If you've caught yourself thinking about your career in biopharma lately , and part of that process has included an inkling of doubt that you're not doing enough , this episode of the Business of Biotech is about to either inspire you or make you feel terrible about yourself .
I'm Matt Pillar , and my guest on today's show is an MD who , early in his career , was on the Faculty of Medicine at the University of Lisbon , clinical Registrar and Research Fellow at the University of Birmingham and a practicing physician .
Then he joined industry as medical director at Wellcome before its acquisition by Glaxo and GSK , and served as medical director for Abbott Labs operations in Portugal .
Then he played a hand in regulatory work as vice chairman of the new drugs committee at Portuguese regulatory authority , infarmed , and as a member of the European Medicines Agency's Committee for Medicinal Products for Human Use .
Then it was back to industry when he became VP of the International Medical Organization for BMS , then VP of Clinical , regulatory and Medical Affairs at Nabi Pharmaceuticals , then VP of Global Medical Affairs at UCB , then EVP and COO at TXL and then Chief Medical Officer at Bone Therapeutics .
Then he tried his hand at captaining biotech ships as CEO at Zaluna Immunotherapy . Then back to Bone for a few years in the CEO's chair . In addition to serving as entrepreneur in residence at AdBio Today , he's a board member and chairman of multiple committees for the Alliance for Regenerative Medicine . He's associate professor at the University of Lisbon .
He's founder and managing director of MC4TX , he's executive chairman of the board of directors at StemBond , he's non-executive director at Swarm Oncology , he's CEO at Kiji Therapeutics and most recently he was appointed president of ISCT , the International Society for Cell and Gene Therapy .
Like I said , you're either inspired right now or wondering why you're so lazy , but either way , you might have guessed by now that my guest on today's show is the tireless Dr Miguel Forte .
Dr Forte , welcome to the show . Thank you , matt . Thank you for having me and thank you for that introduction . Very thorough , very detailed . I hope it inspires as you were going through . It told me . Well , I've had quite a bit of fun along the way .
How are you ? Where does the energy come from ? This is what I want to know when does the energy come from ?
I think the energy comes from that fun , from the excitement , from actually owning what you do and impacting others in doing it . I'm very curious . I like the projects that I bite on and I really throw myself completely at the things that I am doing , so that's where the energy comes from .
It also comes from the fact that those around me allow me to devote the energy to those things the International Society for Cell and Gene Therapy .
For those who are not familiar , as you know , the business of biotech covers a wide gamut of biotech , from traditional biologic therapies through cell and gene technologies . So for those who are maybe not familiar with ISCT , tell us a little bit about ISCT and what its mission is .
Sure . Now ISCT is the International Society of Cell and Gene Therapy . It's an organization that started very much as an academic organization but grew to bring together all different players in cell and gene therapy academics , regulatory people and , very recently , also industry . I was actually instrumental in bringing industry into ISCT .
The mission is to enable the adequate development of new cell and gene therapy products for the benefit of patients , and I think this is important because it focuses on doing it well and adequately from one side .
It well and adequately from one side , but also checking that those that are not adequately developed and proven cell therapies are also identified and pointed so that they don't continue to lead patients into the wrong way .
So the mission is a global mission , a mission to bring all those players together with that clear vision of bringing benefit to patients in cell and gene therapy .
The fun about it is precisely by interconnecting all those elements the science , the business that comes with it , the regulatory decisions , the risk-taking or not risk-taking and , above all , the benefit for the patients risk-taking and , above all , the benefit for the patients .
And being global has the opportunity of learning from each different region and bring those learnings to regions elsewhere . I'm going to go on to a tour in Asia tomorrow and I'll be speaking in Singapore and then going to Taiwan , really because there's a lot of expansion there and we as a society want to help that , foster , that , be part of that development .
Tell me a little bit about how that mission is executed in practice . I know that ISCT holds at least one very important and well-attended conference annually where a lot of companies present data . What other venues are there or avenues for companies to get involved and to share information and sort of have that effect that you're describing ?
Yeah . So I think there's multiple aspects about it . One is the membership . You can have individual membership so you as an interested person , as a professional in the field , can become a member , but also your organization , be it a lab , be it a research center , be an industry company . That membership provides a network opportunity .
You sit in committees , you discuss , you learn . So it's above all that sharing of opinion .
Then , when you bring all those opinions together , it becomes a key opinion leader organization by setting guidance , by publishing white papers , and then we bring all of this together in terms of network , exchanging of experience and communicating of leadership opinion in the meetings . And we have one annual meeting that happens in oscillates between Europe and the US .
