Vial CEO and Co-Founder, Simon Burns, sits down 1 on 1 with Humberto Antunes, Partner at Gore Range Capital and Ex-CEO of Galderma, to discuss current challenges in the clinical trials industry.
Simon Burns: Thank you for joining us. I appreciate you taking the time to speak with us today.
Humberto Antunes: It’s great to be with you Simon. Very exciting.
Simon Burns: Awesome. Quick introduction before we jump in I’m Simon, CEO and co-founder of Vial. Vial is a next generation CRO that promises faster, higher quality trial outcomes powered by technology any phenomenal clinical co operations team. Humberto would like a quick background before we jump in, from you.
Humberto Antunes: Sure. I’ve been in dermatology all my life. The since college and I, I’m a partner at Gore Range Capital where we partner with inventors, entrepreneurs to develop new medical solutions. We have a very strong focus in skin health but that’s in a very broad sense. And that includes, no, goes beyond dermatology, plastic surgery etc.
I was the CEO of Galderma for 20 years ah, the, probably the largest independent dermatology company out there. And and before that I, I worked with Novartis as well for 12 years.
Simon Burns: Amazing. Let’s jump in. We’re excited to speak to you today about the challenges in running dermatology trials for the exciting developments in the field. But to kick it off, you work with a lot really sage biotech founders. What advice do you have for them when they’re approaching their first clinical trial? How do you guide them through the clinic?
Humberto Antunes: Yeah first I always say to put patients interests first. It’s put patients first. That is incredibly important. They often, regulatory buddies want to have priority or the CRO or the physician and it usually comes back to bite at you. It is always put the interests of the patient first.
That’s the first part. The second one is why I’m a very strong advocate of innovation when it comes to clinical trials. Be very careful with the innovation. Don’t try to innovate too much of the protocol or endpoints or the measurements. Regulatory agencies are not very creative as and and second, very often you can overrate the level of innovation you’re having and other people have trialed, tried and have failed for good reasons.
So I would say try to be careful there on the innovation. Third it while respecting the [inaudible 00:03:27] priorities, try to go to humans as fast as you can. And that is to fail fast. The way and the phase to be to understand that, the cream didn’t cross the b- the skin or, it didn’t meet the endpoint. It didn’t reach the biomarkers. So try to go to humans as fast as possible.
And, fourth, and perhaps one of the most important ones is don’t fall in love with the technology. Fall in love with the patient needs. The falling in love with [inaudible 00:03:57] very often have a technology, didn’t meet the endpoints. It other technologies have become better and people stick to the old technology. They were in love with the technology, not on the solution and for those things.
So those are my recommendations. There are many things but if you take care of those four probably you’ll have a very successful company.
Simon Burns: That’s great. Taking a wider angle lense on the field what has been the most surprising to you in dermatology research? What took you by surprise? And any recent findings or recent focus areas?
Humberto Antunes: Yeah there have been many surprises, the disappointing ones and the good ones. The the disappointing one is, I had been working on the barrier, the skin barrier, in fact, for very long time and and I like to follow what perhaps our grandmothers thought were the right thing for something, and I always thought that, perhaps, taking care of [inaudible 00:05:01] to cover the first three, four, five years. It you would protect that little patient from having worsening effects over time.
Those were studies were incredibly long and five years studies and had to follow patients over decades. And it never worked. never worked. I thought it was gonna work and dedicated a lot of my time, a lot of people’s time. It’s a lot of thesis. A lot of PhD thesis that dedicate themselves to this and it just didn’t work. The now, unfortunately there have been tremendous new drugs and [inaudible 00:05:38] in biologics and soon in immunology targets that will work and satisfy those needs.
So if you can’t go one way, there are other ways. Now, also gene therapy, is surprising, it’s I’m, we’re seeing some results in gene therapy that are very exciting. I thought it was gonna take a lot longer to get those results and we see some promising results [inaudible 00:06:07]
Simon Burns: Let’s follow that thread. Over the next five years what are the exciting developments that you’re attracting that you think are gonna be the most exciting?
Humberto Antunes: Oh there are so many ones. I believe that staying healthy longer, it’s going to be more important than treating diseases, okay. The upside for us, as mankind, was stay staying healthy longer. And now, the medical system, it’s more of a sick care system than a health care so there are a lot of rewards for treating disease and not as many rewards for just staying healthy.
However, in dermatology, we’re so lucky that we have aesthetic medicine, and we call it aesthetic medicine, [00:05:00] which is actually not aesthetic only. It is about staying healthy. It’s about protecting our skin and making it last longer and do it’s job longer, with less wrinkles, with more collagen, with no and continue to be, good looking and feeling confident and interact and social [inaudible 00:07:08] medicine has an impact on mental health that is incredibly important.
