Episode Transcript
[00:00:01] Speaker A: Happy New Year, friends, and welcome to another episode of the Bench to Boardroom podcast. I am your host, Cynthia Steele, and today's guest is Dr. Cheryl Rowe Rendelman from the Omar Consulting Group. Cheryl is the founder and creator of the Omar Consulting Group, and nope, nope, not doing that either.
Hey, new year, friends, and welcome to another episode of the Bench to Boardroom podcast, where we talk about the transition from academics to industry. I'm your host, Cynthia Steele, and today's episode is with Dr. Cheryl Rowe Rendelman. Cheryl is the founder of the Omar Consulting Group, who largely helps companies navigate the regulatory space when it comes to taking an ophthalmic drug, specifically from bench to bedside.
Many people don't understand the complexities involved.
No fault of their own, but they don't understand the complexities involved with transitioning from working in a pre clinical setting and then eventually bringing that drug to humans. It is really a fascinating process. It's very involved. And if you want to learn more, Cheryl mentioned some good resources for you if that's something that you're interested in, from developing your own drug to that being a potential career path for you.
Cheryl has a bachelor's degree from Princeton University and a PhD in biochemistry and biophysics from the University of Houston. She went from teaching biology to the children of movie and theater stars to being first in the country in the biochemistry field. When she got her degree, literally, she graduated number one in biochemistry in the country and seemed well on her way to have a career path as a faculty member, either in a prep school or at the University of California, San Francisco.
But then she found something else. She found another path for herself, first learning about industry in general and using cells in drug development. She has an excellent story about actually confronting somebody from a company after he gave a presentation and maybe fact checking a few things that he said. The guts on this woman, you will be amazed. And then how she decided instead of traveling all the time, she decided to stay home with her family and instead start her own consulting group, which, as she'll tell you, was a terrifying prospect, but something that's become so much more rewarding than I think even she could have imagined. We also touch on golf. Cheryl is an avid golfer, and she has a really good case to make for why you also should take up golf. She's still trying to convince me, for.
[00:03:20] Speaker B: The record, but I think I might.
[00:03:22] Speaker A: Actually be almost there after this interview. So grab something. Sit down.
[00:03:30] Speaker B: Grab something to drink. Sit down.
[00:03:32] Speaker A: You're going to love this one. We have some really good laughs during this podcast. So, without any further ado, my episode.
[00:03:39] Speaker B: With Dr. Cheryl Rowe Rendelman. Welcome to Veg the boardroom. It is such an honor to have you here.
[00:04:06] Speaker C: Thanks for having me.
[00:04:08] Speaker B: So, for our audience who don't know you, please introduce yourself.
[00:04:15] Speaker C: Well, I'm Dr. Cheryl Rowe Rendelman. Since 2006, I've been running my own consulting practice called Omar, which stands for ophthalmic medical and research consultants.
We run a practice that takes people to the FDA.
I did this after having worked in industry for a while and figuring out where were the holes in industry and some of the problems with getting drugs that were being developed at the bench to the FDA and then being approved as drugs that we can use. And I found lots of holes, but there weren't a lot of people who were around to plug them. So I started my own practice.
[00:05:03] Speaker B: That's so cool. We're going to get to that part of your life where you made the decision to do that. But let's start from the beginning. So were you always interested in science?
[00:05:16] Speaker C: Well, yeah, I think I had a scientific bent in me, but I think I was more of a political and social advocate, following in the steps of my mom.
My mom, I remember from very early times, was making sandwiches, and I was making them along with her for people who were making the march on Washington. And I was too young to go around with her.
She would have these meetings with these high level next generation politicians in our house. And I just thought it was cool and normal that these people were at our house having these pow wows, these meetings, and all these community people were in the house, and they would give me a bottle of bubbles and I'd blow them at the meeting and have fun and things like that. I thought that was normal. So that was my trajectory. She then became my girl scout leader, and then that was clearly social advocacy from a way other platform.