And then we have regional meetings I mentioned to you . I'm going to talk at the regional meeting in Singapore . I'm going to have a regional meeting in Europe for the end of the year . Those moments are moments of gathering , moments of sharing opinion , moments of network , but also moments where you can communicate your most recent research and discuss .
We have a particular focus on those meetings to have what we call roundtables , where slides are not presented but the audience is asked to discuss , precisely to have that engagement , that interaction , that discussion , and we're also very keen on young researchers .
We have a program to those that start their professional life , able to engage with others , with the leaders , learn and take professional opportunities . So we see ourselves as setting the standards , being opinion leader organization and a forum for network and exchange of views .
I was introduced to the organization when I moved into cell and gene therapy by Bruce Levine and I was fascinated .
Fascinated with the science , fascinated with the passion of those involved in the field and fascinated with the opportunity of impacting and not only contributing to the field but taking from the field to my daily job in the companies or other organizations I was active in .
Yeah , you told me that Bruce Levine introduced you to ISCT sometime back and you've held various positions in ISCT since that introduction . But I remember you telling me that you were really surprised , sort of shocked .
I'm assuming that this exposure was sort of early in your foray into cell and gene technologies , because I remember you telling me that one of the things that shocked you was the potential value that cell and gene therapies could bring to patients .
I guess I'd like you to sort of I don't know compare and contrast where you came from with this , throwing yourself back into those earlier days , this new exposure to cell and gene therapies .
Yeah . So I started to work with Bruce , kurt Gunther and others on the society about 15 years ago when I moved into cell and gene therapy and I went to the first annual meeting and it was really a bit of a cultural shock . Previous to that I had launched an anti-TNF for autoimmune diseases and was actually the third anti-TNF .
So it was well-established fields with well-defined commercial relationships and moved into saline gene therapy where it was predominantly academic . This was probably 10 years before the first product in saline gene therapy came to really . I mean , the first significant product came out .
So when I stopped , went into the first meeting , I saw the huge potential , a potential of really going to the core of the pathogenesis , the core of the disease , and be able to have long-term benefit or even cure a disease . That was a transformational moment .
We have here a very impactful new technology or series of new technologies , but at the same time I realized that there was a long way to go for the industrialization , for the translational aspect of taking that science into a product and making it get to patients .
We still have those challenges in challenging therapy today because of the complexity of the technology and the difficulty of the access . We really need to transform the science into a product and then make that product available to the patients , and I saw a long journey ahead of us at that meeting .
So it was a kind of the wonder of the benefit and the awareness of the challenge that really got me into it and I actually like those two things . I mean , I like the passion of a fantastic new thing and I actually like the challenges .
Yeah , you also told me at that time that one of the things you looked forward to was the potential for scientists to have a lot of fun doing what they do developing these therapies .
Yeah , because the science is complex but needs in its dissection , in its explanation , in its dissection , in its explanation . When I tend to speak I say that small molecules is kind of unidimensional , biologic is kind of two-dimensional , but cells is three-dimensional . The complexity , how you harness the mechanism of action of a cell .
It's like a text or a sound or a film versus a live person . You can never control your product completely because the cell has multiple elements that are at the same time acting . So it's the fun of trying to manage that from the scientific point of view setting the hypothesis , confirming the hypothesis and translating it into a product . And so , yeah , it's .
And I must say also that because the group of people , they all share this passion , the passion of developing the science , exciting science with relevant products and benefit to patients , it becomes a community that you like to belong to .
Yeah , you , you know , know , your career up until that point was storied . I mean , that's not an overstatement to say that it was storied . You'd made a lot of progress , You'd done a lot of great things . You'd done those things in more , as you said , traditional and established biologic spaces . You know antibodies and anti-TNF .
To your point , enough to your point . Did you or do you feel any sense of trepidation or uncertainty when you step into an entirely new arena ?
Yes , but I like that . I think it's good to experience new things . I like to always be in a situation that I control something but not everything , and there's always a new element Excel . That was actually my first really cell engine therapy and when I was approached I realized this is probably the next generation of medical development .
In my early stages of my career , when I finished my training , I was involved with the first HIV patients in Portugal . So I did my thesis on HIV and had an opportunity to go for one significant revolution , one significant event in the medical history , which was the HIV and being able to be associated with the first clinical trials , with the first products .
And I felt the same thing when I came to cell and gene therapy , because I realized we're at the dawn of a new era in terms of products and it's actually very fascinating that today we use that virus , that is the HIV virus , modified to use it for gene engineering , the cells .
And that tells me that our ability to deal with a challenge , transform it into an opportunity , be able to have the science behind it with all ways of the focus , which is , deal with the disease , manage the virus and make the use of it for the next generation of medical development .
So , yes , I felt the trepidation of walking into a new era , but there was the excitement of being able to impact , learn and see new things .
