Liveyon Pure Cast – The Stem Cell Market Bubble. (E02)

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Episode 2 – Liveyon Pure Cast – The Stem Cell Market Bubble

Dr. Alan Gaveck:                  Hey welcome back to the Liveyon Pure cast, I guess that’s the Pure Podcast.

John:                        The Pure podcast on YouTube.

Dr. Alan Gaveck:                  Right on. Today I’m with John Kosolcharoen again and I wanna talk about the industry that we’re in. This, not so much stem cell industry, but we would say Regenerative Industry using cells, or nucleoid cells.

John:                        The Regenerative Medicine Industry.

Dr. Alan Gaveck:                  Regenerative Medicine Industry. Well we know that stem cells themselves has been around since the 50s. Umbilical cord blood since the 80s. But really in the United States it’s only over the last several years that it’s really become prominent here.

The question is, at the rate that it’s been growing and with all the backbiting that’s going on in the industry, is it just gonna fall apart? I mean, is it gonna get…

John:                        Ooh.

Dr. Alan Gaveck:                  Is it just gonna get…

John:                        Is there a stem cell bubble. Is that what you’re asking me?

Dr. Alan Gaveck:                  Yeah, yeah. Is there a stem cell bubble? Is it just going to implode on itself because it’s grown too fast and it’s a war?

John:                        You know, that’s a great question and I’ve been asked this a lot of times. Especially you know, being the CEO of Liveyon and Liveyon Labs. With all the resources and money that we have into the facility. And in this market, we’re just coming out with a new product at this time, and this is my answer. I think that the stem cell industry, the degenerative medicine industry is really kinda like the housing industry. The housing industry, is there a bubble?

I think there is a stem cell bubble. You know when you see companies popping up all over the place, when you see a stem cell clinic on every corner, when you see advertisers in papers and people just in it for the money. It’s kind of been this smash and grab with all the labs out there that we found that have been, just not doing things correctly. Cutting corners. Setting up shop and not going through validations and then all that stuff that we saw from some of the other companies-

Dr. Alan Gaveck:                  Right.

John:                        On the fraudulent testing, where they had test done and then we found fraudulent documentation, and tweaking of some of the numbers to make themselves look better. I think all of those things are gonna catch up to the industry and the FDA is gonna have to come in and put some type of heavy regulation it.

But like the housing market, I think it’s here to stay. I think that the FDA need to come in and really, really take a look at heavily regulating the industry a little bit closer and that’s gonna wipe out the majority of the players that aren’t doing things correctly.

Dr. Alan Gaveck:                  Is it not true that November 2020 is really a timeline that we’re looking at?

John:                        Yeah, it is. The FDA said that they will be coming in and looking at manufacturers really. How…

Dr. Alan Gaveck:                  Right.

John:                        How they’re going to govern manufacturers and so…

Dr. Alan Gaveck:                  But that’s pretty critical because right now if you look at the, what’s it called, Code of Federal Regulations, right?

John:                        Mm-hmm (affirmative)-

Dr. Alan Gaveck:                  Title 21, Code of Federal Regulations, and it says guidelines, but unfortunately it says the FDA may choose to or not to enforce said guidelines.

John:                        Yeah well, I think you know that other problem is, and I’ve heard this from some of the regulatory bodies, that due to the recent federal shutdown-

Dr. Alan Gaveck:                  Right.

John:                        And due to the lack of staffing, they really just don’t have the manpower to take a look into every single manufacturer. I mean, I think we were a little bit fortunate that we got into the regulatory…

Dr. Alan Gaveck:                  Right, early on…

John:                        Aspect early on. And so we’ve had that oversight-

Dr. Alan Gaveck:                  You’d think, you know. Even Dr. Gottlieb in one of his articles said that, “He feels like the FDA is an analog system trying to work in a digital industry.”

John:                        Yeah.

Dr. Alan Gaveck:                  He said because they can’t keep it up, and a phrase that you used, “Drinking out of a fire hose.”

John:                        Mm-hmm (affirmative)-

Dr. Alan Gaveck:                  I mean, there’s only so much that they can do to keep up. However, that brings us to the point. Manufacturers need to take responsibility for this industry.

John:                        They do.

Dr. Alan Gaveck:                  And I’m very proud of the fact that you as head of CEO of Liveyon have driven this company towards regulatory compliance. Not only regulatory compliance, but actually setting the standards that could be the guidelines down the road.

