The Enterprisers
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Manufacturing And Supply Chain: Making Space Between A Rock And A Hard Place
12/1/2023
Biopharmaceutical companies can’t afford to halt production lines due to manufacturing violations next year. Manufacturing and supply chain processes will require fresh thinking and flexibility in 2024.
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The Power Couple Behind Krystal Biotech
11/1/2023
Krish and Krishnan, the husband-and-wife team that founded and leads Krystal Biotech, cleared a path to market for the first ever topical and redosable gene therapy.
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4 Ways To Gain A Competitive Edge In This Bio/Pharma Talent Shortage
11/1/2023
Pharmaceutical companies should prioritize gaining control over the talent management process in order to build a robust candidate pipeline. Here are four effective strategies for recruiting, training, educating, and retaining workers.
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Companies To Watch: Freya Biosciences
11/1/2023
Freya Biosciences is enlivening the long-time lonely space of reproductive health, starting with a new focus on the vaginal microbiome.
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In September, You Testified Before Congress On The Inflation Reduction Act’s (IRA) Real-World Impact On Rare Disease R&D And Small Molecule Therapies. Can You Summarize The Key Points?
11/1/2023
See the answer from John Crowley, chairman and CEO at Amicus Therapeutics.
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How Prioritizing OpEx Can Raise Sinking Biopharma Valuations
11/1/2023
As investment in the life sciences industry decreases, young companies struggle to keep the lights on. Young companies may overcome these challenges by implementing operational excellence (OpEx) early on in drug development rather than waiting until manufacturing startup.
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AI & ML: A Review Of EMA And FDA’s Approach
11/1/2023
In this article, we outline the AI- and ML-related documents and guidances the FDA and EMA have released thus far, comparing and contrasting their areas of focus and concern.
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Navigating The Complexities Of Research In Private Practice
11/1/2023
The clinical trial ecosystem is complex, but making smart choices and enlisting effective help allows private practices to contribute to life-changing research.
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Pfizer To Provide Individual Participant Data At Scale
11/1/2023
Pfizer has made a commitment to return individual data to its clinical trials participants through its Participant Data Return initiative.
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Building A Business Model For Novel Antibiotics
11/1/2023
In the challenging development space for novel antibiotics, Spero Therapeutics is using partnership, external validation, and formulation science to develop drugs treating bacterial infections both rare and common.