Data, Drugs, and Disruption: Biotech for a Better Future with Ed Fleischer

Heath Fletcher (00:14)
Hello, hello, welcome to The Healthy Enterprise. My guest today is Ed Fleischer. ⁓ Ed is a quality control executive who has been working in the biotechnology environment for many years. He's now taken his experience to start his own consultancy called Beachside Compliance Solutions, where he specializes in analytical and quality control issues. Ed is also a very good storyteller and there's lots to take in. So let's get started.

How you doing, Ed? Thank you for joining me today on this episode.

Ed Fleischer (00:45)
He thanks for having me on. Yeah, I'm Ed Fleischer. I have a one man consultancy called beachside compliance solutions. beachside because I live two miles from the beach. I'm down in beautiful sunny Southern California. I live near the beach. I never go there, which is, you know, shame. But what? That's the way it is.

Heath Fletcher (01:07)
What's, what's, what's your, what's your closest beach?

Ed Fleischer (01:10)
I live in Carlsbad. okay, there's a fabulous beach. And if you ever get down to Carlsbad, everyone, it's a beautiful place to visit. Legoland is here. So we've got some attractions there, big flower fields, beautiful beaches.

Heath Fletcher (01:25)
We almost went to Legoland. were down in California a years ago with my wife and our two sons and we hit all the hot spots in Legoland. We kind of burnt out. We'd just finished. We were on our way back from San Diego and it was towards the end of the trip and I literally couldn't convince everyone to go to one more amusement park.

Ed Fleischer (01:46)
Yeah,

I could see that. But yeah, we had SeaWorld, there's a zoo, we've got the Safari Park, some great museums, some beautiful parks and beautiful ocean and beaches here.

Heath Fletcher (01:58)
Ed, you gotta get to the beach.

Ed Fleischer (02:00)
Well, like I said, I get in my name and I used to, went, when we first moved down, went quite a bit, but lately everyone's been so busy. It just isn't happening.

Heath Fletcher (02:09)
Okay, well tell us what you're busy doing. You've got a long history in the...

Ed Fleischer (02:13)
Yeah,

so I'm an old-time analytical guy, so when I got out of grad school in 1983...

I got a job as a research associate in a small company that was working on interesting new technologies to make vaccines, subunit vaccines. So instead of the old killed virus, we were going to go ahead and clone the bits that would make a good vaccine and put them together. Unfortunately, the company ran out of money. And then I went to another vaccine company. And then I got a, I was recruited by an old boss of mine who I.

the first company worked with, he had just joined a company at the time called SmithKline in French, famous for making Tagamet. They were building a new biotech division and he wanted to hire someone who could work with proteins and I had worked with him before. So he recruited me there and I stayed there for 17 years. worked for SmithKline in French and then SmithKline Beachum and GlaxoSmithKline, three different companies and I never left the building. I was in building 30 at Upper Marion in Pennsylvania the whole time.

And worked on all kinds of stuff, analytical method development, validated methods. We supported IND, so investigation on new drug applications, mainly on the protein side. I did do some small molecule work, but most of it was on the large molecule side. And once the Glaxo merger happened, they got really serious and they basically split their biotech group away from the...

from a general development group and I went with them and I ended up running a QC group that was making all kinds of investigational products for the Glexo portfolio. I actually wrote the proof of structure document for a drug called Mepalusumab, which is on sale still today. Yeah, so I got to work on that. ⁓ It's a ⁓ asthma drug for ⁓ a xenophilic driven asthma.

Heath Fletcher (04:08)
Is that right?

Ed Fleischer (04:19)
When we worked on it, we couldn't get it to work in the clinic. We called it the world's most expensive placebo because it was safe, very great, but we couldn't get it to work. then ⁓ my understanding was a clinician in Canada saw the data and he said, I know what you're doing wrong. You're testing it with everyone with asthma and your drug works on a specific type of asthma. And they redid the clinical trial and Lowe-Behill had worked and it's still in the market going strong. It's great product.

And then, so I was on the East coast all that time. ⁓ then I got recruited to go out to, Amgen West. ⁓ you know how these things happen. I was at a meeting, it was an FDA workshop and I ran into a guy I used to work with. He had left, ⁓ Glaxo during the merger, I think. So I hadn't seen him for three or four years. I ran into, we had lunch. He goes, ⁓ Hey, I might have something for you. Give me your contact number. So I gave him my card and totally forgot.

Right? So this happens all the time, but there's never any follow through. So like a month later, I get a call and it's a headhunter, a recruiter from Amgen saying, hey, I got your number and we'd love to talk to you. Could you send me a CV? So I sent him a CV and then they did a couple phone interviews and then they flew me out. And this was up at the Amgen facility that was up in Seattle. I toured Seattle the two days it didn't rain.

