Certara

St. Louis, MO, United States
St. Louis, MO, United States

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News Article | February 15, 2017
Site: www.marketwired.com

HONG KONG, CHINA--(Marketwired - February 09, 2017) - Meltwater, a global leader in media intelligence solutions, today announced it has closed a $60M debt funding round with Silicon Valley Bank and Vector Capital in order to ramp up strategic acquisitions. The announcement comes as Meltwater is seeing significant organic growth across all markets. Founder and Chief Executive Officer (CEO) Jorn Lyseggen recognizes the opportunity for a number of acquisitions in various markets moving forward that will fuel both organic and inorganic growth. "We see acquisitions as an integral part of our growth strategy," Lyseggen said. "We believe in the next 24 months we will see high M&A activity in our space, and we raised this capital to give us the firepower to take an active role in these processes." Since 2009, Meltwater has acquired 9 companies, including the recently announced Encore HQ, a 500 Startups Alumn known for their social media alerts powered by data science. "We are primarily looking for proven technology in data science, machine learning and natural language processing," Lyseggen said. "We will also look at companies with a dominant position in a particular market or vertical." "Closing this credit facility with Tier 1 lending institutions such as Silicon Valley Bank and Vector Capital is a great vote of confidence in Meltwater," said Martin Hernandez, Chief Financial Officer (CFO) at Meltwater. "As we look to further expand our already significant global footprint, we believe we've found great partners to work with that can help us fund organic growth as well as continue our acquisition strategy." "We are delighted to partner with Meltwater in support of their continued growth and success," said Alex Slusky, Vector's Founder and Chief Investment Officer (CIO). "We enthusiastically support their vision to create and define the market for Outside Insight -- where business signals from vast arrays of external data on the Internet can be captured and transformed into actionable and valuable insights for executives and operating teams." About Meltwater Meltwater helps companies make better, more informed decisions based on insights from the outside. More than 25,000 companies use the Meltwater media intelligence platform to stay on top of billions of online conversations, extract relevant insights, and use them to strategically manage their brand and stay ahead of their competition. With over 50 offices on six continents, Meltwater is dedicated to personal, global service built on local expertise. Meltwater also operates the Meltwater Entrepreneurial School of Technology (MEST), a nonprofit organization devoted to nurturing future generations of entrepreneurs. For more information, follow Meltwater on Twitter, Facebook, LinkedIn, YouTube, or visit www.meltwater.com. About Silicon Valley Bank For more than 30 years, Silicon Valley Bank (SVB) has helped innovative companies and their investors move bold ideas forward, fast. SVB provides targeted financial services and expertise through its offices in innovation centers around the world. With commercial, international and private banking services, SVB helps address the unique needs of innovators. Learn more at svb.com. About Vector Capital Vector Capital is a leading global alternative asset manager specializing in transformational investments in established technology businesses through private equity and credit investments. Vector identifies and pursues these investments in both the private and public markets. Vector actively partners with management teams to devise and execute new financial and business strategies that materially improve the competitive standing of these businesses and enhance their value for employees, customers, and shareholders. Among Vector's notable investments are 20-20 Technologies, Aladdin Knowledge Systems, Allegro Development, Cambium Networks, Certara, ChyronHego, CollabNet, Corel, Emarsys, IPVALUE Management, LANDesk Software, Niku, Gerber Technology, OpenSolutions, RAE Systems, Register.com, Saba Software, SafeNet, Sizmek, Technicolor, Teletrac, Tidel, Triton Digital, VFO, and WatchGuard Technologies. For more information, visit www.vectorcapital.com.


