Pharmetheus consultants and advisors present a unique collection of experiences and combination of skill sets.

Elodie Plan

Prof. Mats Karlsson, Advisor, COB

  • Co-founder of Pharmetheus AB
  • Ph.D. in Pharmacokinetics and M.Sc. in Pharmaceutical Sciences
  • Professor of Pharmacometrics at the Pharmacometric Research Group, Uppsala University
  • Research focus on methodological development and application of pharmacometrics to drug development and drug usage
    • Leads a research group with >40 scientists, successfully supervised 35 students to their PhD, mentored >30 postdocs, published 250 peer-reviewed full-length research articles and is co-developer of 3 widely used pharmacometric software
  • Served as consultant to pharmaceutical industry for 20 years, and contributed with pharmacometric analyses to >20 successful filings for new drug applications in Europe and the US
  • Link to Mats Karlsson’s publications

Dr. Marie Sandström, Senior Consultant, CEO

  • Co-owner of Pharmetheus AB
  • Ph.D. in Pharmacokinetics and Drug Therapy and M.Sc. in Pharmaceutical Sciences
  • Experience as Lecturer and Associate Professor in Pharmacokinetics and Drug Therapy, Uppsala University, years 1997-2003
  • Experience in all clinical phases of Drug Development from AstraZeneca, years 2003-2013, as:
    • Clinical Pharmacometrician / Pharmacokineticist
    • Head of Clinical Pharmacology in Södertälje
    • Clinical Pharmacology & DMPK Projects Director in the therapeutic area of  Neuroscience
    • Global Director Clinical Pharmacometrics
  • Link to Marie Sandström’s publications

Dr. Elodie Plan, Senior Consultant, VP

  • Co-founder of Pharmetheus AB
  • Ph.D. in Pharmaceutical Biosciences, M.Sc. in Biostatistics and Pharm.D.
  • Research focus on investigating pharmacometric methods and developing novel models for discrete data
    • Therapeutic areas include Neurosciences -epilepsy, Alzheimer’s, pain, migraine, Parkinson’s, schiziophrenia-, Gastroenterology, and Women’s Health -endometriosis, uterine contractility-
    • Methodologies involve Markov models, time-varying hazards models, and repeated time-to-categorical events models
  • Experience as a Visiting Scientist, member of the Systems Biology group, at the contracting company Metrum Research Group, CT, USA
    • Development in a Bayesian framework of a semi-mechanistic model component predicting fracture rate in bone-related diseases
    • Support in consulting work -contribution to proposals, writing of reports, technical advices and pharmacometric analyses-
  • Pharmacometric tutoring performed at several workshops
  • Pharmacokinetic-pharmacodynamic modelling executed in collaboration with different pharmaceutical companies
  • Link to Elodie Plan’s publications
Elodie Plan

Prof. Lena Friberg, Advisor

  • Co-founder of Pharmetheus AB
  • Ph.D. in Pharmacokinetics and Drug Therapy and M.Sc. in Pharmaceutical Sciences
  • Professor in Pharmacometrics at the Pharmacometric Research Group, Uppsala University
  • Research focus on development of population PK and PD models for desired effects and adverse events
    • Therapeutic areas include bacterial infections, oncology, schizophrenia, rheumatoid arthritis, and QT-prolongation
    • Model-based translation of in vitro and animal PKPD to patients, and predictions from early to late phase development
  • Consultant to pharmaceutical industry:
  • Performed and advised on a wide range of PK and PKPD-modeling projects within bacterial and fungi infections, septic shock, endocrinology, oncology, rheumatoid arthritis, multiple sclerosis, schizophrenia, QT-prolongation and arrhythmia
  • Several of these projects have directly supported filing and interactions with EMA and FDA
  • Link to Lena Friberg’s publications

Dr. Andrew Hooker, Advisor

  • Co-founder of Pharmetheus AB
  • Ph.D. in Bioengineering, M.Sc. in Bioengineering, B.S. in Physics (Minor in Mathematics)
  • Associate professor at the Pharmacometric Research Group, Uppsala University
  • Degrees from University of Colorado, University of Washington (Seattle, USA), followed by post-doc at Uppsala University (Sweden).
  • Research ranges between methodological and applied pharmacometrics
    • Optimal experimental design
    • Methodological problems associated with building and evaluating Pharmacometric models
    • (Repeated) time-to-event model building
    • Development and use of PKPD models
    • Therapeutic areas include cancer, addiction, PET, biologics, etc.
  • Primary developer of the software programs Xpose 4PsN and the optimal design program PopED
  • 8 years experience as a consultant to pharmaceutical industry, including support and regulatory interactions leading to successful filings for new drug applications in Europe and the US
  • Link to Andrew Hooker’s publications

