Tag Archive | "drug development"

Simulation and Modeling: Is Pharma Light Years Behind Aerospace?

By Paul Thomas, Senior Editor

In a recent article in the Journal of Computer Aided Molecular Design, Walter S. Woltosz, chair and CEO of Simulations Plus, a maker of simulation and modeling software for pharmaceutical R&D, ponders the question of why computer-based simulation and modeling for drug discovery and development are so far behind that done in other industries, particularly in aerospace. Woltosz has experience working in both aerospace and pharma.

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Merck’s Integrated QbD Approach: Patient-Focused and Bringing Manufacturing Closer to Development

By Paul Thomas, Senior Editor

At AIChE 2011 in Minneapolis yesterday, a team from Merck discussed the approach the company has taken to better integrate QbD work among drug substance and drug product teams, and across the organization in general. The talk was part of the inaugural AIChE Excellence in Integrated QbD Practice Award session, chaired by Eric Ahuja and John Lepore, two of the leaders at Merck in advancing QbD. (We’ll have more on the award winners in the coming days.)

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Should Fast-Track Process Serve as a Model for All FDA Approvals?

FDA’s accelerated approval process has been used to speed time to market for severe or life-threatening diseases since 1992, and many drug manufacturers regularly take advantage of the program—which requires less pre-market clinical activity (based upon surrogate study endpoints) with the expectation of increased post-approval confirmatory studies.

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The Need for New Models in Finding New Molecules

By Paul Thomas, Senior Editor

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Rees’ Modest Proposal: Fully Integrated Research & Development

In a just-posted audio interview with Gareth Macdonald of inPharmatechnologist.com, Hedley Rees, managing consultant at Biotech PharmaFlow, describes his vision of a two-stage drug development model, one that includes a design stage (fully integrating research and development units) and manufacture stage.

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QbD Classics: Process Modeling and Control in Drug Development and Manufacturing

What are the must-read texts of Quality by Design? I posed this question recently on LinkedIn, and would love to hear your input. Here is another nomination, from Pfizer’s Salvador García Muñoz, who with Cynthia A. Oksanen, edited the July 2010 issue of Computers & Chemical Engineering, a special issue devoted to Process Modeling and Control in Drug Development and Manufacturing.

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