Our Team

• Ph.D. in Pharmacokinetics and Drug Therapy and M.Sc. in Pharmaceutical Sciences
• Experience in pharmacokinetics and PKPD-modelling across several phases in drug development
• Experience as Senior Lecturer and Associate Professor in Pharmacokinetics and Pharmacodynamics, Gothenburg University, years 2010-2017
• Experience as Consultant at Exprimo NV

• 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

• Experienced Helpdesk Manager
• IT Process Implementations
• ITIL V3 and Cap Stream Certified
• Incident and Change Management

• Holds a Master of Science degree from Stockholm School of Economics.
• 25 years of operational, financial and strategic business experience as an executive in the life science field.
• Currently he serves as CEO of Devyser Diagnostics AB, a Swedish diagnostic company.
• Previously, he served as CFO of Boule Diagnostics AB, a Swedish publicly-traded diagnostic company and CEO of their US subsidiary Clinical Diagnostic Solutions Inc.
• He has also been CFO and Deputy CEO of IRRAS AB, a Swedish publicly traded med-tech company, CEO of Doxa AB, a Swedish listed med-tech company, and CFO of AlgiPharma AS.
• He currently serves as Chairman of the Board of Personlig Almanacka Nordic AB and board member of Binero Group AB (listed at Nasdaq First North Growth Market).

• 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

• M.Sc. in Statistics
• Formerly Global Head of Statistics and Chief Statistician for Pfizer Inc. with responsibility for approximately 250 statisticians and a budget of $50M
• Fostered a culture of collaboration across statisticians, clinical pharmacologists, and clinicians to enable and deliver MIDD
• Led quantitative assessment of late stage probabilities of technical and regulatory success through modeling and simulation for all late-stage assets compared to industry/therapeutic area benchmarks
• Member of cross PhRMA statistics group, led collaborations delivering such things as Data Monitoring Committee member training
• Quantitatively assessed more than 50 potential external business development assets
• Over 25 years of drug development experience in Neuroscience, Pain, Cardiovascular, Infectious Disease, Rare Disease

• Ph.D. in Pharmacometrics, M.Sc. in Pharmacology and Pharmacometrics, Pharm.D.
• Internship experiences as pharmacometrician in pharmaceutical companies (Pierre Fabre, Eli Lilly)
• Research experience in pharmacometrics includes:
  • Population PK/PD modelling and simulation of analgesics and sedatives
  • Dose optimization in children
  • PBPK modelling of preclinical data

• Ph.D. in Pharmaceutical Biosciences and M.Sc. in Biomedicine
• Experience as clinical pharmacology research scientist at AstraZeneca R&D, Mölndal, Sweden with focus on phase I and II drug development within the field of metabolic
  disorders.
• Extensive experience with mechanism-based population PK modeling including complex absorption, non-linear elimination, enzyme induction, metabolite kinetics and complicated
  target binding relations etc.
• Population PK/PD modeling in areas such as: Type II diabetes, Obesity, Hematological
  disorders, Infectious disease, SLE (Lupus), Oncology, Depression etc.
• Experienced with development and implementation of new platform technics to facilitate
  Model Informed Drug Development.
• Contributed modeling and simulation support for 5+ successful NDA filings.

• 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

• Ph.D in Pharmaceutical Biosciences and M.Sc in Drug Discovery and Development
• Research experience in pharmacometrics includes:
  • Population PK and PKPD modeling and simulation with a focus on biological medicinal products displaying target-mediated drug disposition
  • Modeling underlying variables using hidden-Markov models
  • Investigating sampling strategies for model-based dose individualization of coagulation factors
  • Clinical trial (optimal) design

• Ph.D. in Pharmacometrics, M.Sc. in Biostatistics, Pharm.D.
• Hospital residency
• Internship experience as pharmacometrician at Sanofi
• Research experience in pharmacometrics includes: 
  • Population PK modelling for antibodies in pediatrics (regulatory submission for Phase III studies)
  • Model-Informed Precision Dosing of an antibiotic and an immunosuppressant

