Automation, digitization, and utilization of data to drive future innovation in cell and gene therapies: A conversation with Dr. Bruce Levine of the University of Pennsylvania’s Perelman School of Medicine

In this episode of the Heidrick & Struggles Leadership Podcast, Heidrick & Struggles’ Jeff Boyd sits down with Dr. Bruce Levine, the Barbara and Edward Netter Professor in Cancer Gene Therapy and the founding director of the Clinical Cell in Vaccine Production Facility in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania. Levine discusses the partnership between academia and industry and offers his perspective on what is important to attract the best technical, scientific, commercial, and leadership talent to the space of selling gene therapy. As an advisory board member for many companies, he also shares how he is advising these organizations, specifically with regard to their talent agenda and building out technical and CMC expertise. Finally, he discusses automation in medical manufacturing and advocates for the importance of leaders taking on mentorships and actively engaging in the development of their teams.

Below is a full transcript of the episode, which has been edited for clarity.

Welcome to the Heidrick & Struggles Leadership Podcast. Heidrick is the premier global provider of senior-level executive search and leadership consulting services. Diversity and inclusion, leading through tumultuous times, and building thriving teams and organizations are among the core issues we talk with leaders about every day, including in our podcasts. Thank you for joining the conversation.

Jeff Boyd: Welcome to the Heidrick & Struggles Leadership Podcast. Hello, I'm Jeff Boyd, a partner in Heidrick & Struggles’ New York office, and the regional managing partner of the Healthcare & Life Sciences Practice in the Americas. In today's podcast, I'm excited to speak with Dr. Bruce Levine, the Barbara and Edward Netter Professor in Cancer Gene Therapy and the founding director of the Clinical Cell in Vaccine Production Facility in the Department of Pathology and Laboratory Medicine and the Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania.

He is also the co-founder of Team Immunity Therapeutics and of Capstone Therapeutic, both spinouts of the University of Pennsylvania. I had the pleasure to personally work directly with Bruce managing the technical transfer from academia to industry, which ultimately resulted in the first CAR-T therapy commercialized in the world. Since then, thousands of patients have benefited from his therapy. 

I'm honored to have him on the Heidrick Leadership Podcast. Bruce, thanks very much for joining us today. 

Bruce Levine: Hey, Jeff. Great to be with you. You know, I have been thinking about those days back in 2017 and the approval. And I saw something that Kite [Pharma] had treated 13,000 patients. Novartis, I’m guessing, probably 10,000. And between the other developers, we're talking about BMS and J&J, it's got to be between 25,000 and 30,000 patients who have received the commercial versions of CAR-T therapies. And then, when thinks about the clinical trials, we're probably around 30,000. It's amazing to think what's happened over the past decade or so.

Jeff Boyd: That is amazing, Bruce. And I just remember those early days and seeing the story of Emily and how many thousands and now tens of thousands of patients are living full lives now. So, again, quite an honor.

To kick off this conversation, I'd just love to get your outlook for 2023 and beyond in the cell and gene therapy space.

Bruce Levine: Yeah, so as far as approvals in the US, coming up, I think we'll have TIL approval—so tumor-infiltrating lymphocyte product. There's one, the LiCL for melanoma. There’s one developed in the Netherlands that has received hospital exemption, also for melanoma. And then we have, in Europe, approved Avalo. It's for multi-virus infection post-allogeneic stem cell transplant. We have a T-cell receptor product for synovial sarcoma, Afami-cell, that will probably be approved. And I think what will be a big milestone is in sickle cell disease. The first CRISPR product will probably be approved this year, so I think that's significant because we've got approval with a technology that was just discovered a decade ago. And it's reaching patients in an indication sickle cell disease, where, as you know, it's generally an underserved population. So, I think that's a big approval to look forward to. And, more broadly in the field, I think we're seeing more integration of gene engineering, gene editing, potency enhancements. We're making progress in solid tumors. It's not as quick as we had hoped, but it's tougher generally than the blood cancers. And then we can get into more details on the challenges and talent, which I know you're interested in, and also financing and the regulatory evolution. 

Jeff Boyd: Thanks Bruce. Well, it is just remarkable to see this evolution when we talk about everything from the rapid translational science through discovery, through CMC [chemistry, manufacturing, and controls], through regulatory pathways, to health authorities. It's very important to understand how talent is so critical in this process. We’d love your perspective on what you think is important to attract the best technical, scientific, commercial, and leadership talent to the space of selling gene therapy.

