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: [00:00:01] Welcome to the Outcomes Rocket podcast where we inspire collaborative thinking, improved outcomes and business success with today’s most successful and inspiring healthcare leaders and influencers. And now your host, Saul Marquez
Saul Marquez: [00:00:18] Outcomes Rocket listeners welcome back once again to the outcomes rocket podcast where we chat with today’s most inspiring and successful health care leaders. I want to really thank you once again for tuning in and invite you to go to outcomesrocket.health/reviews give us a rating and review them through Apple podcasts and one of our favorite things is looking at when the listeners let us know what they think. So drop us a line there. Let us know what you think of the show. I want to introduce to you an amazing guest today. His name is Ira Pastor. He is the CEO of Bioquark Incorporated. He is an extremely amazing individual focused in health care for almost two decades now his interest lies in combinatorial biologics and they’re working to the level of the regulatory genome and just really doing some amazing things for age reversal as well as disease reversal. Super intriguing stuff that I think everybody is going to get a kick out of and really learn something from. So without further ado I want to open up the mic to my amazing guest Ira and let him fill in many of the gaps and then introduction. Ira welcome to the podcast.
Ira Pastor: [00:01:29] Thanks for having me on. Really appreciate it.
Saul Marquez: [00:01:31] Absolutely Ira. And so why did you decide get in the medical sector to begin with.
Ira Pastor: [00:01:36] I got my start as a pharmacist and in pharmacy training back of the day. They still haunts a few semesters of what was referred to as pharmacologists or medicinal botany. So I guess I know throughout the development in the industry the last 30 years or so I’ve always had appreciation for the natural world and sort of the fact that we live on this planet with organisms that sort of from a health and wellness perspective are are really much further advanced than we are as human beings. So you know obviously the audience is well aware that many members of the amphibian Kingdom are capable of replacing lost or damaged organs and limbs that are identical in both structure and function to the original they did in placing right. Yeah. I mean they do the same for limbs and hearts parts of their brains spinal cords obviously and we have a spinal cord Legion a serious one in a wheelchair the rest of our lives at the same time. They’re very good. This is lesser known but it goes back to sort of seminal work in the 1940s reversing the diseased phenotype. So as an example cancer is you know cancer strikes all of us on this planet from humans to dogs snakes frogs the trees on down the line. But how the lower organisms deal with it is much different than we do. I mean they just shrug it off and like to turn tumors and other forms of cancer back into normal tissue and they do it very easily. And so you know the concept for Bioquark was basically taking a look at this what we know was for intuition epic morphic regeneration and reprogramming that is done throughout the natural world and throughout the biologic Kingdom are reconnecting it to humans because here we are are the most advanced species on the planet and yet we when it comes to sort of disease and degeneration we’re not adding too well with regard to cures for some of these major diseases Alzheimers cancer just heart failure what have you. Basically wanted to take a look at a sort of from a different angle. And so when we got into the area that was what we defined as combinance where the biologics companies worry over talking about how we could develop pharmaco therapeutic interventions that do more than one that basically don’t fall in those sort of a single magic bullet formula. The farm has been working well for this hundred years but basically how we think outside the box and say well ever more for regeneration is based on tissue reprogramming and this analytic events in control of the innate immune system how do we create Formic therapeutic materials bio products and refer to them as that can do multiple things at once and be ultimately developed regulated register as sort of a single drug entity that sort of the path that we decided to take with this company and ultimately how we develop products of that nature and then utilise them for what we refer to as the three Rs regeneration repair and ultimately rejuvenation of aged tissues in the human.
Saul Marquez: [00:04:40] I think that’s super interesting. You’re looking at this from a completely different perspective out of a box and looking across the species aisle so to speak and questioning why can’t we use some of these things that are going on or are there. Give us an example of how Bioquark and you and your team there have improved outcomes by using these concepts.