• PharmD & PhD in PK & PKPD modelling, Post-Doctoral Fellow at the University of Manchester in Optimal Design.
• Joined Servier as Pharmacometrician in 2005 to plan, conduct, and report population PK & PKPD analyses for diverse clinical drugs in Cardiology (HTA, Heart failure, Anti-coagulants/stroke), CNS (Depressive disorders), and Rheumatology (Osteoarthrosis, Arthrosis).
• Held different team manager positions at Servier from 2008 to 2013, when she became Head of Global Pharmacometrics & Clinical Pharmacokinetics, managing a team of 20-25 people and working on early phase PKPD, late phase PKPD, PBPK/QSP, and clinical PK (NCA, IVIVC).
• Extensive experience in designing and conducting individual clinical trials and drug development programs, as well as regulatory interactions from pre-IND to filling including scientific advices with different agencies (EMA, FDA, PMDA, NMPA, ANVISA, KFDA, Health Canada, etc.).
• Actively involved in Servier R&D transformation by coordinating a group delivering strategic guidance for drug development covering non-clinical drug safety, DMPK, clinical PK & PKPD, PMx, CMC, and BMK; more recently, also acting as the chairwoman for the Translational Medicine Project Review.
• Member of the M&S EFPIA group, DDMoRe foundation board, PAGE Scientific Organizing Committee, and CPT:PSP editorial team.
• Co-supervised 15 PhD students in collaboration with different academic groups.

• Ph.D. in Pharmacology and M.Sc. in Molecular Biology
• Authored clinical study protocols and reports of early phase clinical studies within respiratory, gastrointestinal and neuroscience disease areas at AstraZeneca
• Clinical lead in oncology companion diagnostic development, registration and medical communication at Agilent Technologies, in collaboration with pharmaceutical companies
• Clinical evaluation of hardware and software medical devices to document safety, performance and clinical benefits at 3Shape

• Ph.D. in Pharmaceutical Sciences and M.Sc. in Pharmacy
• Research experience includes:  
  • Development of a mechanistic pulmonary drug absorption model
  • PBPK modelling of different pharmaceutical formulations  
  • PBPK modelling of both preclinical and clinical data

• M.Sc. in Mathematics/Statistics from Pierre et Marie Curie University in Paris
• Worked 10 years in data programming for pharmacometrics in the pharmaceutical industry
• Worked 5 years in data programming for clinical trial reporting in the pharmaceutical industry
• Worked 5 years in biostatistics in a Contract Research Organisation
• Experience in software development

• Holds a MBA from Uppsala University and a Master of Science degree from the Royal institute of Technology in Stockholm (electrical and biomedical engineering).
• Experience from two CEO positions, Vita Nova Ventures AB (Publ) (a CRO company) and Falck Ambulans AB (healthcare services) and more than 25 years’ experience from research, clinical trials, product/service development, and international complex sales and marketing.
• Since 2006 she runs her own management consulting firm focusing on analytic work, developing road maps, strategic plans, project managements, brand, profile, value work, and implementation of market access strategies.
• Has served on several boards of directors during the last 12 years. Today she is a member of the board of Blekinge Institute of Technology and Arocell AB (Publ.) and serves as the Chairman of the Board of Directors of Specialplast Wensbo AB, Earlabs AB and HoofStep AB.
• Received the national prize “Supergasell 2016” (Dagens Industri).

• 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

• B.Sc. in Mathematics and Pedagogy from University of Latvia
• Experience in software development and automated report generation for PsN
• Experience as a teacher of mathematics

• 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

• 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

• B.Sc in Statistics and Computing.
• Over 15 years of experience working as a Data Programmer in Pharmacometrics and Statistical Programmer at Novartis and Pierre Fabre Institut.
• Expertise in all aspects of programming activities related to phase I to IV clinical trials, from study set-up to study report, data pooling and HA submissions.
• Worked across multiple therapeutic areas, including Neuroscience, Ophtalmology, Immunology, Respiratory and Oncology.

• Ph.D. in Pharmacometrics, M.Sc. in Bioengineering and Bioinformatics
• Former pharmacometrician internship at Pierre Fabre
• Research experience in pharmacometrics includes:
  • Population PK/PD modelling in oncology for small and large molecules
  • Mechanistic modeling of tumor growth inhibition in xenograft mice
  • Simulations and optimal dose prediction

• Ph.D. in Life Sciences, M.Sc. in Pharmacology and modeling, Pharm.D.
• Hospital residency
• Experiences within academic research groups and pharmaceutical companies (Servier, GSK, Novartis):
  • PK/PD modeling of antipsychotics and adverse events, DDI of cytotoxic drugs
  • Model based dose individualization in psychiatrics and geriatrics patients
  • Simulation work focused on model validation methods and NOAEL determination

• 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

• ITIL Foundation certified in IT Service Mangement
• Certified Windows Server Administrator
• Experienced Linux System Administrator
• Has worked as Senior IT consultant
• Experienced IT manager, in both public and large private entities