So it was beautiful. It was beautiful. was up there in September, I think it was September, end of September, end of October, beautiful day there. Really liked it. They made a really nice offer. I had to convince the family this would be a good move. we went out and I took my wife and my two daughters out hunting, house hunting, and it rained all four days. It rained so hard, the rain was coming up from the ground. It was a pineapple express. I don't think they call them that anymore, but.

Heath Fletcher (06:12)
my gosh.

know they're called atmospheric rivers now.

Ed Fleischer (06:19)
Yeah,

atmospheric rivers not and it just rained the whole time. Luckily we found a house we all liked and then we moved out there and I was there for about four and half years. Amgen decided to close the plant, it was a GMP manufacturing plant and move everything out. So I was kind of a free agent. I interviewed a bunch of places. I got recruited by Genentech to come down and run their QC group in Oceanside and that's where I still live.

It's down in Carlsbad, which is just south of Oceanside. Genentech is a beautiful biologics manufacturing plant in Oceanside. ⁓ They've upgraded it. They've added some new single use technology. It's a beautiful facility. One of the nicest ones I've ever seen and worked at. So was there for a while, then I went to a corporate role there. And I spent a lot of time up in South San Francisco. And then I got recruited to go back up to Seattle to join a company at the time called Seagen.

They're now owned by Pfizer. And when I asked the family, hey, who wants to go back to Seattle? ⁓ Surprisingly, everyone said, well, you can go. We'd prefer to stay in sunny California. So I did a long distance commute for three years. I had an apartment up there and I would fly up and spend as much time as I could to do face to face stuff. And then I'd come back home and spend some time with the family here. then, and then COVID hit. Yeah.

And we to figure out how do we do this remotely? So I spent a lot more time doing remote work there. The success story there was I was hired to get the group ready to deliver with three products that were going through the approval stage. So three BLAs that were going out to get these done in three years. And all three of them were approved while I was there. I like to say I had a hand in some of it. And that was very successful. So this was a

Heath Fletcher (07:45)
California.

Ed Fleischer (08:13)
company that specializes in antibody drug conjugates, which I think everyone's hearing about now. It's a real revolutionary treatment. It's sort of that silver bullet technology where there's opportunities to treat ⁓ oncology in a very different way, with certainly much less chemotherapy and very targeted. So I was there for three years. We launched all three. ⁓

By then the commute was kind of grindy.

Heath Fletcher (08:43)
Yeah.

Ed Fleischer (08:46)
So I moved to Gilead, who happens to have a site right across the street from the old Genentech site I worked with. They had an AVC, an antibody drug conjugate, and they were launching, they wanted to beef that up. So I ran, I was there for about a year and a half, and then they announced they were gonna close the Oceanside site down. And ⁓ I said, well, I'm not moving, I'm done. And I said, well, ⁓ I'll open up a consultancy and see what happens.

The good thing is, you know, I knew a ton of people in the business. You know, I've been all over. I went to almost all the Amgen sites, all the Roche sites, you know, in LinkedIn, had literally thousands of contacts. So I reached out to some people and there's big consulting firms that hire what were called 1099 employees, you know, not derisively, but they hire people with my skill set.

I did a big job, ⁓ a couple months work with one of the consultancies. And then ⁓ I had a bunch of travel I wanted to do, so I didn't work for a couple of months. And then I got another call from another consultant group and they needed someone to come in and visit a site and spend a couple of weeks assessing their validation program. So I flew in, met some wonderful people, ⁓ read a bunch of documents, talked to some people, made a bunch of recommendations.

And then I got another consultancy called and then more and more. And like I said, I've been just busy the whole time, which is great. It's kind of interesting. It's not what I thought it was going to be. It was different in some ways. And the thing I thought was, oh, you fly in and you do some work and then you leave. And that's what we used to say. You know, we hired consultants. They don't care what the outcome is. Well, it turns out they do care. I really do care about the outcomes.

that of the places I work and I follow them and you know, I stay in touch with people to see, you know, we propose these fixes or we did this work, you how did it work out? And one, like I said, I flew in, they wanted me to evaluate their validation program. I spent a week on site and then I spent ⁓ about a week writing a report, you know, giving them some feedback and then they asked me to continue on, you know, kind of ad hoc, hey, an analytical problem came up.

Could we book some time with you? ⁓ So that's been really successful to do that. I think the key things is you need to stay current. Regulations are always changing, guidances are coming out. And you need to be able to really understand what the customer wants and then deliver to what they need. They don't want more, they don't want less, they just want kind of what they want. And sometimes they don't know what they want. You have to help guide them there.

So it's been really crazy. Like I said, I'm doing one right now. It's a big job. They hired literally dozens of consultants to do some of these assessments and stuff. And it's been really fun. ⁓ get to see, know, these are companies I've, some of them I've worked with before, some I haven't. ⁓ It's no surprise I run across people I've worked with before in my prior life and stuff. So it's been really fun and exciting. ⁓

Downside is if you don't work, you don't get paid. it was a shocker to me that last Labor Day was the first time in 41 years I did not get paid on Labor Day to work, to not work on Labor Day. It was, was, it was stunning to realize that, you know, if you've worked in a company, they pay you not to work some day.

