Emerging Issues for Pharma R&D: A Practical Approach for Pediatric Drug Programs

In this webinar, Dr. Barry Mangum from Paidion Research and Dr. JF Marier from Certara discussed how pediatric considerations fit into the overall drug development program. They also made recommendations for addressing issues from both a practical and scientific perspective. Anonymized case studies were presented with a review of historical issues with a focus on solutions for today (ie, licensed comparators differences in US and EU, importation issues, and endpoint selection).

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Certara’s Best of Blogs 2016

A 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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Rare Disease and Orphan Drug Development

There are 7,000 rare diseases impacting 350 million patients worldwide, yet only 300 of these diseases have approved treatments. This gap, impacting 95% of those suffering from rare diseases, represents a huge unmet medical need. Modeling and simulation approaches are not only ideal for the development of drugs for rare diseases, but are encouraged by regulators.

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Learning from Failure: Leveraging Biosimulation for Pediatric Drug Development Success

The high rate of trial failures, increasing regulatory demands, and ethical imperatives all require a reexamination of the current approach to pediatric drug development. Biosimulation is a proven approach that will help optimize trial design and inform the drug label. This approach can support global regulatory strategies that increase the likelihood of success for pediatric drug development programs.

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Conducting Virtual Trials Using PBPK to Drive More Precise Label Claims

Biosimulation technology is revolutionizing the way in which the pharmaceutical industry does business and how the regulators are reviewing new drug approvals. Biosimulation leverages both empirical analysis of clinical data and mechanistic in silico approaches. The latter approach encompasses both in vitro-in vivo extrapolation (IVIVE) and physiologically-based pharmacokinetic modeling and simulation (PBPK M&S).

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Modeling and Simulation Supports Post-Approval Commitment in Oncology

Modeling strategy provided sponsor with rational basis for quantifying efficacy benefit of approved dose to avoid Phase IV trial, saving $6-20 Million and redirecting resources towards other programs. A global biopharmaceutical company was seeking to fulfill a post-approval commitment to regulatory authorities for its currently approved oncology drug. Regulatory approval in the given indication was […]

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Modeling and Simulation Supports Competitve Product Profile Assessment

Modeling strategy provided sponsor timely and compelling support for positive efficacy signal of in-licensing candidate, helping to secure $23 Million financing round and advance compound to Phase IIB. A specialty pharmaceutical company was seeking to provide rapid, quantitative support to fund its in-licensing strategy for an oral Type 2 anti-diabetic agent. Limited data from a […]

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