Life Science Connect Blog
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mRNA & RNA Therapeutics In 2023: Where Do We Go From Here?
12/7/2022
To figure out what the future holds for companies in the RNA sector of the ATMP space, I sat down with four executives to discuss their wildest hopes, dreams, and expectations. As you’ll note, there is no shortage of work facing the RNA therapeutics industry in the year(s) ahead. But there’s also a lot for which we can hope.
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"Lean On Me": Defining Risk-Sharing In Cell & Gene Therapy Manufacturing Partnerships
11/1/2022
While I cannot define precisely what (or which) shape(s) risk-sharing will take for the multitude of unique CGT products in the works, I’ve been privy to several conversations that go a long way toward defining the current state of these evolving ATMP outsourcing partnerships and business models.
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“Risky Business:” How Cell & Gene Therapies Are Upending Partnership Models
10/25/2022
This article is the final installment of a three-part series examining how advanced therapy scientific and quality expectations are impacting outsourcing business practices/models today and, hopefully, creating a foundation for greater risk-sharing in the future.
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Beyond “The Building Phase”: Evolving The Cell & Gene Outsourcing Paradigm
10/18/2022
This article is part two of a three-part series examining how advanced therapy scientific and quality expectations are impacting outsourcing business practices/models today and, hopefully, creating a foundation for greater risk-sharing in the future.
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“Science Over Steel:” Exploring The Foundations Of A Hybrid CGT Outsourcing Strategy
10/11/2022
This article is part one of a three-part series examining how advanced therapy scientific and quality-related challenges are impacting outsourcing models. We start first by unpacking the considerations ATMP innovators are faced with as they evaluate the increasingly popular hybrid outsourcing model.
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From Manufacturing To C-Suite: “Scaling Up” C&G Therapy Communication
6/20/2022
Though "communicate often" is a commonly offered best practice in the CGT space, what is rarely discussed is what this can and should look like, especially when it comes to elevating information from the manufacturing floor/team up to the C-suite. Mark Gergen, CEO of Poseida Therapeutics, gives us a great idea of what this can look like for growing CGT companies.
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The “Renaissance” Approach To Cell & Gene Therapy Manufacturing
6/13/2022
We’re all familiar with the concept of the “Renaissance Man/Woman". In the context of the CGT space, however, can there be such a thing as a “Renaissance Company”? My conversation with Poseida Therapeutics' CEO Mark Gergen proves that there can be and establishes why a generalist mindset is necessary to bring the CGT manufacturing paradigm to maturity.
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Can USP, NIST, & NIIMBL Conquer The Biggest AAV Quality Challenge?
5/18/2022
As the CGT industry continues struggling to sufficiently characterize its AAV, USP's Fouad Atouf and I unpacked the ins-and-outs of this ongoing USP, NIST, and NIIMBL AAV quality initiative — as well as the CGT industry’s greatest needs from such a collaboration.
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A Different Perspective On The Current C&G Manufacturing Capacity Constraints
5/10/2021
If you talk to anyone today about the decision behind constructing their own manufacturing facility, you’re likely to run into one of two big reasons spurring companies to make the investment in their own manufacturing footprint.
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Two Tips On Navigating C&G Outsourcing Relationships In A Competitive Landscape
5/4/2021
It can be a bit overwhelming to keep tabs on all the movement occurring in the C&G industry today. You can’t open a newsletter or read an article without learning about company launches or acquisitions, clinical/manufacturing/regulatory milestones (or pitfalls), new partnerships, or facility ribbon cuttings/shutterings. While most of the glitzier headlines on C&G manufacturing highlight firms’ decisions to keep manufacturing in-house, outsourcing still plays — and will always play — a critical role in the development of these complex therapies.