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The Next Generation of Psychedelics Focused on Patient Access
Episode

Blake Mandell, Co-founder, and President of Transcend Therapeutics

The Next Generation of Psychedelics Focused on Patient Access

In this episode of the Outcomes Rocket Pharma, we are privileged to host the outstanding Blake Mandell, co-founder and President of Transcend Therapeutics. Transcend Therapeutics discovers, develops, and delivers next-generation medicines to work towards a world in which people no longer suffer from neuropsychiatric disorders. 

In our conversation, we cover Transcend’s goal to discover and develop drugs from analogs of classic psychedelics and how they fit better into the care paradigm. Blake discusses the current statistics of adults suffering from major depressive disorders in the U.S, his vision of where Transcend will be in the next years, challenges, the Multidisciplinary Approach for Psychedelic Studies (MAPS), and more. He also shares his insights on working with psychedelic substances and the possible treatments it offers for patients suffering from depression and other neuropsychiatric disorders.

 

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The Next Generation of Psychedelics Focused on Patient Access

About Blake Mandella

Blake is the Co-Founder and President of Transcend Therapeutics. Blake previously led the Frontier Technology Practice at Ali Core, where he helped incubate two companies in 2020 that have since raised $20 million in venture capital. He co-wrote the Psychedelic Science Funders Collaborative Landscape Report and was a founding advisor to the PSFC Investment Circle.

The Next Generation of Psychedelics Focused on Patient Access with Blake Mandell, Co-founder and President of Transcend Therapeutics: Audio automatically transcribed by Sonix

The Next Generation of Psychedelics Focused on Patient Access with Blake Mandell, Co-founder and President of Transcend Therapeutics: this mp3 audio file was automatically transcribed by Sonix with the best speech-to-text algorithms. This transcript may contain errors.

Kyle Wildnauer-Haigney:
Hey everyone, this is Kyle, your host for the Outcomes Rocket Pharma podcast. Today, I have the wonderful opportunity of welcoming Blake Mandell to the show. Blake is a co-founder and president of Transcend Therapeutics, which discovers, develops, and delivers next-generation medicines to work towards a world in which people no longer suffer from neuropsychiatric disease. Blake previously led the Frontier Technology Practice at Ali Core, where he helped incubate two companies in 2020 that have since raised $20 million in venture capital. He co-wrote the Psychedelic Science Funders Collaborative Landscape Report and was a founding advisor to the PSFC Investment Circle. Blake, welcome to the show. It’s great having you.

Blake Mandell:
Thanks for having me.

Kyle Wildnauer-Haigney:
So maybe to start things off, you just tell me about yourself. What drew you to working in the pharmaceutical industry?

Blake Mandell:
I think it’s probably my own suffering I’ve had in years past. I spent years of my life suicidal, depressed, anxious, compulsive, addicted, and thankfully I got to recover. But it’s probably no surprise to you. I know you’re spending a lot of time with people in various pharma roles that treatments for neuropsychiatric disease are actually quite poor. And so the reason that I’m working on what we’re doing here at Transcend, is to give people like the friends I have that didn’t recover a chance.

Kyle Wildnauer-Haigney:
Wow, that’s incredibly powerful. And you know, I’m so glad that you’re taking your own challenges and turning it into a way to help others, right? And that’s so much of what health care provides you the opportunity to do. You know, I was wondering what excites you about the day-to-day work and the stage that you’re at Transcend Therapeutics?

Blake Mandell:
Well, obviously, you know, I’m sure you’ve had many people say this, but it’s really fun working at an early-stage company. Things move quickly. You learn you’re wrong, you correct it. But really, the stage is exciting because we hope to have clinical data that the compounds we’re working with have efficacy in patients with depression, PTSD, suicidality, and other neuropsychiatric diseases within the next 18-24 months.

Kyle Wildnauer-Haigney:
Wow. So Blake what is it that you do different from what other companies do today?

