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
Martin Bergstrand, Ph.D.
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.
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.
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
Agneta Franksson, M.Sc.
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).
Martin Fransson, Ph.D.
Consultant & Data Protection Officer
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
Prof. Lena Friberg, Ph.D.
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
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.
Quentin Leirens, M.Sc.
Associate Consultant & System Developer
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
Per Lundström, B.Sc.
B.Sc in Behavioral Sciences at Uppsala University
Experience within administration, advertising and graphical design.
Mats Magnusson, Ph.D.
Principal Consultant & Team Leader
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
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
Peter Milligan, Ph.D.
Chief Executive Officer
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.