Drug Discovery, Drug Research Editorial
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Quality And Regulatory Professionals Joined At The Hip
11/27/2023
The context and scope of what quality, regulatory, and technical teams – CMC development professionals – need to accomplish has changed dramatically. It’s a different paradigm, and when you add a CDMO to the mix, it's a very interesting conversation.
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What We Need To Unlock Next-Generation mRNA Therapeutics
11/13/2023
mRNA is an incredibly nimble platform for drug discovery and development, but in order to truly unlock the next generation of mRNA therapeutics, we need to think outside the box (and we also need more funding).
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Baxalta v. Genentech: The Latest Case In Patenting Functionally Claimed Antibodies
11/10/2023
On Sept. 20, 2023, in Baxalta v. Genentech, the Federal Circuit invalidated patent claims directed to functionally claimed antibodies, finding that they failed to satisfy the enablement requirement. The author of this article is a patent attorney and he shares the key takeaways for biotech/pharma companies going forward.
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Legal And IP Protection For New Biotechs
10/31/2023
Want to ensure you've got your biotech legal, IP, and patent bases covered? Join Business of Biotech host Matt Pillar and BlueSphere Bio CEO and biotech legal expert Keir LoIacono on 11/13 for the live, interactive, and FREE digital event Legal And IP Protection For New Biotechs.
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Key Considerations For Cell & Gene Therapy Developers To Tap Into AI
10/24/2023
In the authors' first article in this two-part series, they discussed the opportunities for AI to assist cell and gene therapy companies. In this second article, they examine how cell and gene therapy developers can wisely harness AI, with a look at outsourcing vs. developing in-house solutions, data acquisition strategies, the three stages of managing AI/ML algorithms, and more.
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Oh, Oligonucleotides! Everybody Wants In
10/23/2023
“We’re working on oligonucleotides,” says the bubbling biotech. “We can do oligos!” cries the eager CDMO. So it’s a deal? Hang on, says Tony Sampognaro, Director, CMC Project Management, at oligo-focused Stoke Therapeutics.
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Outsourcing Needs More MBAs (Yes, You Read That Correctly)
10/16/2023
Tony Sampognaro of Stoke Therapeutics recently received his MBA. He thinks many others in our industry should do so as well. He believes its what we need to outsource more efficiently, and work better with CDMOs.
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Opportunities For AI To Assist Cell & Gene Therapy Companies
10/10/2023
Although AI/ML is still in a nascent stage in the cell and gene therapy sector, it has an enormous amount of potential to transform overall business models, early R&D, clinical trials, manufacturing and operations, and regulatory compliance support in these key ways.
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More Gene Therapy Outsourcing – Can It Be Quantified?
10/9/2023
According to ISR Reports inaugural Gene Therapy CDMO Benchmarking survey, well over half the respondents confirmed a complete manufacturing reliance on external partners. Outsourcing has sure come a long way ... more details within.
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Using Automation For Antimicrobial Screening
10/5/2023
A major challenge with antimicrobial drug development is the necessity to test millions of drug compounds in the hope of finding one that will kill a given microbial pathogen. Laboratories are using robotic machines and automated solutions to try growing previously unculturable organisms that might be sources of antimicrobial compounds — and these efforts are finding success.