Yeah , you know . One of the other things we talked about was the global reach of ISCT and it's interesting I was thinking about that your commentary around the global reach and the importance behind having global reach .
And you know , for people like you who are deep in the space , for people like me who cover the space primarily from my perspective , primarily from the , you know , in the context of the United States and Europe , a lot of the global considerations in this nascent technology are easily forgotten , right Like . One of the things that you mentioned was ethics .
I think in the US and in Europe , where cell and gene therapies have really taken a foothold and where much of the progress has come from , we've seen , you know , the evolution away from some unfounded and some very well-founded ethical concerns .
I'm curious about , you know , one , a two-part question what do you see as ISCT's sort of global responsibility in fostering cell and gene therapies ? And then , what's that ethical element ? What are you seeing out there in terms of where there are still ethical battles to be waged ?
Yeah , I mean you touch on a very important point for me , because when I decided to kind of run for president and take on the role , I had this motto , which is a global presence for local impact . And it's really part of my agenda , not only internally as an organization but really externally , to make sure that we have that global presence .
Because , I mean , science is global and medical need is global . What is not global is the capacity to pay , the capacity to deliver these products and the capacity to really have the infrastructure for this . And so I think we have a responsibility , because science is global deliver these products and the capacity to really have the infrastructure for this .
And so I think we have a responsibility , because science is global and the medical need is also global , to try to make those two meet , those two objectives meet . And so ICT has the opportunity , because of that global membership , to not only monitor , learn from everything that is happening and exchange the experience .
I mean I'll give you two things I think it's important that we tackle , from an ethical perspective and from a responsibility in the field perspective , the access to patients , and for these therapies to be delivered , they need to have a certain level of infrastructure , not only for the supply chain , but also the knowledge to administer and monitor the use of them ,
and IACT contributes to that in terms of the teaching , and we need to acknowledge that we have an ethical responsibility for the regions where the structure is not present to foster that . But also very important is the price of these products , and we need to integrate multiple aspects . Going to the price of these products , it's the investment into them .
It's a transformational event that gives you a cure and consequently avoids a certain element of costs . But also , on the other side , comes on the opportunity cost and the affordability which , if science is global , affordability is definitely not global and varies from region to region . And I think it's important that we don't avoid these difficult discussions .
We don't avoid these difficult discussions and I feel particularly well positioned to tackle this challenge , which is not an easy one , which is as an industrial , as an academic , as a physician which treated patients and still cares for what is the benefit of the individual patient or the patient population for us to tackle it ?
The benefit of the individual patient or the patient population for us to tackle it . And we see some regions Brazil , india taking some approaches to make the delivery of these products available and we need to foster that understanding at the same time that we cannot curtail or impact negatively the innovation and it's the balance between the two .
And I go back to the HIV challenge . I mean we had the same challenge at the time . I still remember being involved in those discussions . It's a review of that to a next level , with the different parameters , but with the same principle , and the ethical principles are crucial here .
I mean , what we do is fun , the science is enjoyable , but what we do it for is for the benefit of patients and , as I said before , the need is global . The capacity to deliver these products for multiple reasons is not global and we need to find a way to bring that together .
Yeah , this being your charge as the newly appointed president at ISCT , you've had some time to think about it .
I understand there's quite a long sort of president-elect cycle and , as I said , you held various capacities in the organization prior to becoming president-elect , so you've had some time to think about it and this globality and sort of ethical charge being a mantle that you've taken on in your new role there . What can you share with us about the how Like ?
For instance , it occurs to me that to have that patient impact and affordability play , perhaps maybe I don't want to make any assumptions but perhaps maybe part of it is um manipulating or adjusting who's at the table right Like , what are some of the like do you have ? Do you have plans to sort of um expand influence within ISCT ? Do you have ?
You're like , what are some of the plans that you're you're thinking about ?
or implementing , there's different things that need to be considered . First of all is the technical aspect .
I think we need to continue to improve the technology that is used to produce , to develop these products , and we're seeing decentralized manufacturing , automated and decentralized manufacturing , automated and closed system manufacturing , and the ability of taking this to faraway geographies , even within well-developed countries like the US .
There's some regions inside the US where the facilities are not well catered for , and so we need to bring the ability to produce closer to the patient .
At the same time , we also need to consider how can we bring that to other regions where the infrastructure is even less adapted , and that's where we come in terms of training , setting the standards and helping those sites to learn .
So one thing is the technical development , the other one is the training and the infrastructure , and then , obviously , we come to the elements of finance , which is important in terms of how can we respecting intellectual property or respecting the need for development , respecting the return on investment , but really adapted to different circumstances and different capabilities
locally ? And so the forum for discussion and the forum for opinion leader within ISCT is one of the things that we wanted to do and , as you said , bring them together .
