Name:
An interview with Miguel Forte
Description:
An interview with Miguel Forte
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Duration:
T00H15M42S
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https://cadmoreoriginalmedia.blob.core.windows.net/9b231357-e4b5-4966-a41a-cb0a1f02c894/Miguel Forte - Interview - V1.mp4?sv=2019-02-02&sr=c&sig=BCSg%2Bxmw50P5viCrM18LAWvcLQNh3H%2FzqrJyUg%2FflME%3D&st=2024-05-05T18%3A10%3A57Z&se=2024-05-05T20%3A15%3A57Z&sp=r
Upload Date:
2022-06-01T00:00:00.0000000
Transcript:
Language: EN.
Segment:0 .
[AUDIO LOGO]
SARAH REHMAN: Would you like to introduce yourself-- a little bit about your career today and how you're enjoying the event.
MIGUEL FORTE: Thank you, Sarah. And thanks again to you and RegMedNet to the opportunity to talk here Yes, I'm Miguel Forte. I'm the CEO of Bone Therapeutics, a regenerative therapy, cell therapy company. And I'm very excited to be here because this actually has been now more than 10 years that I'm a member of ISCT. I've taken different roles. And, in fact, this year, this meeting, starts myself as president-elect for ISCT.
MIGUEL FORTE: So very, very keen on the field. Very, very keen on the meeting today and what we're achieving here, because in the end it's not just having fun. It's not just doing science. It's developing products, and, above all, bringing value to patients.
SARAH REHMAN: Definitely, definitely. And we were together in Barcelona two weeks ago. You were so kindly the chair of our panel. And I thought that was a really interesting discussion about building strategic partnerships and how to maintain trust within collaborations. And I think that's something that ISCT brings and fosters for the community. It's been amazing to talk to people in person. Have you found collaborating with people and actually meeting people in person has had an influence?
MIGUEL FORTE: You're correct. I have, as a principle not only to do my role in the company, but to participate in the field, because together, we're going to be able to succeed. And it's formal collaborations, like when you establish a relationship with a CDMO because you have a product and you want it to be developed and produced. But it's also informal relationships-- when you talk to people, when you network. You say, I had this difficulty with this product, or my clinical trial is facing these challenges.
MIGUEL FORTE: And people give you suggestions. And, again, multiple organizations-- and yes we were, just two weeks ago, in the meeting organized by Arm. We're here today, now, meeting organized by ISCT. ISCT is in a particular position because ISCT brings a series of professionals in the field of cell and gene therapy-- academics, regulatory people, industry, lab technicians. And that diversity gives a special opportunity for different discussions to take place, for a broad network to be established.
SARAH REHMAN: And what do you think, for the industry as a whole, is the greatest challenge to overcome and really collaborate together and to work on?
MIGUEL FORTE: As I mentioned just a minute ago, it's 10 years that I've been with ISCT and attending ISCT meetings. 10 years ago, this was an academic, experimental field. You probably remember the very funny quote from Bruce Levine, 10 years ago we were considered cute. Today, we are an established industry. Business is interested. Investment is being put in and channeled.
MIGUEL FORTE: And, above all, again, we're seeing products in the market. So we're at a different stage. And again, we can talk about that later, one of the reasons why I made my bid to become president of ISCT is precisely because representing the industry network wants to take this society, which is a translational society, from early stages of R&D to bringing products to the market. This to come to the point that probably one of the challenges the field is now facing is patient access.
MIGUEL FORTE: And we need to concentrate on that. Patient access, not only because of the technical aspects, but also because of reimbursement aspects, the practice aspects. People need to be trained how to use these products. Patients need to be prepared how to receive them. So the bucket, the group of patient access, is one challenge. We continue to have challenges in terms of manufacturing, even though a lot has expanded there.
MIGUEL FORTE: And I think technical aspects, in terms of gene editing, gene delivery. Just came out of a meeting where we saw some of the challenges in terms of the results, and sometimes bad results, sometime safety issues. All of that is part of the maturity of the system. So the second challenge is to go from individual examples to aggregated analysis.