Ira Pastor: [00:05:05] No absolutely. So as mentioned we are looking in our development platform is based on therapeutics that have more than 1 moiety or object moiety and can do multiple things so it is an example. We are working with a set of groups overseas one particularly in India right now on spinal cord regeneration research and this is an area that has really languished since the beginning of the pharmaceutical industry. Ultimately how we deal with neurogenesis in the central nervous system for the correction and repair of severe lesions which ultimately as humans leaves us paralyzed not just the rest of our lives. So we really want to understand how we could go beyond what exists currently whether that they are therapeutics that stimulate only one aspect of neurogenesis or areas like stem cells which have been exciting or been on the radar screen for a couple of decades now but really haven’t hit the the ball out of the park yet. And so this is an area where we thought it would be ideal for our research program because when it comes to the area of spinal lesions we’re dealing not just with the ability to grow new nerves and connect them in the appropriate ways but also how we deal with all of the scar tissue and other sort of Vetri within the the wound itself and how we turn that from scar tissue back into sort of normal tissue microenvironment bounden spinal cord. So you know we have been partnering our technology with firms in areas that we can speed up the clinical development and this is one area where had some very interesting phase 1 2 outcomes so far in the red of spinal cord injury starting from sort of age a complete loss of function and loss of sensation and begun moving some patients in our early clinical program up the path towards Asia b c and ultimately contemplating a complete reversal paralysis. So this is a very exciting area for us. We can’t claim yet that we’re getting people jumping out of wheelchairs but we are beginning to see the progression and the reprogramming of tissue just like it occurs in amphibians and other friends of nature that don’t have to worry about paralysis and how we begin to get the owning and control of the bladder back so forth and ultimately the muscular response. So that’s been one area that’s been very exciting for us and we this day the entire central nervous system just as a target moving for the next 10 years and answering our long term plan is a very important area.
Saul Marquez: [00:07:56] That’s super interesting Ira and congratulations on being able to get this amazing work done. Just imagine yourself sitting there might able to move. Then all of a sudden a company comes out with something that can help you find that help. That’s pretty amazing. And how far away was this scientist. You probably get this question a lot but for Mr. Superman that you know was working so hard to get a solution.
Ira Pastor: [00:08:23] Well that’s a bit of a longer story a little bit of background and experience in the pharmaceutical industry and as you’re well aware you know the last since the start of the inception of the modern pharmaceutical industry the sort of a trend has been in researchers attempting to reduce in studying a health disease at the most basic components. So you know proteins gene cells and sort of continually looking for targets to develop drug compounds that interfere in some fashion with biologic process. But the problem has been that from the perspective of drug development many of these targets while they have generated wonderful treatments for us and trillions of dollars of wealth most of these traditional targets are what I refer to as the big a sort of inflammation immune response fibrosis thrombosis haemorrhage and then Zilker information the processes in the process. These are all outwits of disease. Ultimately we’ve done very little as an industry to develop biologics or biomaterials and drugs whatever you call them for the biologic factors that precede the pathologic disease. And this has been one of the stumbling blocks. So you know a combine that with the fact that the reductionist approach that’s used to identify disease mechanisms or targets has been Wheatly ignored the fact that disease is rarely if ever a consequence of an abnormality in a single gene product or so but is an emergent state of multiple biologic processes that interact the complex networks. So ultimately now why hasn’t this been done in the past. Because it is an integrated complex combinatorial target as most of them are acting in a dress with a single magic bullet it’s not going to happen. So this is why. And you know obviously this is a very unique concept that is not the way we’ve looked at things for 100 years. I mean we might have looked before the modern era in this way in the sense of what we use as therapeutics but ultimately now we’re seeing some of this reawakened in the minds of folks in the industry. And a case in point you my former employer when I used to work at GlaxoSmithKline they recently entered this area that some folks are getting their feet wet. So what is suitable is how one can get the drug completely out of the equation and just deal with the signaling events that are occurring. So I think we’re beginning to see even though it’s slow. I think we’re beginning to see the move by some of the old paradigm of saying well OK maybe things don’t always need to be done with a single magic bullet chemical and look like something else. And that’s why we’re doing what we’re doing and ultimately in the future you know we can help Christopher Reeve now but he’s just like that will be something that we’ll be able to eliminate in 20 years so.
Saul Marquez: [00:11:24] It’s pretty interesting and thanks for the context there. I totally agree with you Ira this concept that we know we’re always targeting the disease and that what happens before that to prevent it. And I think it’s a really great thing to have you focus there thinking about the mindset that exists today and then that the health care leader what would you say a hot topic that they should be thinking about today as it relates to taking care of their patients and running their business.