News Article | May 15, 2017
Site: www.businesswire.com

PRINCETON, N.J.--(BUSINESS WIRE)--Certara®, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced that it has appointed Sandy Allerheiligen, PhD, to the newly-created role of Senior Vice President of Health Economics and Education. “Budget restrictions are a reality for governments, payers and patients alike and drug value is going to play a growing role in drug development and patient access decisions,” said Certara Chief Executive Officer Edmundo Muniz, MD, PhD. “Sandy is an expert at applying quantitative methods and systems pharmacology to experimental and real-world data to create drug-disease models that enable sponsors to make smart decisions. Her teams’ models are already used to inform drug discovery, preclinical, clinical and patient access decisions. At Certara, we are going to broaden the scope of that work and include payers in the discussion. We are excited to have Sandy as a senior leader on our team,” said Dr. Muniz. “In the past, sponsors had to clear three hurdles to get a drug approved; they had to prove product safety, efficacy, and quality. Now, they need to overcome a fourth hurdle and demonstrate the product’s value to patients to ensure patient access and reimbursement,” said Dr. Allerheiligen. “Sponsors will have to negotiate with every health authority and payer and prove the value for patients. Model-informed drug development (MIDD) will provide sponsors with the quantitative data they need to make a successful case. I am delighted to join Certara because its vision will enable MIDD to reach its full potential.” Previously, Dr. Allerheiligen served as Vice President of Data Sciences and Predictive and Economic Modeling, Center for Observational and Real-world Evidence at Merck, a role to which she was appointed in 2015. She joined Merck in 2010 as Vice President of Modeling and Simulation, and was promoted to Vice President of Quantitative Pharmacology & Pharmacometrics within PPDM in 2013. Prior to that, Dr. Allerheiligen was Global Senior Director of Pharmacokinetics, Pharmacodynamics, and Trial Simulation; Senior Director of Drug Disposition, and Distinguished Fellow and Chief Scientific Officer of Quantitative Pharmacology at Eli Lilly & Company. Dr. Allerheiligen received her PhD in Pharmaceutics from the University of Texas, Austin. She completed her postdoctoral fellowship in Gastroenterology and served as Clinical Assistant Professor of Clinical Pharmacology at The University of Texas Health Science Center at San Antonio. As an active member of the industry, Dr. Allerheiligen is a Fellow of the American Association of Pharmaceutical Sciences and has served on several National Institutes of Health Working Groups focused on modeling and simulation. She is a member of the American Association of Pharmaceutical Scientists, American Association of Clinical Pharmacology and Therapeutics, and the International Society of Pharmacometrics, which honored her with its 2016 Leadership Award. Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies. For more information, visit www.certara.com.


PRINCETON, N.J.--(BUSINESS WIRE)--Certara®, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today launched its Clinical Outcomes Database Explorer (CODEx). An intuitive, web-based platform, CODEx enables drug development teams to easily visualize, explore, analyze and communicate content from Certara’s Clinical Trial Outcomes Databases and assess a given compound’s probability of success against competitor drugs. Publicly-available clinical trial data represent an underutilized source of information. If properly extracted and analyzed, they provide valuable input for facilitating go/no go decisions, performing comparative effectiveness and portfolio evaluations in support of in/out licensing, and optimizing overall drug development decisions, including dose and dosing regimens. CODEx facilitates the effective use of information from the Certara Clinical Outcomes Databases, which are a collection of well-organized clinical drug efficacy and safety data from the published biomedical literature for different diseases. The 40 Certara databases are divided into four major categories: CNS and pain; inflammation; oncology; and cardiovascular, metabolic and other therapeutic diseases. The oncology category, for example, includes data on non-small cell lung cancer, metastatic breast cancer, acute lymphoblastic leukemia, and non-Hodgkin’s lymphoma. Additional databases can be developed upon request. Information is organized by trial, arm, patient demographics, treatment regimen, and outcomes for analysis-ready queries. “CODEx is a user-friendly and highly interactive interface used to make sense of the large and valuable amount of competitor clinical data available from the literature,” said Certara Director of Consulting Services Leon Bax. “Through CODEx, scientists can efficiently explore data trends regardless of knowledge of the therapeutic area or coding.” “CODEx presents data in a clear, consolidated format to give users insights into data availability and data patterns, which can subsequently be leveraged in model-based meta-analyses for assessment of comparative effectiveness, endpoint-to-endpoint correlations, and probability of clinical trial success,” added Certara Vice President of Database Products Nancy Zhang. “Its selection of interactive tools allows scientists to choose the best plots, graphs and tables to communicate and brainstorm best analysis strategies.” Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies. For more information, visit www.certara.com.