Heath Fletcher (12:09)
That's right.

That's right.

Ed Fleischer (12:33)
⁓ it's worked out good. So there's a lot of flexibility. You know, you can turn down jobs if you don't want to do it. ⁓ you can pick and choose somewhat. but it's been really fun and really exciting to do it. I wasn't ready to retire. I still thought I had some juice left. Sure. And it's worked out pretty well. Like I said, I've met some, people that I worked with. One place I went, I had lunch with one of my old bosses who was at the other company. It was great to see her. So it's really good to stay in touch and.

Heath Fletcher (12:38)
Yeah.

Ed Fleischer (13:03)
You know, the business changes. mean, the stuff I used to do even 10 years ago is somewhat outmoded now. So you really need to stay current.

Heath Fletcher (13:11)
what's going on. And how do you stay current? What do you use to keep

Ed Fleischer (13:16)
Well,

there's all kinds of websites and stuff. you you can subscribe. I'm very active. I was more active than LinkedIn when I had more time, but LinkedIn is always a wealth ⁓ of things. You can subscribe to different aggregators. like Fierce Biopharm, Fierce Biotech, Pharmaceutical, they aggregate stuff up and send stuff out. ⁓ You know, I still pop in on the FDA website every couple of weeks just to see what they're posting.

There's all kinds of, I was in the GMP space for so long, the regulated part of the business that there's various things like the pink sheets that come out and tell you what's going on in the regulated world. I think everyone that's gonna tune in here knows that ICH came out with new guidance on stability that just got released. It's the first, I keep thinking, I wanna say 15 years.

They updated that. I couldn't be wrong with the dates, but it's been a while. they consolidated a whole bunch of, they had a bunch of guidances that were spread out amongst different sections of the ICH world. And they consolidated one into one big document. So I'm just getting ready to download that and read through the changes and see what's new. When clients call, I'm sure they're gonna have questions about that. How do you interpret this new guidance and what could you recommend?

Heath Fletcher (14:43)
So what kind of innovations are you seeing now in this space that you didn't see five years ago?

Ed Fleischer (14:52)
AI is certainly popping up. to no surprise, ⁓ when you type anything now, it's filling in your sentence as you go. And sometimes it's not what I want to write, but they're suggesting things. ⁓ It was really interesting. were at an offsite, gosh, was about a year and a half ago, and we were kicking around what a global strategy would look like. And somebody opened up. ⁓

Chad GPT typed in global QC strategy and it spit out something that was probably 95 % good, which is just discourting to me. It's somewhat discerning to me because, you know, that's my expertise.

Heath Fletcher (15:36)
You s***.

Great.

Ed Fleischer (15:38)
And you could replace it. Of course, there were errors and stuff, and you'd have to customize it. if you were trying to get a lot of information gathered quickly, assuming the source subject is pretty good, and QC has been around a long time, ⁓ you could probably generate some pretty good information without a lot of

Heath Fletcher (15:59)
Well, I mean, like you said, the intelligence is not surprising in the sense that, you know, I've had many of these conversations over the last few weeks. Some of the comments that are coming back are that, you know, if we look at it like this technology is really something that was built by everybody. It's been, it's a collective, it's all our collective knowledge as a species, all

piled together into one place, which if you researched it for your entire life, you'd never scratch the surface of it. But collectively we're dumping all this information into a database that is taking everyone's thoughts, considerations, research, strategies, ⁓ outcomes, ⁓ you know, whatever, whatever information is out there is being pooled. so

When I think about that, it's really, it's quite an incredible ⁓ possibility and opportunity that we have all that information at our fingertips where we can now type things into into ChatGPT or whatever program. There's so many of them now. We always revert to that one because it was one of the first ones.

Ed Fleischer (17:17)
That's the one that I'm most familiar with.

Heath Fletcher (17:19)
So they, and you get back, you get back a collective perspective. ⁓ you know, it's, I, I don't remember actually who said that, but I'm actually really glad they said that because it's kind of shifted my outlook on, on AI and where that's going. And I think, you know, it is going to be the future. is our, it's our collective intelligence really.

Ed Fleischer (17:40)
Well, and

some of it is, know, we deal in data in the pharmaceutical world, the biotech world. It's data driven. And ⁓ we've got a lot of data that sits there that there's probably some value. We haven't figured out how to harvest that value. You know, one thing that we do in QC, we run the same tests over and over and over, either on the same molecule or it's slightly different on a different product. And what do you get?

Heath Fletcher (17:47)
Right.

