Virtualisation of drug development and clinical trials

The drug development process is time consuming, costly and risky, with most drugs entering pre-clinical, and even clinical, development failing to gain approval. Approaches that streamline the drug approval pipeline and reduce associated research and development costs are a priority. Alacris Theranostics offers a set of technologies that virtualise significant components of the drug development process, allowing multiple scenarios to be tested in silico in a rapid, safe and inexpensive manner. With its proprietary ModCellTM system, Alacris offers the possibility of implementing ‘virtual clinical trials’ to predict the efficacy of repurposed or novel drugs within patient groups. Based on your own (company) or publically available molecular profiling data sets (e.g. ICGC, TCGA), in tandem with available information on drug targets and approximate binding constants, in silico testing can be carried out at any stage of the drug development process from drug pre-synthesis to post-selection for clinical development.

Biomarkers

While virtual clinical trials are able to predict whether a non-stratified clinical trial of a new drug in specific patient populations will likely succeed or fail, the combination of deep molecular analysis and computer modelling will not, in the short term, fulfil the criteria required for drug approval by regulatory agencies. Alacris therefore offers Biomarker Identification services; the combination of model predictions and molecular profiling data enable identification of biomarker sets indicative of patients who are potentially responsive to specific drugs. Application of these biomarkers can then be used to stratify patients for inclusion within smaller, more rapid and cheaper clinical trials, expediting both the repurposing of available drugs and approval of new drugs.

Beyond Oncology

Although the core activities of Alacris are currently focused on oncology, due to a range of factors such as sample availability, the rich cancer research knowledge base, and the dramatic, often easily interpretable changes in the genome, transcriptome or proteome of the cancer cell, Alacris’ technologies have a broad range of application and can be translated to other areas of medicine and prevention. We are increasingly active in research areas outside of oncology and would be happy to discuss your project needs.


Applications in Personalised Cancer treatment and Cancer Drug development

With its proprietary ModCell™ system, Alacris Theranostics applies a new, revolutionary systems biology modelling approach to better match patients to therapies and therapies to patients. ModCell™ generates a “Virtual Patient” model for individualised prediction of therapy outcome through the integration of next generation sequencing derived genome and transcriptome information with a generic cancer model of molecular processes in tumour onset and progression.

ModCell™ – a unique approach

ModCell™ combines complex information on signalling pathways, as well as functional, kinetic and drug data from scientific literature and databases to predict drug response. The information can be represented in a network, including cross talk, to provide insight into functional relationships. Using ModCell™, complex genome, transcriptome, and other omics data derived from a patient tumour can be integrated into the network enabling prediction of tumour specific responses to targeted drug treatment. Rather than testing novel therapeutic strategies on actual patients, with the associated risks to their health and well being, at Alacris Theranostics we use computer models based on millions of data points to carry out virtual patient modelling and virtual clinical trials.


Alacris Theranostics’ services for the Pharmaceutical industry:

In ‘virtual clinical trials’ ModCellTM facilitates application for pharmaceutical industry virtualizing (i) the testing of single drug response on large patient groups, e.g. for clinical trials for drug approval or for the identification of patient cohorts including biomarkers for companion diagnostics, (ii) the testing of combinatory drug response on large patient groups, e.g. for clinical trials for drug approval or for the identification of patient cohorts including biomarkers for companion diagnostics, (iii) the repurposing (repositioning) of drugs from other disease indications for the treatment of cancer and (iv) the rescuing of drugs that failed in stage II and III of clinical trials because of low efficiency rates rather than non tolerable side effects for the patients. Such drugs can be approved for particular (responding) patient groups.

Facilitating cancer drug development and approval
  • Accompanying early drug development for identification of individual responder groups by utilising public or company provided datasets
  • Supporting product life cycle management by identification of new indications for approved drugs using in silico modelling
  • Identification of optimal drug combinations for specific patient cohorts
  • Rescuing of drugs which fail in phase II / III clinical trials due to low response rates
  • Enabling more rapid approval of drugs in targeted non-randomised trials

Single Response

Single Response

Combinatory Response

Combinatory Response

Repurposing

Repurposing

Rescuing

Rescuing


Personalised Cancer Treatment

  • Developing more targeted personalised treatment for cancer patients
  • Avoiding negative side effects
  • Reducing health costs for non-necessary treatments

Biomarker identification

  • Selection of patients or adequate biomarker sets to stratify patients for targeted clinical trials
  • Biomarker identification as companion diagnostics for personalised oncology

Next Generation Sequencing services

  • Full spectrum of Next Generation Sequencing applications on our Illumina HiSeq 2500 and Roche GS FLX+ sequencing platforms at any stage, from sample processing to data analysis
  • Integrated analysis tools for oncogenomics

ModCell Ergebnisse