So that is the first thing that I do see a lot of new solutions coming either to, to fill areas or to empty areas or to improve the quality of skin or to take care of wrinkles. Those, that’s an area that I’m very excited about. The and then there is immunology, inflammation, protein and gene. Those, the convergence of those technologies together with digital are transformative in health care.
I’m very exited to see what’s going on in those areas. We’ll probably talk a little bit la- later about some of them.
Simon Burns: Great. You were the CEO and chairman of Galderma for several years m- quite the organization to lead global sales force, preclinical, clinical aesthetic in general dermatology. What were the lessons over your career leading that organization?
Humberto Antunes: Oh there are so many lessons. It’s a whole lifetime of of lessons and and warned that this, I said right in the beginning is put patients’ interests first. And understand that the needs what you need to do for anything you’re gonna do is understand what the needs are. And then try to simplify things. Try to simplify. The world is extremely complex and if you can simplify the answers or simplify the questions, have elaborate on those questions really well so that you try to simplify the question or decrease the size of the obstacle so that you can tackle it better.
Those are incredibly important things. The I am passionate about dermatology and passionate about skin health in general. The it interacts with so many areas of of disease. You can’t just look at one area. And I’ll also have learned that in, in the convergence of technology is extremely important, what’s going on with digital, what’s going on in in engineering in general. It internet of things that would be so important as well and so I would look for more of that. The innovators for the future can tackle some of these exciting opportunities that are out there.
Simon Burns: Great. Let’s go into a segment we like to call “Overrated Underrated” I’ll run through a list of concepts. You tell me if you think they’re overrated and underrated and why. The first is the atopic dermatitis boom it, has it peaked overrated or underrated?
Humberto Antunes: AD boom peaked?
Simon Burns: Yes.
Humberto Antunes: Doubly overrated statement. It’s just starting. Dupilumab is out there but [inaudible 00:09:54] just arrived [inaudible 00:09:56] is going to arrive. There are some JAKs that are being under development. Gene therapy hasn’t even started in AD so AD is many times larger than psoriasis. Totally underrated. Overrated, I mean, just [inaudible 00:10:13]
Simon Burns: Uh, do you know dermatoses as an area of interest therapeutically, overrated or underrated?
Humberto Antunes: I’m going to answer with two parts. There is a part that is underrated, another parts that is overrated. Underrated and [inaudible 00:10:25] okay it’s hopefully it will cure genetic conditions. It, so that is the genome dermatoses, there are over 3,000 genome dermatoses. And and an incredibly needy areas. So this is a great, incredibly exciting to have genome dermatoses. The genes themselves are totally overrated.
Behavior, proteins and how we metabolize those proteins. They play a huge role in our health. So you can’t blame you parents for everything, how you interact with the environment, with food, with habits, plays an incredibly important role in our genetics framework so why, gen- the genome dermatoses are underrated, perhaps. I would say that genes are overrated.
Simon Burns: Let’s talk about protein degradation approach, as you mentioned it earlier, [inaudible 00:11:23] overrated or underrated?
Humberto Antunes: I think it’s underrated. It’s unknown yet. So I did say that proteins are incredibly important it’s and and they are just as important, they play a huge role in treating diseases. The there’s an incredibly exciting area of protein degradation. There’s PROTAC approaches and some other technologies that are emerging exactly because it degrades the proteins that would cause the diseased condition.
It it promises to have less side effects than protein inhibition. It goes with the natural course of your body and and that is very exciting. And [inaudible 00:12:08] is a very good example. It they are not doing dermatology down there. They’re doing lots of other areas and there are another dozen companies working on PROTAC and some other technologies that are very complex with this ternary compounds.
The you can have this proteins of interest and how to bind and degrade them. It will most likely, stand next to gene therapy in terms of importance of technologies and satisfying needs.
Simon Burns: Let’s talk about the jack and the ticks a lot of [00:10:00] talk in dermatology about it about the recent Pfizer deal. Lots of movement there. do you think of the field and the, those two
Humberto Antunes: Still underrated. Still underrated because they have not hit the market yet. Ritlecitinib from Pfizer seems to be a very promising family combination. Jack Soley’s work with pairings they’re always two pairs and and ritlecitinib may, may be more unique, have a more unique profile than [inaudible 00:13:15] with JAK-3 and not specific with JAK-1 or JAK-2.