Ed Fleischer (18:09)
when you run something literally hundreds of thousands of times in the industry. If you're making a monoclonal antibody and you follow the guidance, everyone is going to look for aggregates. So they're going to use size exclusion chromatography to do that. So everybody who's developing a BioPharm product is going to run some version of a size exclusion chromatography method on this.

which means if there's literally thousands of monoclonals in development, there's probably hundreds of thousands of data points that could be drawn on and help you understand, if you see this, this is what it means to be a well-characterized molecule. You'll know this ⁓ aggregation or this dimer or this ⁓ appearance of some other form in your product.

you know, there should be no surprises there. You know, that's what I've done for, you know, 40 years I've run these things. Now someone who has very little knowledge could type this in and probably develop a very robust specification that would enable them, you know, to test and release the product where we used to have to run these things over and over and over again to build up the data. And that's one thing that, you know, all these companies that do this, they've got literally millions of data points.

sitting somewhere, and if it's in QC, it's in the LIM system, Laboratory Information Management System, with a lot of other information that could be useful. And we're just starting to harvest that stuff. My question is, if I run the same test all the time and I get the same answer all the time, what is the value of me running it all the time? It costs money to do. Is there other ways that we could, say if the process runs,

Heath Fletcher (19:55)
Right.

Ed Fleischer (20:03)
in its design space and the raw materials have been, you know, analyzed and tested and they work the way they're supposed to, what's the likelihood of me finding anything that's wrong? It's very slim, but it costs to do these tests. takes time. takes manpower. You've got capital equipment involved, other opportunities to possibly not do so much testing. And certainly the agencies are willing to look at that. know, I assume anyone was in

this concept of design space, the quality design space was if your raw materials worked in a certain space and your manufacturing delivered in a space, as long as the product was in that space, it couldn't be wrong. Why would you have to test it? All you'd have to do is prove its identity and did it work? All the other stuff wouldn't have to be done, but we're not there yet. And that might be where we're heading.

because now there's another way to unleash all this data to do that.

Heath Fletcher (21:06)
So over your years of, ⁓ of work, what area do you like the most? What's, what's your sweet spot?

Ed Fleischer (21:15)
There's a lot there's there's there's been some some you know one thing is you get to work with some truly extraordinary people Yeah, I mean I Was never the smartest person in the room There are some really smart people out there that really understand all kinds of things you get to work with really cool technology You know it's always changing right you get to work with you know if you're in the commercial space You know you can be working with you know 25th leader

25,000 liter bioreactors, just huge magnitudes of volume of water and product. And you get to work on stuff that really impacts people's lives. I always have a story that really got to me. ⁓ I happened to be in London getting ready to go up to Cambridge. ⁓ There was an analytical symposium held every year at SmithKline Beach Home, and they would pick people to come up and

and give a talk about what they're doing or, know, mix and mingle. And I was selected to come up. And we were told, you know, you shouldn't wear company swag when you travel to London because the Smith Klein at the time didn't have a great reputation with animal rights people. We did do animal testing and it was not unusual for people to get, you know, abused ⁓ if you wore that. Well, I was an American and I didn't listen. So I had my Smith Klein Beecham hat on.

baseball hat, you know, that that's how you can pick Americans out there. There people who wear baseball hats in Europe. So I'm sitting on this train platform and this lady comes up and she goes, Do you work for Smith Klein Beach? And I said, Yeah, yeah, I do. And she goes, I want to thank you. You gave him my son's life back. And I go, how he goes, he was a severely depressed individual. He was involved in one of the clinical trials for Paxol, which was a

a drug to treat adult depression. And she said, within two weeks, three weeks, he was his old self again. We were so worried that he was gonna kill himself because he talked about it. And he took this drug and he's my son again. I wanna thank you. Very powerful.

Heath Fletcher (23:34)
Very powerful.

Ed Fleischer (23:35)
And you

know, this wasn't like we brought, you usually we would bring patients in and they would talk about, you know, how they've used the drug and what it's done. This was five minutes on a train platform in 1997, I think. Yep, really powerful.

Heath Fletcher (23:43)
study.

in London, England.

For the two of you to cross roads at that exact moment and for her to have some sort of association with the company you work for, I mean, and you were told not to wear your logo on your hat. Had you not done that, she would never have known. That's a crazy story.

Ed Fleischer (24:08)
So it's very powerful though because the medicines we deliver, ⁓ they may not cure you, but they certainly give you hope. We were racing to get an oncology ⁓ drug approved and ⁓ the chief medical officer said, people are counting on us. We cannot delay this. We have people that are literally in the clinics waiting for this to be approved so they can take our medicine because

Heath Fletcher (24:10)
Very powerful.

Ed Fleischer (24:37)
they have the hope that this drug might not cure them, but it will certainly delay their end game. And maybe they'll be alive to see their daughter or son get married, or they'll see that grandchild take their first step, or they'll do something that's important to them. And we can give patients hope by delivering these products. And that's a real powerful motivator, right? To say that there are people that are depending on us to deliver these medicines.

and we need to make sure they're safe and effective and they can get to them in time.