Ira Pastor: [00:11:51] Well I think a very hot topic is the transition in the mind to not just treating but how the interventions that one sees coming down the pike whether it’s five or ten years but they’re coming. How we move from a treatment basis or treatment centric modality to a curative one. One example of this as you know we speak about oncology and agribusiness is sort of the here’s an example of an area that for decades know has been based around what we refer to it in the company as sort of the geocentric mentality that at the end of the day cancer is something whether it’s surgery or radiation or chemo or smart drugs or immunotherapy that would kill. But once again you look around nature and the ones that survive cancer are the ones that deal with it. It has nothing to do with killing just like you wouldn’t cut out parts of your brain with Alzheimer’s disease. Does it always make sense to kill a tumor or like our friends in the natural world can we turn it into something else like normal tissue. So really thinking of these unique concepts and you know whether they’re here today or whether they’re coming down the road how we can begin to take a witness were that much of a holistic view on the patient and ultimately how that will impact the way I run my practice as a clinician and ultimately look at what that patient represents or whether it’s a treatment event that we’re going to maintain as such for a period of time or whether hey there are X Y and Z coming down the pike or 500 clinical trials. Let’s begin to integrate some of these new concepts and help this entire shift which reveals clinically transformational occur more rapidly.
Saul Marquez: [00:13:48] Ira I would agree. You know and thanks for those Scots listeners that think about these ideas the Irish sharing here I mean it is transformational medicine and the traditional approaches that we’ve been doing and let’s face it it’s we can do things better. So not to just pat ourselves on the back for all the amazing things that we’ve done because we have we have. But what can we do that’s transformational. And these are some really interesting concepts. Ira let us know of a time when you guys made a mistake or fail and what you got out of it.
Ira Pastor: [00:14:22] Well I think my grander experience in the last ten years in this company but also thinking to some of my other experiences from my previous company and also developing sort of non-traditional Therapeutics has been running to quickly with idea is that of though the regulators understood them were not necessarily ready to approve that example prior to this and this is sort of one of my connections into into sort of it’s combinatorial dynamic. I worked for 10 years in the biochemical arena and was involved in design of drug development which was an area that the FDA created back in originally in 1996 ultimately created formal guidelines in 2004. So basically once again how you merge this concept of multiple biochemical entities in one and how you regulate that and they created a wonderful set of guidance on how companies should go about doing this including some of the biggest ones. Pfizer was funding us in time but at the end of the day what we realized that was a big difference between the regs that were put on the documents and ultimately how the teams internally at FDA wanted to develop. So that was an example of getting something far into development into Phase 3 and ultimately getting delayed substantially further our sort of registrational development because in those particular cases the FDA was used to seeing clinical data occurring before preclinical data which is in essence what the guidelines allowed you. So you know we have hundreds of patients of clinical data but yet were we were pushed back to the ranch and the rabbits for a couple of years. That was one example of sort of running a bit too fast because the regs were sitting there on line but sort of not thinking that you know the Reges registrational system is is more than just the regs it’s sort of the organic system that people and personalities. And so that’s one thing.
Saul Marquez: [00:16:23] That’s such a great takeaway Ira and for everybody that’s in the business of either pharmaceuticals or device or any product that’s being regulated by them. It’s very important to remember that there’s a human factor in as well.
Ira Pastor: [00:16:37] Exactly.
Saul Marquez: [00:16:38] Great takeaway. And so now what we do. How do you after that happen. How do you handle things based off of that experience.
Ira Pastor: [00:16:47] Very well structured early preclinical development program not skipping anything and ultimately using the same guidance that you know they put out there as far as CMC and pharmacokinetic and pharmacodynamic were that basically understanding that even though there are ways to speed things up and opportunities we still need the dot all the i’s and cross the t’s now realizing before we get final approval so it just made us a little more structured a little more conservative in how we’re developing this program. But nonetheless it did not scare us away from the fact that hey our drug product at the end of the day our API is going to look different than other JPI but it will be it will be a drug like anything else.
Saul Marquez: [00:17:36] Love it. That’s a great lesson there and thanks for sharing it. Tell us a little bit more about an exciting project that you’re working on today.
Ira Pastor: [00:17:44] Sure. So the one that generated quite a bit of excitement last year has to do with some of what we are moving forward with on the living conniver research funds. I know this is going got a lot of excitement in the in the blogosphere with zombies and Frankenstein references and so forth but it was a little less dramatic than that but ultimately we’re focusing on how we can use any existing research model that has existed in the United States for a couple decades now for toxicology and pharmacokinetics and some of the dynamics that he’s using recently deceased cadaver subjects have donated their bodies to science to test some of these particular models in human neurogenesis and vascular Genesis in the higher brain and brain stem. Obviously this is a unique area but it has gone on. Maybe it’s not as sexy as cancer or Alzheimer’s research but it has occurred for many years now. Alternately we are looking at it as one of the tools in a basket on how we study complex complete human regeneration in many different forms so this has been an interesting idea for us sort of venturing beyond the the rats and the rabbits and the pigs. But you have this you have a model there that is legal is ethical and we’ll be interested in what comes out of in this particular part of our Pergram higher.