But but it may bind to other genes and other proteins that do not play a role in the disease. I think why I’m very excited about ritlecitinib because of it’s specific to JAK-3. We may have a need for other JAKs that will have an ex- very strong binding to one protein and very little to anything else so that it just works where it needs to work and and it’s not cause side effects.
The it there are a couple companies working on those concepts and I’m very excited about them.
Simon Burns: Next up, the new and soon to be approved topical AD therapies from [inaudible 00:14:07]
Humberto Antunes: Look I take my hats off to the people that did the execution on those drugs. They’ve done a tremendous [inaudible 00:14:19] and the medical marketing of them. The there is a lot of excitement and expectation for both drugs from both sides. Now, while, how is that gonna compete in the market place? I think it depends it depends on the market and I think that the market will decide if it would be, success or not.
Simon Burns: And lastly the -omic revolution has not touched dermatology a- as much as some people might like. What is your sense of the -omic revolution for new therapies-
Humberto Antunes: Underrated.
Simon Burns: … on treatment.
Humberto Antunes: Underrated it’s a very good question, Simon, thank you. It it’s underrated. There’s an incredibly complex area. It you know there’s this behind road precision medicine is. Precision medicine, I think, is the future outside for mankind. So that we need to know more about disease to better diagnose the condition, select and develop better drugs and medical devices to meet those needs [inaudible 00:15:23]
I do believe that the -omics revolution will be incredibly important and we’re not talking about -omics I talk about the genomics, the proteomics, metabolomics and they all play an incredibly important role in this year’s and that’s why we need to be careful not to say that one is, overrides the other because, really, you can’t live one without the other.
And so you mentioned in atopic dermatitis and psoriasis and they are very common conditions. Psoriasis affects about 3.2, 3.8% of the population. With very large regional differences. I think it’s close to zero in Tanzania and, believe me, they have their share of dermatological ailments but it’s not psoriasis. And it’s over 10% in Norway so this makes it an incredibly diverse disease and and the onset of psoriasis, the severity, the modalities they vary tremendously so having the right -omic profile [inaudible 00:16:24]
You actually will help managed care. Managed care will, help them decide if or avoid, stab therapy. They will avoid recurrence of the disease, have longer remission periods and that, hopefully, is cheaper for managed care and they should work, with the physicians we have that. I would hope they would incentivize the physician to use more -omics in the whole overall thing.
In, in psoriasis with [inaudible 00:16:59] being almost close to a hundred percent in many drugs and having a, it’s probably 20 years ahead of atopic dermatitis. You might ask yourself is it as needed in psoriasis since you have very effective drugs. From the efficacy standpoint, maybe not. But in atopic dermatitis, I think that it’s easy to make the point today we have Dupilumab. It’s very safe. But there are a few patients that have, side effects and it doesn’t work on everybody.
It works in 60%. We’re gonna have just Tralokinumab just arrived. [inaudible 00:17:34] is going to arrive soon. There are many of the JAKs that are being worked on it so understanding the disease will be better. I think the disease, atopic dermatitis is much larger than than psoriasis. I think numbers are between 15 and 20% in children, 7 to 10% of the population. And because it it manifests itself in so many different ways and some atrophy that you have on the skin interacts with other comor- comorbidities.
It’s very complex. I think we’re just scratching the surface, understanding all the -omic standpoints there. I would expect a wave of new treatments. Of innovation and and thanks to -omics so that will tell us better how to to tackle those problems. Yeah, very exciting times, Simon.
Simon Burns: [laughs]
And then, lastly it’s been a difficult time in public markets for biotechs, a difficult time in private markets raising capital you don’t have to go [00:15:00] too far to find data points to, to back up all those stories. How do you advise biotech founders, biotech teams who are navigating a bridge of very difficult market climate today?
Humberto Antunes: Yeah, to have discipline and stick to the big go here. They’re working on very important things and particularly private markets. There’s this, you’re working on creating true value. True value for patients, true value for physicians. Value for investors and when you work for creating value for everybody, money will come it’s way because money needs to work. Money, on it’s own, it serves no purpose. And markets public markets stock markets it, it plays different roles.
There are different priorities and it’s a bit more complex but it’s a great source, of course, to to find funds [inaudible 00:19:29] not the right timing to go public but they will come back. It, I’m sure, will come back. In the meantime, let’s get private money to work and create value and and there’ll be access later no d- no doubt about it. Have to have patience.
Simon Burns: [laughs]
It was phenomenal chatting. Thank you for taking the time, Humberto, I really appreciate it.
Humberto Antunes: Simon, great talking to you. Have fun. You take care.