Heath Fletcher (25:13)
Well, yeah, and I guess there's a bit of a misconception sometimes about big pharma and, you know, they're, the need is there. I mean, diseases is quite abundant and, these are solutions, right? Maybe like you say, they're not cures, they're not, ⁓ going to resolve the problem, but like you said, improve quality of life potentially for people. ⁓

Certainly in that young gentleman's case, ⁓ he changed his life actually and he had a lot of life ahead of him. yeah, to get up and go to work every day knowing that what you're doing is actually going to have some sort of ⁓ positive outcome for someone's life. mean, that's why most people enter the healthcare, health tech, medical system in the first place.

You want to make a difference.

Ed Fleischer (26:10)
The company that previously, they were in New Jersey, the team I worked with, and I would fly to Jersey every month. And all the conference rooms had people's names on them. And I never really thought about it. And then one of the longtime guys there said, do you know why that is? And I was like, no, just people liked them. He said, these were the first 12 people to take our medicines in the clinic.

And most of them are still alive. And you know, they were diagnosed with breast cancer four or five years ago, and most of them were still alive. ⁓ Taking the drug, either treat them and put in remission or they were still able to, and I said, wow, that's released something. And then, you know, I was there and they got the news that one of the first people to be dosed, and this would have been like,

2017, 2018, she just passed away. Which was sad. But I thought that was really cool that they memorialized the first 12 people to take the medicine and gave them names. And I said, why isn't that more well known? How come I didn't know this? I'd been visiting the site for six months. I saw the names on these rooms and I didn't ask, why are they named that? And there was no story around it. So it was really nice that he shared that.

Heath Fletcher (27:32)
Right.

Yeah. Yeah, that's, that is important. so you're, from your perspective, I mean, you, you, I mean, you're not a founder, ⁓ you're not, you know, in upper management, you're actually on the, you're at the front line working on these medicines and, and at the, at the molecular level.

Ed Fleischer (27:58)
Well, yeah, so that was a long time ago when I got into management. So I was, you know, I used to run big groups. I was a senior director and stuff and I couldn't probably turn an HPLC on anymore. But, but it's important to understand the fundamentals of, what we're doing and stuff. That's why, you know, I don't know anybody who still doesn't keep up on a lot of the like

Heath Fletcher (28:03)
Right.

Okay, yeah.

Ed Fleischer (28:26)
you know, the real key basic applications of the work. know, when I used to do work in the lab, ⁓ the changes have been so tremendous on some of the analytical tools being used, know, new detectors, ⁓ moving to these micro volumes instead of large volumes for testing, ⁓ rapid answers. mean, we used to do... ⁓

One of the tests that you have to do in the biological world is to look for adventitious agents that may be transformed or transferred through the process. So if you're using live cells, they could be infected with viruses. Sure. Those are live cells, right? So one of the tests is looking for mycoplasma, which is a little tiny organism that may or may not be present.

Luckily, we've never found it in any place I work, if you get it, it shuts you down. But there's a, so the old test that everyone accepted was this broth culture test. You'd get your sample and you put it in this broth and you mix it up and then you grow indicator cells and then you look at these cells like 15 days later and 28 days later and compare them to healthy cells. And if you have the virus, the cells will be different. They'll be.

Heath Fletcher (29:27)
well.

Ed Fleischer (29:52)
they'll be dead or they'll have different morphologies and so it took 28 days. So the clever scientist said, wait a minute.

That means if I have a drug product, a drug substance that making and I want to release it, I can't release it for 29 days because I have to get this result. And that's true. So we targeted 32 days to release a batch. Well, what if it was in high demand and you wanted to get this out faster? Well, you were kind of stuck. So this really interesting technology, PCR comes along, preliminary chain reaction.

where you can amplify bits of DNA and run tests to show if something's there. Eventually, they started doing this in Mycoplasma. You can now run this test in your lab. don't have to ship it anywhere. You can run your lab and get the data in days.

Heath Fletcher (30:46)
amazing. speed that process up dramatic. Yeah. Well,

Ed Fleischer (30:51)
So

there's all kinds of stuff coming up that they're looking at rapid sterility testing. know, there's the new therapy, it's not new anymore, it's been out for 10 years. The CAR T therapy, that's human, know, a patient comes in, they donate their own material, plasma, blood, whatever it is, and that becomes part of the product. And it's fast. You have this stuff in, you need to get this back to someone in two weeks.

Heath Fletcher (31:14)
wow.

Ed Fleischer (31:21)
How do you do a 28 day test if the patient is going to get it back in two weeks? So there's all these new technologies to speed up ⁓ these rapid technologies to speed up the process. So these life saving products can get back to patients. Yeah. So cool. Cause I remember doing PCR when I did it the first time I amplified dog DNA because we had a big dog and I wasn't

I was not, I hit a Samoyed, they shed like crazy, the hair got in the mixture, boom. I didn't understand the techniques that you needed to do that.

Heath Fletcher (31:58)
Right.