MIGUEL FORTE: Carl June and others, in a meeting yesterday, were talking about hundreds of patients that have been treated with CAR T. So we are now at a stage that we're able to take a step back and look at population analysis, and take another learning from the science as it is. So another challenge of maturity, of growing into that. Then I think there's quite a few other small challenges. Some of them that are not specific to our industry and to our field, is really the overall context.
MIGUEL FORTE: We had COVID. That impacted some of what we were doing. And we're now having the conflict in Ukraine, which is actually impacting also some of the clinical studies and the environment for investment, which is kind of, in a way, being more difficult. So I think like the others in society, we need to navigate those challenges and focus on the specific challenges that I would say for us, which is, as I said, patient access, manufacturing, and maturity of the system.
SARAH REHMAN: That is really interesting you say that because I think it's easy to disconnect science and society when really the two or so intertwined that you can't have one without the other. And you can't disregard the context of the world that we live in and how science fits into that. It's really interesting.
MIGUEL FORTE: No, absolutely. Why? Because the people that do the development are integrated in the system, in the overall. And the patients for whom we are developing the products, obviously, are out there, as well. And clinical trials are global, particularly-- and you may have seen some companies made serious efforts to take patients that were in Ukraine, just to bring them out so that they could continue the clinical trials.
MIGUEL FORTE: And again, it's really just a small example of-- we don't really think of all the implications of a conflict like that, and how we need to manage it, even all the way down, I would say, to cell and gene therapy development.
SARAH REHMAN: Yeah. Why not? Do you think there are any lessons that the cell and gene industry can take from other industries even if it comes to overcoming regulatory hurdles or scaling up-- things like that?
MIGUEL FORTE: Yeah. I think the regulatory is a particularly interesting point, because the regulators have evolved with the fields and with us. I, myself, was a previous regulator. I was a member of the European agency. And I understand the fact that regulators have a mission, which is protect patients but deliver the product to patients. And they want to learn, as well.
MIGUEL FORTE: And I think they are getting a bit less risk averse and a lot more collaborative in terms of finding pragmatical solutions. Tomorrow, I'll be really kind of challenging Peter Marks on a discussion about what are the CMC challenges. It goes back to what I was saying before in terms of the manufacturing. The end result of the manufacturing, before it gets to patients, is to go through the regulatory hurdle.
MIGUEL FORTE: And I'm going to ask him, precisely, what are the pitfalls? What are the challenges? And what can we do about the manufacturing and the CMC part of the cell and gene therapy products? And in the preparations, or what I expect him to say is that some concerns that he has, but also some solutions, or pragmatical solutions that he's going to bring to the field so that we, together, accelerate and minimize the efforts with a safety concern, nevertheless, to bring products to patients as quickly as possible.
MIGUEL FORTE: Again, the point of access, that I mentioned before.
SARAH REHMAN: Yeah. And so why do you think that they are becoming so risk averse. It's quite a--
MIGUEL FORTE: They're not getting risk averse. They're getting less risk averse.
SARAH REHMAN: Less risk averse, sorry, I mean. Yeah.
MIGUEL FORTE: But the question is very important. Why? Because they're learning. Because they're getting accustomed to it. Because they're seeing multiple. It's another signal of the maturity of the fields. And you asked me, are we taking the learnings from other sides of the industry-- other? Yes, because if you go back-- established product like small molecule vaccines, biologicals-- there's a lot of streamlined approaches in regulatory.
MIGUEL FORTE: I think cell and gene therapy was being established. And we were all learning. And the regulators were also trying to find their way into this. But as we, together, have evolved, they're being able to take practical lessons from other regulatory approaches to other products into the cell and gene therapy. And that's giving them some comfort in being able to take a bit more risks because they've seen more products, they've seen more examples.
MIGUEL FORTE: Back to the point I made before, instead of individual CAR T patients, we're seeing just population analysis. So we're all getting a lot more comfortable. And the regulators are going with that flow, keeping, nevertheless, their role, which is ensure quality, safety, adequaty, efficacy, documentation, and patient access, in the end.