Bruce Levine: Yeah, it is a challenge and it's a reflection of how much the field has grown. It's grown in the progress of the science. It's grown in the companies being formed and financed, and it's grown in new people coming into the field. So, how we think about attracting the best talent is [asking,] what is your mission? Is that mission clear? Is it clearly communicated? What is your organization’s culture and how is that communicated? Who is the leader and what is their connectedness to the science and also what is the organization’s connectedness to patients? And not everyone has that. We're fortunate at Penn, we're an academic institution that does both research and patient care, and that is intertwined. And we have the ability to make that connection with people doing the science and doing the manufacturing and testing because we deliver the final cell product to the infusion centers. So, we have people that can directly meet the patients, and often we have patients and families who want to tour our facility and they get to meet the people who are growing their cells and other patients. You mentioned Emily Whitehead, that turned out to be a long-term relationship. And what a remarkable story and a remarkable family. I think what we're finding in this area of medicine is that it is the ultimate personalized medicine because you're using the patient's own cells to treat their disease, so they feel connected to their therapy and connected to the people who are generating their therapy.

You know, it is hard because, as an academic institution, we've lost people to industry and then we have to recruit, hire, train, and think about retaining. And we've also put a lot of effort into our training program. So, how do we accelerate our training program so that we can get people into producing the science, into the process development lab and into the manufacturing lab more quickly?

Jeff Boyd: Yes, thank you. It is so inspiring to go to the Children's Hospital of Philadelphia and to see these innovations coupled with the manufacturing, coupled with the treatment of these patients really all under one roof, and really as one of the first organizations at UPenn to form a significant industry partner.

How do you see the role of academia in industry evolving to the future? 

Bruce Levine: Well, I'll tell you, we've had a relationship with industry going back 25 years. When Carl June and I were at the Naval Hospital, we had companies approach us and that continued once we moved to Penn in 1999. And it's just been an organic process of working with industry. Now, you mentioned CHOP, the Children's Hospital of Philadelphia, and I think it's also noteworthy that the first two gene therapies of different classes—Kymriah, for pediatric ALL [acute lymphoblastic leukemia] and Luxturna for a genetic form of blindness—both came out of Penn and CHOP, and out of Philadelphia. And Luxturna is Spark Therapeutics and Kymriah is Novartis. And now we have spinouts from our Center for Cellular Immunotherapy. So, we've had that experience of things have just grown. 

Now, as far as the academic industry, relationship, we're comfortable here with that, at Penn. I saw a report last week that last year Penn had the highest licensing income of any academic institution in the country. So, I think we have that established here now. It does take effort to build and it does take time to build. 

As far as how we work, and I've said this to you before, we had to learn a new language in working with Novartis. What is a workstream? What is bandwidth, right? I say we had to learn “Novartian” because that was a whole new way of working. We had experience with industry, not industry of the size of Novartis.

Jeff Boyd: Absolutely Bruce. So, following up on that, there are many companies that are privileged to have you on their advisory board supporting them as they enable new therapeutics. How are you advising these organizations specifically with regard to their talent agenda and building out technical and specifically CMC expertise?

You know, we spoke about the time that we worked together, Bruce. It was clear that with these therapeutics and with this modality, CMC is critical and really moved, as I like to say, to the front of the classroom. So how are you advising these organizations that you support? 

Bruce Levine: Well, first we should probably do my disclosures. I'm a co-founder of Tmunity Therapeutics, which was recently acquired by Kite, and of Capstan Therapeutics. I serve on the scientific advisory boards of Akron Bio, Avectas, Immuneel, Immusoft, IN8bio, Ori Biotech, Oxford BioMedica, Thermo Fisher Pharma Services, UTC Therapeutics, and Vycellix. So, each of those has their own unique niche and stage. Now, what I'm advising is where they are in their development pathway. And what they're asking of me is to come at it as an immunologist with expertise in manufacturing. And the opportunity to gain insight into where these companies, where the technology is going, I think, is just by virtue of the fact that they haven't been around so long, honestly. So, each of those is complimentary for me to gain some insight, but also provide some insight back to each of these companies. Again, it's like choosing favorite children, but just to pick one, Immuneel—and Carl June and I both serve on the senior advisory board of Immuneel—they're developing CAR-T cells in India with the [knowledge] that the therapy needs to be much more affordable. So, how can we reduce the cost of manufacturing, the cost of analytics, to provide a therapy to a country of well over a billion people? It's just not feasible to do it as we do it in the US. And I think there are lessons that we can take from Immuneel as they're proceeding along their development. Because if we have a hit in a solid cancer, there aren't enough humans on earth to be able to manufacture for indications that are 10 to 20 times more prevalent than the approvals that we have in the blood cancers. 