Ed Fleischer (32:02)
So we know better now how to do this and they made some amazing things. You buy kits, pre-made kits and stuff, you put your sample in, boom, you you can get this data out. When I say quickly, you still have the validity and everything. It's probably gonna take you a year to do it, but once you get it in, it can revolutionize, you know, how you do your release test.

Heath Fletcher (32:20)
That's amazing. ⁓ when you were leading teams back in the organizations you worked at, what would you say your leadership style was when you were running the show there?

Ed Fleischer (32:36)
Well, the feedback was I was authentic. I am what I am. I don't try to change that. It doesn't work. It doesn't work. But I've worked with people that did, and they weren't authentic. So very authentic. By then, I had a lot of experience. I'd almost seen everything, although every time I say that, I see something I never saw before. I like the technology. I like the aspect of building teams. I appreciate.

Heath Fletcher (32:45)
No.

Ed Fleischer (33:04)
the wild diversity that the science world gets. It was amazing when, so when I, I'll go back to the Glaxo days, we had a team of 40 people. I was one of the team members and we went, you know, we're doing some, you know, some ice breaking and it turned out, so we're in Pennsylvania, only two people on the team were from Pennsylvania. And there were 28 people from other states and there were 13 or 12 or 13 from other countries.

and stuff. And we people with all kinds of wild experiences, know, people that did grad school in out East, ⁓ East, not just East United States, but, you know, out in Poland, people that worked in Japan, China, all over. And it was amazing to see how, you know, the bad word of DEI, the diversity part ⁓ really came together. So it was great to have people with all kinds of points of views.

Knowing ⁓ you can make a safe space so people could argue and debate. They're not going to get nasty about it, but you can bring up diverse points. Hey, this will never work. I remember we're having this thing. I proposed something and the woman next to me said, there's no way in hell that will work. I turned to her and said, you're going to eat those words because I know exactly what is because this experiment, they could get it to work. I said, I know you're doing wrong and I will get it to work. I did get it to work.

But I didn't take it as a challenge when she said that. She didn't think I was an idiot. She just didn't think it was going to work. But it did.

Heath Fletcher (34:37)
Right.

That's interesting thing about science is that it really is, ⁓ it crosses all boundaries, doesn't it? There are people researching things, some of the same things all in every country in the world. then sharing that information is where ⁓ science actually has breakthroughs.

Ed Fleischer (35:01)
Yeah, because we all have the same, you if you're working in the biological world, there's a lot of the same challenges. know, the regulations are set to address certain things. And then you have to meet those regulations. And there's always a reason why. When people badmouth the FDA, said, hey, look, they have a job to do. And they do it well. I've never had an inspector I thought was unfair. I've been through 40 something FDA.

EMA, Koreans, Chinese, Japanese, from all over. They come in and they have a reason to come in and look because there's bad actors out there. I remember I was at a workshop around raw materials and this was when, I want to say 2007, and some clever people in China figured out you could substitute something and it looked just like heparin until you took it.

You know, literally, I can't remember how many people died in the States because they got this ⁓ counterfeit heparin product. And that changed how we did testing. They said, Hey, you know, just some new things you have to do now to be able to release this stuff because we found people that could find a workaround and stuff. they've got a role to play. yeah, one of the greatest things is you get to work with some really interesting people. I've got to go to a

Heath Fletcher (36:11)
⁓

Yeah.

Ed Fleischer (36:29)
some really interesting places. mean, you the company sent me to Singapore to give a talk. I used to go to Europe four or five times a year, all over the States. ⁓ get to meet, like I said, you get to meet some amazing, some amazing people, some really smart people, some people that know stuff that I didn't even know you needed to know.

Heath Fletcher (36:51)
So you were doing presentations, like speaking and doing delivery talks. Did that, that was a, a large part of what you did?

Ed Fleischer (37:01)
Well, it's something that, you know, if you're going to lead people, you need to get up in front and talk to them. In fact, it was really interesting. This goes way back. So when I was in high school, my goal was to become a doctor. I wanted to be a doctor. And I was talking to this counselor and he said, you know, you should probably do something around public speaking. I said, like, debate? Because I didn't have no interest in debating. He goes, no, you should take an acting class.

Because if you can get up in front and say other people's words and act, you'll be very comfortable talking to large groups. So I did. I actually took a year of acting. And it was really useful because you're right. If you can get up and say other people's stupid words, you can say your own stupid words. that was one of the things that helped me.

Heath Fletcher (37:40)
No kidding.

Ed Fleischer (37:57)
moving to management, never had issues with getting up and talking about my work or presenting, you know. ⁓

teams work, being able to put together slide decks, you always have to talk to slide decks, and also making engaging talks. I got invited to go to England for this analytical symposium. The first year I gave a poster. So we did some experiments. We said, hey, this is what we set out to prove. Here's the hypothesis, and here's the data. So we had the poster session. Like 30 or 40 people presented posters. And then the next year, they said, hey,

we'd like you to come and give a talk, a 30 minute talk. So I said, ooh, this will be good because there's like 150 leaders in the company are here. The vice president, the big vice president of analytical holds this. I said, this will be a great chance for me to talk to them because a lot of people knew me, but they hadn't really seen me talk about something. I put together, I get 30 minutes to talk. We're in Cambridge at Robinson College.