Isct at the last annual meeting in Vancouver that you pointed out too , the day before , we gathered regulators from all over the world , from the US , from Europe , the MHRA in Switzerland , from Asian countries , japan , taiwan and there was a meeting that was not open , it was selected by invitation so that we could have a discussion among the regulators .
And the objective ? I could summarize the objective in two aspects Calibrate the risk-taking attitude on regulatory decisions and tackle the access with the elements of training , pricing , affordability and access . And I think , that forum for discussion , being able to be a player that brings everybody together .
I mean , difficult decisions are difficult , difficult discussions and decisions are always , as a by definition , difficult and challenging , but we need to take them , and I think we're in a particularly good position to bring those players together . So that's the element .
Also , another thing that we touched on and I think it's important , which goes also from a proactive point of view in the ethics , is making sure that , as we play more and more with our genetic structure , that we know how to do it properly and we set the boundaries . I mean , we cannot do anything that we want to do .
It needs to be done with a purpose , with a stepwise approach , with a regulatory oversight , with an ethical conscience and , I think , setting the standards for that is another thing that I'm also quite keen on , involving other organizations because ISCT is one player , there are other players as well and bring all those players together to make sure that we have this
proactive ethical attitude for access , for the things that we do , for pricing , for the technical elements . And again , if we do that , we should not do that for Europe , we should do that globally . And that's where I think IACT becomes a cornerstone of that discussion .
Yeah , very good . You mentioned HIV earlier and you said that in your new capacities you've been able to pull a little bit from the HIV playbook that you played a key role in so many years ago .
And I'm curious about where else you're able to pull from your history in small molecules and vaccines and traditional biologics development , in the capacity you have now at ISCT and Kiji and others . And I want to tackle that from both sides of the equation Like what translated ? Like what do you still pull from that serves you well ?
And then , on the flip side of that , like what doesn't translate , what do you have to go and relearn to move into and be impactful in this space ?
I mean , I must say I've been very fortunate because those different experiences not only and relearn , to move into and be impactful in this space . I mean , I must say I've been very fortunate because those different experiences not only give me fun but also give me the opportunity to learn and then translate that learning into a new situation .
When I moved into TXL , there was a very exciting group of people focused on the science and I came from a very well-organized large pharma with all the processes and I realized , okay , this is an opportunity of bringing those processes and structure the approach .
At the same time we were developing medicinal products and in fact there is a process , there is a natitude , there is a certain set of parameters that need to be applied to whatever kind of product small molecules , vaccines , I mean it's the generation of the right evidence .
So I was able to bring that structure and probably that was the moment where I realized there was fun on startup organizations , because you have a raw material that you're able to shape and , having those previous well-structured large pharma experiences , I was able to impact there .
So I would say , and I said it before , when you develop a cell therapy product , the mindset is not different than developing a small molecule . What changes is the specificity of the product , the technology behind it . I mean , I always use this example you can very simply sterilize a small molecule .
You cannot sterilize your final product , that is a cell , because you're actually going to kill the product , but nevertheless you need to provide sterility for both . So it's the principle that is applicable to any of these products , but then the specificity is declined according to the specific product .
And it was clear to me that duality , and it was important because when you go to the regulators and I say I've developed this , I generated the evidence , I went through the clinical trials the way you would expect . But , by the way , here are the aspects that relate particularly to the product .
The mechanism of action is , as I mentioned before , is also very complex . That's where we come to a very dear concept for the regulators in this context , which is potency . Potency , which is probably , if you measure in a small molecule , is just the quantity of the substance . Potency here needs to be the activity of the cell and the mechanism of action .
And how do you define that , saying that this cell with this potency is going to do what we want the cell to do .
This is a product , and so it's that specificity that I realized that was applicable only to living products that are cell and gene therapy products , but nevertheless the framework is the same as any of the other developments in terms of , you know , clinical pharmacology , preclinical and all those elements .
And that was another element of fun because I could bring something from my previous life , learn from the new life that I was having and not only benefit myself but bring benefits to the discussion .
You you're alluding to . You're providing a beautiful segue to my next question . As I mentioned in the intro , you've got the unique experience certainly unique among biotech execs that I've interviewed on the Business Biotech Podcast in that you have some pretty solid regulatory experience in the EMEA solid regulatory experience in the EMEA , as I said .
You were on the Committee for Medicinal Products for Human Use there and in your last response you talked a little bit about sort of that regulatory paradigm and how it differs . So tell me a little bit about that . How does that experience in the regulatory realm influence your work as not just at ISCT but also as a biotech CEO in the cell and gene space ?
