(upbeat intro music) - [Announcer] This is "Carolina Business Review," major support provided by Colonial Life, providing benefits to employees to help them protect their families, their finances, and their futures; High Point University, the Premier Life Skills University focused on preparing students for the world as it is going to be; Sonoco, a global manufacturer of consumer and industrial packaging products and services with more than 300 operations in 35 countries.

- The economy continues to confound and defy for sure how other economic cycles have behaved during what is thought as part of a possible pre-recession business cycle.

Welcome again to the most widely watched and the longest running program on Carolina business policy and public affairs seen every week across North and South Carolina.

In a moment, we start to look at those issues like the economy, like employment, like commercial real estate, and other important dynamics.

And later on we are joined by a genomic editing innovator.

Dr. Mitchell Finer, the Chief Executive Officer of Life Edit Therapeutics joins us.

- [Announcer] Major funding also by BlueCross BlueShield of South Carolina, an independent licensee of the Blue Cross and Blue Shield Association.

And Martin Marietta, a leading provider of natural resource-based building materials, providing the foundation on which our communities improve and grow.

- [Announcer] On this edition of "Carolina Business Review," Stacia Neugent from Crew Charlotte, Robert D. Long of Chester County Economic Development, and special guest Dr. Mitchell Finer, CEO of Life Edit Therapeutics.

(upbeat music) - Hello and welcome again to our program, Stacia and Robert.

Good to have you both here.

Robert, I've gotta start with you.

Billion-dollar projects are being announced the last 12 to 18 months, certainly in South Carolina, but North Carolina just had another pile on with Toyota Battery.

It's up to $13 billion project in just that one project.

Robert, I promise I'm not being a doomsayer, but anytime we have that kind of exceptional economic development, don't you worry on the other side of this how you fill jobs?

What about the later on effect?

All of those things.

- Oh sure, I mean, I've been doing econ development for over 30 years.

I had personally never seen a billion-dollar project until last year and I saw 15 of 'em and we ended up lending to the Admiral Corporation project earlier this year.

That was one of those.

But it is sort of an exciting time to be an economic developer from that perspective.

I think part of what's driving that first wave is particularly the battery and the battery technology.

That's a much longer lead time from the time you announced a project to the time you produce that product, the battery or the component for the batteries.

And that was that first wave, very capital intensive.

And I think a lot of it is as a country, we sort of pushed that primarily to Asia, battery technology back into '80s and now we're playing catch up to bring that technology back and of course do like the Inflation Reduction Act.

There's a massive amount of incentive to basically grow that supply chain domestically and we're taking full advantage of it while we can.

Those funds won't last forever.

I think this next wave that we're seeing right now is more of the other components associated with the EVs, not quite as capital intensive.

And then again, as you go into the third and fourth wave, it'll be even less capital intensive.

But I think it's just this bubble we're in right now.

But, you know, a great success for North Carolina.

And I know South Carolina has had quite a bit success with that first wave of battery and battery-related projects as well.

- Yeah, and you were probably one of the folks talking about this, but insiders in economic development in South Carolina a couple of years ago now, maybe a little bit longer, there was a concern that, well, we've got too much automotive industry exposure.

Does this just pile onto that?

Or do you think this is gonna work its way through the system?

- So like I said, I think there's gonna be more change over the next decade when it comes to vehicles through electric vehicles and really since, you know, the formation of the internal combustion engine.

I mean, there's just a massive amount of change.

That being said, you know, with the existing companies that are there, with Scout Motors coming in, I think there's still plenty of opportunities to grow that supply chain or as a state, obviously, with Boeing, they moved into aeronautics, and as any place else that's a local county like Chester, as a state, you want to diversify when it's possible.

But as a state we are super strong when it comes to the automotive sector and I think that has helped us as a state lean some of these big announcements over the last couple years.

- Stacia, as a tax partner, as a key leader in Crew Charlotte, which is the commercial real estate women in the Charlotte region, I mean, you know a little bit of something about commercial real estate and financing around commercial real estate.

What are you hearing among some of your contemporaries in the business about the commercial real estate space?

Are they concerned?

Is there more angst?

Is there less angst?

What's going on?

What are you hearing?

- Yeah, it's kind of all over the board.

Definitely more angst is common than less.

The interest rate hike has been huge.

So it's hard to make deals really paper and make sense with the interest rates so high.

I know I had several calls yesterday with clients that were thankful that the Fed held the interest rates.

So that was at least a small win.