Prof. Ulrika Simonsson, Advisor

  • Co-founder of Pharmetheus AB
  • Ph.D. in Pharmaceutical Biosciences and M.Sc. in Pharmaceutical Sciences
  • Professor at the Pharmacometric Research Group, Uppsala University
  • Experience as post doc with Pharsight Corporation, CA, USA and as a pharmacometrician at AstraZeneca, Mölndal, Sweden
  • Research focus on how modelling and simulation of PK and PD can be used to optimize drug development
    • Holds large grants within the field of tuberculosis
    • Is the lead for M&S in the European IMI funded consortium Predict-TB
  • More than 15 years of experience as a pharmacometric external consultant to drug development companies including regulatory interactions and filing
    • Patent pending for dosing nomograms based on Ulrika’s consultancy work
  • Therapeutic areas include malaria, tuberculosis, HIV, thrombosis/cardiovascular diseases, diabetes, insomnia, prostate cancer, hypertension, asthma and cortisol insufficiency
  • Link to Ulrika Simonsson’s publications

Dr. Martin Bergstrand, Senior Consultant

  • Co-founder of Pharmetheus AB
  • Ph.D. in Pharmaceutical Biosciences and M.Sc. in Biomedicine
  • Experience as clinical pharmacology research scientist at AstraZeneca R&D, Mölndal, Sweden Focus on phase I and II drug development within the field of metabolic disorders, e.g. diabetes.
    • Clinical drug development in phase I and II trials with multiple drug candidates ranging across several mechanisms of action
  • Extensive experience with mechanism based population PK modeling including complex absorption, non-linear elimination, enzyme induction and metabolite kinetics
  • Pharmacodynamic modeling in areas such as: Type II diabetes, Infectious disease, SLE (Lupus) and Oncology
  • Experience as contract researcher on behalf of several pharmaceutical companies
  • Link to Martin Bergstrand’s publications

Dr. Niclas Jonsson, Senior Consultant

  • Co-owner of Pharmetheus AB
  • Ph.D. in Pharmaceutical Biosciences and M.Sc. in Pharmaceutical Sciences
  • Associate Professor of Pharmacometrics at the Pharmacometrics Research group, Uppsala University
  • Experience as Senior Consultant at Exprimo NV and as Global Head of Modeling & Simulation at Roche:
    • Pharmacometric project management
    • Population PKPD modelling and simulation expert
    • Developer of methodology to manage large pharmacometric projects with critical time lines
  • Original developer of the software programs Xpose 4 and PsN
  • Link to Niclas Jonsson’s publications

Dr. Mats Magnusson, Senior Consultant

  • Co-owner of Pharmetheus AB
  • Ph.D. in Pharmaceutical Biosciences and M.Sc. in Pharmaceutical Sciences
  • Experience as Senior Consultant at Exprimo NV, and as Visiting Scientist of the Pharmacometrics groups at Pfizer:
    • Population PK/PD modelling, simulation and optimization of trials in paediatric populations
    • Mechanistic modelling of monoclonal antibodies
    • Benefit-risk assessment
    • Developer of methodology to manage large pharmacometric projects with critical timelines
    • Link to Mats Magnusson’s publications

Dr. Joakim Nyberg, Senior Consultant

  • Co-founder of Pharmetheus AB
  • Ph.D. in Pharmaceutical Biosciences and M.Sc. in Engineering Physics
  • Experience in system development and project management mainly with high security systems
  • Research focus on practical and methodological optimal design
    • Primary developer of the optimal design tool PopED
    • Worked with estimation methods for Pharmacometric models
    • Therapeutic areas include diabetes, oncology, immunosuppressant and QT-prolongations
  • Team leader for a large phase III study, involving project management, QA/QC processes and data security
  • Link to Joakim Nyberg’s publications

Dr. Jakob Ribbing, Senior Consultant

  • Co-owner of Pharmetheus AB
  • Ph.D. in Biopharmaceutical Sciences and M.Sc. in Pharmacy
  • Extensive experience as the Pfizer pharmacometrics subject-matter expert on Allergy and Respiratory disease (e.g. COPD, Asthma and Allergic Rhinitis)
  • Many applications of non-linear mixed effects modeling, to both individual-level (internal-trial) and aggregate level (literature-summary-level) data
  • Numerous applications of modeling for:
    • Setting target/hurdles for interim, trial or program continuation, or PoP/PoM/PoC declaration and transition
    • Making decisions on interim, trial or program continuation, or PoP/PoM/PoC declaration and transition, as well as dose/regimen selection, in various phases
    • Translation across populations and endpoints
    • Pharmacoeconomic simulations of real-life outcomes
  • Link to Jakob Ribbing’s publications

Dr. Celine Sarr, Senior Consultant

  • Ph.D. in Pharmaceutical Biosciences, M.Sc. in Biostatistics and Pharm.D.
  • Hospital Residency
  • Experience as Senior Consultant at Exprimo NV, as Senior expert modeler and cluster leader in the Modeling and Simulation group at Novartis:
    • Population PK/PD modelling and simulation e.g. Oncology
    • Project team, internal decision and submission support
    • Portfolio and operational management
  • DDMoRe scientific coordinator and product lead of the model repository
  • Link to Celine Sarr’s publications

