BIO From The Editor and Guest Columns
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Life Sciences RIM: Modernization & Moving Ahead
9/28/2022
Life sciences companies are getting more strategic and ambitious about regulatory information management (RIM). This article shares four key findings from an industry survey and insights for moving ahead in today's world, including a look at advanced technology's role.
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Pharma Process Validation: Initial Conclusions Are Often Deceptive
9/26/2022
As a pharmaceutical consultant, this author has observed many pharma process validation outcomes. In this article, he provides insights into two recent process validation problems that could have been avoided with an enhanced developmental approach and a greater understanding of the impact of CMAs and CPPs.
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6 Best Practices For Biopharma Talent Management In 2023
9/23/2022
The Great Resignation. Inflation and the rising cost of goods and services are compelling workers in a variety of industries to seek higher salaries. This is being acutely felt in the life sciences industry. We need to revolutionize how we're approaching talent management in pharma and biopharma in order to succeed in this environment.
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The “Liberation” Of Science Yields A New Class Of Biopharma Leadership
9/21/2022
Purespring Therapeutics’ Richard Francis is among the dozens of big pharma executives who have defected to biopharma startups on the science, tech, and finance tides. “When I saw some of the acquisitions we were doing, it occurred to me that there’s no correlation between the places from which good science is emerging and a big R&D budget," he says.
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3 Strategies For Small & Midsize Biotechs To Launch Drugs Successfully
9/21/2022
Small and midsize biotechs can no longer rely on traditional commercial models. Launching new drugs is one of the most critical phases in the product life cycle, and often these entities’ entire existence depends heavily on a successful rollout. This article shares trends and three strategies for success.
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Biden’s Biologics Mandate And A Moonshot
9/19/2022
Thoughts on biotech executive orders, cancer cabinets, moon landings, and other important public/private partnership news you might have missed while the rest of the country was screaming at each other over inflation and social politics.
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Collaborating With Academia For Drug Discovery Targeting Immune-Mediated Diseases
9/16/2022
Last year, Janssen Biotech and the University of Oxford established a collaboration to understand pathogenic pathways driving immune-mediated inflammatory diseases. They have been creating a cellular map of expressed genes and proteins. This article shares what the collaboration has accomplished so far.
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Decentralized CAR-T Manufacturing Reduces Costs & Complexity, Expands Access
9/14/2022
High costs are endemic to CAR-T cell therapy treatments, leading to a large gap in healthcare between those who can afford to pay and those who cannot. However, changes in manufacturing processes — namely decentralizing them — can reduce costs and complexity while also expanding patient access.
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Biopharma Facility Modular Design & Construction: Key Considerations
9/12/2022
In terms of facility design, the term “modular design block” is used for “pre-engineered” or “predesigned” solutions. This approach suggests that a new facility design need not be unique but can use and leverage a pre-engineered set of component pieces. The further down the supply chain that standardized modules and components reach, the wider the benefits to the entire industry.
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Nearing An IL-2, IL-15 Combination Inflection Point
9/11/2022
In a therapeutic space crowded with clinical activity, IL-2/IL-15 frontrunners are emerging, many of them in combination programs with big-time biologics. We caught up with one of those frontrunners, SOTIO CEO Radek Spisek, Ph.D., for perspective from the front of the pack.