So the science came, I guess, after I realized in school that I had aptitude.
Others probably realized I had aptitude, and they started throwing at me from high school this science track kind of stuff, and I gobbled it up from the very beginning.
It's what I surrounded myself with. I could relax with it. I found that exploration of math and exploration of biology and chemistry were all things that I enjoyed doing. And it wasn't route memorization for me, it was digging deep and finding why. So as a little kid growing up in the inner city in Baltimore, it was unusual, but that's what I did.
[00:07:27] Speaker B: Now. I agree. I was actually just thinking about that this morning. How much I appreciate history as long as there's a context, if we can see how the past fits into our present.
But in school, it's rote memorization. Like you said, the birth and death dates of all these historical figures and the day and the year that such and such a document was signed. And at least in my mind, that doesn't click, that doesn't spark any sort of fire. But if you can show me, in a way, scientifically, mechanistically, how this happened and then this and then this and then this, it makes a world of difference. Now you've got me. Now you got me thinking.
I love that came from that perspective.
[00:08:17] Speaker C: I agree. Even my history teacher, her name was Hannah Glaser, in high school had a.
She called it an inquiry method of teaching history. So if you knew the day and dates, that was okay, that would get you a c. But if you knew the context of why certain decisions were made, if you understood who were the parties that were in power and who was struggling at the time that received the a. And so it was the hardest a I'd ever gotten.
And Hannah, bless her heart, has just passed away this year.
And those of us who passed that course actually did a memorial for her because we knew at that time, and even to this day, that this was an incredibly special way of teaching history.
I use it all the time. I use it all the time.
[00:09:24] Speaker B: Let that be a note that high school teachers can make that much of a difference in the lives of their students, that their students will have a memorial for them after they. That's amazing.
Wow.
Thank you, Ms. Glaser. What a special woman.
Thank you for sharing.
Was your. I guess. Let's start with your trajectory through college. Graduate school. What was your dissertation on?
How did you start getting into ophthalmology?
[00:10:03] Speaker C: So I ended up after high school, applying to a bunch of different schools and visiting, and settled on going to Princeton. And I came to Princeton as an engineering student because I had been bathed in all this science stuff back in high school. And I call myself a failed chemical engineer. I spent two and a half years as a chemical engineer at Princeton when I realized, after having had a summer job, that's not quite what I wanted to do. And that's a little late for someone to start changing their major, because you have to have had taken a language if you're a non chemist and other kinds of things. And I did. I changed my major, and I selected an advisor. Her name was Martha Constantine Patton. And Martha was at that time implanting what we call a supernumerary eye into tadpoles to watch it link up to the back of the brain. And so that entire year that I was with her, we were looking at how nerves from the eye find their way to the central nervous system and make a connection.
I was late to the laboratory, so I didn't have good hands. I had the hands and brain of an engineer, but I didn't have the hands of a biologist, so she wouldn't let me near any of the very delicate experiments. So I had to learn by looking over the shoulder of another undergrad. His name was Robert Garcia, and he was wonderful. He let me come into the laboratory at night and I'd start doing some manipulations and help me to get my Princeton thesis off the ground.
When it was time to finish the thesis, Martha had handed me off to another fellow who was a new professor, and he was looking at how the omatidia in flies actually hooked up to the brain. I wanted nothing to do with flies. Flies are not fun models to work with. And I'll say this because it's 40 years later, but I remember opening up the caps of the little chambers that the flies were in and the flies would fly out. And then I realized that was a mistake and tried to get them back in. And I was not successful because all the crosses that happened that year were unexpected. First we thought we had some horrible mutant, but it wasn't. It was because of this one thing that I had done in the laboratory. So at that point I thought, I'll never study eyes. My career is over.
[00:13:15] Speaker B: My, I remember Drosophila experiments, of course, in my undergraduate genetics class, everyone did these. And our favorite flies were the ones with the withered wings, right? Because they didn't go anywhere. The other ones, they were everywhere. It drove us.
