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.

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 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.

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.

Our Communications

Latest news from Pharmetheus

Learning

July 20, 2021

We are currently refining and developing our internal training course curriculum for the remainder of 2021 into 2022. We can also reflect upon the courses delivered during the first half of 2021. What a pleasure it was to learn from our PBPK experts as they reprised the workshop they offered to FDA. Our newcomers in particular appreciated the broadening of their awareness of, and skill set in, a highly complementary quantitative approach.

Read more about our training programs here. See the previous post on PK-Sim/MoBi workshop at the FDA here.

Services

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

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.

Our team

Pharmetheus consultants and advisors present a unique collection of experiences and combination of skill sets.