Pharmetheus partners with biotech and pharmaceutical companies that develop medicines for patients with often life threatening diseases. Pharmetheus’ professional consultants use a fit-for-purpose approach to find the right strategy to address its clients needs.
“At Pharmetheus we strive to understand the context and the challenges at hand to tailor the service to meet the client’s needs. It might be a complex problem requiring a complex solution, a simple problem with a simple solution, or anything in between. Today, we are able to help our clients with most quantitative questions in all phases of drug development.”, says Elodie Plan, Principal Consultant and Team Leader at Pharmetheus.
Strategic level services
In the ten years since its establishment, Pharmetheus’ service offering has broadened and deepened while keeping pharmacometrics analyses at its core. Pharmetheus now provides strategic services with consultants working as embedded scientists in client projects as well as offering courses in all its areas of expertise.
“We have been partnering with a number of companies with the embedded scientist model we implemented a few years back, and we have also started offering workshops. We are also going above and beyond pharmacometrics, while leveraging it, with an emphasis on model informed drug development, and an extension to more mechanistic approaches, such as physiologically based pharmacokinetics and quantitative systems pharmacology.”, says Elodie Plan.
Physiologically based pharmacokinetic (PBPK) and quantitative systems pharmacology (QSP) are extensions of pharmacometrics. PBPK-QSP models allow for simulation and prediction beyond the immediate observations and can describe the dynamic interaction between biological systems and drugs by integrating biological information to test a hypothesis. This helps address questions around drug-drug interactions and pediatric programs, for example.
Going ‘in silico’ instead or ahead of ‘in vivo’
Elodie explains that some of the biggest trends in pharmacometrics are the emphasis on communication, making the field more accessible to outsiders, and the ongoing digital revolution. Pharmetheus has taken significant steps to engage in both these trends by offering communication training to their staff and developing digital tools that can support the prediction of different scenarios. The company is also analyzing how artificial intelligence can be integrated in the company’s toolbox.
Another trend relates to new modalities of treatment. There are drugs being developed with better modes of delivery of biologics into human cells and therefore better targeted, often used in cancer treatment, an area where Pharmetheus’ ‘in silico’ models – the Latin term for inside a computer – can contribute.
“It really feels like immuno-oncology is a field that will help us cure cancer soon and quantitative approaches like modeling can facilitate increasing the understanding around key questions, by making different hypotheses and assumptions, and thereby support decisions on level and timing of dose”, says Elodie Plan.
Developing new methods
As drug development is determined by regulatory frameworks, Pharmetheus has to be up to date and even anticipate new regulations from agencies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Marylore Chenel, Principal Consultant and Team Leader, explains how Pharmetheus ensures that the company’s analyses, reports, and advice are in line with all relevant guidelines.
“We are not limiting ourselves to reading new guidelines, we are also eager to actively contribute to them by developing new methods, writing opinion papers and commenting on new draft guidelines. We participate in workshops to be part of the dialogue between authorities and the industry on how MIDD can be best applied”, she says. As soon as new guidelines are published, the team at Pharmetheus ensures that all consultants who go through regular training are fully updated. This means Pharmetheus is able to adopt new methodologies to address client needs and can develop tools to be compliant with new guidelines. The responsibility for this work falls to R&D and the scientific leads of each of Pharmetheus’ areas of expertise.
“Our R&D is developing ways of working and tools for our consultants so that we can ensure reproducibility, that is high quality in our service delivery independent of the consultant doing the job. It’s a way for us to be effective and efficient. Sometimes we are supporting development of drugs for a life-threatening disease, so time is of essence” says Marylore Chenel.
Pharmetheus’ effective service delivery is also a product of the company’s unique, reproducible analysis and reporting environment that can easily update a report if new data becomes available or if an issue is identified in the quality control process. This system for submission-ready reports has also been very well received by regulatory agencies.
- Pharmetheus offers model informed drug development (MIDD) services to make drug development more efficient and safer. This includes trial design and analysis, program strategies, special populations, special considerations, or regulatory interactions.
- Pharmetheus services include expert advice, fit-for-purpose reports, embedded scientists, training courses, and scientific publications. All within the company’s three approaches Pharmacometrics, MIDD strategies and PBPK-QSP.
- The company’s consultants all have PhDs in Pharmacometrics, Pharmaceutical Biosciences, Clinical Pharmacy or other relevant scientific fields.