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Overview of Certara, Inc.
Certara, Inc. (symbol: CERT) is a global provider renowned for its biosimulation technology and advanced decision support systems that drive model-informed drug development. Utilizing scientific software and consulting services, Certara empowers biopharmaceutical companies, academic researchers, and regulatory agencies to optimize drug discovery processes and enhance patient care. The company excels in leveraging biosimulation, drug development, and model-informed development techniques to provide robust solutions that transform the way medicines are developed, assessed, and regulated.
Business Focus and Core Offerings
Certara integrates highly specialized simulation software with expert regulatory consulting and technology solutions. Its offerings are designed to streamline various stages of the drug development lifecycle, from early discovery to clinical trial design and regulatory submissions. By bridging complex scientific data and actionable insights, the company assists in reducing the reliance on extensive clinical trials, accelerates regulatory approvals, and enhances patient access to novel therapies.
Advanced Technology and Simulation Capabilities
The company is at the forefront of innovation with its comprehensive suite of software solutions. Certara's offerings include modeling and simulation platforms which incorporate advanced techniques such as quantitative systems pharmacology (QSP) and physiologically-based pharmacokinetics (PBPK). These tools are designed to simulate human physiology and drug interactions, thereby refining dosing strategies and minimizing risk during clinical development phases. The introduction of integrated solutions, such as Certara Cloud, demonstrates the seamless connectivity of different software products, enabling customers to manage licenses, perform detailed analysis, and generate reliable insights within a unified workflow.
Regulatory Science and Consulting Services
Certara's expertise extends into regulatory science and consulting, areas that are critical for navigating the complex frameworks of drug development. By offering detailed regulatory strategies and scientific consulting, the company supports clients in meeting the rigorous requirements of global health authorities. The unique combination of advanced modeling software and regulatory insight helps clients reduce uncertainty and increase the probability of successful regulatory outcomes, offering a significant strategic advantage in the competitive pharmaceutical market.
Market Presence and Competitive Position
Operating across the Americas, EMEA, and Asia Pacific, Certara has cemented its role as a key contributor in the drug development sector. The company’s clientele includes major global biopharmaceutical companies, leading academic institutions, and influential regulatory bodies. Its technology-driven approach to accelerating drug development positions it uniquely within the competitive landscape, providing a robust alternative to traditional clinical trial methodologies and reinforcing its authority in the realm of biosimulation and regulatory strategy services.
Integrated Solutions and Client Benefits
One of the signature aspects of Certara is its integrated platform approach. Products like Certara Cloud offer a centralized portal for accessing multiple software solutions, thus streamlining workflows for users managing diverse aspects of drug development. This integration not only enhances operational efficiency but also provides a scalable and interoperable environment where feedback from users is continually incorporated into the evolution of the company's software suite. By addressing complex drug development challenges with precise and reliable modeling and simulation tools, Certara ensures that scientists and regulators can derive actionable insights more rapidly.
Scientific Expertise and Industry Application
Certara leverages its scientific expertise to address inherent challenges in drug development. The company’s simulation solutions facilitate more informed decision making, improving both the efficiency and safety of clinical trials. Its scientifically advanced models enable the transformation of raw data into strategic insights, thereby streamlining the path from research to patient care. This expertise is critical in an industry where optimizing therapeutic outcomes and meeting regulatory demands are of utmost importance.
Conclusion
In summary, Certara, Inc. stands as a sophisticated confluence of technology, scientific expertise, and regulatory insight. Its comprehensive suite of modeling, simulation, and consulting services provides a concrete foundation for revolutionizing the drug development process. By consistently delivering precise, integrated solutions and employing advanced simulation techniques, Certara plays an instrumental role in bridging the gap between innovative research and the swift, safe delivery of new medicines to patients.
Certara has appointed Nancy Killefer and Cynthia Collins to its board of directors, effective August 1, 2021, increasing the board to eleven members. Killefer brings over 30 years of executive experience in pharmaceuticals and healthcare, previously serving as a director at McKinsey & Company. Collins, with over 40 years in biotechnology, was CEO at Editas Medicine, where she led significant advancements in gene editing. Both directors aim to leverage their expertise to enhance Certara's drug discovery and development processes.
