BIO From The Editor and Guest Columns
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Debra Weiss, RN: Big Impact In Small, Non-Profit Bio
3/8/2024
The career of Debra Weiss, RN, MSN, and COO at the biopharma Gates Medical Research Institute (Gates MRI), offers a case study in creating success through service-oriented leadership.
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Navigating China's Biologics Approval And Accelerated Pathways
3/8/2024
Pharma companies doing business in China have four key routes to register drugs faster than the standard ways. This discussion breaks down accelerated pathways and offers tips on how to approach them.
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Shocking! Biotech Facilities Don't Maintain Themselves
3/4/2024
Don't get trapped in the misconception that only biomanufacturing process systems need maintenance. Here are some real-life examples of facility maintenance programs gone wrong.
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The Innovator's Dilemma with Lumen Bioscience's Brian Finrow, J.D.
3/3/2024
In biotech, when "one of these things doesn't look like the other one," it can be a blessing or a curse. On one hand, scientific novelty is praised and rewarded. On the other, unfamiliarity breeds skepticism from the investment community. Brian Finrow, J.D. embraces that reality and the challenges that come with it.
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Green Gains In Biopharma Without Closing Facilities?
2/29/2024
Going green is virtually impossible for biopharma companies with legacy systems, but going greener might be within reach. Here are some ideas to get started.
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Comparability Considerations For mRNA Product Development
2/28/2024
Given the mRNA-based products' variability and unique challenges, you may need to modify the standard comparability approach. Let’s discuss strategies for any development stage.
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FDA’s Updated Guidance On Human Genome Editing: New Implications & Remaining Questions
2/27/2024
On Jan. 29, 2024, the FDA released the final version of the guidance document on human gene therapy products incorporating genome editing. This article shares what changed between the draft and now final version of the guidance, and what open questions remain for the industry and scientific community to help resolve.
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How Pharma 4.0 Can Unlock The Full Potential Of External Manufacturing
2/27/2024
To address today's challenges and other headwinds, pharma/biotech organizations and CMO/CDMO partners need to re-evaluate and improve externalized operating models. Consider further investing in digitalizing collaboration processes as part of operational excellence and digital transformation road map efforts.
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The Industry’s Positive Outlook For ADCs In 2024
2/26/2024
Check out the results of DeciBio's Antibody-Drug Conjugates 2024 Industry Survey, which predict another bullish year for the growing modality.
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Process Mapping For More Effective Knowledge Management
2/26/2024
It takes a patchwork of knowledge from multiple complementary mapping tools to generate the process knowledge needed for success in pharmaceutical and biologics manufacturing.