[00:13:33] Speaker C: Oh, my goodness. I remember coming back to that laboratory and there was like a bloom of flies. And I realized this is not what it's supposed to look like. I better collect these.
That was Princeton.
I wrote my thesis and everybody had to write a thesis. So it wasn't an honors thesis or anything. You just had to write one. So I wrote my thesis. And after Princeton, I went away to teach. And I taught at the crossroads school of Performing Arts, and I taught science. I was a very young science teacher. My students were the students of actors and musicians and they were all well healed in the theater and television and movie. And so I learned how that half of the world lives but those kids have to pass biology, too.
I had to create a course.
[00:14:34] Speaker B: Teach.
[00:14:35] Speaker C: Them to dissect animals and to do it in a way that didn't mess up their fingernails or anything like that.
This is the way the other half lives. I didn't know anything about this.
[00:14:47] Speaker B: I didn't know anything about this until right now.
[00:14:53] Speaker C: For me, I was a young teacher. I was learning things. I was learning these parents, they were very well healed in the movie and television industry. And to this day, I still watch a movie to the very end because one of my students is going to be there. So that's kind of the way that was. But I taught school in Santa Monica and I taught school in Houston. And at the end of my last year teaching school in Houston, my headmaster came to me and asked me, still very young teacher, what did I want to be when I grow up? I said I wanted to be a teacher. And he sadly shook his head like this.
And I was moved to tears because I thought I was being fired.
But he was trying to give me a pep talk. He was trying to tell me that none of the teachers in the school that I was at, it was St. John's School in Houston, was trying to teach their third graders how to isolate DNA.
But that was part of my curriculum.
[00:16:25] Speaker B: You are never too young to learn.
[00:16:29] Speaker C: He said, I think there's something there in you, and you need to go after your phd.
And I came home and I told my husband at that time what the guy had said, and lo and behold, he was overjoyed. He thought about, because he couldn't tell me that, but he was overjoyed. And he said immediately, go take your a. This is Texas. So Houston, Texas. There's plenty of schools there.
And I did find a wonderful school, and I applied. And the next thing I knew, I was in an accelerated PhD program with a fellow named Joe Ickberg. He immediately asked me to write a grant.
Immediately. Is he kidding?
And I wrote this grant to look at second messengers and basically a continuation of what I had done at Princeton with Martha Patton, second messengers from nerves that allowed them to talk to one another. Grant was granted two rounds. Wow. Which paid for all of my PhD program. And when I graduated from the University of Houston, I graduated number one in the country in biochemistry.
And I remember that because I'll tell you the story. We were all lined up to graduate, and my advisor, or the department chair, Dr. David, too, was looking at us all in the gowns, and we're all getting ready. And he says, oh, he says, you got the wrong gown on. I said, what are you talking about? He says, oh, you didn't hear. He says, you have this award. You are number one in the country. So there was this gown with this extra foo foos and this la la. He says, you got to go change.
And I said, I can't change. He says, why?
And that's because as graduate students in Houston, it's very hot in June. We had made a joke that we weren't going to wear anything underneath our gowns.
[00:19:09] Speaker B: No one in the country in biochemistry, and you're naked under your robe.
Cheryl, this is the best story I've ever heard.
So what did you do? Did you have to run to the bathroom then?
[00:19:33] Speaker C: So I had to run to the school store to get a new gown. And the lady at the school know pulled out this gown and the stole and things like that, and she said, take off your gown. I said, no, I can't take it off here in a store. And she put me behind a little thing, and she said, nobody could love you but your mother.
And I took the gown. I put on the little stole and the little and came back. And the other folks in my class, they were having the best laugh ever because they know that all I was wearing underneath this gown was this little green teddy. So that was after University of Houston.