John:                        Yeah. You know, I mean, we have a lot at stake here and I think the industry deserves that quality of manufacturing, that quality of control and when the dust settles… The housing market was horrible right? [inaudible 00:05:15] crashed and a lot of things happened, but here we are, eight years later, 10 years later, 12 years later, and things have stabilized and gotten back to normal and even recovered nicely. And I think the stem cell bubble is something that will happen. That a lot of these companies will be wiped out, maybe a lot of clinics that aren’t doing things right, that don’t have the patient’s best interest in mind will have some trouble, and that will kind of level the playing field.

And the people that are here to stay, hopefully, will continue to grow the industry. I think the industry has great potential. We’re just at the beginning of it.

Dr. Alan Gaveck:                  The potential is immense when you read the stuff that’s going on around the world.

John:                        Mm-hmm (affirmative)

Dr. Alan Gaveck:                  I mean it is really big. Not only with the industry that we deal with specifically, cord blood cells, but when you look at induced pluripotent cells and all these other potentials. And as this technology moves forward and the only way the technology is gonna move forward is by having responsible companies and labs that put their money back into the industry.

John:                        Yeah, right now I’m, I don’t wanna say that we’re self governed, but we kinda are.

Dr. Alan Gaveck:                  Kind of.

John:                        And so, you know, it’s my job as CEO of Liveyon Labs to make sure that we’re compliant. To make sure that we’re following the guidelines. To hire the people that have the experience, the knowledge and the willingness, in order to take the company in the right direction. It’s really about that vision because when we have our board meetings and everybody says, “So what does Liveyon’s future look like?” It looks like, if we do things the right way, we’ll grow, you know we do clinical trials, we applied for a biologic license. We get an IND application. In all of those things we’ve already built our validation and our SOP’s to fit what is to come. So I think we are already ahead of the curve.

Dr. Alan Gaveck:                  Well I think if you take a snapshot picture of Liveyon, you see the largest group of people are the sales people, cause they’re out on the streets, right?

Second are the scientists and the lab techs.

John:                        Mm-hmm (affirmative)-

Dr. Alan Gaveck:                  And then what’s the third largest division there?

John:                        Compliance.

Dr. Alan Gaveck:                  Compliance. I mean it’s just the way it is. Because without compliance and without science we don’t need the guys in the field, or the people in the field aren’t gonna last very long. So it’s good to see, it’s good to hear that you’re optimistic about the future and it’s really nice to see that you’ve taken responsibility for this company in making sure that it does have a lasting future, but more importantly, that hopefully it will be the standard bearer.

John:                        Yeah, I think in order for our company and the industry as a whole to have longevity, this is the path that we have to take. It’s as clear as day.

Dr. Alan Gaveck:                  I agree. I look forward to it. Hey thanks everybody, we’ll see you again next time.

John:                        All right.

 

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Medical Professional Viewing Only (Disclaimer)


This site was intended for education purposes only and strictly for use by medical professionals. The FDA recently re-confirmed, there is only one registered stem cell product, and while there is enormous promise in stem cell therapies, and thousands of ongoing experimental applications trying to establish efficacy, these are not at the point where they would meet the scientific standard.
The FDA has stated:
Stem cells, like other medical products that are intended to treat, cure or prevent disease, generally require FDA approval before they can be marketed. FDA has not approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications.
http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194655.htm
This site is not intended for consumers.
If you are considering stem cell treatment in the U.S., ask your physician if the necessary FDA approval has been obtained or if you will be part of an FDA-regulated clinical study. This also applies if the stem cells are your own. Even if the cells are yours, there are safety risks, including risks introduced when the cells are manipulated after removal.
“There is a potential safety risk when you put cells in an area where they are not performing the same biological function as they were when in their original location in the body.” Cells in a different environment may multiply, form tumors, or may leave the site you put them in and migrate somewhere else.
If you are considering having stem cell treatment in another country, learn all you can about regulations covering the products in that country. Exercise caution before undergoing treatment with a stem cell-based product in a country that—unlike the U.S.—may not require clinical studies designed to demonstrate that the product is safe and effective. FDA does not regulate stem cell treatments used solely in countries other than the United States and typically has little information about foreign establishments or their stem cell products.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm286155.htm
Stem cell therapies have enormous promise, but the science in each use is still in the developmental stage. Professional judgment and expertise is needed in using stem cells for any therapeutic use, and we urge anyone embarking on the use of stem cell therapies to consult the national health data bases to evaluate current information from clinical trials and the FDA websites on human tissue should also be consulted to get its current evaluation of any therapy.