I think it's very simple . I mean you need to understand your customer , your audience , right , and if you have been that customer , you're going to be the perfect provider of evidence of benefit of anything to your customer . So having been with the regulators , having been a regulator , I understand the expectations .
I'm able to say , ok , if I was on that position , this is what I would like to see . When I was at that position , that's what I was provided to see .
So if I'm now in a position that I need to generate the evidence , I know what my first customer because if I take a product to the market and to the patient , the patient is my end customer is the one who's going to get the benefit in the end .
The physician is the one who's going to prescribe , but the first customer is going to be the regulator that is going to allow my evidence to take the product into the market . So understanding that the expectations of the regulators is going to make my job a lot , lot better .
So it helps me definitely in terms of my daily job of developing new medicinal products , but from an IACT point of view , brings to the next level . I mentioned to you before that regulatory discussion .
I'd share that discussion with the regulators from all over the world and I could actually tell them look , what we're doing is taking your conscious , your discussion , your thinking , into access to patients with a product , and being a player like you before and now , like what I'm doing now , enables me really to be able to share the discussion and take it the way
I want to take it . So it has been very , very useful in terms of being able to understand the other side of the wall , to be able to take the learnings and experience on this side of the wall , and , at the same time , it gave me a fantastic network and an ability to really navigate these discussions .
I think it's when I was a regulator I used to say I like to talk to industry and either I am right and I will stand to my principles in the discussion , or I am wrong and I'm happy for whoever industry or otherwise tells me and convinces me so .
And that perspective of being able to be on both sides and being able to discuss confident and assured of what you're thinking but be ready also to understand new arguments was instrumental for that experience then and for what I've done afterwards .
Yeah , with the benefit of that regulatory experience I'm curious about , I'm going to ask you to apply . I guess I'll ask you where you apply in the development process , like , how early do you begin to apply your sort of regulatory perspective ?
Day minus one , okay , because it's the very and I was actually on discussions yesterday in London with a group and I was actually saying we will only know when we talk to the regulators , only know when we talk to the regulators .
So we need to prepare our arguments and anticipate what the discussion is going to be , but , as soon as possible , have that engagement .
It takes two to tango and while you're doing the translational process of developing your product , you need to engage with the regulators as soon as possible because you build the awareness you learned on the discussion and when you get to the final moment of getting your BLA or your marketing authorization , there's an history that both sides have gone through together ,
with different heads , different responsibilities , different perspectives , as it should , and then you know that the final outcome has been a rich , discussed process .
So , to your point , you need to think that from day one , but you should not go before you know what you're going to discuss and you have your own ideas , because you're not going there to be told what to do .
You're going to go there to validate what you believe you want to do , and so you ask the question , you provide the answer and you get the yes or no to your answer , not .
The question is yes or no to your answer , and so you need to be able to provide the answer , and my experience as a regulator helps me build that answer that I need then to validate with the acting regulators currently .
Yeah , you know , the other thing that I think is often overlooked or not thought probably deeply enough about is the fact that regulatory activity can be a rate-limiting factor in terms of fundraising right , like raising the capital to keep your business going .
So I'm going to ask you this question , sort of from the Kiji perspective , from the biotech entrepreneur perspective how important is it to translate early sort of the regulatory promise of something that you're working on and be able to communicate that to potential investors ?
Yeah , nothing more expensive in developing a product than go to a regulatory discussion , having gone through a long process and then having told your process stinks , you need to go back into something else . Right Before you get a lot committed , you need to go along . So it's important that interaction .
Now it's also important that you and we go back to that risk taking . I think life is always about taking decisions , and decisions involve risk , and the regulators have a responsibility because they need to manage the risk , not for them , but the risk for who they represent , which is the use in the patients .
But the risk is not only the risk of potentially consequences and side effects , but also the risk of not providing a benefit to patients . And I think the regulators always need to think these two things , which is the benefit risk .
The typical equation of a regulator is I need to provide the benefit and I need to understand the risk , but if I overplay the risk , I will actually reduce the benefits and change the risk to the other side , which is the risk of not providing a good benefit to a patient in need .
And so it is important to have all of that on your decisions and very quickly decide what you're going to do take the decisions , challenge that with the regulators and then develop the product and take it to the market . So it's important that , as a CEO , as EG , we're about to take the study to a clinical trial .
It's important that we engage with the regulators to make sure that we have the right package , we have the right evidence to go into the clinical trial and once you have the clinical trial and the data , you're able to really go to the subsequent step .
So it is important to understand the regulatory people expectations and in build it in your decision , in your process , the technology and the people behind the technology . They will be confident that the people is making the right decisions . So 50% of the element is already assured . The other one is what it is it's does it work or not ? That's fine .