PRINCETON, N.J.--(BUSINESS WIRE)--Certara®, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced that it is partnering with Phase I Unit, Peking Union Medical College (PUMC) Hospital’s Clinical Pharmacology Research Center (PUMCH-CPRC) in Beijing to help Chinese pharmaceutical companies enhance their drug development processes. Phase I Unit at PUMCH-CPRC will employ Certara’s Simcyp® Population-based Simulator to develop physiologically-based pharmacokinetic (PBPK) models in support of Chinese new and generic drug applications to the Chinese Food and Drug Administration (CFDA). “We are proud to support China’s efforts to foster healthcare innovation. By increasing its adoption of PBPK modeling and simulation, it will expedite its pharmaceutical companies’ drug development processes and regulatory submissions, whilst also helping to bring safer therapies to market,” said Simcyp President and Managing Director Dr. Stephen Toon. “An increasing number of Chinese pharmaceutical companies want to use PBPK modeling and simulation as part of their drug development plans. We felt that the best way to maintain Certara’s high scientific standards for these Chinese customers and help circumvent some of the language-related commercial impediments was to partner with Phase I Unit at PUMCH-CPRC, which is one of the most prestigious academic pharmaceutical research institutions in China,” added Dr. Toon. “We are delighted to expand our partnership with Certara and be able to provide Chinese pharmaceutical companies with modeling and simulation consulting support to strengthen their regulatory submissions,” said Professor Pei Hu, MD, professor and director of Phase I Unit at PUMCH-CPRC. Certara and Phase I Unit at PUMCH-CPRC already have a great partnership track record. The two organizations have been working together for several years to increase PBPK modeling and simulation education and training in China and have co-hosted several national workshops. Phase I Unit at PUMCH-CPRC uses Certara’s modeling and simulation technology for first-in-human, point-of-care, and late-phase clinical trials. It has many years’ experience using both Certara’s Simcyp Simulator and Phoenix® software and has published numerous peer-reviewed papers based on research conducted using those platforms. Phase I Unit at PUMCH-CPRC is a Phoenix Center of Excellence. CFDA also employs Certara’s Phoenix software and is a regulatory affiliate member of the Simcyp Consortium. PUMC Hospital, which was founded by the Rockefeller Foundation in 1921, conducts clinical research into severe, rare and complicated diseases. It has 4,000 employees and is affiliated with both PUMC and the Chinese Academy of Medical Sciences. Certara’s Simcyp Simulator is the pharmaceutical industry’s most sophisticated platform for determining first-in-human dose selection, designing more efficient and effective clinical studies, evaluating new drug formulations, and predicting drug-drug interactions and PK outcomes in clinical populations. These include vulnerable populations such as pediatric patients, pregnant women, and patients with impaired organ function. Phoenix is the most advanced, intuitive, and widely-used software for PK, pharmacodynamic, and toxicokinetic modeling and simulation. Through this new partnership with PUMC Hospital, Certara is providing Chinese customers with access to its modeling and simulation technology and helping accelerate safer and more effective drug development in China. Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies. For more information, visit www.certara.com.


News Article | August 10, 2017
Site: www.businesswire.com

PRINCETON, N.J.--(BUSINESS WIRE)--Certara®, the global leader in model-informed drug development and regulatory science, today announced that it has added externalization technology to its D360 scientific informatics platform. The resulting new product, D360 Partner, facilitates collaboration between sponsors and their external research partners. Those external collaborators could include academic institutions, contract research organizations or third-party research groups. Those partners all have similar data access and communication requirements to members of an internal research project. “Prior to the launch of D360 Partner, this type of collaboration required a custom solution, posing challenges both from an information technology and an informatics perspective. Our new solution provides external research partners with highly secure access to only authorized project data,” said David Munro, president, Phoenix Technologies at Certara. “This new Partner option further expands D360’s ‘faster time to insight’ benefit by enabling external collaborators’ work to be integrated directly into the research project,” he added. According to Atrium Research, externalization R&D expenditures nearly doubled between 2011 and 2017 in the biopharmaceutical industry. More than 75 percent of companies have at least one R&D partner, and it is not unheard of for a major company to have more than 100 R&D collaborators across the entire R&D spectrum. Furthermore, drug discovery outsourcing is continuing to grow in popularity. A recent Visiongain report predicts that it will become a $43.7 billion dollar industry by 2026.1 D360 Partner was developed in response to client requests and is now being rolled out at a top 10 pharmaceutical company. D360 is Certara’s self-service data access, integration, and visualization solution used to query multiple cheminformatics and bioinformatics data sources and make informed go/no-go and next step research decisions. It is used by more than 5,000 scientists worldwide at both large pharmaceutical and specialty research organizations. D360 Partner provides external collaborators with access to project-specific sponsor queries and data views. They can also use the full suite of D360 analysis and collaboration tools, and share and annotate project-relevant information. A simple user management system allows partners to be added and removed as projects change. Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies. For more information, visit www.certara.com.