Dr. Marcus Björnsson, Senior Consultant

  • Ph.D. in Pharmacokinetics and Drug Therapy and M.Sc. in Pharmaceutical Sciences
  • Experience as Senior Clinical Pharmacometrician and Neuroscience Therapy Area Pharmacometrics Expert at AstraZeneca
    • Population PK/PD modeling and simulation in a large number of drug development projects
    • Modeling of informative dropout
    • Experience from all phases of clinical drug development
  • Link to Marcus Björnsson’s publications

Dr. Martin Fransson, Consultant

  • Ph.D. in Medical Science and M.Sc. in Applied Physics and Electrical Engineering
  • Experience as Consultant of modeling and simulation in pharmacokinetics
  • Postdoctoral research in toxicokinetics
  • Research has focused on
    • Population PK modeling of anticancer drugs
    • PBPK modeling of heavy metals
  • Team leader and coordinator for IT work packages in European and Swedish infrastructure projects for biobanks, including project management, design of use-cases and information models for biobank databases
  • Link to Martin Fransson’s publications

Dr. Chayan Acharya, Consultant

  • Ph.D. in Pharmaceutical Sciences, M.Sc. in Physics, B.Sc. in Physics (Minor in Mathematics and Chemistry)
  • Former Postdoctoral Fellow at Uppsala University in Pharmacometrics research group
  • Research experience in Pharmacometrics includes:
    • Population PK/PD modeling and simulation and optimization of clinical trials
    • Developer of an R-package for population pharmacokinetic model diagnosis using non-compartmental analysis metrics
  • Therapeutic areas include immunosuppressant and pain management
  • Link to Chayan Acharya’s publications

Dr. Sofia Friberg Hietala, Consultant

  • Ph.D. in Pharmacology and M.Sc. in Pharmacy
  • Experience as Senior Clinical Pharmacometrician at AstraZeneca
    • Pharmacokinetic/pharmacodynamic analyses in studies across all phases of clinical drug development
  • Pharmacokinetics and Pharmacometrics Assessor at the Swedish Medical Products Agency
    • Scientific assessment of marketing authorization applications, specifically regarding dose-finding, ADME properties, drug-drug interactions and special populations
    • Scientific advice and normative work (contributing to regulatory guidelines)
    • Former Vice-Chairperson of the Modelling and Simulation Working Group at the European Medicines Agency
  • Link to Sofia Friberg Hietala’s publications

Dr. Emma Hansson, Consultant

  • Ph.D in Pharmaceutical Biosciences and M.Sc in Pharmacy
  • Research experience in pharmacometrics includes:
    • Population PK/PD modeling and simulation in oncology
    • Development of an overarching PK/PD modeling framework in oncology, linking exposure, longitudinal biomarkers, adverse effects and treatment outcome
  • Pharmacometric tutoring performed at several workshops
  • Pharmacokinetic & Pharmacometric assessor at the Swedish Medical Products Agency
    • Scientific assessment of clinical pharmacology aspects, especially population PK and PK/PD analyses, as part of regulatory evaluation of Marketing Authorization Applications
    • Member of the expert group on modelling and simulation at the European Medicines Agency
    • Therapy areas covered include e.g. oncology, endocrinology and infectious diseases
  • Link to Emma Hansson’s publications

Arnaud Pharasyn, IT and Data Manager

  • M.Sc. in Physics from the Ecole Normale Supérieure de Lyon
  • Experience as Consultant in the IT sector
  • Expertise in Software Development and Data Processing within Astrophysics, Electronics, Gaming industry, and Geophysics
  • Involved in the IT support to the personnel and students at the Geophysics department of Uppsala University
  • Responsible during more than 3 years for the maintenance of the IT infrastructure at the Swedish National Seismic Network

Anna Olofsson, IT and Data Management Support

  • M.Sc in Biotechnology Engineering from Uppsala University (minor in Bioinformatics)
    • Master’s thesis on biomarker analysis in cardiovascular disease
  • Experience with bioinformatic analysis of patient data

Emma Ångström, Finance and Administration Manager

  • B.Sc. in Business Administration and Economics from Uppsala University
  • Experience of working within finance and control since 1997, including positions as:
    • Auditor at PwC
    • Production Controller at Fresenius Kabi
    • Manager within Finance and Controlling at the Swedish Medical Products Agency

Beatrice Attered, Communications Manager and Administrative Assistant

  • M.Sc in Business Administration at Stockholm university and B.Sc in Political Science at Uppsala University (Minor in Marketing and Economics)
    • Master’s thesis on knowledge sharing within large and diverse organizations
  • Experience within marketing and administration

Dr. Kajsa Harling, Senior Systems Developer

  • Ph.D. in Scientific Computing and M.Sc. in Biotechnology Engineering from Uppsala university
  • Expertise in software development for pharmacometric modelling
  • Developer of PsN
  • Experience in algorithm development, numerical optimization and high performance computing

Gunnar Yngman, Research Assistant

  • M.Sc in Pharmacy from Uppsala University
    • Master’s thesis on individualization of fixed-dose combination regimens
  • Post-graduate experience from the pharmometric research group at Uppsala University
  • Ph.D student at Uppsala University
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