Certara is the leading drug development consultancy with solutions spanning the discovery, preclinical and clinical stages of drug development.
In a recent Expert Review of Clinical Pharmacology article, I assessed the status and future direction of precision dosing in clinical medicine.1 Model-informed precision dosing (MIPD) is a modeling and simulation (M&S) approach in healthcare that is used to predict the most effective and/or least toxic drug dose for a patient. MIPD could revolutionize healthcare […]
Read MoreBiologic drug development is a rapidly evolving sector in the biopharmaceutical industry. Immunogenicity is an inherent challenge with this complex class of drugs. A quantitative systems pharmacology approach can be used to predict and better manage immunogenicity, and as a tool to guide clinical and regulatory decision-making in biologics drug development.
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In the ongoing commitment to education and coinciding with the launch of Phoenix 8.1, Certara has introduced a new certification program available through Certara University. The new online accreditation program validates the scientists’ PK/PD data analysis skills using Certara software such as Phoenix WinNonlin and expands their professional reach. I caught up with Ana Henry, […]
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As a quality consultant and quality system subject matter expert in the Life Sciences Industry for over 25 years, I have worked for many pharmaceutical companies both large and small and as a consultant with many clients in the pharmaceutical, biotech, and medical device industries. These clients possess a range of experience in software validation—from […]
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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 MoreCertara performed scientific and commercial due diligence of an investment opportunity (Rivipansel for Vaso-Occulisive Crisis in Sickle Cell Disease) for a private equity firm.
Read MoreCertara Strategic Consulting scientists used model-based meta-analysis (MBMA) to support developing a fixed-dose combination of ezetimibe and atorvastatin.
Read MoreMaking the right choices in drug development often means the difference between getting a new medication to patients and it ending up in the scrap heap of failed programs. There is a surfeit of publicly available information on approved drugs as well as those currently in development. How can sponsors turn clinical trial data into understanding that helps chart the course for investigational drugs?
Read MoreMBMA integrates internal and external drug development data to inform proprietary commercial and R&D decisions. The insights gained via MBMA support designing less costly and more precise trials with an eye toward achieving commercial success for both the drug and portfolio.
Read MoreStaff writer Ron Rosenberg interviewed Piet van der Graaf, PharmD, PhD, vice president of quantitative systems pharmacology at Certara and former director of XenologiQ, a QSP consultancy.
Read MoreToday’s powerful and actively evolving computational tools enable sponsors and regulators to understand potential drug characteristics and subject responses earlier in development, with greater certainty. Model-based approaches support timely, confident decisions across the development and regulatory life cycle by gathering disparate sources of information about a drug, its competitors, target disease and patients into a […]
Read MorePhysiologically-based pharmacokinetic (PBPK) modeling can address various questions raised in drug development and regulatory review, and is used most extensively to predict and quantify the extent of drug-drug interactions (DDIs) from both in vitro and clinical data. This assists with dose selection and the design of clinical studies as well as informing decisions relating to […]
Read MoreWhile biosimulation has been an important element in drug development for some time, its impact over the past 18 months with regard to label optimization has been profound. Specifically, FDA’s acceptance of Physiologically-Based Pharmacokinetic (PBPK) modeling and simulation has impacted key label elements in more than a dozen cases, driving down R&D costs and timelines, […]
Read MoreRG7652 is a fully humanized monoclonal antibody targeting human PCSK9, a regulator of serum low density lipoprotein cholesterol (LDLc) levels. RG7652 prevents degradation of the hepatic LDLc receptors by blocking PCSK9 binding and thereby resulting in efficient LDLc uptake by hepatocytes. The pharmacokinetics of RG7652 have been evaluated in healthy subjects after single and multiple […]
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