That's the risk that every biotech investor is prepared to take . What you should not take is a risk on inadequate management , not taking the right decisions , not engaging with the right interactions , not doing the regulatory diligence . That reduces the risk of developing the product .
This finesse around leadership of a company and management that you're getting at . Where did it come from ? In you , I mean your history as an academic , as a physician , you know , as a regulator , as a scientist , speaks for itself . At what point did you decide to pursue entrepreneurship and how did you equip yourself ? Like learn it right , like learn the trade ?
You're talking about some nuanced , you know , biotech management stuff right now . Where does that come from ?
I think even before I finished I school I was .
I was involved in in in a in a science forum in london and I was taken as as a student because I had good marks and so they took me and I participated in the science forum and I liked it and when I went back to Portugal I said I'm going to organize a similar thing for Portuguese students and so , and if I go back , I like to organize things , I like
to bring people and try to understand what they like to do and get the puzzle using that . So it started there and then , obviously , when I was doing my clinical work again back to the HIV , I set up the clinical gut patient's clinic and structured it again .
So it's always been kind of a reflex of structuring and I think it's important to always set where do we want to go , setting that vision and who can play the different pieces of getting us there , because if you adapt well , they will feel happy because they're doing something that you can do and enjoy but also challenge them so that they grow and consequently
you get a good puzzle . I'll give you another example . At a certain point in an organization well , actually at PMS we acquired another company and my boss at the time came to me I want you to do the integration of the two companies .
And I said I'll do it on one condition I will handpick the team anywhere in the organization and nobody will question who do I select ?
When you say handpick the team , you're saying handpick the team that handles this integration .
Yes , I would say the people , the different people , because I think that is essential in terms of building the team , integrating the different personalities , experiences and interests and growing people different personalities , experiences and interests and growing people .
And so I mean leading organizations , leading people and growing people , and I could give you other examples . It's one thing that is fantastic . I mean it goes back to having something as a raw material and then shape it . Developing a product is the same thing .
Developing a person is also similar , and as you integrate the different pieces and have the vision of how one's going to question it , I want to dig a little deeper . On the whole no one's going to question it thing , was there some creative thinking about the people that you wanted to have on that integration ?
You might have faced some objection if you didn't say , hey , no one questions me .
No , no , because I said I want the people for where I know them and for what they will be delivering . And you may say , well , that's not needed . I said I will , I believe it's needed . So judge me by the outcome at the end .
So and obviously I think I don't want to give the perception that nobody questions and it's a walk to bits I wanted to come across with that perspective happy to learn , happy to change , but very clear on setting . This is the vision , this is what we need , this is what I believe contributes to that .
If I'm told wrong and proven wrong perfectly , I'll change , but it's important to make sure that we build to that objective , to that vision , and carry the people behind . Yeah , I want to learn a and carry the people behind .
Yeah , I want to learn a bit more about Kiji . The company was founded in 2023 , so we spent quite a bit of time talking about ISCT , which we could spend a whole lot more time talking about , your work there , but I don't want to give Kiji short shrift . The company was founded in 2023 .
You assume the role there at its founding , are you the founding CEO ? In other words , to create new companies . So at a certain point they've asked me to do due diligence on a project that I had identified in this research center in Spain . I did due diligence and I said this is a worth objective . And why did I say it was worth ?
It's because it was taking cells that are safe , easy to produce , that have been used extensively , but they've never really delivered enormous efficacy Some efficacy , but not enormous and they were actually engineering .
It comes back to the essential thing , which is cell engine therapy , which is optimize the source of the cell and optimize the function of the cell by engineering the cell . And so I said this is actually centered to what cell engine therapy can deliver . And the data was very compelling in different animal models . So I said , yes , I think you should invest .
And they said would you want to lead CoFAM ? And so that's how I came into it . There's quite a lot of work that the research group has already done .
So when we picked it up and took the license on the technology , we're now able to take that into the industrial translation , generating the data not just from an academic point of view for a publication , but from a very clear translational , industrial perspective , to make a product that can be commercialized and be brought to patients .
And that's where all the elements that we talked about of how do you take those steps come in , and I think it's great to be able to understand the science and play with the science .
It's also great to understand how you take it through the development , but also how then you bring it to the market and make it a proposition that has a return on those that invest and a fantastic opportunity to treat patients .
25% of the patients with acute graft carcinoma disease have currently no treatment opportunity and we believe that we can bring them a significant value and the evidence that we have preclinical but well solidified , with very detailed mechanism of action explaining how the cells go to the site and deliver an immunomodulatory effect , because we engineer them to have a
receptor that takes them to the site where they need it and another gene makes them produce the factor that controls the inflammation . So we kind of professionalize the cells for the therapeutic benefit at the site of the need , and so I believe that we will be able to bring a significant increase on the benefit .