This report studies the Global Biosimulation Market, analyzes and researches the Biosimulation development status and forecast in United States, EU, Japan, China, India and Southeast Asia. This report focuses on the top players in global market, like Certara Simulation Plus Dassault Systèmes Schr?dinger Advanced Chemistry Development Chemical Computing Group Entelos Genedata Ag Physiomics PLC Rhenovia Pharma Market segment by Application, Biosimulation can be split into Application 1 Application 2 Application 3 United States, EU, Japan, China, India and Southeast Asia Biosimulation Market Size, Status and Forecast 2021 1 Industry Overview of Biosimulation 1.1 Biosimulation Market Overview 1.1.1 Biosimulation Product Scope 1.1.2 Market Status and Outlook 1.2 Global Biosimulation Market Size and Analysis by Regions 1.2.1 United States 1.2.2 EU 1.2.3 Japan 1.2.4 China 1.2.5 India 1.2.6 Southeast Asia 1.3 Biosimulation Market by End Users/Application 1.3.1 Application 1 1.3.2 Application 2 1.3.3 Application 3 2 Global Biosimulation Competition Analysis by Players 2.1 Biosimulation Market Size (Value) by Players (2015-2016) 2.2 Competitive Status and Trend 2.2.1 Market Concentration Rate 2.2.2 Product/Service Differences 2.2.3 New Entrants 2.2.4 The Technology Trends in Future 3 Company (Top Players) Profiles 3.1 Certara 3.1.1 Company Profile 3.1.2 Main Business/Business Overview 3.1.3 Products, Services and Solutions 3.1.4 Biosimulation Revenue (Value) (2011-2016) 3.1.5 Recent Developments 3.2 Simulation Plus 3.2.1 Company Profile 3.2.2 Main Business/Business Overview 3.2.3 Products, Services and Solutions 3.2.4 Biosimulation Revenue (Value) (2011-2016) 3.2.5 Recent Developments 3.3 Dassault Systèmes 3.3.1 Company Profile 3.3.2 Main Business/Business Overview 3.3.3 Products, Services and Solutions 3.3.4 Biosimulation Revenue (Value) (2011-2016) 3.3.5 Recent Developments 3.4 Schr?dinger 3.4.1 Company Profile 3.4.2 Main Business/Business Overview 3.4.3 Products, Services and Solutions 3.4.4 Biosimulation Revenue (Value) (2011-2016) 3.4.5 Recent Developments 3.5 Advanced Chemistry Development 3.5.1 Company Profile 3.5.2 Main Business/Business Overview 3.5.3 Products, Services and Solutions 3.5.4 Biosimulation Revenue (Value) (2011-2016) 3.5.5 Recent Developments 3.6 Chemical Computing Group 3.6.1 Company Profile 3.6.2 Main Business/Business Overview 3.6.3 Products, Services and Solutions 3.6.4 Biosimulation Revenue (Value) (2011-2016) 3.6.5 Recent Developments 3.7 Entelos 3.7.1 Company Profile 3.7.2 Main Business/Business Overview 3.7.3 Products, Services and Solutions 3.7.4 Biosimulation Revenue (Value) (2011-2016) 3.7.5 Recent Developments 3.8 Genedata Ag 3.8.1 Company Profile 3.8.2 Main Business/Business Overview 3.8.3 Products, Services and Solutions 3.8.4 Biosimulation Revenue (Value) (2011-2016) 3.8.5 Recent Developments 3.9 Physiomics PLC 3.9.1 Company Profile 3.9.2 Main Business/Business Overview 3.9.3 Products, Services and Solutions 3.9.4 Biosimulation Revenue (Value) (2011-2016) 3.9.5 Recent Developments 3.10 Rhenovia Pharma 3.10.1 Company Profile 3.10.2 Main Business/Business Overview 3.10.3 Products, Services and Solutions 3.10.4 Biosimulation Revenue (Value) (2011-2016) 3.10.5 Recent Developments For more information or any query mail at [email protected]