• Ph.D. in Pharmacy
• Experience as modeling and simulation scientist at Idorsia Pharmaceuticals
• Research experience in pharmacometrics includes population PKPD modeling and simulation in different therapeutic areas
  • Oncology (modeling of myelosuppression, tumor growth, and overall survival)
  • Cardiovascular (modeling of platelet inhibition, concentration-QT analysis)
  • Immunology

• Ph.D. in Bioengineering, M.Sc. in Bioengineering, B.S. in Physics (Minor in Mathematics)
• Professor in Pharmacometrics 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.
• Co-developer of a number of software programs including Xpose 4, PsN, and the optimal design program PopED
• 11 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

• Ph.D in Pharmaceutical Biosciences and M.Sc in Clinical Pharmacy.
• Research experience in pharmacometrics includes:
  • Population PK/PD modeling and simulation.
  • Development of fast and robust novel methodologies through model-proxy analysis for automated model building and model evaluation.
  • Model-based analysis of competing risks with interval-censored data.
  • Optimal design of clinical trials for anticipated drug effects and clinical status assessment.

• Ph.D. in medicine and M.Sc. in Pharmacy
• Research experience includes:
  • Population PK/PD modelling and simulation of anticancer drugs (chemotherapy and targeted therapies)
  • Special patient populations, e.g. pregnant patients and paediatrics
  • Application of pharmacometrics in clinical settings

• 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

• PhD. in Pharmacokinetics and Drug Therapy, M.Sc. in Pharmacy
• Researcher at the Pharmacometric Research Group, Uppsala University
• Long time experience of pharmacokinetics and pharmacometrics from drug development, regulatory assessment, research and teaching
  • Pharmaceutical industry (Kabi Pharmacia, Astra Zeneca, 5 years)
  • Regulatory authority (Swedish Medical Products Agency, 9 years)
  • Academia (Uppsala University, 10 years)
• Research focus includes methodological and applied pharmacometrics. e.g.
  • PK and PKPD in hemophilia
  • Dose individualization
  • Various pharmacometric aspects for biological medicinal products

• PhD. in pharmaceutical biochemistry.
• Experience as Consultant PBPK Modelling and Simulation at SGS Exprimo and Systems Pharmacology Expert at Bayer
  • Advice preclinical and clinical drug development teams how to apply PBPK modelling across different stages of clinical drug development, for advancing small and large molecules
  • Contribution to the filing of new drug applications, and experience with regulatory interactions
  • Experience in when and how to apply PBPK modelling across different stages of clinical drug development, for influencing internal and regulatory decisions
  • Therapeutic areas include oncology, women’s health, cardiovascular diseases, inflammatory diseases, hematology, pain and ophthalmology
• Experience as DMPK project representative, PBPK Expert and Laboratory team leader at Takeda, Nycomed and Altana Pharma
  • Consulting clinical drug development teams as Expert for ADME and physiology based pharmacokinetic (PBPK) modelling
  • Development of in vitro ADME and immunological assays with HPLC/UV-Vis, LC/MSMS, radioactive tracer or flow cytometry detection

Long experience in software development and maintenance of HR and payroll applications:
• Manager for several software development teams
• Senior project manager and scrum master
• Monitoring data processing
• Requirements and testing
• Customer support and training
• Administration

• Ph.D. in Pharmacokinetics and M.Sc. in Pharmaceutical Sciences
• Professor in Pharmacometrics at the Pharmacometric Research Group, Uppsala University
• Research focus on methodological development and application of pharmacometrics to drug development and drug usage
• Experience of PK and PD across small and large molecules and across many therapeutic areas including oncology, endocrinology, infectious diseases, respiratory and CNS disorders.
• Co-developer of several pharmacometric software, including PsN and Xpose4
• Served as consultant and have provided in-house training courses to pharmaceutical industry since 1990

• B.Sc in Computer Engineering at Zagreb Polytechnic for Technical Sciences
• Work as linux system administrator at Styria IT, providing support to developers and managing Linux servers

• Ph.D in Pharmaceutical Biosciences and M.Sc in Molecular Biotechnology Engineering
• Post doc with Hoffman-La Roche providing modelling and simulation in support of a new β-lactamase inhibitor
• Research experience in pharmacometrics includes:
  • Clinical trial design
  • Population PK/PD modeling and simulation
  • Development of a framework for model based PK/PD modeling framework for antibiotic dose selection

• Ph.D in Pharmaceutics and M.Sc Pharmacy.
• Research experience in pharmacometrics includes
  • Population PK/PD modeling and simulation of chemotherapeutic drugs in pediatrics and adults.
  • Time-to-event modelling of composite and competing end-points.
  • Development of a PK/PD framework for design of trials evaluating optimal dosing in conditioning regimens prior to allogeneic cell transplantation.
  • Modelling immune reconstitution after allogeneic cell transplantation.
  • Communicating results to medical professionals without pharmacometric background.