A similar product , but not engineered , is likely to be approved by the FDA , a product from Mesoblast . We have shown in vitro that we have better efficacy than that product in the same model because we engineer the cells , as I said , to target and potent deliver of therapeutic benefit . So I believe we're going to bring a significant opportunity for those patients .
And then we can take it beyond to other indications like inflammatory bowel disease , psoriasis , where we know that we can induce the T cells to really modulate the inflammation . So I'm quite excited with that perspective . That's why I took the opportunity of accepting the CEO role .
And again , it's the other element of bringing different people , building the team , building all the Ks and taking this to the next steps . Also the challenging element of bringing new money to take all the finance , all the process and generate the evidence and again , in the end , bring value to patients .
Yeah , so you just explained why you took the position at Kiji . It occurs to me , and again , in the end , you know Dr Miguel Forte is , uh , is is exposed to a lot of opportunity in terms of getting getting on board right , putting skin in the game , um , in in new biotechs , what , what's ? What are some keys to your decision-making process ?
You know , cause it's , it's jokingly , it's . It's also almost easy to say well , dr Forte doesn't know how to say no . Clearly he does everything , which which we know is not true . What goes into your decision-making criteria around the projects you decide to get involved with ?
I think the first one is obviously the strength of the science right and the likelihood of the hypothesis .
Yeah , as you were talking , I remember probably last uh , three or four discussions that I had and uh , there were two that I said I don't think this is uh , differentiated enough or interesting , and there was another one , uh recently that uh that I was approached and uh , and I think , yes , this is that , this is interesting , it's uh , and and and I'm helping
the founder to really position it well , I think it's important to first and foremost , understand , I mean , is this a good science ? I mean , is the data that we're looking well-generated and representative of the hypothesis , and does that hypothesis bring value over and above what currently exists ?
Is there a differentiation and is this possible to be done and we'll be able to get to the mark , and what will be the challenges of the development and is this financeable ? So all those elements that go into it . I think it's also important to understand the team .
But the team , I mean it needs to be the team that generated up to that point , because you probably need to evolve the team as you become more and more industrial . So , in other words , the team is part of like the finance is something that you add on to a project , but it's important that the founders are committed , involved but also are able to let go .
It's kind of having a child you raise the child initially and then others will teach your child , others will take over , others will make them a professional in society .
It's important that the different players from the founders , the team , the investors , the board all of those elements are really played at the different steps so that what gets projects started is not what gets a product approved and a product sold at the end .
Yeah , yeah , very good . You've been doing this for quite some time , spending a lot of plates , taking on a lot of different projects . I'm hoping that you can share with our audience , many of whom are aspiring , aspirational biotech CEOs , some thoughts about how to manage your time and your priorities . I mean , who better to take advice like that from than you ?
Dr Forte , what would you say about balancing the demands of leadership in a business ? That if you're focused on one thing in this business on building one biotech business , and not even involved in associations and the like , you've got a lot to manage . So what's your advice there ?
Yeah , I think , first and foremost , it's important to understand what's important and what's not important . There's a lot of things that are not important , so you shouldn't waste time with them . Second is , obviously you need to have a bit of foresight and say , okay , this is going to become relevant . How do I manage ?
I think probably the biggest challenge of having different projects is each one has got his own rhythm and his own agenda , and balancing them . It's the challenge . So you need to say , well , this , I cannot miss this , I could miss and balance the two . Second , it's important to have the right teams , the right people that will kind of extend what you're doing .
And I think it's also important to balance between , I mean , the commitment that you have on executive roles , because you have an executive responsibility , or non-executive roles , where you have an advisory responsibility , and it's a good blend of the two , and you shouldn't really have too much of what , at least too much of the executive , because then you'll start
getting conflict on time . Of the non-executive , you may have more , but it's important to look at your panel of things to do and decide the ones that you cannot miss and the ones that you may say , well , this is less important , let's do it other way , or let's delegate that to someone else .
Yeah , so , speaking in terms of importance , I'd like you to tackle this next question from two perspectives , both perspectives of ISCT and Kiji . I would ask you for perspectives on every single thing that you're presently involved with , but we'll focus on those two for now .
What is the next most important thing for your leadership of ISCT and the next most important thing that's on your agenda at Kiji ?
The most important thing for me on ISCT is precisely that mobile slash ethical perspective . I've asked Bruce Levine to lead our ethics committee and , as you know , he was past president . He's got a long history in multiple perspectives and we've been doing quite a bit of journey together .