So, you know, ⁓ one of the newer colleges there, ⁓ I had the second day, I thought it was a great spot, it was the first talk after lunch, the second day. So, ⁓ the lights go out, they said, hey, you know, I get up there, you know, they're saying, here's the podium. When you're two minutes out, this red light is gonna come on. It means you better be on your last slide, ready to wrap up. So it's pitch dark. I'm going through it, I'm on my last slide, this red light comes on and it...

It looked like the freaking sun to me. was just like a little tiny thing. ⁓ my God. I finished up and I said, boy, I hope everyone enjoyed it. They turned the lights on. First off the hall's half empty because people are not back from lunch or they're planning on leaving. The other half that was there, half of those guys were asleep because we always have a big dinner and visit to a pub the night before. And the few people that were there said, hey, you did great, Ed. love

So the third time I go over, they asked me to give the keynote speech after dinner. Because a lot of these guys got to know me better and said, hey, he's kind of got a wacky sense of humor. So I gave a talk called A Yank's Eye View of ⁓ Smith Klein Beacham and stuff.

Heath Fletcher (40:11)
Hey, wow!

Ed Fleischer (40:28)
And I put together a bunch of funny slides and stuff. And just before we get ready to talk, the slide projector doesn't work. This is slides, node school slides. The computer plugged in. So there's something wrong. I have to, they said, well, what can you, so I did like a 20 minute stream of conscious thing, entertaining these guys until the slide deck got up. And then I did my presentation and stuff. And then the last time I went,

Heath Fletcher (40:38)
Yeah. No, it's not a projector.

Ed Fleischer (40:56)
They said, you know, you've done a poster, you did a talk, you did a keynote. You can just show up and enjoy yourself. And I did. And then, and then we merged with Glaxo and they changed the structure. I never went to that again. But yeah, that's a key thing. You know, if you're going to be a leader, you have to be comfortable talking. You have to be able to be very comfortable. You need to be able to talk about good stuff and bad stuff. Yeah. Well, you know, and that's that's a key thing.

Heath Fletcher (41:15)
Yeah.

Ed Fleischer (41:25)
You know, I knew of another guy, he was in a leadership role. He virtually had panic attacks if he had to talk. You could tell that it was not someplace he got energy from. It was very trying and it was like, you know, this is kind of going to be a block for you. You're never going to get any higher because you know, the expectation is you can get up and talk about whatever they need to with very little notice. He had to do a lot of planning if he was going to do a presentation where

Heath Fletcher (41:42)
Yeah.

Ed Fleischer (41:55)
I said, let me read the slides once and I'll go.

Heath Fletcher (41:58)
Right. Well, and you just mentioned something too about having hard conversations. It's like you, you know, to be able to either speak in front of a large audience or have hard conversations with one person. mean, sometimes that can be just as debilitating for some leaders is not being able to say things that you got to say that sometimes is not great news or...

Ed Fleischer (42:19)
Yeah, it's always a tough thing. like I said, the benefits of being in the leadership spot way outweighed the ones not because I got to do stuff that I wanted to do and how I wanted to do it. And often it worked out pretty well. So I was able to get these guys to pay me for 41 years. So that's got to be worth something.

Heath Fletcher (42:42)
You brought value to the table, I think.

Ed Fleischer (42:44)
And

the other part, I went back, one of the ways we used to introduce ourselves, we had this one slider called a career journey. And basically on the top it maps out kind of like, you know, how you got to where you are now. And the bottom is like, well, not just, did you get there? How did you really do it? You know, what motivates you? What gives you energy? What are you really proud about doing? You know, one of the things that when I was younger, I used to get a lot of work assigned to me because I always still live.

In fact, one of the VPs used to call me a FedEx ad because I always deliver. He would ask me for stuff and I would get it done and stuff. That's not a bad nickname, right? Because I would deliver and that's key thing. And the other part is, can people trust you? You know, we have a lot of relationships here. lot of stuff has to be based on trust. I trust you to do this. In fact, I always tell people, I'm going to ask you to do something. I will likely not.

Heath Fletcher (43:24)
That's a good one, FedExEd.

Ed Fleischer (43:44)
check up on you because you said you're going to do it. But if you don't do it, I will likely never ask you again and stop because I'm not a micromanager. I work with people that used to say, let's discuss this down to the third decimal place. And I'm like, my God, we've got all these smart people. That's not the direction and help they need to do that. It's very demotivating. So I like to deliver stuff saying, you know, it's the, it's kind of the West Point thing. They talk about

Heath Fletcher (43:49)
Right.

