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OPEN ACCESS: BioRAM–based Decisions

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  • Filippos Kesisoglou, Ph.D.

    Kesisoglou is a Senior Principal Scientist in the Biopharmaceutics group, Pharmaceutical Sciences and Clinical Supply, Merck Research Laboratories (West Point, PA) where he is leading the Modeling & Simulation Quantitative Biopharmaceutics and Oral Biopharmaceutics efforts. His research work and responsibilities include the in vitro, in silico and in vivo biopharmaceutical evaluation of oral formulations across development phases from FIH formulation to late stage and lide-cycle management stages, including Regulatory Agency interactions and setting of clinically relevant specifications. He serves as the biopharmaceutics subject matter expert within Pharmaceutical Sciences and cross-functional technical project review committees and several innovation teams. He holds a diploma in Pharmacy from Aristotle University of Thessaloniki, Greece and MSc and PhD degrees in Pharmaceutics from University of Michigan, Ann Arbor, MI. He has authored/co-authored more than 40 scientific papers or book chapters and more than 50 meeting abstracts/podium presentations in the fields of biopharmaceutics and oral drug delivery. He has been an invited speaker to national/international workshops and meetings in the field of biopharmaceutics and absorption modeling. He has been a reviewer for multiple pharmaceutical journals, and he is currently serving in the Editorial Advisory Board for Journal of Pharmaceutical Sciences. He is an active member of AAPS, serving in the steering committee of the Quality by Design and Product Performance Focus Group and as the PPB representative on the AAPS Membership Strategic Oversight Committee.

  • Anette Müllertz, Ph.D.

    Dr. Anette Müllertz is professor at the Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark. She is head of Bioneer:FARMA, Danish Drug Development Center, a business unit of Bioneer A/S, based on a grant from the Danish Ministry of Science and Technology given to establish research based scientific services within the area of drug development. After receiving her PhD degree in lipid nutrition at the Technical University of Denmark, she went to work for Novo Nordisk A/S, on development of structured lipids, digestive lipases and digestion models, among other projects. In 1998 she joined the University of Copenhagen. She is heading the Rational Oral Drug Delivery Research Group, focusing on developing predictive biopharmaceutics tools for oral drug delivery and lipid based drug delivery systems.

    Anette has 160+ publications in international, peer-refereed journals (h-factor: 44 (Google Scholar)), as well as 10 book chapters; the majority of these being within the area of biopharmaceutics. She has been supervising 9 post docs, 40 PhD students and numerous master students, primarily at the University of Copenhagen, but also at other universities. She has been involved in the organization of many international meetings, both in Europe and the US and has been invited to speak at international meetings on more than 50 occasions. She is a driving force in the EU sponsored Innovative Medicines Initiative Consortium Oral Biopharmaceutics Tools (OrBiTo) as co-lead of the API characterization work-package. She was the winner of the 2005 AAPS Lipid Based Drug Delivery Award and is in the steering committee of 2 AAPS Focus Groups (FGs); The Lipid-based Drug Delivery FG (Chair 2010-12) and the QbD and Product Performance FG (Chair 2013-15).

September 8, 2016
Thu 12:30 PM EDT

Duration 1H 30M

This live web event has ended.