BIO From The Editor and Guest Columns
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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.
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Risk And Supply Chain Continuity Management: Biologics Industry Perspectives
2/26/2024
We spoke to three long-standing members of BioPhorum’s Risk and Business Continuity Workstream about their companies’ approaches to risk management, supply chain continuity, and what they learned from the pandemic. Among them are Melinda McCants, senior resiliency officer at Amgen.
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Precision Radiopharmaceuticals with Ratio's Jack Hoppin, Ph.D.
2/21/2024
Multimodal approaches to the delivery of radiologically active compounds have created a fertile environment for players in the space to put on a precision medicine clinic, so to speak. What’s more, Radiopharmaceuticals create a unique business opportunity given the closely related and necessary companion diagnostic arena.
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Understanding And Navigating Diverse Regulatory Environments
2/21/2024
Drug developers aspire to treat patients globally, but navigating diverse regulatory structures around the world gets tricky. These consultants offer a primer on the regulatory bodies of the world.