Bio Simulation Technology Market is estimated at $1.01 billion in 2015 and is projected to reach $2.99 billion by 2022 growing at a CAGR of 16.6% from 2015 to 2022. Reduction in the cost of drug discovery and development and risk of failure of drug molecule are some of the factors driving the market growth. Furthermore, R&D investments in biotechnology and pharmaceutical industries, growth in the biologics and biosimilars markets, increased use of personalized medicines, technological advancements and periodic product upgradation are the key factors vitalizing the market growth. However, lack of standardization, high R&D costs associated with development of biosimulation software and lack of skilled professionals are some of the major restraints hampering the market growth. Industrial bioprocessing, nutraceuticals, agri-food production and biosimulation in the defense will provide opportunities for market growth over the forecast period. Pharmaceutical and biotechnology companies segment is valued to account largest share across the global market. North America is anticipated to command the largest share and Europe is expected to register the highest growth due to increasing government funding and the large number of pharmaceuticals and biotechnology companies in this region. Some of the key players in this market include Certara USA Inc., Simulation Plus Inc., Dassault Systèmes SA, Schrödinger Inc., Advanced Chemistry Development Inc., Chemical Computing Group Inc., Entelos Holding Corporation, Genedata Ag, Physiomics PLC, Rhenovia Pharma Ltd., Insilico biosciences, Archimedes, Insilico biotechnology, Accelrys, LeadScope and Compugen. Application Covered:  • Application In Drug Development  o Clinical Trials  o Preclinical Testing  • In Patient Validation  • Application In Drug Discovery  o Target Validation  o Target Identification  o Lead Identification/Discovery  o Lead Optimization Product Covered:  • Software  o Toxicity Prediction Software  o Molecular Modeling and Simulation Software  o Trial Design Software  o PK/PD Modeling and Simulation Software  o Pbpk Modeling and Simulation Software  o Other Software  • Services  o External/Contract Services  o In-House Services Regions Covered:  • North America  o US  o Canada  o Mexico  • Europe  o Germany  o France  o Italy  o UK  o Spain  o Rest of Europe  • Asia Pacific  o Japan  o China  o India  o Australia  o New Zealand  o Rest of Asia Pacific  • Rest of the World  o Middle East  o Brazil  o Argentina  o South Africa  o Egypt What our report offers:  - Market share assessments for the regional and country level segments  - Market share analysis of the top industry players  - Strategic recommendations for the new entrants  - Market forecasts for a minimum of 7 years of all the mentioned segments, sub segments and the regional markets  - Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)  - Strategic recommendations in key business segments based on the market estimations  - Competitive landscaping mapping the key common trends  - Company profiling with detailed strategies, financials, and recent developments  - Supply chain trends mapping the latest technological advancements About Us Wise Guy Reports is part of the Wise Guy Consultants Pvt. Ltd. and offers premium progressive statistical surveying, market research reports, analysis & forecast data for industries and governments around the globe. Wise Guy Reports understand how essential statistical surveying information is for your organization or association. Therefore, we have associated with the top publishers and research firms all specialized in specific domains, ensuring you will receive the most reliable and up to date research data available.


