For Clients

For Biotechnology Companies

The first decisions during the initial stages of drug development are the most critical ones; they determine the therapeutic potential, value and success of a compound. We can provide support from the earliest stage starting with target feasibility assessment, compound format selection and design:

Discovery phase:

  • Do you need to assess how your compound translates to human PK/PD? First projections can often be done with published data. It will give you the confidence to invest in the right idea.
  • Are you evaluating different targets in a pathway and need to select them? We can assess target selection based on kinetics.

Preclinical stage:

  • Do you need to select the best candidate that can stand out against competitors? We can help you design preclinical studies that help you with candidate selection early on in the process, and help you understand and interpret the results of your studies. This includes dose selection and dosing schedule setting for your preclinical studies. We can help you improve the design of animal studies to reduce cost and increase data quality.
  • Do you already have some preclinical and in vitro data, which gives you an initial understanding of the Mecahnism of Action (MoA) and a “feel” for your drug? We can help with human PK/PD translational models which will give you and your investors the confidence you need to carry on with the program. This will help you understand dose / exposure response relationship in preclinical species and how that scales to humans.
  • Are you observing Target Mediated Drug Disposition (TMDD)? We can do a risk assessment and provide mitigation strategies.

Clinical stage:

  • Are you considering moving into first in human studies? We can help you develop strategies for your phase I trial, by leveraging the understanding of your molecule gathered from the preclinical PKPD (exposure / response) relationship.
  • Do you already have a phase I trial running or completed, and want to know how to choose the optimal Recommended Phase II Dose (RP2D)? We can perform PKPD modeling and simulations using your clinical data to inform the Phase II study design or expansion cohorts of your Phase I trial. We can help you with appropriate selection of PK and relevant biomarkers time point selection, dose level and dosing schedules, using standard 3+3 or adaptive designs, with the ultimate aim of arriving at a study design that delivers the most value in the shortest amount of time and at the least expense for your company. 
  • Do you need preclinical, clinical, and non-clinical statistics expertise? We can help with statistical data analysis of your preclinical studies and clinical trials, power studies and more advanced techniques such as re-assessment at interim stages and futility for clinical trials, and with trial design at early-stage (phase I) and mid-stage (phase II). We can help you determine the right dose in sub-populations and identify and describe relationships between subjects’ physiologic characteristics and exposure or response (safety / efficacy). We also provide non-clinical statistics services such as bioequivalence testing etc.

For Pharmaceutical Companies

We provide support to the whole spectrum of questions related to PK/PD for small molecules, biologics and cell based therapies in preclinical and clinical development. In addition we provide:

  • Are you assessing a new opportunity with a biotech company with a novel mode of action? We help to integrate the data and provide an interpretation within a PK/PD, competition and early translation to human framework.
  • Do you have a health authority question or request on small molecule or biologics PK/PD and modelling? With our partner network we can rapidly address and resolve the issue by engaging the right group of experts.
  • Do you need preclinical, clinical, and non-clinical statistics expertise? We can help with statistical data analysis of your preclinical studies and clinical trials, power studies and more advanced techniques such as re-assessment at interim stages and futility for clinical trials, and with trial design at early-stage (phase I) and mid-stage (phase II). We can help you determine the right dose in sub-populations and identify and describe relationships between subjects’ physiologic characteristics and exposure or response (safety / efficacy). We also provide non-clinical statistics services such as bioequivalence testing etc.

For Hospitals

We help hospitals to analyze the data collected from their patients to optimise therapies and to advance the understanding of biologics and the pathology they interact with.

  • Have you collected patient pharmacokinetics data and need to link it to other readouts?
  • Do you want to understand non-responders?
  • Do you want to investigate alternative dose regimens?

We can offer you our in-depth expertise in small molecule and biologics therapies, we can help to analysis your data, and we can help to design efficient studies. We can be your analytical partner to complement your clinical expertise.