I went over to the University of Texas medical School, and I started working with Diana Redburn. And once again, I'm back in the eye. Diana was trying to create ways to transplant or ways to discover how new eyes were developing particular cell groups, because the eye has seven layers of cells in it. How do those cell groups talk to one another? Once again, this second messenger stuff that happened long, long time ago. And I started making these full retinoid cultures with her. And at the end of that postdoc, she told me about a position that was opening up at the university California San Francisco Medical School with Roy Steinberg.
And Roy was dying of multiple melanoma, but he needed someone to take over his laboratory.
And I had no idea that this was the big league. I had no idea.
And at first I said, I can't take that.
And she sat me down and she says, you're taking this.
It was. It was as if she had strapped me to the back of a rocket because my career took off.
Within a month of being with Roy Steinberg, he had sent me to NIH to sit with Carl Cupfer to talk about the ten year plan for the work that was going on in his laboratory and how I would be facilitating it.
[00:22:21] Speaker B: Talk about baptism by fire.
[00:22:23] Speaker C: It was incredible. There were six other students in the laboratory, some of them senior students, some of them students from Europe, students from China. And my job was basically quality control officer, because these laboratory notebooks were not being developed in a way that would be an enduring footprint. And Dr. Steinberg knew that that was something that was required.
But he had so many other fights, frontiers to be fighting on, including fighting for his life.
[00:23:07] Speaker B: Right?
[00:23:10] Speaker C: I stayed with that laboratory until it was clear to me that the faculty position that I wanted was not going to appear.
UCSF and Stanford were mixing up faculty, and so I was now in the mix with senior faculty for laboratory space.
But I had something that they didn't have. I had gone to a cell biology meeting, and there was this company that was presenting at the cell biology meeting about taking RPE cells, retinopigment, epithelial cells from the back of the eye and making them immortal, and then somehow using them to treat diseases in which retinopikmin epithelial cells become aged and degenerate, such as in macular degeneration.
After the talk, I went up to the chief scientific officer, his name was Cal Harley, and I said, hey, I don't think those are RPE cells.
And he said, what do you mean?
And I went on and I talked about, know, this is what it should look like, and that's not what you've got there, and this is what you should be measuring, and you didn't measure that, and you have a cell that is immortal, but that's not RPE like. And I think within a week, I got a handwritten letter from him asking me to come down to Geron Corporation and just have a chat, which turned into a request for an.
I was.
As I said, it was like being strapped to a rocket again. I was there in company that was doing all kinds of things, involved with human telomerase, involved with aging, involved with cloning dollar the sheep. And I was running the macular degeneration program.
[00:25:12] Speaker B: Oh, my gosh.
[00:25:13] Speaker C: And I went with the blessing of Roy. He said, this exactly suits you, he says, because you would probably wither away at the bench because it doesn't allow you to expand the breadth of the kinds of things that you like to do. And that's when he explained that people who work at the bench have depth in terms of how deep they are in a small, particular area, and they become very good. But it's a narrow field and it's very deep, and that my thinking was flipped on its side. And my field was very broad because I was always making connections so I could talk about macular degeneration, and I could talk about growing cells. But then, far to the left, I could talk about signal transduction and all kinds of things that happen in other types of animals and in other types of diseases. And far to the right, I could talk about how this could never become a medical discovery unless the following things happened on the medical side. So that was what I needed from him.
Pushed out the door with his blessings, and I went. And we immediately started making drugs for the FDA. That's when I realized, oh, there are some holes here that we've got to fill.
[00:26:45] Speaker B: Yeah.
[00:26:45] Speaker C: We had members of Congress come down to us to speak about, what does it mean to have telomerase on Board? What does it mean to have this type of therapy? And is it ethical to have this kind of therapy, because it came from that time, from embryos and umbilical cords and foreskins. And the answer at that point was, no, it's not ethical. And most of that work went out of the United States to Europe, okay?
And it's all come back now. But that was the time. I mean, the congressmen thought that we were trying to clone babies and extend the life of people who should have died.