Blake Mandell:
I think at the crux of it is that we’re excited by clinical data rather than preclinical data. What that means is we’re not saying that because something works in a mouse, it will work in a human. People have been trying this for 30 years. It just hasn’t been working. I mean, we don’t understand the brain. I’m not bold enough to say that we’re even close to understanding. And so really, all that we know is if something works in a human, that’s great and that’s actually useful. And if something works in a mouse, that’s very interesting. But over the last 30 years, it hasn’t translated into new medicines for mood disorders. Just to give a couple of examples, there have been a couple of new drugs approved actually in 2019, and neither one of them were compounds that were newly discovered. One of them was a drug whose value in depression was discovered in the nineties, and the other one was actually discovered in the human body in 1938. So we’re working with compounds that we already know have efficacy. It’s not the kind of data that the FDA is going to accept, but it is a series of clinical cases. And that itself is really valuable.

Kyle Wildnauer-Haigney:
So Blake, maybe just to state it very clearly for the audience. Transcend Therapeutics is really working with, you know, psychedelic drugs, compounds that have been used recreationally and medicinally, but not in an FDA-approved way. Is that correct? Or am I misunderstanding something?

Blake Mandell:
No, you’re totally correct. So we at Transcend are working with analogs of the classic psychedelics. Most people know the classic psychedelics as MDMA, sometimes called ecstasy, LSD, psilocybin sometimes called magic mushrooms. So we’re working with analogs of these compounds that the analogs themselves have been used underground hundreds of thousands of times and have actually been used in clinical treatment. And what we’re really excited and moved by and inspired by is that the compounds we’re looking at aren’t necessarily hallucinogenic. So they’re psychoactive like having a glass of wine, but they’re not hallucinogenic. But they seem to have really, from the data we have, the thousands of case reports, they also seem to be very effective. And because they’re not hallucinogenic and they don’t take eight hours like the classic psychedelics, they fit much better into the care paradigm upon approval.

Kyle Wildnauer-Haigney:
That’s fantastic. And I think the focus to those neuropsychiatric diseases, I think that is, you know, there’s really a lot of suffering going on in that space from those diseases, and there’s not many good tools developed, at least for my understanding. It sounds like you’re kind of going down this approach where 20 years ago this was completely taboo. No company would even think about maybe going down these paths or not to the degree that Transcend is. Yet you’re leading the way and really trying to think creatively about ways to help patients. Is that right?

Blake Mandell:
Yeah. The thing that’s even more discouraging is over the last, say, 10 to 15 years, many of the large pharma companies have reduced or completely divested from neuroscience R&D. And I mentioned this briefly before. But it’s because the drugs aren’t working. It’s not that they don’t care. It’s that they have struggled to translate data in mice to humans. I think the former director of the NIH said something like if we were looking to cure cancer in mice, we would have been done 20 years ago.

Kyle Wildnauer-Haigney:
That’s interesting.

Blake Mandell:
And so people pay 40 to 50, sometimes up to a hundred thousand dollars per patient in a clinical trial. And so we’ve derisked our development approach by looking towards thousands of clinical observations and actually many of them in case series that we own demonstrating, one – that our drugs work, two – that they’re safe, but also a lot of the details like what’s the dose, what’s the schedule and what types of patients may or may not respond well.

Kyle Wildnauer-Haigney:
That’s very fascinating. It’s not just the area that you’re focused on the molecules, but it’s also the process and how you source the data. I mean, when you think about pharmaceutical drug development, the R&D budget is massive, and that’s what’s really slows down bringing new drugs to the marketplace. Yet Transcend Therapeutics is taking a novel approach. So, you know, I’d love to just kind of hear a high-level overview of what really excites you about the work that you do today.

Blake Mandell:
The heart of it is working with our team. As you know, drug development is very tough. I don’t claim to be an expert in drug development, but we have that expertise in our team. So my co-founder is the first person to receive NIH federal funding for clinical research with psychedelics since the sixties actually in 1967. And our chief development officer, I believe, is one of the most experienced people in the space. He’s been responsible for nine drugs being approved. He’s been the head of development at five startups that exited for three and a half-billion dollars. And he knows the intricacies of IP with compounds that already exist. He has thirty-nine U.S. patents. And then it’s just wonderful to work with my other co-founder and chairman, Kevin Ryan, with whom I worked at Ali Corp. and launched this business together.

