Welcome to First 90 Days, a series dedicated to examining how pharma executives are planning for success in their new roles. Today, we’re looking at Allogene Therapeutics’ executive vice president of R&D, Zachary Roberts, who’s hoping to bring the first off-the-shelf CAR-T cell therapy to market.
Cell therapy veteran Zachary Roberts joined Allogene Therapeutics at the beginning of the year as the company's executive vice president of R&D. He's joining a team of pros hailing from other top cell therapy developers like Kite Pharma, a Gilead company — and they're looking to make a mark on the industry by bringing off-the-shelf options to the table. It’s a mission that’s taken on more urgency as currently approved autologous CAR-T therapies face manufacturing bottlenecks that often create delays in reaching patients.
While the first CAR-T cell therapies entered the U.S. market in 2017, an allogeneic version that doesn’t require the long wait times is yet to arrive. But Allogene is looking to change that — the biotech began the industry’s first phase 2 trial of an off-the-shelf CAR-T cell therapy in October last year for patients with large B cell lymphoma. And the company has about a dozen therapy candidates in the pipeline from discovery stage to phase 1.
Roberts said the industry is a tightknit community that knows these therapies will meet unmet needs for patients.
"We know what we need to do," Roberts said. "The data has supported our plan moving forward, and we need to refine our messaging to the outside world — we're shifting gears as a company.”
When he moved to Allogene, Roberts joined a cadre of senior leaders he met during his days at Kite — including CEO David Chang.
In our conversation with Roberts, he spoke about the future of cell therapy, the homecoming that awaited him at Allogene and the importance of bringing new solutions to patients across the board.
This interview has been edited for brevity and style.
PHARMAVOICE: R&D is the engine of a clinical-stage company like Allogene. How do you prepare for such an important role?
ZACH ROBERTS: It was a very natural transition. I've been running development programs for a number of years in cell therapy and I've also had a very close eye on leadership in research and translational organizations. One of the things that has proven out is that there are differences among cell therapy products but that the language is very similar. I've learned the art very well. There's still a lot to learn as we get through 2023, but Allogene has all the tools and all the teams ready to push this inflection point forward. It's a thrill to be here.
You've been at companies like Kite and Instil Bio. What ideas did you bring to Allogene?
Both of those companies taught me two things: First, cell therapy has got a long road ahead of it. Its position in the pantheon of treatments for relapsed refractory tumors is very firm. The other thing is that autologous cell therapies, as wonderful and transformative as they have been, have some pretty significant limitations when it comes to reaching all patients who would be eligible for cell therapy. And allogeneic platforms have been an interest of mine for a long time, even going back to my college days. The ideas that I brought here are: How do we craft the development program and a research pipeline that seeks to maximize the impact of the platform in general so that the reach can be the benefit of cell therapy as a modality?
You knew a lot of the people at Allogene before you came on. Does it feel like a bit of a homecoming?
I think it's the most exciting moment for Allogene as we're launching our pivotal studies. This is the big dance. We're at this inflection point where I think the company is ready to start making huge differences in the field.
It sounds like the cell therapy space is a very tightknit community.
It's competitive, but in a friendly way. One of the things I've always loved about cell therapy is that even in a company, if the science is so dense and so cutting edge, it has to have a little bit of that academic spirit. One of the things that successful companies do is take that sense of discovery and push the scientific envelope and focus it into a very efficient development program, which is something Allogene has done very well. I'm a recovering academic, and this has been a perfect place for me to develop my industry career.
How much does patient access play into your R&D strategy?
Very, very much. Our lead program is targeting an indication in which there are already approved therapies. That's not a secret. But we know that a substantial fraction — and there's great variability across the world — of patients cannot access therapy. We know there are a lot of patients out there who would be eligible for this therapy and can't get it. The benefits of off-the-shelf therapy extend across the landscape of oncology because, as I learned firsthand, these patients can't wait.
What conversations should R&D leaders like yourself be having about pricing?
Well, the disclaimer — we don't talk about pricing and won't talk about pricing for quite some time. But for some context, we're seeing reimbursement at levels across the board for autologous cell therapies and even some bispecifics eclipsing the cost of an individual cell therapy. With these products we're seeing truly meaningful differences in patient outcomes and duration of overall survival. What we're seeing is that the market is supporting prices that reflect the benefit these products bring. So I'll leave it at that — I think there's lots of interest and need for transformative therapies.
What is your priority in these first three months?
Christine (Cassiano, CCO) has me in front of the company about every 30 minutes or so. It's been a wonderful welcome in my first 30 days. I'm a sponge here, drinking from the firehose. But I'm also very eager to put my mark on the R&D organization and I'm doing that in a focused way. This is the right moment for the company in that regard because we're shifting gears into a pivotal stance, into a different place than a company that has a number of phase 1 programs. This is now very much an execution focus, and we're working on enrollment and launch preparation. (When) you're running two pivotal trials (that’s when) you're starting to put the pedal to the floor, and taking on new and different responsibilities as an organization such as building out a field force and thinking about what the commercial team looks like.
How would you characterize yourself as a leader?
I think that one of the benefits of being in this field for as long as I've been and as a recovering academic and oncologist is that I know time is life. And that's what I tell my team. We need to be focused and we need to be fast because patients are waiting for us to do this right. If we are successful, as I intend to be, and we get our products to market, then we are helping meet unmet medical need. And this is something I am very vocal about. So I speak up and see opportunities for improvement certainly within R&D but also in other functions. I'm often wrong but I'll be the first to admit that. I am a believer that I'm here for a reason, as we all are, and that's to be open and transparent about our beliefs. That's the leadership I try to bring, and I expect that of my team as well — to challenge me, because that's how we get to the right answer.