Louis Cicchini on Muck Rack

Louis Cicchini

(He/Him)
Denver
As seen in: Drug Discovery & Development, Pharmaceutical Executive, Cell & Gene, Modern Retina
Covers:  Drug development Advanced therapies Cell and gene therapy FDA, CBER, OTP Regulatory compliance and affairs
Doesn't Cover: COVID, traditional pharmaceuticals, prophylactic vaccines
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Five Steps for Successful CGT Commercialization Through Health Systems Partnerships | PharmExec

Five Steps for Successful CGT Commercialization Through Health Systems Partnerships | PharmExec

A successful transition from clinical development to commercial launch in cell and gene therapy requires earl…

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Q&A for innovators: Navigating the complex regulatory world of ATMPs/CGTs | Cencora

Q&A for innovators: Navigating the complex regulatory world of ATMPs/CGTs | Cencora

Navigating the complex world of ATMPs and CGTs? Explore this Q&A to better understand the key regulatory diff…

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Reducing the risk of CRLs for CGTs

Reducing the risk of CRLs for CGTs

How cell and gene therapy manufacturers can lessen the chances of receiving FDA complete response letters thr…

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How Cell and Gene Therapy Developers Can Reduce Risk of FDA Complete Response Letters With Proact...

How Cell and Gene Therapy Developers Can Reduce Risk of FDA Complete Response Letters With Proact...

How cell and gene therapy developers can lessen the chances of receiving FDA complete response letters throug…

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Strategies to drive accessibility and commercial success

Strategies to drive accessibility and commercial success

The cell and gene therapy (CGT) field is advancing rapidly. An ongoing parade of standout innovations is now…

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The future promise of advanced therapies in ophthalmology

The future promise of advanced therapies in ophthalmology

Cell and gene therapies in development for unmet needs.

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FDA's New Accelerated Approval Draft Guidance

FDA's New Accelerated Approval Draft Guidance

What biopharma companies need to know about this evolving regulatory pathway.

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Navigating the landscape of cell and gene therapy development: Insights from the FDA’s new FAQ

Navigating the landscape of cell and gene therapy development: Insights from the FDA’s new FAQ

FDA cell and gene therapy guidance in a FAQ format provides insights on regulatory strategies and safety. Thi…

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Beyond Definitions: The Intricacies of Cell Therapy Categorization

Beyond Definitions: The Intricacies of Cell Therapy Categorization

Explore complexities of cell therapy categorization and its evolution to understand how naming conventions ai…

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Takeaways From Cencora's Inaugural Cell And Gene Therapy Summit

Takeaways From Cencora's Inaugural Cell And Gene Therapy Summit

Collaboration, communication, and competition are key to advancing cell and gene therapy. Experts share insig…

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Transformative Value of Cell and Gene Therapy

Transformative Value of Cell and Gene Therapy

A deep dive into the transformative value of cell and gene therapy.

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