Welcome to our dedicated page for Certara news (Ticker: CERT), a resource for investors and traders seeking the latest updates and insights on Certara stock.
Certara, Inc. (Nasdaq: CERT) is a global leader in biosimulation software, technology, and consulting services that transform traditional drug discovery and development processes. By leveraging cutting-edge modeling and simulation tools, Certara helps biopharmaceutical companies, academic institutions, and regulatory agencies accelerate the development of life-saving medicines while reducing costs and improving patient outcomes. The company's core mission is to optimize drug development through model-informed approaches, enabling its clients to enhance the probability of regulatory and commercial success.
Business Model and Revenue Streams
Certara operates a diversified business model that combines software licensing, consulting services, and strategic partnerships. Its flagship products, such as the Phoenix™ pharmacokinetic/pharmacodynamic (PK/PD) platform and Certara Cloud, provide a unified ecosystem for drug developers to manage, analyze, and model clinical trial data. These solutions are offered on a subscription or licensing basis, ensuring recurring revenue streams. Additionally, Certara's consulting services, which include regulatory science and quantitative systems pharmacology (QSP) expertise, generate significant revenue by addressing complex drug development challenges for its clients. The company also collaborates with regulatory agencies like the U.S. FDA, Japan PMDA, and China NMPA, further solidifying its authority in the field.
Industry Context and Competitive Landscape
Certara operates within the highly specialized niche of model-informed drug development (MIDD), a critical segment of the broader healthcare and life sciences industry. This field is becoming increasingly important as the pharmaceutical sector faces mounting pressure to reduce clinical trial failures and bring new drugs to market faster. Certara's competitors include other biosimulation software providers, contract research organizations (CROs), and in-house solutions developed by large pharmaceutical companies. However, Certara differentiates itself through its comprehensive suite of interoperable software, deep scientific expertise, and long-standing relationships with regulatory bodies. Its solutions are trusted by 15 of the top 30 biopharmaceutical companies globally, underscoring its market leadership.
Core Technologies and Innovations
Certara's technological ecosystem is built around advanced biosimulation and data analytics tools designed to streamline the drug development lifecycle. The Certara Cloud platform, for instance, integrates multiple software solutions into a single, user-friendly interface, allowing clients to access predictive models and analyze clinical trial results seamlessly. The Phoenix platform, widely regarded as the gold standard in PK/PD modeling, is used by leading pharmaceutical companies and regulatory agencies to evaluate drug candidates. Additionally, Certara's expertise in virtual trials and mechanistic modeling enables its clients to optimize dosing strategies, reduce reliance on animal studies, and accelerate regulatory approvals.
Global Reach and Client Base
With a presence in the Americas, EMEA, and Asia-Pacific regions, Certara serves a diverse and global client base. Its clients include over 2,400 biopharmaceutical companies, leading academic institutions, and regulatory agencies across 66 countries. This extensive reach highlights Certara's ability to address the unique challenges of different markets while maintaining a consistent standard of excellence. The company's innovative solutions have been instrumental in expediting drug approvals and improving health outcomes worldwide.
Challenges and Opportunities
While Certara's technologies offer significant advantages, the company operates in a competitive and rapidly evolving industry. Challenges include the need to continually innovate, maintain regulatory compliance, and address the growing complexity of drug development. However, Certara is well-positioned to capitalize on industry trends such as the increasing adoption of model-informed drug development and the shift toward personalized medicine. Its ongoing investments in technology, such as the phased rollout of Certara Cloud, demonstrate its commitment to staying at the forefront of the industry.
Conclusion
Certara, Inc. is a cornerstone of innovation in the pharmaceutical and biotechnology sectors, providing indispensable tools and expertise that accelerate the drug development process. By combining advanced biosimulation software with unparalleled scientific and regulatory knowledge, Certara empowers its clients to bring safer, more effective medicines to market faster. Its strategic focus on innovation, global reach, and trusted relationships with regulatory agencies positions it as a vital partner in the quest to improve global health outcomes.
Certara, a leader in biosimulation, announced that its CEO, William F. Feehery, and CFO, Andrew Schemick, will participate in a fireside chat at the Piper Sandler 33rd Annual Virtual Healthcare Conference. The event is scheduled for November 22, 2021, at 10:00 am ET. Interested parties can access the webcast through Certara's investor relations website. Certara is known for its proprietary biosimulation software, serving over 1,650 global biopharmaceutical firms, academic institutions, and regulatory agencies across 61 countries.
