with a research focus on PK of HIV antiretrovirals and minimal PBPK modeling. His research interests are in infectious disease/vaccines, pediatrics, and comparator modeling....

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October 2, 2022

Professor Jian Li is a Fellow of the American Academy of Microbiology and President of the International Society of Anti-infective Pharmacology. He has an internationally recognised track record in antimicrobial pharmacology and drug discovery with 414 publications (25,557 citations, h-index 78). His research has led to the first scientifically-based dosing recommendations for polymyxins and improved clinical practice worldwide. His team has developed a novel antibiotic QPX9003 from concept to clinical trials. He is a Web of Science Highly Cited Researcher in Pharmacology & Toxicology (2015-2017) and has received numerous awards, including the Australian Academy of Science Jacques Miller Medal (2017)....

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October 2, 2022

Dr. Kerry Jo Lee is the Associate Director for Rare Diseases in the Division of Rare Diseases and Medical Genetics, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER). In this role she leads the Rare Diseases Team, a multidisciplinary rare disease programming and policy team that works to promote their mission to facilitate, support, and accelerate the development of drugs and therapeutic biologics for rare diseases. The RDT also serves as the program management office for CDER’s ARC Program. Dr. Lee joined the FDA as a medical officer in 2014 with the former Division of Gastroenterology and Inborn Errors Products, OND, CDER. Dr. Lee then moved to a position as a clinical advisor for the Office...

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October 2, 2022

Dr. Maryna Kolochavina, PharmD, PhD, PMP. Executive leader and trusted advisor with 18 years of experience in a lifecycle asset management of over 242 rare and orphan medicinal products and advanced therapies in 42 therapeutic classes with 440 orphan drug designations, resulting in approximately $3.2bn in capital committed to alliances with biotechnology and pharmaceutical partners of all sizes. Active patient advocate for people with rare and orphan condition, representing a Patient Voice initiative in Charité, Berlin, Germany. Clinical pharmacology background with translational PhD on rare skin diseases. Member of 14 organisations, 1 board of directors...

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October 2, 2022

Alice Ke obtained her PhD in pharmaceutics from the University of Washington, Seattle, where her research was focused on the assessment of fetal and CNS drug distribution using clinical imaging techniques. She then accepted an ORISE fellowship in the Office of Clinical Pharmacology at the FDA, where she developed and validated PBPK and population PK models to support dose adjustment for pregnant women. After completing her fellowship, Dr. Ke was a research scientist in the Department of Drug Disposition and PK/PD at Lilly Research Laboratories, where she applied population PK and PBPK modeling & simulation techniques to provide model-based advice on the design of clinical pharmacology studies. Currently, Dr. Alice Ke is a senior director of PBPK consultancy at Certara....

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