Kyle Wildnauer-Haigney:
Wow. You have the all-star team, it sounds like. But tell me about the opportunity. I mean, how big is it?

Blake Mandell:
Well, let’s just go with some numbers, and then we can really get into it. Twenty-six million adults suffer from major depressive disorder in the U.S. 60 percent don’t respond to initial course of treatment or relapse. And even today, antidepressants sell over $10 billion a year. Almost all these drugs are generics, so basically they’re very underpriced. And as I just told you, they’re not super effective for patients.

Kyle Wildnauer-Haigney:
So huge market opportunity. I mean, the impact on individuals’ lives is massive. But also there’s a business that can be built, probably many businesses that can be built in this space.

Blake Mandell:
Yeah. So the last year of exclusivity, which was 2007, Zoloft sold three billion in annual revenue. Zoloft is not differentiated from the other 20 plus generic antidepressants, but this was 2007. Mental health was not part of our culture. It wasn’t part of the national discourse, and now it is also in. Also, in 2007, pharma prices were also lower than they are now. So look for me, this is personal. I think that we really have a chance to impact tens of millions of people’s lives, and at the same time, it’s exciting that there’s just an enormous market opportunity as well.

Kyle Wildnauer-Haigney:
Absolutely. So, you know, that’s very helpful and insightful to hear about really the team and kind of the areas that you’re focused on. But I’d love to get your sense of what do you see Transcend Therapeutics developing into in five or 10 years.

Blake Mandell:
So why don’t we take a seven and 14-year view? The only reason I say that is we think that there’s a chance that we can get one of our compounds approved for our first indication in seven years, which in Pharma land is actually very fast. And so in seven years, we hope that our lead program is on the market for depression and PTSD. And so as compared to classic treatments like SSRIs, I think most people would know Prozac.

Kyle Wildnauer-Haigney:
Yeah,

Blake Mandell:
This isn’t a treatment that you take every day, and we’ll only know if it works six weeks later. It’s a treatment that might even work after the first two or three-hour session. And you might only need three or four to work through the trauma that is leading people to feel depressed or have severe PTSD. And then after that, hopefully, they can get back to their normal lives. And the nice thing about having a drug that’s not administered chronically is you don’t have chronic side effects. Most people find they have a variety of side effects from acid psoriasis. That’s a laundry list. I don’t need to go into it. I’m sure some people sort of know the stereotypes around libido. Actually, I’d prefer not to talk about libido on a podcast, but I guess I’ll just continue with that and say that unlike the SSRI’s, where over 60 percent of people don’t respond or relapse from treatment, the exciting things about the set of compounds we’re looking at and even psychedelics more broadly is you’re looking at a much higher response rate rather than a 30 to 40 percent response rate with only mild to moderate effects, you’re looking at a 70 to 80 plus percent response rate. With the PTSD data that MAPS has come back with treating PTSD with MDMA.

Kyle Wildnauer-Haigney:
Yeah,

Blake Mandell:
Something like over half of their patients no longer even qualified for PTSD anymore.

Kyle Wildnauer-Haigney:
Wow. So what you’re saying if I understand you correctly, is these treatments don’t only work in a higher proportion of the patients who are taking them, but they also last longer. Is that correct, that they can avoid relapse?

Blake Mandell:
Yeah, yeah. And the interesting so it’s not that just it works with more patients, but it also has a larger effect. So it’s fast-acting. It’s durable and it’s robust. And that robust thing is actually especially exciting because with most medications in any field, I give you a drug today and tomorrow you’re doing well, and maybe a few weeks later, you’re doing a little less well. But what we found with the MDMA data from MAPS, and I’ll say a bit more about MAPS in a second, is patients do better three months after the treatment than the day after treatment. And that’s not really something that we’ve ever seen before in neuropsychiatry.

