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.

COVID-19 Update

April 2, 2020

Pharmetheus closely monitors the developing COVID-19 pandemic. We are continuing to run our operations largely as normal with close to full capacity. For some time now we have taken measures to ensure the safety and health of our employees and collaborators. These measures have included restrictive travel policies, enabling remote working and the provision of regular updates on our measures taken as a result of the dynamic and emerging situation. We remain fully committed to deliver and satisfy the needs of our clients – thank you for your continued partnership.

June 26, 2020

The majority of the Pharmetheus staff will continue working from home during the summer period. A new decision on continued travel restrictions will be taken in September.
Thank you for your collaboration!

Stay safe,
Peter Milligan, CEO
Marie Sandström, COO
On behalf of the Pharmetheus Team

Our Communications

Latest news from Pharmetheus

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. 

PBPK training at WCoP2020

Please note that WCoP2020 and this workshop has been postponed due to the international COVID-19 outbreak. More information available at the WCoP official home page.

Going to WCoP 2020 in Cape Town?

Join the 1-day hands-on workshop "Open source PBPK modelling with the OSPSuite (PK-Sim® & MoBi®) for MIDD" hosted by Pharmetheus and Pharmacometrics Africa.

Read more and register here.
Register soon, only limited seats available!

Welcome Marie Olsson!

We are feeling grateful! Marie Olsson has joined our Finance and Admin team as Administrative Assistant. She has long experience of administration and stores management, in leading positions. She will help bring further structure and make our daily operations even more effective. See her bio here.

Welcome Siv Jönsson!

It is with great pleasure that we welcome Siv Jönsson to our team! Siv has been working in the pharmacokinetic, pharmacodynamic and pharmacometric areas in the pharmaceutical industry for a total of 5 years (Kabi Pharmacia, AstraZeneca), as a regulatory assessor at the Swedish Medical Products Agency for 9 years, and spent +10 years in academia as a senior lecturer and researcher dealing with methodological and applied pharmacometric projects. See her bio here.

We are active in the biosimilar area

Mechanism based pharmacometric analysis can be a powerful tool in the development of biosimilar drugs. Pharmetheus recently supported a client with evaluating the impact of study design and expected product differences on the power to demonstrate PK and PD similarity. Find out more in a recent paper by Ari Brekkan et al. AAPS J. 2019 Jul 8;21(5):85.

Welcome Ida Netterberg!

We are glad to announce that Ida Netterberg (MIDD consultant) is returning to Pharmetheus after recently defending her PhD thesis at Uppsala University. Ida’s thesis focused on pharmacometric evaluation of biomarkers to improve treatment in oncology. See Ida's bio here.

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
Principal Consultant, MIDD. Board Member.
Senior Consultant, MIDD
Consultant, MIDD
Associate Consultant, System Developer
Associate Consultant, Data Programmer
Board Member
Consultant, MIDD
Associate Consultant, Data Programmer
Advisor
Senior Consultant, MIDD
Associate Consultant, Data Programmer. Data Programming Manager.
Senior Consultant, MIDD
Consultant, System Developer
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
Administrative Assistant
Principal Consultant, MIDD
Senior 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.