But I don't think that we're done seeing interest rate hikes.

I would say, you know, part of it too is just with office space particularly, it's still trying to figure out, are employees gonna come back to the office?

And I feel like we've been talking about this for two plus years, right?

Trying to figure out what the strategy is going to be.

And I think you're seeing what is being built is more highly amenitized office space, things that are making people want to be in the space versus thinking of it as work.

So if they have opportunities to do other things besides just working in the space, people are more open to returning to the office.

- So two years ago when everyone was trying to figure out who was gonna be in, who was gonna be remote, what does the office look like?

Do you feel like that is no longer a fear, but it's starting to manifest now and people get a clearer idea on where we might be or where we are right now?

Do you think it's manifest instead of just fear?

- Yeah, I mean, I do.

I do think that's the case and I think now you're seeing who is willing to come back when you, you know, push 'em against the wall and say you have to be here, and who isn't.

And so I think it's definitely part of it, but I think some of these projects, right, have already been started for a few years and so you had office space under works, right, during covid, and that is completing and there maybe were some adaptations, but you couldn't completely redo it.

So there is still a challenge in the office space and in the multifamily space honestly, too.

There's been challenges there just because the interest rates are making it hard and construction costs and supply of labor has made it a challenging space.

- So as Stacia talks about interest rates, that's a cost of funds, Robert.

I mean, the cost of doing business has gone up pretty dramatically.

- And we've seen on the industrial side, I think we've seen the impact to it as well.

I think a couple years ago, 2 1/2 years ago, there was a mass amount of speculative large industrial buildings built all over Metro Charlotte, most of which were filled while they were still under construction.

As the interest rates creeped up and therefore folks are risk-adverse, the spec stuff has really almost come to a complete grinding halt.

You really have to have a tenant in tow before somebody's willing to pull the trigger on, you know, building a new building at the moment.

- Yeah.

How long do you think we have as a tail on interest rates being as high as they are, a year, five years?

You think you can go along?

- Oh, I don't think five years.

I think it'll probably be the next year, year and a half that you see elevated interest rates.

At some point they're gonna have to come down.

The problem is that people are still spending, so despite the interest rates to cap inflation, people are still spending the money, and so- - [Chris] Companies still spending that you see?

- Companies are still spending, I mean, not as much on just the pure developer side of things, but you know, industrial I actually think has a little bit of a better market because you have the ability to go outside of the central business district and build and there's still a lot of manufacturing distribution activity happening.

And so you are seeing some, you know, development on the industrial space to meet the needs for those people.

And so they're still spending, they're still investing in capital just 'cause the real estate market is the first to see it.

Other markets are still spending, I think.

- Yeah, so Robert, in less than a minute, do you see the industrial space in the markets that you're in along that corridor between Charlotte and Columbia being that strong?

- Sure, so I think, you know, historically the I-85 corridor has been stronger and you've seen a massive amount of activity there.

But as that sort of filled up, I think there's a fantastic opportunity for the I-77 corridor to grow.

And you throw on top of that the scout announcement.

I'm pretty bullish on the I-77.

I know we ourselves are talking to multiple developers about developing industrial parks.

They wouldn't have probably talked to us just a couple years ago, but today they are because they see the opportunities that the I-77 Corridor has for 'em.

- Do you think that's gonna stop short, 10 seconds or less?

Do you think that will stop short or you think they're gonna continue to be- - So I think we're- - [Chris] Five seconds.

- Yeah.

Yeah.

I think we're seeing a little bit of slow down now.

I think by the second half of next year, I think we'll start seeing a little bit more uptick.

- Okay.

All right.

Thank you both.

- Sure.

- Thank you.

- Next week on this program, she is the lieutenant governor of South Carolina, has a very strong business background, has a very assertive way about her around education and economic development among many other things.

We're going to meet and talk to Lieutenant Governor Pamela Evette will be on this program.

Also coming up, Sean Suggs, speaking of Toyota Battery, Sean Suggs is the North American President of Toyota Battery, will be our guest on this program coming up to talk about that very big bet and stake in the ground that they have done for building batteries in North Carolina.

Our guest's company almost seems like the stuff that sci-fi movies are made of.

This language that I'm going to read is taken directly from the company website.

And I quote, "Our next generation platform allows us to target any genomic sequence and develop life-changing therapies for the most challenging genetic disorders."

End quote.

Joining us now to help decode that statement is Life Edit Therapeutics Chief Executive Officer Dr. Mitchell Finer.

