Certara is the leading drug development consultancy with solutions spanning the discovery, preclinical and clinical stages of drug development.
Phoenix 8.1, the newest version of Certara’s innovative PK/PD modeling and simulation software used globally by researchers and drug developers in pharma, academia, and regulatory agencies, will be available on June 15, 2018. Major enhancements were introduced in the Phoenix workbench last year. And as an ongoing commitment to support compliance and efficiency, many features […]
Read MoreThis webinar introduced the importance of bioanalysis and its downstream effects on clinical development and clinical pharmacology.
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There are numerous challenges in developing oncology drugs: (1) they are often very toxic which precludes conducting clinical trials in healthy volunteers, (2) the PK of a drug may be altered in cancer patients due to demographic and physiological differences as compared to healthy volunteers, and (3) cancer patients face elevated drug-drug interaction (DDI) risk […]
Read MoreA selection of short essays from our blog, written to empower our customers with modeling and simulation (M&S) and regulatory writing solutions in order to help them solve the toughest drug development problems. Certara staff contributions range in topic from pharmacometrics to systems biology to the growing importance of regulatory writing and sharing clinical trial results.
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Modeling and simulation (M&S) of complex systems has primarily advanced vertically in differing scientific domains with a variety of domain-specific approaches and applications. The pharmacology to payer (P2P) concept is a way to connect independent domains to address drug development market failures. As an initial proof of concept, we collaborated with a team of clinical pharmacologists, […]
Read MorePRINCETON, NJ – Mar. 12, 2018 – Certara today announced that it is partnering with faculty at the UNC Eshelman School of Pharmacy to launch the Model-informed Drug Development (MIDD) Gran Prix at the 2018 American Society for Clinical Pharmacology & Therapeutics (ASCPT) Annual Meeting.
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Many companies have tried and true clinical pharmacology practices. But when the rubber hits the road for your drug program, will these practices support regulatory success? Has your historic approach to drug development been updated to include the latest modeling and simulation innovations? It’s hard to change how you’ve historically done things. But, do you […]
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Pharmacology to the payer (P2P) is an innovative approach to create a framework for dialogue between drug sponsors, regulators, and payers. The core structure is the sequential linking of quantitative mathematical models—pharmacology, pharmacokinetics/pharmacodynamics (PK/PD), disease progression, epidemiology, health utilization, and health economics. In this blog post, we discuss how working with an amazing team of […]
Read MoreWatch this webinar with Dr. Graham Scott, Senior Director of Clinical Pharmacology at Certara Strategic Consulting, to learn why you should invest in “apocalyptic clinical pharmacology.” Dr. Scott presented case studies that illustrate how sponsors can benefit from a clinical pharmacology strategy that uses model-informed approaches to inform and “fill in the gaps” of clinical trials.
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Analogous to how a geologist surveys the “lay of the land” to determine if oil lies underneath, or an investment advisor strives to understand the “lay of the land” to decide how to invest in a turbulent market, sponsors and regulators also need to determine how to best utilize and report modeling and simulation results […]
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During my years reviewing applications for the US FDA, I encountered a lot of poor planning concerning a drug’s clinical pharmacology program. This poor planning left the company either lacking data to make informed decisions or scrambling at the end of development to address unanswered issues. Early planning is key to regulatory success, not only […]
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In JRR Tolkien’s Lord of the Rings, the power of the one ring forged by the evil sorcerer, Sauron, is used to control all of the disaggregated, independent kingdoms of Middle Earth. Similarly, but without the malice, the “pharmacology to the payer” (P2P) quantitative framework can be viewed as a way to unite and connect […]
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Orphan drugs are used to treat rare diseases and disorders. This year marks the 35th anniversary of both the landmark Orphan Drug Act, a law passed by the US FDA that created legal and financial incentives for pharma and biotech to pursue rare disease R&D, and the formation of the National Organization for Rare Disorders […]
Read MoreOrphan drugs affect 350,000 people worldwide, including 10% of the US population and 1 in 25 Europeans. Model-informed drug development (MIDD) approaches, such as PBPK and PopPK have been embraced by sponsors and regulators, and play a key role in modernizing and accelerating orphan drug development.
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Drug developers can’t take an adult clinical trial protocol and simply retool it for pediatrics. Yet, in my work at a pediatric clinical research organization (CRO), I frequently see sponsors attempt to do just that. Successfully implementing a pediatric drug development plan poses challenges regarding trial planning, design, and conduct. In this blog post, I’ll […]
Read MoreWatch this webinar to learn from Dr. Julie Bullock, Senior Director of Consulting Services at Certara, how gap analysis can help you ensure that your development program will contain all the elements needed to satisfy regulators and investors during all phases of drug development from IND to NDA.
Read MoreMounting healthcare and R&D costs, high drug attrition rates leading to decreased numbers of new molecular entity approvals, and growing demands from regulators and payers indicate that a paradigm shift is needed to improve efficiency and productivity across the drug development continuum.
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In my 35 years of working to develop safer, more effective medications for children, I’ve often been asked about how to navigate the regulatory landscape in the US and Europe. In a previous blog post, I discussed the latest FDA trends regarding pediatric drug development. In this blog, I’ll focus on the path for achieving […]
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