FROM THE EDITOR

Quality Risk Management: Reduce Risk By Embracing It

Despite the resources available to help companies develop a QRM program, such as the ICH Q9, there are several challenges that commonly prevent a successful implementation. Ghada Haddad, director in global sterile and validation at Merck, suggests several best practices that can help overcome these issues. 

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BIOPROCESS INSIGHT

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BIOPROCESS CONTRIBUTING EDITORS

  • CROs In A Business Exchange With Silicon Valley?
    CROs In A Business Exchange With Silicon Valley?

    As an applied economic theoretic, by driving out inefficiencies from the current model used by researchers to find and contract with CROs, the Science Exchange should improve the business model for drug discovery. But will all parties — Pharma/Bio, CROs and individual researchers — benefit equally? 

  • FDA News Roundup: Valeant, Pfizer, Boehringer Ingelheim, And More
    FDA News Roundup: Valeant, Pfizer, Boehringer Ingelheim, And More

    What FDA decisions have you missed recently?

  • Does Adversity Build Character Or Reveal It?
    Does Adversity Build Character Or Reveal It?

    Denice Torres is the president of McNeil Consumer Healthcare, a Johnson & Johnson company, and winner of HBA’s 2015 WOTY award. Listening to her acceptance speech reminded me of legendary pro football coach Vince Lombardi’s philosophy — “Adversity doesn’t build character, it reveals it.” 

  • Pharma’s Orphan Drug Binge: Redefining Corporate Social Responsibility?
    Pharma’s Orphan Drug Binge: Redefining Corporate Social Responsibility?

    A few months ago, Senator Elizabeth Warren launched a proposal for a “swear jar” bill that would require law-breaking Big Pharma companies to contribute 1 percent of the profits from each of their blockbuster drugs to NIH research. While this proposal was highly contested by members of the industry, I questioned if there couldn’t be a benefit to this bill apart from punishing law breakers and bolstering drug R&D. Would seeing pharma push more of its profits into research boost the industry’s image?   

  • Lilly Banks On Equity Investing To Grow Pipeline
    Lilly Banks On Equity Investing To Grow Pipeline

    Lilly continues to partner with academic institutions and biotech companies, and more recently has been entering into a greater number of collaborations with other Big Pharma companies. But one area where the company has devoted significant resources, and which is certainly a big part of Lilly’s partnering strategy, is equity investing.   

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