Dr. Finer, welcome to the program.

- Thank you very much.

It's a pleasure to be here.

- Dr. Finer, just very quickly I do want to ask you about that, but when we back up and zoom out and look at life sciences, bio and life sciences in the Carolinas, it is in general 150,000 employees, billions in capital investment and economic impact.

I mean, this is big stuff and I know you know that, and I know you're headquartered in Durham, but when we try to understand how big that is and exactly what you're doing, how do you decode what genetic splicing and therapies and editing, what does that mean and how does that get to an end user?

- So, many medicines are either pills in a bottle, and that's the historical medicine, aspirin for example.

And they're small molecules and they affect...

They're distributed mostly orally and they go all over the body and they have broad effects and they actually target a particular part of the body and have a therapeutic effect.

The next step up are larger molecules like insulin.

And insulin is the first protein that was made with recombinant DNA technology.

So it's a bigger protein that's used to treat type 1 insulin-dependent diabetes.

That's injected subcutaneously.

And while it does go all over the body, the bigger the molecule, the higher the specificity.

Now we're in the era of genetic medicines.

There's been roughly a dozen genetic medicines that have been approved both in the United States and within the European Union.

And some countries like Japan as well have approved genetic medicines, China, Russia, and these are taking engineered cells.

These are cells from the human body, taking them out.

And these cells have broken genes and these genes can be repaired outside of the body.

For example, a recent approval was for the treatment of a disease that's common, XUS, more common XUS, it's one of the most common rare diseases on the planet.

There's probably a million people with this disorder.

It's called beta thalassemia.

It's an inability to produce hemoglobin.

And there are many companies that have now, there are at least two and there will be more that have developed approved drugs in which the blood-forming stem cells resident in the bone marrow are taken out of the patient.

Then in the laboratory or the manufacturing suite, they're engineered with a correct gene, put back in.

And what's almost miraculous is that these patients are cured, those genetically modified cells go to work and deliver their hemoglobin, but those approaches use viruses that have been made defective.

And those viruses, a simple way to look at them is they're essentially dump trucks and they have to be manufactured at great expense.

But now we've all now been through the pandemic and we've seen the power of vaccines, and I'm sure the audience has heard about messenger RNA vaccines.

And so now messenger RNA is a very defined substance.

It can be made to be a vaccine, but what we develop are precise tools that can be made by messenger RNA, that can go in and fix broken genes in genetic disorders, pediatric genetic disorders where there's one broken gene.

We call that a monogenic disorder.

- And since I don't wanna cut you off, but there are so many things we have to unpack and one is the mRNA that is acronym we hear more about in the media.

But I wanna let our panelists jump in here.

Question for Dr.

Finder.

- I guess the one question I have is that, I guess, is it like FDA approved or what's the overall governing body, and I guess the question I have is obviously, you know, I used the word big pharma, but they obviously enjoy having lifelong patients 'cause it means more money over the lifetime of the patient.

And if you're as, it's really a breakthrough technology if you can do a kind of a one and actually cure, I mean, that's pretty fascinating to me.

- Yes.

No, those are two very good questions.

And so the answer to the first question is, in the United States we're regulated by the Food and Drug Administration.

We also have each individual hospital.

When a drug is investigational that is not approved, it's in an early stage of development and it's being evaluated in patients.

Hospitals have what are called institutional review boards, IRBs, that review the drug and review the clinical protocol.

But the FDA, one needs national approval before one can go to individual hospitals to start testing a drug and the FDA has a process called an IND, investigational new drug process, in which mountains of data are required.

And there's several groups within FDA, there's a group that reviews drugs, small molecules and what are called biologics like insulin.

And then there's a separate group within FDA that's specialized in cell therapy, which includes adult cells that may be modified or unmodified, but also you've all heard about the stem cell field, and what was quite contentious some 20 years ago, embryonic stem cells, which are no longer used, but a newer process of creating stem cells outside of the body from normal adult cells that can be used to create any cell type at will.

So those are considered cellular therapies, and then engineered viruses and then approaches like messenger RNA, there's a group at FDA called Center for Biologics Evaluation and Research, CBER.

And they govern the ability of both academics and biotech companies and pharma companies to move into human clinical trials.

They monitor those trials and the sponsor is in close contact with the FDA, and the FDA will review at the end at the end of the clinical trials.

Clinical development usually takes seven to 10 years to get sufficient both efficacy data that the product has therapeutic benefit, and safety data, which is the essential part.