Certara (Nasdaq: CERT) has secured a five-year contract from the FDA for its Pinnacle 21 Enterprise software, which enhances the agency's ability to review clinical and non-clinical study submission data. This agreement continues a long-standing partnership and follows previous contracts awarded in 2011 and 2015. The software streamlines data validation processes, allowing FDA reviewers to assess data quality more efficiently. This contract also supports the FDA’s DataFit program amid new technical rejection criteria implementation.
Certara, Inc. (Nasdaq: CERT) will release its third-quarter 2021 financial results on November 9, 2021, post-market. A conference call with management to discuss these results will occur at 5:00 p.m. ET. Interested investors can join the call by dialing (833) 360-0946 for domestic and (914) 987-7661 for international participants, using Conference ID: 1968232. The event will also be available via a live and archived webcast on Certara's Investors webpage.
Certara specializes in biosimulation software and technology, assisting over 1,650 clients globally.
Certara, Inc. (Nasdaq: CERT) has appointed Patrick F. Smith, Pharm.D., as the new president of Integrated Drug Development (IDD). He succeeds Craig R. Rayner, Pharm.D., who will transition to a role as a distinguished scientist. Dr. Smith brings extensive experience in drug development, particularly in infectious diseases and oncology, having previously served as senior vice president of IDD strategy and innovation. His leadership aims to enhance Certara's biosimulation and quantitative approaches across the drug development life cycle, positioning the company for continued growth.
Certara Appoints New Chief Commercial Officer
On October 5, 2021, Certara (Nasdaq: CERT) announced the appointment of Drayton T. Virkler as Chief Commercial Officer. With over 20 years of experience in the pharma sector, Virkler's role focuses on enhancing global commercial strategies and business development. Previously at IQVIA, he led sales and marketing, achieving annual revenue growth. Virkler aims to broaden Certara’s reach in biosimulation technologies, ultimately improving drug development processes for clients worldwide.
Certara has successfully acquired Pinnacle 21 for approximately $250 million in cash and 2.24 million shares of restricted common stock. This strategic acquisition aims to enhance Certara's capabilities in clinical data management and regulatory compliance, crucial for expediting drug development. Pinnacle 21's software is already adopted by leading biopharmaceutical companies and regulatory agencies like the FDA. The acquisition is expected to boost Certara's revenue and adjusted EBITDA, with updated financial guidance anticipated in November 2021.
Certara has launched Synchrogenix Writer, a cloud-based regulatory SaaS product aimed at automating and improving the quality of patient narratives critical for clinical study reporting. This innovative solution addresses the inefficiencies of the traditional manual writing process, which is costly and time-consuming. By enabling data-mapping and early drafting, the software ensures consistency, reduces risk, and accelerates the time to regulatory filing. With over 10,000 patient narratives already delivered, Synchrogenix Writer is positioned to meet evolving global regulatory requirements.
Certara, a leader in biosimulation, expands its Integrated Drug Development division with a new clinical science group led by Philippa Marshall, M.D. This expansion includes important appointments: David Mitchell, Ph.D., as Senior Vice President of Strategic Engagement, and C. Glenn Begley, M.D., Ph.D., and Colin Pillai, Ph.D., as Senior Scientific Advisors. These strategic hires aim to deepen expertise in model-informed drug development and enhance partnerships with various stakeholders, further positioning Certara in the biopharmaceutical sector.
Certara Receives FDA Grant for Biosimulation Model
On September 20, 2021, Certara (Nasdaq: CERT) announced the award of a U.S. FDA grant to enhance its Simcyp MechDermA™ model for assessing virtual bioequivalence in generic drug development. This is the fourth grant awarded to Certara for this purpose. The project aims to verify the predictive performance of biosimulation models, ensuring safer and cost-effective drug development. The Simcyp model previously demonstrated bioequivalence for diclofenac sodium topical gel in 2019, helping to streamline clinical trial requirements.
FAQ
What is the current stock price of Certara (CERT)?
What is the market cap of Certara (CERT)?
What does Certara, Inc. do?
Who are Certara's main clients?
What are Certara's key products?
How does Certara differentiate itself from competitors?
What industries does Certara operate in?
How does Certara help reduce clinical trial costs?
What is Certara Cloud?
What is model-informed drug development (MIDD)?
What regulatory agencies does Certara work with?
Where is Certara headquartered?
