As part of part of Advanced Therapies Week in Miami, FL, alongside the World Stem Cell Summit this past January, the 2020 Phacilitate Leaders World event was one of the last major biotechnology conferences to take place as planned in 2020 before the coronavirus pandemic changed everything. BPI was a major partner at this event, and in this month’s featured report, we highlight the aspects of the conference that will be of greatest relevance to our readers.

BioProcess Insider and BioProcess International editors come together to report on what can best be characterized as a “reality check” for the cell and gene therapy industry. While financing flows in, companies are facing questions over how best to spend that money. Manufacturability issues continue, quality control challenges remain, and investors want to see results now. Even before COVID-19 introduced a new layer of difficulty, the industry was juggling a number of concerns and suffering from some growing pains. The articles below will give you a snapshot of this business on the brink of greatness.

Patient Access Tops the List of Advanced Therapy Milestones at Phacilitate 2020, by Dan Stanton
At Phacilitate, Susan Nichols (chief executive officer for Falcon Therapeutics) highlighted 10 events from 2019 that drove conversation, investment, and innovation in regenerative medicine. Although clustered regularly interspaced short palindromic repeats (CRISPR), business consolidations, and production capacity powered the cell and gene therapy (CGT) space, a new, proactive focus on patient access topped Nichols’s roundup. Here, BioProcess Insider founding editor Dan Stanton summarizes her “top 10” and sets the stage for the discussions to come.
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Discussions at Phacilitate 2020: On Business, Manufacturing, and Future Trends, by Cheryl Scott
Presenters in Phacilitate’s three main program tracks represented sponsor-developers of cell and gene therapy products, contract service providers, and technology suppliers to the industry. Topics included process and product development strategies for advanced therapies, regulatory and inspector expectations, automation and closed-system processing, the choice between in-house and outsourced manufacturing, quality assurance and control, analytical methods, viral vectors, and artificial intelligence and industry 4.0. Here, BPI senior technical editor Cheryl Scott reports on discussions across the three main program tracks: manufacturing, future trends, and a “biotech bootcamp” for the leaders of young companies.
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The Technology of Tomorrow — Today, by Dan Stanton
Sponsored by BPI and BioProcess Insider, the “Tech of Tomorrow Zone” at Phacilitate 2020 played host to a number of companies showcasing platforms and ideas that they believe could revolutionize cell and gene therapy manufacturing. Some common themes arose in this diverse zone, highlighting technologies from stem-cell supply solutions to viral-vector filling. Participating companies are aware of the complexities involved in producing regenerative medicines, and each proposed solution was intended to reduce the burden on cell and gene therapy developers in bringing their products into and through clinical testing. Cost of goods (CoG) is a major talking point in current processes, so every company was conscious of how its ideas can fit with industry’s drive to reduce CoG and improve cell and gene therapy accessibility to patients.
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