News Article | December 6, 2016
Site: www.businesswire.com

PRINCETON, N.J.--(BUSINESS WIRE)--Certara®, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced that it is extending its activities relating to drug safety assessment by establishing a new strategic Quantitative Systems Toxicology (QST) initiative. The initiative, which will be managed by the company’s Simcyp division, leverages its Quantitative Systems Pharmacology (QSP) expertise and the investment already made in the development of its Cardiac Safety Simulator (CSS). In addition to the strategic and sizeable resources that Certara has already committed to this initiative, the launch is strengthened by the award of several significant grants, including the EU-ToxRisk project, a collaboration with the US EPA to accelerate the shift in toxicology towards a new mechanism-based chemical safety testing strategy. Simcyp’s work will focus on developing organ-specific mechanistic models to strengthen drug safety assessments. This work will further enable the industry to move away from animal testing toward mechanistic modeling of the cause-consequence relationships of chemical adverse effects. “Thirty percent of adverse drug reactions cannot be predicted by current pre-clinical animal testing and existing modeling methodologies,” said Certara Chief Executive Officer Edmundo Muniz, MD, PhD. “Mechanistic modeling, and specifically QST, has the potential to address this very sizeable challenge. We believe that the time is right to invest in this paradigm-shifting approach and form this new program within Simcyp.” “We have been encouraged both by the award of various publicly-funded grants and by our pharmaceutical industry clients, to extend and expand our activities in the area of QST beyond cardiac safety assessment and more broadly embrace all drug safety areas,” said Simcyp President and Managing Director Steve Toon, PhD. “As with physiologically-based pharmacokinetics and QSP, the market, recognizing deficiencies in currently commercially available drug safety related software and consultancy services, has turned to Simcyp with its demonstrated commitment to high quality, peer-review research and software development, to harness the increasing understanding of the mechanistic determinants of drug-related toxicities and develop predictive software tools for use in the continued drive to improve drug safety.” QST takes toxicology beyond characterizing adverse events on the basis of empirical endpoints and focuses instead on modes of action and adverse outcome pathways. It integrates in vitro and in vivo toxicity data with the wealth of “omics data” (genomics, proteomics, metabolomics, etc.) available via computational modeling. “Off-target” reactions are critical to understanding adverse safety events because these reactions cannot be predicted from a drug’s known pharmacological properties. Certara is the first company in the industry to offer fully integrated QSP and QST biosimulation services, allowing for a simultaneous assessment of efficacy, safety, and therapeutic index. This holistic, quantitative approach to managing risk-benefits is essential in complex drug development programs such as immuno-oncology combination therapies. Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies. For more information, visit www.certara.com.


PRINCETON, N.J.--(BUSINESS WIRE)--Certara®, the leading provider of decision support technology and consulting services for optimizing drug development and improving health outcomes, today announced that the Standards Council of Canada (SCC) has awarded Good Laboratory Practices (GLP) certification to its Certara Strategic Consulting (CSC) Montreal facility. CSC Montreal has passed the requisite inspection and study audits and is now recognized as a GLP compliant Toxicokinetic Test Site by SCC. “To derive the greatest value from modeling and simulation (M&S), sponsors need to incorporate these quantitative methods into their drug discovery and development process as early as possible,” said Dr. Martin Beliveau, director of CSC. “By attaining GLP accreditation, we underscore the high quality of our toxicology analysis services, demonstrate the SCC compliance of our processes and procedures, and underscore to sponsor companies the many benefits of incorporating M&S into their pre-clinical programs.” CSC Montreal performs toxicokinetic analyses to support the pivotal toxicology programs required for new drug regulatory submissions. Drug concentrations observed in animals and the appearance of toxic adverse effects are routinely incorporated into M&S workflows to derive safer initial and escalation doses for first-in-human trials. These M&S workflows can also provide insight into the minimum anticipated biological effect level (MABEL) of a drug and efficacious outcomes. Formed from the merger of Pharsight Consulting Services, Quantitative Solutions, and d3 Medicine, CSC is the largest global pharmacometrics consultancy. CSC is comprised of more than 100 scientists, most with PhDs, using a wide range of M&S methods and technologies to support global sponsors in bringing new therapies to patients. Regulatory agencies are increasingly promoting the use of M&S in drug programs to inform key decisions. M&S has been highlighted in more than a dozen regulatory guidance documents over the past few years and is used by those agencies to review drug submittals. Certara is a leading decision support technology and consulting organization committed to optimizing drug development and improving health outcomes. Certara’s solutions, which span drug discovery through patient care, use the most scientifically-advanced modeling and simulation technologies and regulatory strategies to increase the probability of regulatory and commercial success. Its clients include hundreds of global biopharmaceutical companies, leading academic institutions, and key regulatory agencies. For more information, visit www.certara.com.


PRINCETON, N.J.--(BUSINESS WIRE)--Certara today announced that the U.S. Environmental Protection Agency (EPA) is using its Simcyp® Population-based Simulator to support the Agency’s high-throughput toxicity testing program.

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