Certara, Inc. (Nasdaq: CERT) will announce its second quarter 2021 financial results on August 5, 2021, post-market. A conference call with management is scheduled for 5:00 p.m. ET to discuss these results. Investors can join by dialing (833) 360-0946 domestically or (914) 987-7661 internationally, using Conference ID: 2728807. An archived webcast will also be available on the Certara website. Certara specializes in biosimulation technology, assisting over 1,650 clients, which include biopharmaceutical companies and regulatory agencies worldwide.
Certara has appointed Nicolette D. Sherman as Chief Human Resources Officer, bringing over 20 years of HR experience in the biopharmaceutical sector. Previously, she was CHRO at Oyster Point Pharma, where she developed HR strategies for a newly public biotech. Her tenure at Sanofi included roles as Vice President of North American HR Operations and Global Leadership Development. CEO William F. Feehery expressed confidence in Sherman's ability to enhance Certara's capabilities and corporate values, further aligning with the company's mission to transform drug development.
Certara has launched an upgraded version of its BaseCase software, aimed at enhancing the market potential for biopharmaceutical and medical device companies. The new capabilities, which include Data Connect for real-time data updates, aim to improve communications regarding product value. The software is currently utilized in over 60 countries by more than 30,000 users, including leading global firms. This development reflects a strategic move to strengthen Certara’s position in the value-based healthcare sector, providing tools for effective market access and medical affairs.
Certara announced the renewal of its licenses for biosimulation software by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for the eighth consecutive year. The PMDA has utilized Certara’s Simcyp™ and Phoenix™ software since 2014. These tools aid in drug development by optimizing dosing regimens and predicting interactions. Certara collaborates with over 130 biopharmaceutical firms in Japan, including the top 10 by R&D expenditure. The continued adoption of biosimulation supports the development of therapies for challenging diseases.
Certara has appointed Carol Gallagher, Pharm.D., to its board of directors, enhancing its governance with her 30+ years of drug development and commercial leadership experience.
Previously a CEO and venture partner, Dr. Gallagher has a notable background in biopharmaceuticals, including her role in developing the cancer drug ZYDELIG. Her experience spans companies like Eli Lilly and Amgen.
Dr. Gallagher's addition is expected to contribute to Certara's mission to accelerate drug development through its biosimulation software, supporting over 1,650 global clients.
Certara, Inc. (Nasdaq: CERT) announced participation in upcoming virtual investor conferences featuring CEO William Feehery and CFO Andrew Schemick. They will speak at William Blair's 41st Annual Growth Stock Conference on June 1 at 11:40 a.m. ET and the Jefferies Virtual Healthcare Conference on June 4 at 10:00 a.m. ET. Live webcasts will be available on Certara's investor relations website and can be replayed for 90 days. Certara specializes in biosimulation software to enhance drug discovery and development for over 1,650 global clients.
Certara has launched new versions of its Immunogenicity and Immuno-oncology Quantitative Systems Pharmacology (QSP) Simulators to tackle challenges in developing biologics and cancer therapies. The updates enhance the simulators' capabilities, allowing for better predictions of clinical outcomes and the testing of therapy combinations. Certara's tools are now critical in regulatory submissions, highlighting the growing importance of QSP in pharmaceutical R&D. The simulators have successfully predicted outcomes for various cancer treatment scenarios, including solid tumors and blood cancers.
Certara reported Q1 fiscal 2021 results with revenue of $66.7 million, a 16% increase from Q1 2020. Net income rose to $1.1 million, with adjusted EBITDA climbing 20% to $23.9 million. The company updated its full-year guidance, projecting revenue between $277 million and $285 million, and adjusted EBITDA of $100 million to $102 million. First quarter bookings grew 34% year-over-year, indicating strong demand for its biosimulation platform.
Certara has launched its innovative Secondary Intelligence™ software, designed to predict off-target safety issues that could affect drug development. This software is the first of its kind, providing critical data on secondary pharmacology and enhancing decision-making for drug developers. With safety issues contributing to around 25% of candidate failures, this tool aims to improve the efficiency and precision of safety assessments, potentially accelerating clinical success. Certara serves over 1,650 clients in 61 countries, highlighting its significant role in the biopharmaceutical sector.
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