[00:27:42] Speaker B: I remember this time. I vaguely remember this time. I remember reading stuff in the paper about this and even being a young person who is not 100% invested in science yet. But I had this sense, this is ridiculous. Thinking that taking cells, taking stem cells from the umbilical cord, as you say, and then using these cells to help people, that's not murder.
That shouldn't be considered unethical. That shouldn't even be a crossroads for anybody. This is a beautiful resource that we have. And I remember, again, being very young, thinking, what are they talking about? That's ridiculous.
I'm amazed that you're on the forefront of that.
[00:28:39] Speaker C: Yeah, I was there listening and speaking to the senators and congressmen who came down to Jerome Corporation, and I think I had the same reaction that you did as they asked their questions. But it also let me know that the public doesn't have the benefit of the background, the education, the breadth that we do as scientists so they can be fed a conclusion that is not necessarily a conclusion that you and I would come to.
And that conclusion could stick, and it could wreck a field of inquiry in science. And as scientists, we have to be responsible for how we communicate our craft, because not everybody that we're communicating with is a scientist. As a matter of fact, 90% of the people that we communicate with are not scientists.
[00:29:49] Speaker B: I love this, Cheryl, because one of the things that I always worry about as somebody else who communicates with external stakeholders about things that are going on internally, you have to always be very careful that you're whittling down your message to a point that it's understandable, but it is still accurate. And we've all seen those headlines. Chocolate's good for you, red wine is good for you. But what they don't tell you is you can't just go eat a couple of Hershey bars a day and expect that to be the fountain of youth for you.
So actually, a good story about this is with regards to weed and glaucoma, right? I mean, I'm sure you get those questions, too, but when I was doing glaucoma research, there would always be one or two people, and you could always tell who they were, what question they were going to ask when they approached, just based on their whole demeanor. And they would say, talk to me about pot and glaucoma. And I would say, here's the thing, though.
You need to smoke constantly to lower your intraocular pressure. And usually the response was something in the realm of hold my beer. But like, no, you don't understand.
You don't understand how much weed we're actually talking about here. So I would not rely on that as a way to lower your pressure. And in fact, based on pressure fluctuations could actually make it worse. So don't consider that necessarily therapeutic at this time.
But the perception is still out there. Weed is going to help your glaucoma, or chocolate is going to help you with aging and things like that. So you're spot on that it has to be accurate, but also understandable. And thinking about it from the public perspective, I think it puts a whole different spin on it versus the stakeholder perspective.
[00:31:42] Speaker C: Yeah, I agree.
I'm not sure enough of us who are in science are trained to communicate what we do or even to write it in such a way that it's impeccable.
And I guess the word unimpeachable is probably the better word. Not impeccable. None of us are impeccable, but we have to.
It's part of the chore of being a scientist. I mean, look at what's going on now in the world with plagiarism and heads of universities stepping down because of very small impeachable acts. Yeah, I agree.
[00:32:36] Speaker B: Actually, that's a good point. I heard recently that my alma mater, Loyola University in Chicago, is doing a speaking course. And of course they're focusing on seminar talks and they're talking about research based talks.
Well, first of all, there's an art form for doing a ten minute talk versus a 45 to 60 minutes research seminar. Right? Again, whittling down your message to an understandable point.
But I also feel like there should be a spin on that as well for exactly what you're talking about. Let's take a scientific article and write a headline.
Find something in a journal that you find interesting. Write up a summary as if you were writing it for a newspaper, and find a way to not make it so sensationalist that someone's going to run off and begin an entire political platform behind it, but make it engaging enough that people will be interested and want to learn more.
[00:33:42] Speaker C: I agree. That would be great.
[00:33:45] Speaker B: If anyone's listening, that's a great idea. You should write that down.
So then tell us, how do you.
Yeah, go ahead.
[00:33:55] Speaker C: I was going to say, after leaving Geron, I went to another company to learn how to develop drugs specifically for the eye. And after that company, I went to the largest med ed company in the world, Suther and Hennessy.
