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

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.

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

Our Communications

Latest news from Pharmetheus

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.

Welcome Ola Caster!

We are happy to welcome Ola Caster in our growing enabler team. Ola comes most recently from a position as a Senior Researcher at the Uppsala Monitoring Centre, where he worked primarily with methods for adverse effect detection and benefit-risk assessment in the post-marketing setting. He has more than ten years of experience from research in statistics and data science, including a PhD in Computer and Systems Sciences. See Ola's bio here.

Welcome Marie Karlsson!

The Pharmetheus team has recently been strengthened by our first dedicated Project Coordinator, Marie Karlsson. Marie has long prior experience in monitoring data processing and project management in software development. See Marie's bio here. Welcome!

ACoP in Orlando

Come meet us at ACoP in Orlando next week. Drop by our booth to discuss model informed drug development with our experts and leaders. There are still opportunities for free speed consulting, should you want input to your strategic or hands-on work.

Speed consulting at ACop 2019

This year, during the ACOP Meeting in Orlando, Pharmetheus will offer professional pharmacometric consulting sessions (~30 min), free of charge. Talk to us about Pharmacometrics, PBPK, Regulatory strategy, MIDD strategy, and much more! These sessions are open to everyone and independent of any current or future plans to use our services.

Mats Karlsson awarded BCPT Nordic Prize 2019

Congratulations to our Advisor and Chairman of the Board, Prof. Mats Karlsson, who has been awarded the BCPT Nordic Prize 2019 for his deeds in the field of pharmacometrics, which has been of great importance for both science and education.

Welcome Ari Brekkan and Antonio Klaric!

Pharmetheus continues to grow and we are very happy to announce the arrival of two new team members, Ari Brekkan, MIDD consultant, and Antonio Klaric, System administrator. Ari recently defended his PhD thesis at Uppsala University. His work focused on the application and use of pharmacometric models in the development of biological medicinal products. Antonio has experience in a variety

Welcome Qing Xi!

A new talent joined our experienced team! We're excited to announce that Qing Xi, working more recently at the University of Otago, New Zealand, started at Pharmetheus.

Page 2019 in Stockholm!

Pharmetheus is at PAGE 2019 in Stockholm! We look forward to seeing you at booth no. 19-20.

A warm welcome to Robin Svensson

A warm welcome to Robin Svensson, joining our MIDD consultants team! Robin recently graduated from Uppsala University with an important thesis work on how pharmacometrics can be used to improve decision-making for development and use of drugs against tuberculosis.

Pharmetheus is very happy to announce the addition of two new consultants to our growing team.

Enrica Mezzalana joins us from Exprimo. Enrica has a PhD in Bioengineering and Bioinformatics and has been working for >5years as a pharmacometrician to support model informed drug development both in industry and in consultancy.

Pharmetheus is delighted to announce the appointment of Richard J Anziano as Chief Statistician.

Rich was formerly Global Head of Statistics and Chief Statistician for Pfizer Inc. with responsibility for approximately 250 statisticians. In that role he led the quantitative assessment of late stage probabilities of technical and regulatory success through modeling and simulation for late-stage assets compared to industry/therapeutic area benchmarks. He was a long standing member of the cross PhRMA statistics group.

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.
Senior Consultant
Board Member
Principal Consultant, Chief Statistician
Principal Consultant, Board Member
Senior Consultant
Consultant
Associate Consultant
Associate Consultant, Data Programmer
Board Member
Associate Consultant, Data Programmer
Senior Consultant
Associate Consultant, Data Programmer
Senior Consultant
Consultant, Systems Development
System Administrator
Associate Consultant
Principal Consultant
Senior Consultant
Senior Consultant
Project Coordinator
Board Chair, Advisor
Analyst Consultant, System Administrator
Administrative Assistant
Principal Consultant
Senior Consultant
Chief Executive Officer
Consultant
Principal Consultant
Administrative Assistant
Senior Consultant, IT Manager
Principal Consultant, Board Member
Contract Manager
Associate Consultant, Data Programmer
Associate Consultant
Senior Consultant
Senior Consultant
Analyst Consultant, Systems Developer
Chief Operations Officer, Deputy CEO

Request our services

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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.