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The Company at the Crossroads. Part 1: To Commercialize or Not?
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Joseph J. Villafranca, PhD
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Conrad J. Heilman, Jr., PhD
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Siddharth J. Advant, PhD
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Every biotech company reaches a point in its development where it must decide what path it will take after it passes the start-up phase. This article discusses what the company must consider to decide what business model it will follow.
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The Outlook for Quality by Design
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Laura Bush
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The complexity of Quality by Design leads naturally to questions of how much work it requires, how many companies have the resources to do it, and what the payoff is for anybody.
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The Art of the Deal
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Jim Miller
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Risk mitigation should be a key aspect of any contract manufacturing organization's business strategy.
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Minimizing the Problem of OOS
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Steven Walfish
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Statistical methods for calculating confidence intervals, tolerance intervals, and capability analysis to reduce out-of-specification situations.
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Protecting Patents for Personalized Medicine
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Michael J. Shuster
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Pauline Farmer-Koppenol
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There are several challenges associated with protecting patents for personalized medicines.
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Global Manufacturing Challenges Industry Regulators
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Jill Wechsler
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The heparin debacle and other crises involving imported drugs and biologics has put pressure on the US FDA to step up its oversight of foreign drug manufacturing.
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