By Bikash Chatterjee, President and CTO, Pharmatech Associates

As major blockbuster drugs come off patent, the scramble among generics to capture these new markets is just beginning. We can expect the U.S. market to experience continued change and consolidation with cost cutting remaining at the top of the priority list for big pharma. We can also expect emerging market drug powerhouses to try and gain market share as these blockbusters come off patent. Pressure to be competitive in these new market opportunities is creating a sort of perfect storm.

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By Ali Afnan, PhD, Principal, Step Change Pharma, Inc.

Over the years, pharma’s key objective has changed very little: getting active pharmaceutical ingredient to the patient. Although we no longer dose extracts of willow tree bark, the practice of blending API with excipients to add bulk or facilitate flow dates back to the Romans. The Remington tablet press or gelatin capsules of 1875 remain virtually unchanged today. Regulations haven’t changed that much either, in the fifty years since most of them were drafted.

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by Agnes Shanley

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By Paul Thomas, Senior Editor

This month, the not-for-profit Regulatory Harmonization Institute was launched, with the mission of being a regulatory body to better represent the interests of emerging countries and “non-regulatory stakeholders.” (Read RHI’s press release here.) Founding members include BIO, the Generic Pharmaceutical Association (GPhA), and other notable global organizations, as well as representatives of AstraZeneca, Bausch & Lomb, and other major drug and device manufacturers. (See below for profiles of the organization’s leadership.)

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By K.R. Karu, Industry Solution Director, Sparta Systems

[Editor's Note: This article originally appeared on the Sparta Systems Blog. Permission to republish has been granted by Sparta Systems.]

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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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