SARAH REHMAN: So it's not so much that they're less risk averse, it's just that they're understanding the benefit and what is actually happening.
MIGUEL FORTE: And getting more comfortable with it, more technically. Yes.
SARAH REHMAN: So where do you see the future of the field going within the next five years, I'd say?
MIGUEL FORTE: Well, in the next five, 10 years, we're going to see more products coming out. We're going to see an establishment of the current technology. We're going to have significant discussions about the access, the reimbursement, HTA-- Health Technology Assessment. So we're going to see a maturity of the field. But I think beyond that, what we're going to see more and more, is the coming together of cell and gene therapy.
MIGUEL FORTE: The vision that I have, we're going to have this field delivering therapeutic products that are, one way or another, optimization of cellular function through gene-editing technologies. We're going to engineer cells for a therapeutic purpose. And that engineering of the cells will give us the opportunity of real cures. And that discussion is already-- and there was an article from Carl June recently saying, cures, are we there yet?
MIGUEL FORTE: And we are approaching. And it's because we're able to modulate the cell, train the cell, something that I've coined and use a lot-- professionalized the cell for a therapeutic effect. And that professionalization is using a cell that can do something, and sometimes cannot do it enough or is not able to do because it's genetically deranged. And we can go there, fix the tools, and get it to do properly.
MIGUEL FORTE: And this idea of engineering, but using biological techniques and gene editing techniques to engineer a cell, is really where we're going to go. And so we're going to see cells engineered to a purpose, professionalized to therapeutic benefit, and really aiming at cures, or establishing-- I mean correcting-- disease, and treating emerging disease.
SARAH REHMAN: It feels like we're really on the cusp of the future now.
MIGUEL FORTE: Correct. And if we go back to 10 years ago, we're "a cute thing." Now we're an established business. 10 years in the future, we're going to be the next major wave of evolution in medicine. I feel myself very lucky to be able to be part of this. And it's actually the second medical revolution that I-- in the beginning of my career, I was involved with HIV, and saw the first patient, the first treatments. And now we control it pretty well.
MIGUEL FORTE: Cell therapy, I came in in the beginning, as well. There were a few products being developed-- nothing in the market. Saw the emergence of the market. And we're going to see now, in the near future, that revolution of the cell-engineered for a therapeutic purpose.
SARAH REHMAN: So this is my last question-- what are you looking forward to most or what have you enjoyed most at ISCT so far?
MIGUEL FORTE: I think the words is probably togetherness and network. Goes back to the point you made about collaborate-- doing things together. It's the opportunity of being part of a group that have the same passion and bring different experience, and different technologies, and different knowledge. And so the opportunity of being here, talking to colleagues, hearing the development, also setting principles, and being kind of a leadership role in the society, taking position about important topics.
MIGUEL FORTE: I was discussing about hospital exemption the other day which are major topic in Europe. Others are discussing about access to these medications in less favored countries, like Africa, India, and beyond, which is an important point. Others are talking about health technology assessment. So it's the opportunity of coming together, get an update on what's going on, see friends and colleagues, collaborate, network, and impact the field, again, for the benefit of what we do, which in the end will revert to benefit to patients.
SARAH REHMAN: So that's the last of my questions. Do you have any take-home points that you'd like to say.
MIGUEL FORTE: No, just to thank you and others, because part of that networking, message setting, and sharing of ideas requires people like you to have this interview, sharing them, bringing it to them. So you have a role that is essential and critical for the success of what we're trying to do here-- ISCT and others.
SARAH REHMAN: I'm happy, yeah. I agree with what you said earlier. I do feel quite privileged to be here in this space of time in a really, like on the cusp of an area. It's really amazing to be part of something, even if I am kind of on the periphery, as well.
MIGUEL FORTE: No, no. You're the vehicle of the information. You are the vehicle of the change. And so altogether, are really making it happen.
SARAH REHMAN: Well, thank you.
MIGUEL FORTE: All right. Thank you. Thank you, Sarah. Thank you for the opportunity.
SARAH REHMAN: Thank you. [AUDIO LOGO]