Common questions. Clear answers.

inSilics offers computational simulation of one or more treatments in one or more patient populations. Each project combines the analysis modules that best address the client's questions.

A study can explain mechanisms of action, compare treatments, explore differences in response, characterise higher and lower responders, investigate safety, identify biomarkers and prioritise targets, pathways or new indications. It produces scientific evidence to support research, development, medical and medical marketing decisions.

We can work in any therapeutic area where the disease biology and the treatment's molecular effects can be defined. This includes marketed treatments and those in development, small molecules, biologics, monotherapies, combinations and other interventions with known targets or mechanisms.

Within one project, we can compare drugs, doses, dosing schedules, administration routes, combinations, comparators and populations defined by molecular, clinical or demographic criteria. The platform can be adapted and extended to represent the specific scenario the client wants to study.

We simulate treatments in individual molecular models built from real human data. This goes beyond statistically combining published results in a meta-analysis.

Scientific and clinical evidence defines disease alterations, population characteristics and study constraints. We then simulate treatment in each virtual patient and analyse individual responses and overall cohort behaviour. This reveals heterogeneity, subpopulations and mechanisms that an average result can conceal.

Our in-house repository is built from human molecular studies available through NCBI Gene Expression Omnibus (GEO). For each project, we select data and profiles that best represent the disease, tissue and population of interest.

We can also incorporate data from clients, hospitals, universities, researchers or specialist repositories. This can include molecular and clinical information such as transcriptomics, proteomics, biomarkers, diagnoses, endpoints, demographics, exposure, dose, response and comorbidities. Aggregate clinical data can also be used to reproduce their proportions in individual virtual patient populations.

Client information becomes part of the study assumptions and constraints, making the project more tailored and relevant. When additional specialist data are needed, we can work with experts in their collection and interpretation.

Simulation is possible even for rare diseases or when patient data are limited. We start with human molecular profiles and reproduce known disease alterations, such as activation, inhibition or loss of function in specific proteins or pathways.

Each virtual patient is checked against the agreed molecular and clinical criteria. Patients that reproduce the expected phenotype can join the population and receive the treatment virtually.

We usually work with cohorts of 500 to 1,000 virtual patients. Where the design requires it, we can expand each cohort to a few thousand and generate subpopulations with specific characteristics to compare response scenarios.

An idea, a need or a list of questions about a disease, treatment or population is enough to start. We can guide the project whether or not the client has their own data or modelling expertise.

At the first meeting, we help define the primary and secondary objectives, the questions to answer and the claims requiring scientific support. We also agree on treatments, comparators, populations, assumptions, analysis modules, collaborators, timelines and deliverables.

We incorporate the client's data, hypotheses or internal knowledge as study constraints. This aligns the project with their scientific, medical and strategic needs from the outset.

inSilics manages the full process: cohort preparation, treatment and scenario configuration, simulation, analysis, scientific interpretation and deliverables. The client has one point of contact with experience in pharmaceutical projects.

Depending on the study, the team can include physicians, molecular biologists, bioinformaticians, machine learning specialists and clinical research experts. We also collaborate with universities, hospitals and European specialists in specific therapeutic areas.

Clients choose their level of involvement. They can delegate the full project or contribute to design, reviews, interpretation and scientific communication, including co-authorship where appropriate. AI supports specific tasks. Human specialists perform or review the scientific design, interpretation and final writing.

As a guide, a standard project can be completed in around three months from acceptance to the final presentation. We agree on the timeline with the client, considering the questions, selected modules, available data and collaborators.

Each project includes an initial planning meeting and a final presentation. Progress meetings, scientific reviews or sessions with medical and marketing teams can be arranged where useful.

Questions that arise during or after the study can become additional scenarios, modules or follow-on projects. This builds on the populations, models and knowledge already developed and progressively extends the value of the initial work.

The client receives a PowerPoint presentation and a report tailored to the agreed scope. These include results, conclusions, materials and methods, study assumptions and the information needed to interpret and use the findings.

Depending on the communication strategy, we can also prepare papers, posters, oral conference presentations, internal or specialist presentations, training materials, tables, appendices and specific scientific documentation. We can present results directly or prepare and train the teams who will communicate them.

Analyses and deliverables are agreed before the project starts. Internal analyses used to ensure sound execution can be included in the final materials when they add value and fall within the agreed scope.

We check data quality, consistency of assumptions, disease representation and results across patients, populations and scenarios. The workflow is reproducible, and each relevant result undergoes technical and scientific review.

Traceability connects treatment targets to biological pathways, molecular effectors, and individual and population outcomes. Sources, criteria, constraints, methods and analytical decisions are documented in the report.

We assess robustness by comparing individuals, cohorts, models and scenarios. Relevant molecular, experimental or clinical evidence helps contextualise and strengthen conclusions. We can also design further validation using data from clients, hospitals, universities or clinical specialists.

Results can be prepared as complementary evidence to support, contextualise and strengthen the project's wider evidence base. They can also contribute to scientific supporting materials for interactions or communications with the FDA and EMA.

The harmonised ICH M15 guideline sets out principles for planning, evaluating and documenting modelling evidence in drug development. For projects with this purpose, we can extend the analysis, traceability and documentation to suit the intended context of use and the client's regulatory strategy.

Read FDA ICH M15 · Read EMA ICH M15

The client receives and can use the data, results and deliverables generated within the contracted scope, under the project terms. These can support internal activities and agreed communications, publications or materials.

The source code, platform, algorithms, workflows and previously developed methods remain protected inSilics technology. Clients receive the results and documentation needed to use them, while the source code remains with inSilics.

Confidential information is used only to carry out the project and is managed under the agreed confidentiality terms. Client data and results are reused, displayed or published only with their express permission.

Results can guide research and development, support medical and marketing strategy, generate hypotheses, inform study design, support claims, select biomarkers, prioritise populations and prepare the next experimental, clinical or regulatory steps.

They can also become publications, posters, conference presentations, training materials, internal communications or specialist content. We adapt the format and level of detail to each audience to make the findings useful.

Support can continue after delivery through interpretation sessions, expert meetings, training, presentations, papers or posters, participation in scientific or regulatory meetings, and extended analyses. The aim is to help clients gain the greatest scientific and strategic value from their investment.