Pharmetheus: Advancing model informed drug development

Demands from payors and regulators for differentiated products necessitates creative integration of available data/information, with future trial data, to accelerate drug development in an efficient, cost effective and ethical manner.
Pharmetheus
  • Has expertise in model informed drug development (MIDD) to support and inform study and program strategies and decisions.
  • Has a track record of efficient delivery of fit for purpose solutions, including complex situations.
  • Has access to a broad range of complementary drug research and development disciplines (including pharmacometrics, clinical pharmacology, statistics and regulatory) and academic subject matter experts.

Pharmetheus: transforming quality science to informed decisions

Drug development moves at a swift pace in an ever-changing competitive landscape and project teams are constantly facing new challenges, demanding a flexible proactive and adaptive mindset.
Pharmetheus
  • Offers a broad range of fit for purpose analytical solutions, including data programming, across all phases of research and development (incorporating submission and post approval activities).
  • Has a broad resource pool to accommodate varying needs, including modeling, training, interaction with regulatory bodies, expert advice and full-time equivalent support.
  • Has experience of, and expertise in, a wide range of therapeutic areas.

Pharmetheus: when efficiency meets quality

Scientific rigor, quality, compliance and traceability are cornerstones in clinical drug development and regulatory submissions. This requires reliable technical solutions and experience to efficiently leverage MIDD in these settings.
Pharmetheus
  • Has robust processes for reproducibility and documentation of analysis results.
  • Has considerable experience of delivering submission ready reports.
  • Has independent quality control (QC) to monitor and check on our deliverables.

Pharmetheus offers consulting services focused on the application of quantitative approaches to support drug development decisions.

Our Communications

Latest news from Pharmetheus

COVID-19 impact


Pharmetheus continues to monitor the challenges presented by the COVID-19 pandemic and its effects on our company and in the field of clinical drug development. Read more about our approach and latest updates here.

We are hiring!

Pharmetheus is looking for a Quality Control - Medical Writer Consultant to support our team. Read more here here.

Welcome Quentin Leirens!

We are happy to have Quentin onboard in our Enabling team. Previously he was as a scientist at SGS Exprimo (2011-2020). His research experience includes model-based simulations for supporting drug development decision making, many of which have been submission projects. He has been extensively involved in the development of the Simulo software for clinical trial simulation. Quentin will work from his home office in Belgium. See his bio here.

Welcome Anaïs Glatard!

We are happy to have Anaïs onboard as a MIDD consultant. Her research experience (from academic groups as well as pharmaceutical companies) includes PK/PD modeling, simulations and dosing individualization. Anaïs will work from our Uppsala office in Sweden. See her bio here.

Benefits with modeling circulating tumor cell counts as a predictor of overall survival

We would like to bring everyone's attention to a recent publication highlighting the benefits of an innovative quantitative modeling framework. The framework uses circulating tumor cell counts as a predictor of overall survival in metastatic colorectal cancer. Dr. Ida Neldemo (previously Netterberg), main author of the publication, conducted this work before joining Pharmetheus, during her PhD under the supervision of Pharmetheus’ advisors Prof. Mats Karlsson and Prof. Lena Friberg. Find the article here.

Pharmetheus stands ready to apply the principles of this publication to our client’s drug development program.

Welcome Ninni Sylenius!

We continue to expand our team with Medical Writers/Quality Control Reviewers. Ninni Sylenius has been working with clinical studies in the cardiovascular field at Uppsala Clinical Research Center, and previously with pharmacovigilance at Novartis and Sanofi Pasteur MSD. She also has experience as a research assistant in cognitive neuroscience and as a community pharmacist. Ninni is based in Stockholm, Sweden.

Welcome Viviana Moroso!

We continue to expand our team with Medical Writers/Quality Control Reviewers. Viviana has been working as a freelance medical writer and editor in several clinical fields. Her previous research experience includes database genotype analysis and in vitro work in the field of Immunology of liver transplantation. Viviana is based in Luleå, Sweden.

Welcome Mikael Ringh!

We expand our team with Medical Writers/Quality Control Reviewers. Mikael’s research experience includes bioinformatics and biostatistics, applied in autoimmune diseases and CNS disorders. He has previous experience in drug development and production at Roche and GE Healthcare. Mikael is based in Rennes, France. See Mikael's bio here.

Pharmetheus presence at ISTH 2020 congress

Pharmetheus colleagues are co-authors to 4 abstracts to be presented at the virtual International Society on Thrombosis and Haemostasis Congress 12-14 July 2020.