Kyle Wildnauer-Haigney:
Interesting. And so tell us about MAPS. I’ve heard of this program before in other contexts, but I’d love to get your take on it.

Blake Mandell:
Well, no one in the psychedelic space would be able to do their work without MAPS. Map stands for the Multidisciplinary Association for Psychedelic Studies. Their founder and executive director is Rick Doblin, and he is the driving force behind how any of the other organizations, whether for-profit or nonprofit, working with psychedelics to potentially treat neuropsychiatric disease. He’s the reason that any of us are able to do the work that we do. Rick’s been at this since 1986 when it was almost impossible to do work with compounds that were scheduled in the early seventies. And their major focus is looking at MDMA-assisted psychotherapy for the treatment of PTSD. And I would urge everyone who’s listening to go and look up their phase three data. It’s just incredible. They’re working with people who on average have had severe treatment-resistant PTSD for over 15 years and after three courses of MDMA assisted psychotherapy, which involved people sort of preparing for the session, having the session with a couple of therapists and then integrating whatever they learned from that session into their lives after just three of those, you could say, course of treatment, a majority of the people responded and with quite a large effect size as well. I’ve met many of the patients that they’ve treated, and we’re just very grateful for what they’re doing. One other thing I’ll say as well is the reason that they are paving the way is so important is that enables the rest of us to have the same regulatory pathways. So it’s one thing for the DEA to let you do research. But if the FDA doesn’t believe that it’s interesting, we shouldn’t be wasting our time. And so what Maps has done is Rick and his team have spent decades working with the FDA to demonstrate to them that these patients need help, and it doesn’t matter whether the compounds are scheduled or not. They should be allowed to do trials. And if the data is good, the FDA should and now is accepting it.

Kyle Wildnauer-Haigney:
That’s amazing, and it offers so much hope for patients struggling with these neuropsychiatric diseases. You know, it’s just really hats off to what you’re working on and what the broader industry is working on as well. I would love to get your thoughts and this is kind of orienting the conversation more towards the future. So we are at this what feels like a threshold or precipice where we are going to see a proliferation of new kind of psychedelic-based therapies. What are you most excited about? What are your predictions for the pharmaceutical industry kind of within this lens for the next 20 years or from this point on?

Blake Mandell:
Well, first, I’ll answer on what it looks like for society. And then I’ll answer for what it looks like for companies like ourselves. So for society, it means that people finally have the opportunity to have treatment for what they’ve been suffering with for years. And unlike SSRI’s, which many patients say it mutes their feelings of life, the psychedelics and the analogs were working with many people report that it enables them to really flourish in their own individual way and work through their own personal trauma that’s been holding them back from themselves, their families, their jobs, really everything that matters to them. And so I hope that in 20 years, as more and more drugs of this type get approved in our society continues to reduce the stigma around mental health and around these currently scheduled compounds, patients can basically become not patients anymore. They can become people who don’t worry about these kinds of things. And that’s my hope for society at large. For the industry, I think that there are some logistical challenges around the classic psychedelics, which is why we’re working with analogs. It’s going to be very difficult in the infrastructure to have eight-hour sessions, which sometimes the classic psychedelics require. There’s already a dearth of psychiatrists, there’s already a dearth of therapists. And so I think what will need to happen is therapists and psychiatrists’ time will need to be spent on the most valuable things, the things that only they and not technology can do. So 20 years from now, I’m hopeful that not only are these medicines approved for patients but that patients are able to leverage technology in ways that maximize the time of the therapist. So this could be like virtual CBT before and after treatment. How can people prepare for these experiences in a way that obviously a therapist and a psychiatrist should be available? But how do we maximize their time given the existing shortage?

Kyle Wildnauer-Haigney:
Really, You know, it sounds like this picture you’re painting as a whole host of services and coordination with the insurer, the provider, and probably new entities that will have to be developed to support these new therapeutics and to support these highly effective treatments for this group of patients who didn’t really have hope before. Does that sound right?

