Earlier this summer I had the fortunate opportunity to speak with Dr. Michael West, of BioTime, and pick his brain on various aspects of the stem cell industry, what it’s faced, and where it might go. It was a perfect follow up to my post in March that explored BioTime’s acquisition of Geron’s stem cell program, and I can tell you that BioTime is a company that’s placing some well placed bets on the future and the opportunities provided by the stem cell industry.
My conversation with West was one of several interviews given to a wide range of interviewers this year, and it turns out that he’s a quite approachable company executive. Our conversation took place at about the same time as one with Paul Knoepfler, which revealed (to my surprise!) that West was an early skeptic of the potential of adult stem cells. In mid-July, West also spoke with Michael Ray at Seeking Alpha about several products in Biotime’s clinical pipeline, hinting at developments regarding Renevia, a product based on hyaluronan hydrogels that’s a delivery vehicle for autologous transfers of adipose derived cells. By the end of August Renevia received the go ahead for human clinical trials so it will be interesting to see that story unfold. There were other posts, but content-wise these were the most comprehensive. If you find more please send them my way.
I’ll split up what I covered with Dr. Michael West into several blog posts, so be sure to check back for updates. Today, let’s see how industry has upped the ante on the standards of stem cell products.
Productizing stem cells evolves, yet they continue to intrigue
As a 20-plus year veteran of the stem cell industry, Michael West has witnessed the evolution of the marketplace, being associated with Geron and Biotime for about a decade each.
When I asked him about his perspective about the changes in the field throughout that time, West explained that one of the biggest shifts has been with how adult stem cells’ pluripotency is defined. It turns out to be an enormously important change that’s most obvious to people in industry that strive to fabricate functional cells while coping with new science emerging from stem cell labs.
West recounted how academic ES cell studies used to be published with differentiation defined by the mere presence of markers alone. Expression of proteins associated with particular cell types, like Brachyury for mesodermal lineages, was enough to claim that differentiated cells functioned as intended in the experiment.
But West suggested that processes based solely on differentiation protocols have become too basic. Since companies must adhere to industrial standards, West explained that cells labelled with differentiation markers don’t pass muster in the marketplace.
“We’re really trying to address how to productize cells to FDA standards,” explained West. “We will enter an era where purified defined progenitors need to be described in finer detail,” he said, adding that cell products should also be characterized in terms of the functions associated with their purported identity.
These standards definitely raise the bar for publishing and commercialization, but also are a boon for patients and companies; consumers pay for the functionality of cellular therapies, not for the expression of a stem cell marker.
Not surprisingly, many of the basic aspects of research have stayed the same throughout West’s tenure. He emphasized that there’s still the need to be competitive, to be creative, but that the excitement pluripotency brings to the table has stayed throughout his years. “They’re really magical cells”, exclaimed West, a statement that confirms his place as one of the many believers in the industry that still rally around the potential pluripotent cells have for human health.
Next time, I’ll look into some of the projects BioTime currently has in development and see how they might fare in the coming years.
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