And that is where I really learned the art of communicating, because my role as scientific associate and then medical director was to communicate with the regulatory bodies on one side, patients on the other, physicians in the middle. And it wasn't just about vision, it was about every drug that that company took on.
And I learned very quickly that how important it was for me to gauge what I was saying and to understand my audience and that what I was stating might be recorded and then twisted if I wasn't careful.
I was in charge of several physicians who would go onto these podiums at these huge meetings, and I had to make sure that they understood the quote unquote message so that they could deliver it.
And if there were parts of the message that were scientifically unfounded or I couldn't find or fact check it, which something that we do now in politics. But if I could fact check part of a message, it came out of the talk. Oh, yeah, absolutely.
It was amazing work. It had me going around the world at least twice a year, ending up in different places in front of different audiences, advocacy groups, congresses, groups of physicians, and creating awareness of diseases that were on the horizon versus those that were currently threat.
Understanding them, diving incredibly deep into a bunch of different things, had to work hard. But I had a bag packed at all times because I was on a plane at least once a week going someplace.
[00:36:54] Speaker B: That's the MSL life joke. Well, yeah, you're gone. A couple of days a week on average. And the joke is like that George Clooney movie up in the air, that opening sequence, he just goes through the airport completely, seamlessly. Know, you get to that point where you know where the shorter TSA line is going to be. You know, what shoes to wear, what not to wear. You get to the front of that line, you've got your boarding pass and your id ready to go, because the amateurs do not. They wait, for some reason, to look for their wallet when they get to the front of that line, and you're like, move.
But that's a hard life. It really is.
[00:37:36] Speaker C: It's a very hard life. And you have to literally keep your wits about you the entire time.
It's. It's.
I can't say I didn't enjoy it, because the things that I was exposed to, that was just rare company. Incredibly rare.
But it was hard. And I was raising a son at the time, and I was missing some of the best years of his life by being on the road that much.
And that career gave way to me starting Omar consulting so that I could pull back and have some more me in.
[00:38:32] Speaker B: So then. So you take all this knowledge that you've gained, and you decide to start your own company. So, I mean, to me, that sounds terrifying to say, no, I'm going to set out on my own. What was that like for you?
[00:38:51] Speaker C: It's terrifying.
I knew that you can only raise a child once, and I wasn't conflicted about that. I knew that I needed to be there for this son, this marvelous black man, to grow up and to take his position. Very, very smart kid.
And I was losing out. I was letting other people do that. He needed someone to be there at the junior high school to say, oh, so you didn't do your homework last night.
I thought we made time for that.
[00:39:48] Speaker B: Yeah.
[00:39:49] Speaker C: And to do that in front of his teachers and to let him know that I was on the same page.
So I thought about this very hard about how to do this. I knew that I had developed a set of skills from having submitted so many NDAs and then on the other side, worked in Med ed on so many drugs that were approved but were not getting off the ground because they hadn't made the right type of communications to the FDA or phase four programs hadn't been done.
So I went to my accountant, and he brought me to his lawyer, and he started teaching me about how I could indeed start a business.
I had been working industry, so I had a little cash. He told me that you've got to invest in yourself first.
And I didn't know what that was. And he said, look, I do your taxes, you can do this. And I did that. I did that much.
And then the lawyer created my articles of incorporation. We were incorporated initially in California as an s corp. And I had secured my first contract, which was a company I had worked with previously that was having a little trouble getting an NDA out the door, a new drug application.
And I knew where the bones were. I knew how to get in and knit together the different sections of the application so that it made a cogent story for the FDA. And it wasn't hard for me, and I could do it part time.
So I did this, and I realized I've got time for other clients, and I can still see my kid at the beginning, middle, and end of the day if I wanted to. So these folks made me work on site in California. I would do that, and I would go home and make sure my kid was doing fine, started his homework, and I'd go to my other site and I would work. There wasn't any zoom like this. I couldn't work very well.
