laboratory informatics Taking drug development into the In her series of profiles of bioinformatics companies,
Sophia Ktori looks at the work of biosimulation specialist, Certara
veryone is familiar with the notion of harnessing informatics tools to achieve the truly paperless office, but what about being able to exploit biosimulation and
modelling systems to reduce testing in patients during drug development? It may seem a distant prospect, but biosimulation specialist, Certara, is spearheading the drive both to virtualise much of drug development, and to facilitate the optimisation and personalisation of precision medicine at the point of care.
virtual world E
dosing, designs clinical trials, triages compounds, makes comparisons with competitor compounds, and assesses mechanistic drug performance,’ comments Ellen Leinfuss, chief marketing officer.
Virtualising drug R&D While computer-aided modelling and simulation technologies are now mainstream in many areas of industry, including the design of aeroplanes, trains, and automobiles, the use of mathematically based simulation technologies to model, explain, compare, contrast, and analyse biological processes and interventions is far more complex, says Dr Edmundo Muniz, Certara’s CEO. ‘Nevertheless, the virtualisation of multiple aspects of research and development through the application of in silico methodologies and computational and analytical capabilities is a key and significant trend in drug development.’ It’s a tall order considering that, as Muniz suggests, today, less than 10 per cent of drug R&D, is carried out in silico. ‘Yet we are talking about a $150 billion global R&D market, which virtual technologies can feasibly have a huge impact on, significantly reducing drug development timelines, costs, and attrition rates.’
Certara provides end-to-end modelling and simulation to inform decisions on safety and efficacy of potential drugs using virtual populations
4 SCIENTIFIC COMPUTING WORLD
End-to-end in silico platforms Certara offers what it claims is the most comprehensive portfolio of biosimulation soſtware and consultancy services worldwide, spanning discovery, preclinical, clinical, and post-marketing phases of synthetic and biologics drug development. ‘Certara soſtware informs key safety and efficacy decisions, identifies, optimises, and validates drug targets, determines optimal
Modelling clinical trials design Using in silico approaches to aid the design and optimisation of clinical trials is a major area for Certara’s platforms. Te firm’s model-based meta-analysis (MBMA) platform analyses existing data from in-house and public sources, to help characterise drug class, dose, and response, and so facilitate the design of clinical trials to maximise efficacy, tolerability, and safety. Te MBMA platform also allows the comparison of trials, and combination treatments that may not previously have been dosed in parallel in the same trial. ‘Using our soſtware, drug developers can model different clinical trial
CERTARA, IS
SPEARHEADING THE DRIVE TO VIRTUALISE MUCH OF DRUG DEVELOPMENT
designs to reduce complexity, increase reliability, and optimise outcomes, inform which drugs are likely to fail and, in some instances, replace the need to carry out some human trials – for example, when recruiting subsets of patients will be problematic,’ Muniz states. ‘Our tools can identify the optimal drug dose to achieve the best therapeutic and safety profiles for patient subpopulations, based on genetic profiles, or for subpopulations with co-morbidities, for example. Tis is really important when you consider that almost 40 per cent of doses selected during drug development are either too high or too low, and can result in unnecessary drug toxicity, reduced efficacy, or drug interactions. Further, the use of biosimulation fulfils an ethical imperative,
@scwmagazine l
www.scientific-computing.com
➤
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44