And that's why it takes so long.

- I would say this process takes probably over a decade.

- Yeah, and we're gonna need a quick answer to that 'cause we're gonna run out of time here.

So Stacia, lemme give you a chance to jump in here with a question.

- Yeah, I was just curious how patients get referred to you.

Is it, you know, some things you hear as treatments, you have to be really sick to be able to receive this treatment, or is it widely available or is it more a specialized referral?

- So right now the products we develop are early stage.

We are beginning our dialogues with regulators, but early on we go out to patient groups.

So our lead product for which we've presented data at both scientific and patient advocacy group meetings is in Huntington's disease, which is a cognitive and motor neurologic disorder.

And so we're in close contact with patient foundations to present those results to patients.

And the patient foundations are scientifically and medically very savvy.

They evaluate drugs and they have hitched natural histories of patients' disorders and they make suggestions, you know, these patients would be appropriate for this type of approach versus other patients would be appropriate for other types of approach.

So it's really working with physicians at major hospitals that are treating centers.

Then working with patient advocacy groups are the way we identify patients once we're in the clinic.

And so patients can know about the study and decide if they want to join.

- Is there, you know, when I think about Life Edit Therapeutics, you're clearly splicing, editing, going into the basic building blocks of these genes.

And someone like myself, who's a bit uninformed about it, could be concerned about the ethics of it.

Given the rapid development of vaccines during the covid issue and during that public pandemic, is there a much greater acceptance publicly about things that may be this type of science?

Do you feel like it's easier for people to understand and accept that what you're doing may be exactly ethical and exactly correct?

How do those two things square?

- Right, so many of the therapeutics we developed are based on mRNA technologies, same as Moderna, and mRNA technology is one builds a drug based on assembly of four known building blocks.

And the same four building blocks are used to create Moderna's vaccine or some of the drugs that we develop.

And so those individual four units are very well characterized.

The order in which you string them together is different, and then what you combine them with to inject them into a patient is different.

But there's an extensive amount of studies required by the FDA to show when you inject that drug, where does that drug go?

What parts of the body are affected?

And we're asked to go to ten, perhaps a hundred fold higher dose than a patient would ever take.

When we do this in cells and culture, or when we do animal studies, we're asked to go as high as we possibly can.

And this way we reduce the number of side effects, and the mRNA drugs, mRNA vaccines have now treated hundreds of millions of patients with many with, you know, people have had dose redose.

And so they have an excellent safety profile and the safety profile is continuing to be built.

And so we are drafting off of that safety profile and designing our drugs with those things in mind.

- We have about three minutes left.

Do you have a followup question?

- Sure, I know there's like tests you could do to look at your genetics.

Does that play a role in identifying those patients?

Did it help you with targeting for your therapeutic?

- And 1 1/2 minutes left.

I was wrong.

- Okay, absolutely.

Yes.

So, many patients, some of these diseases are passed down through families and now more and more patients who have had a family member with the disease are getting specific DNA sequencing.

There's 23andMe, and then there are ones that are far more deep sequencing, up to your whole genome.

And some patients show certain symptoms, they go to their doctor, and their doctor orders what we call a full exome sequencing or a full genome sequencing.

And then these things are looked for through computer analysis of the sequence.

And often it could be exactly what the physician thinks it might be, it could be another disorder, but more and more people are getting their genomes sequenced.

- In literally 30 seconds, is it easier to raise money for ideas now than it was pre-covid?

- It is harder.

- [Chris] Really?

- Pre-covid there was a time, you know, within the '21, '22 where due to covid and all the influx of new technologies, it was easy to raise money.

Now we're getting, we had a backlash.

It's really hard to raise money and I expect '24, '25 things will get back to normal and, you know, good ideas that are well planned can always raise money.

- Sorry to cut you off.

You know, it's fascinating and trying to articulate it.

Well done.

Thank you Dr. Finer.

Nice to have you on the program.

Thank you.

- Thank you very much.

It was a pleasure to be here.

- Stacia, good to see you.

Please come back.

Robert as well, please come back.

Good to have you both on the program.

Until next week, I'm Chris Williams.

Goodnight.

- [Announcer] Gratefully acknowledging support by- - Yeah, sorry.

- [Announcer] Martin Marietta, BlueCross BlueShield of South Carolina, Sonoco, High Point University, Colonial Life, and by viewers like you.

Thank you.

For more information, visit CarolinaBusinessReview.org.

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