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Lee Buckler, SVP Advanced Therapies, Blood Centers of America, Advanced Therapies Network, reflects on two decades of working within the advanced therapies industry as Phacilitate celebrates 20 years of operating in the field.
First of all, could you tell me a little bit about your career over the last 20 years?
My career has grown up with Phacilitate. It’s been a beautiful relationship. Together we had great mentors, selfless contributors, and tireless collaborators.
I enjoyed my early days of taking over the ‘Top 10 Events’ mantle from Ed Field, and then handing it over to Susan Nichols.
Check out the agenda for more information on this year’s Opening Plenary >>
My Phacilitate contracts and talks reflect the evolution of my career including Progenitor Cell Therapy, Cell Therapy Group, Regenerative Medicine Jobs, Key Biologics, RepliCel Life Sciences, and Blood Centers of Ameria.
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What inspired you to first get into CGT?
A serendipitous interview with Allen Eaves, Founder & Owner of Stem Cell Technologies, who is clearly to be credited as one of the fathers of the cell therapy industry as we now know it. He infected me with his love, passion, and irrational optimism for the business of cell therapy.
What changes have you observed from the industry over the last 20 years? What’s changed, what challenges have arisen?
- We’ve evolved our label from stem cell research to hematotherapy & graft engineering (ISHAGE), to tissue engineering, to cell therapy, to regenerative medicine and gene therapy, to advanced therapies.
- We’ve gone from FDA approvals of cell-based medicine as medical devices because there wasn’t any guidance or regulations for cell-based products, to whole FDA offices dedicated to nothing else.
- Since the first FDA approvals, we’ve lived through a decade-long drought during which no approvals occurred, to the point now where we are projecting 10–20 per year by 2025.
- We’ve gone from a cumulative $1M in cell therapy annual revenue to $1B+ cell and gene therapy company valuations.
- We’ve gone from 2 cell therapy CDMOs in the whole world to more than you can count.
- We’ve gone from “pharma will never invest in autologous cell therapy” to bidding wars for autologous cell therapy assets.
What key industry events or milestones have stood out to you over the last 20 years?
In keeping with my historic role with the Top 10 list within the Opening Plenary with Phacilitate, here is my top 10 list for the past 20 years (in chronological order). Key events which changed the trajectory of this industry over the past 20 years have to include:
- 2006 – Lonza’s purchase of Cambrex Bioproducts and Biopharma business segments
- 2009 – Alliance for Regenerative Medicine founded
- 2009–2010 – FDA approval of the world’s first embryonic stem cell trial IND (2009) and first patient treated (2010)
- 2010 – FDA approval of Provenge
- 2012 – Novartis deal with U Penn’s t-cell therapy
- 2012 – European approval of Clybera, the first gene therapy approved in Western countries
- 2013 – Japan’s PMDA overhaul of its regenerative medicine regulation
- 2014 – World’s first clinical treatment of an induced pluripotent stem cell (iPSC) product
- 2016 – Bayer and Versant Venture’s $225M Series A investment to found BlueRock Therapeutics
- 2017 – First FDA approval of a CAR-T cell therapy, Kymriah
What memories do you have of the first Phacilitate event you ever attended? What year was it?
My first date with Phacilitate was – as it was for so many others in the advanced therapies space – in a Hyatt basement in D.C. I think it was 2007.
It was an intimate affair. You could easily spend time with everyone you knew or wanted to know and several others you didn’t. We held court in the street-level bar every night with people spilling in and out as schedules or even more intimate affairs dictated.
What ‘unexpected moments’ do you remember from over the past 20 years of Phacilitate events? Do you have any anecdotes or memories that especially stand out from attending our events, that might have surprised or had a lasting impact for you?
A late, whiskey-laden night at the D.C. cigar bar with the industry’s who’s-who led to one of the most memorable meetings in my career with New York city investment bankers the following day.
What do you expect to see from the industry over the next 20 years?
Great therapeutic breakthroughs. An imaginable confluence and convergence of technologies to logarithmically explode our ability to leverage the power of cells, gene and other biological constructs.
If you could speak to yourself 20 years ago, what would you say? Would you have any advice or pearls of wisdom to share?
Never under-estimate the personal and collective power of network building.
What would you say to anyone considering attending Phacilitate’s 2024 Advanced Therapies Week?
Don’t miss it. Period.
