Falcon Therapeutics CEO Susan Nichols presents her keynote at Phacilitate 2020.
(WWW.PHACILITATE.COM)
In a highly anticipated presentation at the 2020 Phacilitate Leaders World event — part of Advanced Therapies Week, along with the World Stem Cell Summit in Miami, FL — 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 in 2019, a new proactive focus on patient access topped Nichols’s roundup. Here, in reverse order, is her full list.
10: Patent Infringement Upheld:
In December 2019, a jury found Kite Pharma (Gilead Sciences) guilty of infringing a patent exclusively licensed by Juno Therapeutics (Bristol-Myers Squibb, BMS) from researchers at the Memorial Sloan Kettering Cancer Center. The patent in question rela...
An attentive audience at Phacilitate 2020
(www.phacilitate.com)
Presenters in the three main program tracks at the Phacilitate Leaders World conference in Miami, FL, this past January represented sponsor-developers of cell/gene-therapy (CGT) products, contract service providers, and technology suppliers to the industry. Topics include 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. At the end of each session, presenters gathered for a short roundtable discussion and questions from the audience.
Biotech Bootcamp
Even as large amounts of money are pouring into the industry, the arena of financing and commercialization presents a daunting labyrinth to many young companies working on CGT candidates. Often founded by scientists and physicians rat...
Graduate research assistant Mason Chilmonczyk examines a dynamic-sampling device after plasma etching in a cleanroom at the Georgia Tech Institute of Electronics and Nanotechnology’s Marcus Building. (Rob Felt, Georgia Tech)
Sponsored by BioProcess International and its sister publication
BioProcess Insider
, the “Tech of Tomorrow Zone” at Phacilitate 2020 played host to a number of companies showcasing platforms and ideas that they believe can revolutionize cell and gene therapy (CGT) 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 CGT developers in bringing their products into and through clinical testing. Cost of goods (CoG) was a major talking point in current processes, so every company was conscious of how its ideas — whether for a microfluid...
schedl_b_and_w.jpg?width=100&auto=webp&quality=80&disable=upscale "Picture of Dan Stanton")