Saul Marquez: [00:19:08] Oh wow. Very interesting. So I can’t imagine that a cup of coffee with you Ira is a normal cup of coffee. I’m sure the conversations that could be had with you at a conference or anything that will be just like this that we’re having right now so if anybody needs Ira out and about at a conference by all means look at his badge. He’s a handsome gentleman and have a conversation with him. I think what you’ll find is you’ll probably get some new ideas and think beyond the box. So thanks for sharing that insight there. It’s really exciting. Never even heard of that actually.
Ira Pastor: [00:19:41] Absolutely. A lot of people have and it is one of those things quietly going on for the last 30 years in the United States. But it’s just as I said it’s not sexy but it’s a form of research that we feel needs to be part of a complete human regeneration program at some point as we fix these these complex diseases that kill us.
Saul Marquez: [00:20:02] Yeah. Very interesting. Ira let’s pretend you and I are building a medical leadership course on what it takes to be successful in medicine training. It’s the one 101 or the ABC of IRA pastor. And so you and I are going to write out the syllabus right now with four questions to this lightning round. You ready. OK. All right. What’s the best way to improve health care outcomes.
Ira Pastor: [00:20:25] Move from any treatment based approach that’s highly targeted towards disease or Orco genomic outputs to a one that focuses on curative interventions and the path of biological events that occurred before one gets that.
Saul Marquez: [00:20:42] What’s the biggest mistake or a pitfall to avoid.
Ira Pastor: [00:20:45] Moving too quickly without comprehensive understanding of the intricacies that are involved in sort of this 21st century systems based model of medicine.
Saul Marquez: [00:20:59] How do you stay relevant as an organization despite constant change.
Ira Pastor: [00:21:03] Always thinking outside of the box with regard to our research programs our disease targets and our collaborative partnerships that any firm civically and in the biotech field needs to have to have a complete successful program.
Saul Marquez: [00:21:23] And what is one area of focus that should drive everything else in your organization.
Ira Pastor: [00:21:28] Never losing sight of our goal. Despite the amazing apprehension towards innovation that unfortunately occurs in the pharmaceutical industry nowadays.
Saul Marquez: [00:21:42] Love that IRA what would you say a book that you recommend to the listeners to add in the syllabus would be.
Ira Pastor: [00:21:48] One of my favorites that ever got me started on this path actually this is an oldie to go look at to the used book section on Amazon but written by University of Indiana’s Dr Paul back in 1968 in the shuffle brain it is one of the first examples of brain transplantation and brain regeneration in the intervening kingdom. It was written basically studying memory and estimation processing but the fact that he was able to move range from one organism to another and keep species alive is a forgotten part of sort of biomedical research but it’s out there and that that occurred in the 1960s. It’s just one of those things that says why don’t we forget so much that happened in the past and why so few people know about these wonderful discoveries years later.
Saul Marquez: [00:22:38] That’s really interesting shuffle brain. So contract listeners take a look at all of these amazing things that we’ve talked about outcomesrocket.health/ira. That’s i r a. You’ll be able to find all of the show notes as well as links to the companies that Ira is working with what is linked to this book shuffle brain that might blow your socks off. So Ira really appreciate all the things that we’ve talked about today. Before I conclude I’d just like to invite you to share a closing thought the listeners and then the best place that they can get ahold of you.
Ira Pastor: [00:23:11] Absolutely. So I’m located www.bioquark.com/ You can contact me there any time and learn about the company from the website. Ultimately we feel that from a future perspective nothing is off the table when it comes to the 100000 people that we lose every day from AIDS related diseases or the 50000 people that die every day from the trauma. It is well within the intellectual capacity of humans to solve these problems related disease degeneration and death. And we really need to think outside the box and not fall into any of the traps set by the previous industry in the century old model that has done well creating treatments but hasn’t cured us of much so nature has a lot of solutions and all we really need to do is follow the lead they show us.
Saul Marquez: [00:24:02] That’s a great message IRA again just want to thank you and encourage listeners to think outside the box. Look at nature for those answers and think in a curative perspective. As Ira has laid out the groundwork here and our thinking so without a doubt. Ira this has been awesome and really want to thank you for making the time to spend with us.
Ira Pastor: [00:24:21] Thanks so much for having me. It was a pleasure.
: [00:24:26] Thanks for listening to the outcomes rocket podcast. Be sure to visit us on the web at www.outcomesrocket.health for the show notes, resources, inspiration and so much more.
The Best Way To Contact Ira:
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