So this perspective of ethical evidence generating , supporting the right development of the cell and gene therapy products is crucial from a global perspective and I'm counting a lot on that committee and the leadership of Bruce there and I will carry it from the Y organization and the Y stakeholders . So that is , for me , the perspective .
I also would like to continue to foster the impact and the recognition about ISCT because it feeds on what we can do . So that's my agenda there . For KeyG , I think the most important thing is to generate the initial clinical data that validates the hypothesis that I mentioned to you . I firmly believe in that hypothesis .
I do believe that the value is there , but the proof is in the eating and if we need to have the evidence that says yes , you validated it , you're able to take the next steps and we're working hard on being able to get into the clinic by middle of next year .
Well , good luck . That's excellent news . I wish you the best on that . Now the final question is what's the next most important thing for you personally ? What's next for Dr Forte ? I think the most important thing To say no more . To say no more , to turn more offers down .
It's to bring what I've done and the experiences and I think that the passion and excitement that I have to others I mean I mentioned to you that we have at ISCT these young professionals I have a couple of young members on my team that I wanted to foster and the growth and the boards that I'm in .
They have either management or the CEO where you could impact . So I think it's great to feel that the effort , the passion , the time that I've involved can be beneficial to someone else to carry on and take that experience .
So I would see myself more and more on advisory people , growth roles relating to boards and other companies , together with the roles that I have at IACT and the Alliance for Resonative Medicine that we didn't talk much , but I'm also part of the board of directors and the executive committee and so really bring all that experience and contribute .
It's the people I do the things with , the people I do the things for and the things themselves that get me excited and passionate about the time commitment that I devote to all of this .
It's a considerable time commitment . I mean , you're planting seeds everywhere , sowing a whole lot of seeds everywhere , and it's inspirational . Like I said from the outset , I was kidding about making people feel bad about how lazy they were born . It's absolutely inspirational and I think you've given some great advice , Lauren .
It's absolutely inspirational and I think you've given some great advice . Before I let you go , though , you just brought up ARM and it was rolling around in the back of my head .
For those who are not as intimately familiar with the industry associations in the cell and gene therapy space , can you sort of compare and contrast ISCT and ARM and your work with each of those , how they differ and perhaps how they overlap and unite ?
We have programs together and I foster a lot of those programs . I think it's because they have a slightly different perspective . One comes from academia and brings industry in . The other one is primarily industry .
Both of them are setting guidance , but they come from a slightly different angle and being able to be in both , I establish a bridge between the two organizations and we have different programs . I mean the ethics discussion is one , some scientific and regulatory discussions is another one , and so that is an opportunity .
But in the principle one is more academic focus . That's how it started . The other one is more interesting and in fact , because 15 years ago when I joined , cell and gene therapy ISCT already existed because it was an academic moment . Cell and gene therapy IACT already existed because it was an academic moment .
Arm was created afterwards and I was somehow part of that creation at the time and then on and off on it because the industry started to emerge , and so there is a need for a kind of corporate organization for industry that represents and lobbies , and ARM has got a perspective of direct lobbying , while IACT has a perspective of guidance and education .
But they complement very well each other and the agenda in the end is the same , which is provide adequate development of products that will bring benefit to patients , but playing different tunes to the same objective .
Yeah Well , your leadership in both associations is certainly appreciated . I've enjoyed this conversation . I'm honored to have you on the show . First of all , thank you very much for spending time with me . I've enjoyed I've really enjoyed the conversation . You're a lot of fun to talk to . I'd like to have you back sometime .
Absolutely , it was a pleasure . I mean , as I said , I'm passionate about this , so I like what I do . I also like to talk about what I do .
So thank you for giving me that opportunity . Yeah Well , your work is selfless though . You know it's easy to look , it's easy to make assumptions when you , when you look at people who are as accomplished as you are Right Like , make assumptions about , well , that guy .
You know he just pursues everything because of his ego what you've earned right , like in the development of the industry and individual people within the industry , and I just really like and respect that about you . So keep up the great work . Thank you for the work that you do yeah and yeah , I'll be in touch . We'll have you back on sometime down the road .
Absolutely , pleasure will be mine . Pleasure will be mine , all right . So that's Kiji . Therapeutic CEO IS All right . So that's Kiji therapeutic CEO , isct president and so much more . Dr Miguel Forte , I'm Matt Pillar . This is the Business of Biotech .
Be sure to visit our video cast page under the listen and watch tab at bioprocessonlinecom , where you can find this and hundreds of other videos of my interviews with biotech builders . While you're there , subscribe to the Business of Biotech newsletter at bioprocessonlinecom . Backslash B-O-B . In the meantime , we'll see you next week and thanks for listening .