Read more about our support to drug development of a recombinant von Willebrand factor in patients with severe von Willebrand disease (abstract numbers PB1541 and PB1544) and of dabigatran in children with venous thromboembolism (abstract numbers PB1271 and PB1272): https://www.isth2020.org/abstracts

New service: Quantitative Systems Pharmacology (QSP)

Physiologically based pharmacokinetic (PBPK) modelling is a technique to predict drug concentration at the site of pharmacological action. It appears natural to combine PBPK models with quantitative systems pharmacology (QSP) models to get a mechanistic understanding of the PK/PD relationship(s) of the drug in patients.

PBPK-QSP models build on prior knowledge, including (patho-)physiology and pharmacology. The independent representations of drug and system parameters allow for extrapolation to scenarios beyond observation. The methodology can enhance drug development programs by informing biomarker strategies and early prediction of clinical outcome. Read more about PBPK-QSP here.

Congratulations Prof. Andrew Hooker!

We would like to congratulate our advisor Andrew Hooker (see bio) on his new position as a Professor of Pharmacometrics at Uppsala University. Andrew was part of founding Pharmetheus in 2012 and regularly contributes valuable expert advice on topics such as optimization of study design and pharmacometrics methodology. Congratulations, Andy!

Welcome Henrik Hellerstedt!

We are happy to welcome Henrik Hellerstedt in our growing IT team. Henrik has worked as a senior IT consultant and has experience as an IT manager in both public and large private entities. Henrik will be working as an IT system administrator and will be based in the Uppsala Office. Glad to have you onboard, Henrik!

Covid-19 Pharmacology Resource

We have now joined the COVID-19 Pharmacology Resource Center. Conquering COVID-19 with clinical pharmacology, innovation, and collaboration.

More information available at the Covid-19 Pharmacology Resource web page

Pharmetheus Approach to COVID-19 related challenges in clinical trial conduct

Pharmetheus is currently working with a number of clients to address the impact of the current COVID-19 epidemic to their ongoing clinical drug development programs. We would like to share our high level approach with the community at large. We see the current situation as both a challenge to our industry/sector but also an opportunity for appropriate and quantitative approaches to mitigate upon these challenges. We believe there are "fit for purpose" options for a broad range of plausible scenarios in clinical trial conduct that have emerged or could emerge.

See our approach

Welcome Julie Janssen and Anna Pousette!

We are very happy to welcome two new team members, Julie Janssen, MIDD consultant, and Anna Pousette, Contracts Manager. Julie's research experience includes the application of pharmacometrics in the clinical setting, chemotherapy and targeted therapies, as well as special patient populations (e.g. pediatrics and pregnancy). Julie is based in the Netherlands. See Julie's bio here. Anna has long experience of project coordination and procurement. Anna will work from our Uppsala office in Sweden. See Anna's bio here.

Open Systems Pharmacology publication

As active and enthusiastic members of the Open Systems Pharmacology (OSP) management team and provider of PBPK-QSP services, we would like to guide your attention to this recent publication, in CPT: Pharmacometrics & Systems Pharmacology, summarizing the principal ideas, organization and functionalities of the OSP platforms (PK-Sim/MoBi) and community. 

Services

Our services include quantitative analyses by scientists with extensive therapeutic area experience industry, academic and regularly settings.

Our team

Pharmetheus consultants and advisors present a unique collection of experiences and combination of skill sets.
Consultant, MIDD
Senior Consultant, MIDD
Board Member
Principal Consultant, Chief Statistician, MIDD
Principal Consultant, MIDD. Board Member.
Senior Consultant, MIDD
Consultant, MIDD
Associate Consultant, System Developer, MIDD
Associate Consultant, Data Programmer
Board Member
Consultant, MIDD
Associate Consultant, Data Programmer
Advisor
Senior Consultant, MIDD
Associate Consultant, Data Programmer. Data Programming Manager.
Associate Consultant, MIDD
Senior Consultant, MIDD
System Administrator
Consultant, MIDD
Associate Consultant, MIDD
Principal Consultant, MIDD
Senior Consultant, MIDD
Senior Consultant, MIDD
Project Coordinator
Board Chair, Advisor
Analyst Consultant, System Administrator
Consultant, MIDD
Consultant, MIDD
Associate Consultant, Systems Developer, MIDD
Administrative Assistant
Principal Consultant, MIDD
Consultant, MIDD
Chief Executive Officer
Quality Control Reviewer and Medical Writer
Consultant, MIDD
Principal Consultant, Enabler Leader
Administrative Assistant
Senior Consultant, IT Manager
Principal Consultant, MIDD. Board Member.
Contract Manager
Associate Consultant, Data Programmer
Associate Consultant, MIDD
Senior Consultant, MIDD
Quality Control Reviewer and Medical Writer

Request our services

If you are interested in our services, please fill out the form below.

How we work

Our way of working, with traceability and accountability from data programming to report delivery, is well adapted to, and highly compatible with, current regulatory requirements.