laboratory informatics ➤
especially for patient populations such as paediatrics, and in oncology.’
Optimised patient care Certara’s simulation and modelling solutions are also being used at the point of care, to instruct and inform clinicians as to the optimum dosing schedule for individual patients, and so help to improve treatment efficacy and reduce toxicity, unwanted side effects and drug-drug interactions. ‘Tis is something that none of our competitors are doing, yet the utilisation of in silico technologies to direct and inform precision medicine – not just at the level of subsets of patients, but for each individual patient – is
CERTARA’S
SIMULATION AND MODELLING SOLUTIONS ARE ALSO BEING USED AT THE POINT OF CARE
another significant trend that we believe will influence patient care globally over coming years,’ Muniz stresses. ‘Biosimulation and modelling could have huge benefits for the global patient care market, especially when you consider the capacity for such technologies to take the guesswork out of prescribing. Yet today, just about zero patient care is currently carried out in silico.’ Certara has partnerships with some 1,200
commercial clients, including all the top-tier pharmaceutical companies, the majority of second-tier, 250 academic institutions, and the world’s leading regulatory agencies, including the US FDA, the European Medicines Agency, and the Japanese and Chinese regulators. Global regulatory agencies represent major users of Certara’s soſtware, Muniz notes. ‘Tey use our soſtware to confirm simulations that companies have already carried out on their drug candidates, or to apply modelling techniques to investigate additional attributes of a drug, and to enhance the level of understanding about drug behaviour in the human body. Regulators also use Certara’s modelling and simulation platforms to explore the potential effects of drugs in patient populations for which real world trials may not be feasible, such as neonates or groups of patients with multiple diseases. And they also use our mathematical and computational capabilities to analyse huge datasets.’
Biosimulation informs drug labelling Drug labelling is a key area that the regulatory agencies are intimately involved with, and in which biosimulation is now increasingly starting to inform drug claims, Muniz says. ‘Te drug
6 SCIENTIFIC COMPUTING WORLD
label is effectively the manual for that therapy, and each claim on that label will directly impact on drug utility at the front end, and thus on profitability. Te label is the ultimate result of possibly 10 to 15 years of R&D and billions of dollars of investment. Te ability of modern simulation to shape and optimise the final drug label is hugely important.’ Certara has been working with companies and with the regulatory agencies to demonstrate the utility of modelling and simulation, using mechanistic modelling and pharmacokinetic-pharmacodynamic modelling, in the derivation of labelling claims. ‘It is over the last couple of years that biosimulation has started to have a major impact on label claims,’ Muniz suggests. ‘FDA’s acceptance of physiologically- based pharmacokinetic modelling and simulation has to date led to Certara’s soſtware playing a key role in the final wording of some 20 new drug labels. To date, our modelling soſtware has directly informed 80 to100 statements on drug labels related to safety and dosing.’ Certara works in close collaboration with
its clients, to ensure optimum utilisation of its soſtware, backed by its consultancy services. ‘Every transaction implies the utilisation of our soſtware and an ongoing partnership around our consultancy expertise. We do not see ourselves as selling soſtware and services. We act as a strategic partner for our clients, and our products help to inform, optimise and verify the most crucial decisions in drug discovery, development and, ultimately, utilisation in the patient. As we believe we are the only company that can provide end- to-end modelling and simulation services, it is important that we collaborate with our partners very early on in the discovery process, and then work closely with them right through to post marketing all the way to the point of care.’
Strategic acquisitions Established in 2008 through the merger of drug discovery informatics firm, Tripos International, with Pharsight, which specialises in soſtware, strategic and regulatory services for optimising clinical development, Certara has since made a number of acquisitions in the field of modelling and simulation. In 2012 the firm took over Simcyp, which offers a modelling and simulation platform for predicting the fate of drugs in virtual populations. Te following year Certara acquired drug development and management consultancy, Great Lakes Drug Development, and in 2014, Certara expanded its regulatory writing and submission capabilities by acquiring Synchrogenix. Ten, in January
2015, Synchrogenix acquired ClinGenuity, the only artificial intelligence-assisted medical writing service in the pharmaceutical industry. Most recently, in December 2015, it acquired XenologiQ, a UK-based quantitative systems pharmacology consultancy. Te XenologiQ acquisition followed on from Certara’s creation, in July 2015, of a global strategic modelling and simulation consultancy, through the merger of its consulting group, Pharsight Consulting Services, with Quantitative Solutions, an international pharmacometrics consulting company. In the area of pharmacometrics, the
company offers the Phoenix platform, which includes WinNonlin for pharmacokinetic/ pharmacodynamic (PK/PD) and non- compartmental analysis; NLME for population PK modelling; Connect for data import/ export and reporting; the IVIVC toolkit; and the Phoenix Knowledgebase Server, a 21CFR- compliant database and repository. ‘Phoenix is used by 1,200 biopharmaceutical companies, 250 academic institutions, and major regulatory agencies,’ Leinfuss adds.
Small molecules and biologics In the rapidly growing discipline of physiologically-based pharmacokinetics (PBPK), Certara’s Simcyp simulator for both small molecules and biologics is supported by a unique consortium, which the firm claims includes the majority of leading pharmaceutical companies, key academic institutions and regulatory bodies. Trough its XenologiQ purchase, Certara now also provides quantitative systems pharmacology technology, which is used for lead optimisation. Te firm’s portfolio also includes the Sybyl and Muse Invent soſtware for molecular modelling, and its informatics platform, D360, which facilitates scientific data access, analysis and collaboration across and between departments and researchers within an organisation, and development partners. ‘We have transformed a set of complementary, yet fragmented technologies and expertise offered by disparate companies, into an integrated, consolidated
and synergistic set of modelling and simulation disciplines. Tis can model biological processes
to facilitate decision making at every stage of
drug discovery and development, from target validation, drug
discovery and lead optimisation, to preclinical and clinical development,’ Muniz concludes. l
@scwmagazine l
www.scientific-computing.com
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