© 2018 by Pharmaeconomica. 

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What We Do

Services

Biosimulation services
Health Economics and Outcome Research (HEOR) and Market Access

We are a team of experts providing custom model driven value based solutions in drug discovery and clinical development.

 

We bring along a unique blend of experimental research experience wrapped around a mathematical modelling framework. Our solutions enable your research projects the power of early human pharmacokinetic or PKPD based simulations, dynamic model based simulation of drug interaction, clinical trial or process optimisation strategies along with a health economic perspective.

Our strong expertise in Physiological pharmacokinetic modelling (PBPK) provides you a wide range of possibilities to speed up your research by making informed decisions or create better clinical designs. These solutions provide significant cost advantages as well as allowing early regulatory acceptance of your research. Regulatory agencies already acknowledge PBPK based mechanistic model driven assessments as a valid methods for crucial decisions in areas like dose selection, evaluation of interaction potential with deciding on the optimum number of studies or study waivers, as well as studies in special populations etc.

 

PBPK based models incorporate the standard experimental data (physicochemical, in-vitro ADME) available with research teams on their molecules with human physiological parameters allowing simulation of human plasma and tissue profiles at dose ranges well ahead of performing clinical studies.

Being mechanistic in design the models are also flexible and can be enhanced as more information becomes available. This opens up a spectrum of possibilities.

 

For a discovery or Pre-IND stages:

 

  • Simulation of plasma and tissue profiles using physicochemical and ADME data in human or pre-clinical species.

  • PKPD modelling and simulation o f human efficacy concentrations

  • Comparison of various lead compounds using their PBPK based human simulation profiles allowing selection of clinical candidate.

  • Comparison with existing SOC or drugs with available clinical or experimental data to identity strategic advantages in safety, dosing regimen, interaction potential or cost of development.

  • Selection of appropriate biopharmaceutical properties to optimise formulation using PBPK based absorption modelling.

  • Support evaluation of new hypothesis or repurposing strategies.

 

For Clinical development stages:

 

  • Selection of doses and dosing regimen for clinical trials based on PBPK simulations and regulatory toxicology findings.

  • Evaluation of drug interaction potential with investigational  drug as a substrate, inhibitor or inducer of metabolising enzymes or transporters

  • Population based simulations to assess the variability across a range of population based physiological characteristics (polymorphism, renal clearance etc.)

  • Simulations in special populations (renal and hepatic impairment. Paediatric)

We help your organization develop a comprehensive and effective Market Access Strategy in order to identify, document and demonstrate product´s value to meet payer demands and secure reimbursement and access to hospital formulary.

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We integrate an early health economic perspective to your research programs to help set priorities, define data collection requirements, and establish necessary performance criteria in terms of:

  • Adding economic viability as a criterion when selecting among development candidates

  • Establishing what data are required to support an economic value argument

  • Establishing what efficacy, adverse event profile, and price are required for an economically viable drug

 

Our services include:

  • Systematic literature review including meta-analysis and indirect comparisons

  • Targeted, strategic literature focused reviews and searches.

  • Development of product value propositions and value messages.

  • Global Value Dossier (GVD).

  • Global and country-specific dossier preparation and adaptation.

  • Reimbursement strategy development.

  • HEOR Landscape reports (disease & epidemiology; HTA; treatment; economic)

  • Health economic evaluations including cost of illness, cost-minimization, cost-effectiveness, cost utility and budget impact analysis.

  • Pricing implementation dossiers.