Ed Fleischer (44:13)
all these strategies, but the general says, I want you to take this hill. He's not going to say, march two miles here and three miles here, dig a trench here, do this. He says, I want you to take that hill. And then we figure out how to do that. You know, I want you to figure out the control plan for this drug, but we know the regulations. We know how the drug was developed. We've worked closely with analytical sciences for method development. You know, I could write a control plan for a typical monoclonal in like three minutes now because we've done it so much.

Probably AI could do it faster.

Heath Fletcher (44:48)
Three minutes to three seconds now. Yeah. ⁓ so interesting. it, you know, it's, you bring great perspective to, ⁓ to your, from your journey. And it's, ⁓ I'm really grateful for you to share it with, ⁓ me and, listeners. And, ⁓ I think you had some really great advice to pass forward and I, I'm sure there'll be some, appreciative people out there hearing your story.

Ed Fleischer (44:50)
Exactly.

So it's tough. mean, it's always been tough in the science world because if you're in the for-profit stuff, they will think of nothing of shutting you down and moving a key asset fails. You're out. That's the advice I always give people. Stay current. Don't be stuck in something that worked even two years ago. You need to constantly stay up to date, not only the technology, but the regulatory space that shapes so much of what we do.

There's so many new things. I'm still learning about how the CAR T stuff works. Right now, we have clients that are doing similar stuff we've done. They want advice on how does this look to you? Read our BLA and give us some feedback. Are there gaps do you see? Or if you don't see gaps, what could be better? How do we defend this practice when we get an inspection done?

Heath Fletcher (46:11)
Thank

Ed Fleischer (46:11)
Or,

or this is kind of weak. You know, what would we need to beef this up? ⁓ those are kind of the stuff that I'm working on now. ⁓ and it's like I said, it's pretty cool. You get to do all kinds of stuff. You don't want to work. And so tomorrow my family and I are going to Disneyland. It's just a long plan. We have annual passes. So we go whenever we can. We couldn't go a couple of weeks ago. So we're going tomorrow. So I'm not going to work. I've told the people, Hey, don't bother me. Cause I'll be, ⁓ hopefully.

Heath Fletcher (46:26)
Nice.

Good for you.

Ed Fleischer (46:41)
on Big Thunder Mountain or eating a ⁓ Dole Whip or something.

Heath Fletcher (46:48)
Well, you enjoy yourself and thank you again for coming on this episode and ⁓ sharing a little slice of your world with us. really appreciate it.

Ed Fleischer (46:57)
Yeah, I can't wait. I can't wait to see what the final product looks like. And it's really interesting. Heath was really excited to do this because who doesn't love to talk about themselves?

Heath Fletcher (47:09)
Especially when you went to acting school.

Ed Fleischer (47:11)
You

have to be able That was high school. I wasn't very good. I think the role I had was I was a townsman and the musical ⁓ music man. So I was an Iowa townsman. But like I said, Yeah, but you know-

Heath Fletcher (47:24)
Is that right?

And it was a musical.

So you can sing and dance too.

Ed Fleischer (47:32)
No,

Heath Fletcher (47:38)
trouble in River City.

Ed Fleischer (47:40)
But yeah, it's really good to be able to speak easily in public. Be a real differentiator because I work with people, like I said, who really smart and they were tortured if they had to get up and

Heath Fletcher (47:46)
Yeah, it's definitely.

And it's learnable. It's not innate in everybody. It's something you can learn and something you can practice and get better at. So yeah, it's great advice. It's great advice. All right, Ed, thanks very much. And we'll talk again soon.

Ed Fleischer (48:13)
Okay, thanks a lot.

Heath Fletcher (48:17)
I really appreciate Ed. ⁓ His storytelling capability is ⁓ obvious. I really liked what he said about leadership style and that's staying authentic. is who he is ⁓ and he has a very, yeah, very clear idea of when there's a goal to be reached that everyone can do their job and when you say you're to do something, you do it, you know, and I think

That's a real great takeaway for a leader. Sometimes leaders have a little bit too much micromanagement going on. And I think that's good advice. You also, you know, reaffirmed that why, why most people in the healthcare, health tech space, why they do what they do is because they're looking for some sort of human outcome for somebody else, a way to improve someone else's life. And, you know, sharing that story of the woman, about her son.

⁓ getting the prescription drugs that helped, more or less save his life. A piece of advice I've never heard before, ⁓ from somebody in upper management is acting lessons, and learning how to, for public speaking purposes. mean, that's a great, that's a great piece of advice. If, if somebody is struggling with, ⁓ doing public presentations or public speaking or giving talks or lectures or something like that.

or even a podcast for example, ⁓ taking an acting lesson. You don't have to go to acting school, but I think a little bit of ⁓ acting and learning how to present ⁓ is great advice. So I think that's super valuable. Anyway, I really enjoyed meeting Ed and I hope you did too. And thanks for listening and stay healthy.