• M.Sc. in electrical engineering from UCLouvain
• Experience as scientist at SGS Exprimo combining work in simulation projects and software development
  • Evaluation by simulation of dosing algorithms, clinical trial protocols, switching strategies between formulations, under-development drug performance vs standard of care, therapeutic drug monitoring strategy
  • Co-Developer of the clinical trial simulator Simulo, several Shiny applications and in-house R simulation frameworks
• Skills in IT administration

• B.Sc in Behavioral Sciences at Uppsala University
• Experience within administration, advertising and graphical design.

• 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

• PhD. in Bioengineering and Bioinformatics and M.Sc. in Bioengineering
• Experience as Modeling and Simulation scientist at Exprimo NV and as Clinical Pharmacology and Pharmacometrics scientist at Menarini:
  • Population PK/PD modelling and simulation (e.g. Oncology and Pain)
  • Mechanistic physiologically based modelling (PBPK), primarily applied to DDI predictions
  • Project team, internal decision and submission support
  • Experience with small and large molecules

• Ph.D. in Medicine and Therapeutics and M.Sc. in Clinical Pharmacy
• Joined Pfizer in 1994 with a responsibility to initiate and implement Population PK, which evolved to become Pharmacometrics.
• Spent 2003 working with Pfizer discovery colleagues to initiate, develop and formalize discovery based Pharmacometric activities and increase awareness of model informed methods.
• From 2005 on, led model informed drug development (MIDD) implementation across Pfizer, on behalf of Global Clinical Pharmacology. MIDD has been widely adopted to develop integrated analyses of relevant data to inform strategy, design and decision making in drug discovery and development. MIDD components have also been incorporated into global regulatory submissions for numerous Pfizer products.
• Became Global Head of Pharmacometrics, Vice President, and member of  Global Clinical Pharmacology Leadership Team in 2007. Responsible for managing, formalizing, coordinating internal and outsourced MIDD activities for Global Clinical Pharmacology across Pfizer enterprise. Responsible for 40 ±5 FTEs located at sites in the USA, EU and Asia. Responsible for budget supporting outsourcing and academic interactions.
• Has collaborated extensively with discipline experts within Pfizer and across the Pharmaceutical Industry as a whole (including Regulatory Agency staff). Has supported and maintained collaborations with academics from leading centres worldwide (over 40 PhD and/or Postdocs).  Areas of collaboration include Pharmacometrics (MIDD), Pharmacokinetics, Pharmacoeconomics, Statistics, Clinical , Pre-Clinical Pharmacology and Drug Safety.
• Provided broader Clinical Pharmacology support for compounds in drug discovery and development (A&R, Gastrointestinal, Cardiovascular, Neuroscience, Sexual Health, anti-viral) necessitating frequent compound/product related visits to Health Authorities.

• PhD in Clinical and Basic Immunology and M.Sc in Medical Biotechnology
• Trained medical writer and editor with, among others, two multidisciplinary EMWA
  foundation certificates in medical writing
• Over 7 years of experience working as a freelance medical writer, editor and copyeditor across multiple therapeutic areas

• Ph.D in Pharmaceutical Sciences and a M.Sc in Pharmacy
• Research experience in pharmacometrics includes:
  • Population PKPD modeling and simulation with a focus in oncology (chemotherapy and cancer immunotherapy)
  • Modeling adverse events, e.g. chemotherapy induced myelosuppression and febrile nutropenia
  • Modeling changes in tumor size and circulating biomarkers and overall survival

• 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

Long experience in retail business, including positions as

• Store manager
• Administrative and security 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

• 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

• B. Sc. Management in Medical Technology from Stockholms Universitet
• Long experience in medical technology, including positions as:
  • Public procurement of medical technology equipment.
  • Product specialist in various medical technology specialties.

• PhD in Pharmaceutical Biosciences.
• Experience in molecular modeling for drug discovery at Orion.
• Experience in using machine learning techniques for ADMET property modeling ( AstraZeneca).
• Discovery and development of proteochemometrics (Uppsala university).