And I was doing this and feeling really fulfilled.
And that was the thing that made, I guess, made me very happy.
Not just I'm smiling happy, but happy from the inside out that I was really doing something that made a difference to me and it made a difference to others.
I started to get to know my colleagues at the FDA. They started to get to know me.
I started doing continuing education and regulatory affairs.
And before I knew it, that's what I was doing for a living.
And very intentionally, I started building the practice. At first it was just little California companies, and then I started stretching out to companies across the United States.
Then we moved to New Jersey, and I tackled the route one quarter and New York.
And then I was introduced to a company from Japan, and I had to learn Japanese. I had to sit there in the company, and I was running the clinical development program.
I was going to Japan once every four months to speak to my higher ups.
It became very clear to me that I could do this and that it was not onerous. And each time I did a new project, I felt each project has its own challenges, and I felt that I had enough in the pot here, I had enough here to be able to look at their challenges honestly and to provide an outside perspective that was appreciated.
[00:44:51] Speaker B: I love that. And I love how you mentioned you feel happy from in here.
You're not just smiling, because if anyone asks any of us. How are we doing? Good. Fine.
I could be dying on the inside, but no, I'm fine.
I do want to take a quick step back, though, because I'm guessing that a lot of my listeners don't understand a lot about the FDA process and going from bench to bedside. So can you take a minute and just describe kind of what is involved in this process and why someone like you and now your colleagues are needed for companies to navigate that process?
[00:45:40] Speaker C: Yeah, why we're needed is really important.
When Big Pharma realized that they could not keep their pipelines full without going out to the small boutique biotech companies that were inventing, innovating, the know how that big pharma had and the sway that big pharma had with the regulatory agencies did not come along with their inquiry into these small companies.
So these small companies would make these deals with Big pharma with no idea of how to move their innovative bench research to a level of development that was derisked so that you could anticipate that it would become a successful drug. And it was only at that de risked stage that big pharma would actually pay off or take your drug and continue up the line to the FDA. And there are many steps, interactions with the FDA that have to happen in order to derisk a project.
So when you're working at the laboratory bench and you're happily labeling your test tubes and you're running the same experiment on the same instrument over and over again, and you've got this animal model that seems to be working, some of the steps that fall away for you because you do it so often, might be extremely important in communicating what you've done to the FDA.
So it's important to make sure that as you get to the point where you believe that there may be a here here or a therapy here, the amount of detail one must take in demonstrating each of your steps, and those things are not typically done in the university or hospital laboratory setting.
And we don't teach them.
We don't teach them. Sometimes it's done for the sake of expedience. Sometimes it's done for the sake of just getting that next grant done.
And that's great for your NIH grant, or your NSF grant, or your bright focus grant. It's absolutely not great for your FDA filing.
So I have to help companies go back and figure out what it is that they did, how often they did it, what were the limits of the quantitation that they did, what were the reagents that they did, whether reagents were useful for use in humans or not.
If they were not, then go back and recreate the entire gimmish with reagents that you can use in humans, creating specifications for the outcome, not just accepting an outcome and creating the right level of non clinical studies to support a clinical trial that they intend to do.
And that last part is really important, because we often do a bunch of animal studies thinking we've done all these great animal studies, so surely the FDA must believe me. But actually, no, they won't. There are areas. There's toxicology, there's immunogenicity, there's pharmacology, there's pharmacokinetics. There is safety, pharmacologic safety, such as the respiratory system, the central nervous system, and things like that, that we tend not to pay attention to unless we have to. So in the meantime, these other types of companies, which we call CRO, sort of sprang up, and they are supposed to fill in those blanks by doing some of those studies that are allowed, that required for getting you to the FDA. But often people at the bench don't know how to say to these CROs, hold on a minute, I don't need that study. I need this study instead.