Blake Mandell:
Yeah, that’s exactly right. And as payers have begun to realize over the last 10 years that behavioral health, you know, mental health, neuropsychiatric disease, whatever you want to call it, is deeply related to expenses with other chronic conditions. And as people improve their behavioral health, they’re oftentimes they’re better able to manage their chronic conditions and the costs go down. And so we look to have a triple win, patients win providers win that they can finally help patients and payers win. That costs can go down because, you know, I’m sure it’s no surprise to you, but medical costs are increasing in a way that’s not really sustainable for our future.

Kyle Wildnauer-Haigney:
Yeah, I think it’s a spot on the answer to, I mean, all of the conversations I’ve had with leaders within the health plan space, you know, they really talk about the importance of mental health and the focus of providing new treatments, new services to a group of members that maybe have mental health challenges today, but also trying to prevent them and be proactive. So I think, you know, the work that you’re doing falls exactly in line with that. You know, maybe one of the last questions here is, yeah, I’d love to get your sense of what are the biggest challenges facing the industry now?

Blake Mandell:
The first challenge is, frankly, with the DEA. For better or for worse, in my opinion, for worse, all the psychedelic substances and almost all their analogs are schedule one. What this means is it’s very, very expensive and difficult to do research with them. So I’m not saying we need to make these medicines tomorrow. I don’t want that. The FDA’s job is to keep patients safe and only approve things that are safe and effective. But I hope that the different barriers to research can come down so that it’s cheaper to do research and that we can discover more things more quickly and cheaper. Just to give you an example of how laborious it is to do research with schedule one compounds. So schedule one technically means no medicinal use and a high probability for abuse. You need to have a safe that’s at least eight hundred pounds literally bolted to the floor with an extra lock into the safe room in order to access any of these compounds for any reason. So that’s just one example, if that’s helpful.

Kyle Wildnauer-Haigney:
Yes, very helpful. I’m picturing Fort Knox right now. Well, Blake, thank you so much for joining the podcast. You know, maybe you could give the audience a closing thought and the best place where they can collaborate with you.

Blake Mandell:
Thank you for having me. It’s been great to be here. One closing thought is to try to imagine what it feels like to have major depression or PTSD. I’ll talk a bit about my own experience with depression just for perhaps a minute, if that’s helpful, because I think it really humanizes the condition. And I think that’s the most important thing as we try to mobilize resources and public sentiment to do research to develop treatments. Depression feels sometimes like life isn’t worth living. It’s like you wake up and you’re really tired and grumpy, and that just never goes away. I spent years not able to feel any joy and I’d worry at night about why I was even living. And so this is what daily life is like for someone with major depression. And thankfully, I got to recover. But I just like everyone to think 20 percent of the U.S. had major depression at some point in their lives. That’s someone in basically every family. Definitely someone in every friend circle. And so I’d even say mental health affects all of us, and I think we all need to recognize that it’s very real.

Kyle Wildnauer-Haigney:
Yeah. Well, Blake, thank you so much for, you know, being so authentic and honest, transparent with your experience and all the wonderful work that you’re doing at Transcend Therapeutics. I want to remind the audience that you are scaling rapidly. And so if anyone listening is interested, I’m sure go on their website and they will have postings for job opportunities. Blake, thank you again for joining the show.

Blake Mandell:
Thanks for having me. And it’s just great to be able to speak about what we’re working on.

Kyle Wildnauer-Haigney:
Fantastic. Have a great day.

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Things You’ll Learn

  • Twenty-six million adults who suffer from major depressive disorders in the U.S. 60 percent don’t respond to the initial course of treatment or relapse.
  • Drugs that are not administered chronically don’t have side effects. 
  • There’s a lot of suffering in the neuropsychiatric space, but there are not many good tools developed. 
  • We need to provide new treatments and services to members who have mental health challenges, but we should also try to be proactive in preventing them.
  • 20% of the US population had major depression at some point in their lives.

 

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