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Pediatric Biopharmaceutics – Part 2: Predicting Performance in Pediatric Populations with PBBM and Virtual Bioequivalence Studies for Pediatric Biopharmaceutics: How Far from Reality?

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Contributors

  • Nikoletta Fotaki, Pharmacist, MSc, Ph.D.

    Dr Nikoletta Fotaki is a Pharmacist, with an MSc in Toxicology and a Ph.D. in Biopharmaceutics-Pharmacokinetics. She participated in several research projects in the School of Pharmacy of the National and Kapodistrian University of Athens and in Hoffman La Roche (USA) before her academic appointment at the University of Bath. She has also worked in the National Organisation for Medicines in Greece. She is a reviewer and scientific advisor of several scientific journals, a Deputy Editor for AAPS Open and member of the editorial board of Journal of Pharmacy and Pharmacology, Dissolution Technologies and DiePharmazie. She is an Associate Fellow of the Higher Education Academy and has been involved in the evaluation of several research proposals. She is also an Adjunct Associate Professor in the University of Waterloo (Canada) and a visiting Lecturer in King’s College London. She is a past chair of the IVRDT Focus Group of AAPS. She has been the chair of the IVRDT Focus Group of AAPS, member of several scientific societies and has been an invited speaker at several conferences.
    Dr Fotaki’s expertise and research are focused on PBPK modeling, in vitro and in silico tools for predicting absorption in normal populations and in special populations, pharmacometrics, biorelevant solubility and dissolution methods, dissolution imaging, IVIVCs and biowaivers.

  • Amitava Mitra, Ph.D.

    Amitava is currently a Clinical Pharmacology Leader at Janssen R & D, where he supports global drug development programs. He has 13 years of experience in the pharmaceutical industry supporting various therapeutic areas and has previously worked at Merck and Novartis. Amitava has a Ph.D. in Pharmaceutical Sciences from University of Maryland, Baltimore. Amitava’s main research interests include clinical pharmacology, modeling & simulation, pharmacokinetics, and biopharmaceutics. He has interacted with several regulatory agencies like FDA, EMA and PMDA on these topics, as part of project support as well as in workshops and consortia. Amitava has published more than 50 research and review articles, and has 30 podium presentations in national & international conferences, on these topics. Amitava has won several awards including the Novartis VIVA Leading Science award in 2019 for his modeling efforts, an award that celebrates exceptional contribution by scientists across the company’s R&D organization worldwide. Amitava has been involved in several cross-industry consortia such as IMI-OrBiTo and IQ. He is active in AAPS and ASCPT

November 17, 2020
Tue 12:30 PM EST

Duration 1H 30M

This live web event has ended.