Jeff Boyd: Yes. Well, thank you for sharing that perspective. I really had no idea that you were supporting so many companies and that is remarkable. 

Bruce, I want to transition to a topic around automation, something that we spent a lot of time speaking about, I should say, in the early days. And Heidrick & Struggles in 2022 conducted a survey that found technology, automation, AI, data, and digital was the top external disruption factor that was noted among organizations. How do you see cell and gene therapies evolving with regard to automation, digitization, and utilization of data to drive future innovation? 

Bruce Levine: Well, that's a big topic and it's critical to progress. So, take automation first. We use devices that are partially automated. There are some devices that are marketed as automation for multiple steps. I think it depends what stage you are in development. We're in early stage, we're at the bench, we're in scale up, we're in first in human phase one clinical trials. For us, automation is helpful, but to a limited degree, because we have processes that do change and we may be swapping out, and if we have a process that is fully automated end-to-end, then we have to go back and reconfigure a device, software, disposables. Now, on the other hand, for a product that is commercialized, where a process is logged, then automation makes more sense. And it makes more sense also where the units that are being produced are high. If we're in phase one and we're doing clinical trials of say, 10 or 20 patients and we fully automate it and then we make a change, then we've got to go back and do all those changes

Now as far as digitization, this also is critical to be able to treat more patients. The amount of effort and labor spent on documentation, on quality assurance, that we spent at phase one is very high. When one gets to commercialization and you're talking about treating 10,000 or 20,000 patients and more, you just can't make that tenable in the long term. So, I'm encouraged by the investment, just taking together automation and digitization. I'm very encouraged by the investment in tools, and equipment, and digital platform developers, and I think that's essential for progress in the field. And a big part of my job now in my position currently is evaluating these new technologies and assessing how they might fit into what we can do here at the Center for Cellular Immunotherapies at the University of Pennsylvania and how they might fit more broadly in the field. And that's where those advisory boards come in, and also my position as immediate past president of the International Society for Cell and Gene Therapy. So it's a very, very dynamic time, Jeff. 

Jeff Boyd: Bruce, one last question. I have known you to be somebody, in spite of how remarkably busy you are, you've always taken an interest in mentoring future technical leaders in the industry, at a very personal level. What advice would you give to the C-suite of these companies regarding those executives personally investing in the mentorship and the development of their teams? 

Bruce Levine: Well, I can make the first part of my answer short and sweet. Basically, no team, no progress. We have integrated teams from the laboratory. I mentioned process development, manufacturing, quality control, quality assurance, regulatory, and clinical. Everyone has to work together. And secondly, mentoring is a responsibility and a necessity. We all know there's a talent shortage. Those of us who have been in the field for a while have a responsibility to mentor early-stage professionals and also people that may be later in their career but coming in new to cell and gene therapy.

An example of mentoring—the long-term colleague that I've been privileged to know in the field is Kristen Hege. Kristen was at a company called Cell Genesys, which conducted the very first CAR-T cell trials. She moved to Celgene, which was acquired by BMS. And just recently, she retired to pursue her lifelong dream of hiking the Pacific Crest Trail, all 2,685 miles of it. And she's blogging about it, but she also thought, “I'm going to do something more, which is to turn this into a fundraiser to benefit early-career women at the Center for Cellular Immunotherapies at Penn.” And so, I think that's emblematic of our field where, whether it’s investigators, clinicians like Kristen, or patients and families like Emily, Gary, and Tom Whitehead, people just feel the need to give back and I think that is inspiring to all of us, and it's a real privilege to be a part of it. 

Jeff Boyd: Bruce, thank you very much for taking the time to speak with us today. 

Bruce Levine: My pleasure, Jeff.

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About the interviewer 

Jeff Boyd (jboyd@heidrick.com) is a partner in Heidrick & Struggles’ New York office and regional managing partner of the Healthcare & Life Sciences Practice in the Americas. He also co-leads the Life Science Tools & Services sector.