Certara is the leading drug development consultancy with solutions spanning the discovery, preclinical and clinical stages of drug development.
Certara’s due diligence/asset evaluation teams are comprised of drug development and commercialization experts who advise on acquiring or investing in emerging biopharma companies.
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 MoreAs the process of drug development has increased in cost and complexity, Certara has developed a service offering to assess a sponsors’ development program across multiple domains, and to craft a strategy to address each.
Read MoreClinical pharmacology accounts for about 50% of a drug label. Its scope ranges from facilitating the discovery of new target molecules to determining the effects of drugs in different populations. From both industry-wide and regulatory perspectives, the levers of clinical pharmacology can address the huge challenges of late-stage attrition and increase the efficiency of drug development in the quest to bring the “ball” into the end zone.
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Do you get anxious about taking tests? Many people do because they want to show their best efforts. Submitting your New Drug Application (NDA) to the FDA can be thought of as the ultimate test of a drug program. Are you confident that you’ll have robust answers to the 40 different questions that the agency […]
Read MoreOctober 4, 2017 – Join this webinar with Drs. Carl Kirkpatrick and Craig Rayner to learn how “pharmacology to payer” (P2P) can be used as a quantitative framework that bridges the disciplines of pharmacology, epidemiology, and health economics to support meaningful dialogue between industry, regulators, and payers.
Read MoreNovember 15, 2017 – Attend 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.
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Will 2017 finally be the year that we overcome the blight of late-stage attrition of promising drug candidates? In a recent commentary, “Improving the Tools of Clinical Pharmacology: Goals for 2017 and Beyond,” in Clinical Pharmacology & Therapeutics, Issam Zineh and colleagues describe several areas where clinical pharmacology approaches can help reduce late-stage attrition and […]
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Thinking Without BordersTM Developing Medicines that MatterTM These guiding principles fueled the creation of d3 Medicine. With a goal of revolutionizing the pharmaceutical paradigm to accelerate developing medicines that benefit society, combining d3 and Certara was a ‘no brainer.’ Delivering on our clients’ mission The d3 Medicine staff join Certara’s Strategic Consulting (CSC) division, which […]
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Pediatric patients are not simply small adults. Children differ from adults in both disease pathophysiology and pharmacokinetics/pharmacodynamics (PK/PD). Yet historically, 80 percent of medicines used in children had little to no data guiding prescribers on proper use. In this blog post, I’ll discuss the challenges of developing drugs for children and explain how quantitative pharmacology […]
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If you have ever argued, as we have, for the resources and time needed for model-based drug development (MBDD), you have likely encountered that irritating accountant in the room who says, “Sure, this modeling stuff sounds interesting, but how much MONEY will this save us?” My answer: $97M of savings per New Drug Application (NDA). […]
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The primary purpose of a clinical trial is to address a scientific hypothesis. To address a hypothesis, different statistical methods are used depending on the type of question to be answered. Most often the hypothesis is related to the effect of one treatment as compared to another. For example, one trial could compare the effectiveness […]
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