• PhD in biochemistry
• Experience in software development
• Experience in design and administration of HPC clusters
• Certified Linux system administrator

• PhD. in pharmacometrics
• Research experience in pharmacometrics includes:
  • Population PKPD modelling and simulation
  • Special interest in kinetic-pharmacodynamic modelling (modelling PD endpoint in absence of PK data) and joint modelling (modelling multiple PK and/or PD endpoints simultaneously)
  • Quantitative systems pharmacology

• 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

• Ph.D. in Medical Science and M.Sc. in Medical Biosciences
• Research experience includes:
  Biostatistics and bioinformatic analysis of clinical cohorts
• Linear regression modeling of large datasets
• Therapeutic areas include rheumatology, multiple sclerosis, and gastroenterology
• Experience in drug development and production from Roche and GE Healthcare

• Ph.D. in Medical Sciences, M.Sc. in Pharmaceutical Sciences
• Experience as Managing Director of SGS Exprimo, Senior Pharmacometrician and Section Director at AstraZeneca, and Modelling and simulation Expert at Ferring Pharmaceuticals
  • Experience in when and how to apply pharmacometrics across different stages of clinical drug development, for influencing internal and regulatory decisions
  • Contribution to the filing of new drug applications, and experience with regulatory interactions
  • Project portfolio and team management
  • Therapeutic areas include infectious diseases, cardiovascular, respiratory, urology, oncology, intensive care, and reproductive health

• M.Sc. in Biotechnology Engineering from Uppsala University.
• Experience in software development.

• 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

• 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

• Computer Science studies at TU Dresden and HTW Dresden
• Brief work in webdesign for Eurojobcenter Dresden
• Training as an IT Specialist at TU Dortmund
• Work as a System Administrator at the IT Department of the TU Dortmund

• 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 and the link to personalized medicine
  • Was during 2012-2017  leading the modelling and simulation work within the European IMI funded consortium Predict-TB focusing on translation of pre-clinical to clinical of anti-tuberculosis drugs
• More than 20 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 tuberculosis, malaria, HIV, thrombosis/cardiovascular diseases, diabetes, insomnia, prostate cancer, hypertension, asthma and cortisol insufficiency

• Ph.D. in Pharmaceutics, M.Sc. in Pharmaceutical Sciences
• Associate Professor in Biopharmaceutics at the Department of Pharmacy, Uppsala University
• Post doc, absorption model development, at AstraZeneca, Mölndal, Sweden
• Long research experience of applying mechanistic physiologically based modelling in areas such as:
  • Pharmacokinetics (PBPK)
  • Biopharmaceutics (PBBP and Drug delivery)
  • Intestinal absorption (mechanistic absorption modelling)
  • Hepatic disposition (transporters and enzymes)
• Research in a wide scope of academic projects including supervision of Ph.D. students.
• Experience as an external biopharmaceutical consultant to drug development companies including in silico model based support.

• Ph.D. in Bioengineering and Bioinformatics and M.Sc. in Bioengineering
• Experience as Clinical Pharmacology and Pharmacometrics scientist at Menarini
  • Translational and clinical population PK/PD modeling (e.g. Oncology and Pain)
  • Experience with small and large molecules
  • Project team, internal decision and submission support

• PhD in Pharmaceutical Biosciences
• Research experience in pharmacometrics includes:
  • Population PK-PKPD modeling and simulation for clinical and semi-mechanistic tuberculosis models
  • Clinical trial simulations to aid decision-making and design of future studies
  • Time-to-event modelling including simultaneous analysis of continuous and time-to-event data
  • Development of a framework for model-based individualized dose optimization
  • Covariate modelling using the full random effects model (FREM) methodology

• B.Sc. in Pharmacy and M.Sc. in Biomedicine
• Experience as community pharmacist in several pharmacies
• Research assistant in cognitive neuroscience at Karolinska Institutet
• Pharmacovigilance experience from Sanofi Pasteur MSD and Novartis
• Monitor in clinical studies in the cardiovascular field at Uppsala Clinical Research Center

• MSc in Physical Education from State University Ghent, Belgium and various courses in pharmacokinetics, statistics, medical writing, pharmacometrics, ..
• Experience across the biometrics subdivisions since 1994, including positions as
  • scientist clinical pharmacokinetics and clinical data reviewer at Janssen
  • global biometrics manager early phase, project manager biometrics and data review coordinator at SGS
  • independent consultant in clinical pharmacology, quality control, medical writing and standardization since 2007
• Expert in quality control review, developer of methodology for quality control review of pharmacometrics projects, performed countless pharmacometrics QC-reviews since 2007
• Expertise in clinical pharmacology, medical writing, pharmacokinetics-related drug labeling, and as project leader for writing-related process improvement, standardization and harmonization