And they may have a suite of studies that they do all the time. But if you're working in a specific field, such as the eye, or if you're working in a specific field, such as the heart or the brain, there are specific studies that you need for those fields. And your CRO, who is a one size fits all type shop, doesn't know that, and you have to do that. So that's in a long way of saying that's what needed to go from bench to bedside. In addition to that, the story behind all of it. What is the story? Can you knit a story from the beginning to the end such that, say, investors might want to take a chance on you before big pharma takes your derisk program that you spent years and millions of dollars on, right?
[00:51:12] Speaker B: No, that's a perfect summation of all of it.
And you're absolutely right. One would not normally think that if you're putting an eyedrop in, you should look at the kidneys and make sure everything's all kosher in there. Check the liver, the thymus, the thyroid, the ovaries, everything to make sure that it's all okay. You wouldn't think that, but you have.
[00:51:37] Speaker C: To, and thank God that we do.
I've had this discussion with many senior investigators saying it's just an eyedrop.
And that's when I realized I have to go back to the beginning with them and talk about, well, let's talk about what's happened with eyedrops.
[00:51:58] Speaker B: So if someone's listening right now and they say, that sounds really cool, a trainee or a postdoc junior faculty, and they think, well, that sounds really neat, what could they start doing now? Do you think if they're interested in a role either as a consultant like you, or even just learning more about the FDA regulatory process, where could they look to get some more information.
[00:52:29] Speaker C: If they're interested more in the FDA process?
The FDA has been given a mandate to communicate its process to the public. So the FDA has an enormous website of information, and that information is so huge that one could get lost in it. I would suggest that they would look at one of the FDA courses for small businesses and take it.
I put a tickler on my calendar for a small business course from the FDA to take one at least once a week. Now, that's not saying I do it once a week, but every week I'm reminded that I'm missing something at the FDA. If I don't take one of these courses, then there is an association called Raps, and I think it's called the regulatory affairs Professional Society. Raps raps trains people very early and young in their career on regulatory affairs. In different areas of regulatory affairs. You might be interested in drugs, biologics devices, you might be interested in writing, or you might be interested in some other form of executing the regulatory affairs process.
RaPs is an organization that you join, and once you join, and I guess you pay your $100, you are exposed to, once again, a library of information and an online discussion set that teaches you about your craft in your field. They also have an annual meeting that you can go to, but most importantly, they have accredited coursework for you. And I just told this to one of my friends who has been working behind the bench.
I guess I've known her now for 30 years, and she wants to leave the bench. She doesn't know how to do it.
And I said, I suggest that you look at quality.
Quality is another part of regulatory affairs. And she says, what's that? And I said, it's what you've been doing, but not being paid for.
And her eyes lit up and I sent her to wraps and I said, I need you to take the course for quality professionals, and I need you to pass it. And when you pass it, you can take it back to your work and say, I now have this credential as a quality affairs professional. I've been doing this work for you for the last 30 years anyway. I want you to match it with pay parity for other quality affairs professionals, or I'm going to leave.
[00:55:44] Speaker B: Wow.
[00:55:44] Speaker C: And quality affairs professionals are often hired as consultants because there's not enough of them.
These are the folks who understand things like, why would you have to audit a laboratory? And when you look at a laboratory notebook, what are you looking for?
When you are looking at the ingredients that are used in a particular drug, what are those ingredients and why do they fulfill the specifications that you do? The travel is everywhere. Because quality affairs professionals have to go to different organizations and different manufacturers.
The first time I did any quality is I was sent off to look at a manufacturing plant in Nutshateau, Switzerland, to understand why you can create this particular biologic in a cell processing plant and how you could do that without there being any human serum anywhere.
[00:56:54] Speaker B: Wow.
Okay.
[00:57:00] Speaker C: Yes. There's quite a bit in that regulatory piece that people can pull and do.
There's a dotted line from the bench to regulatory. And that quality person in a lab, or the quality person in a hospital setting, or the quality person in a medical setting, or the quality person in industry is worth gold. And we don't get them. We don't have enough.
[00:57:29] Speaker B: Wow. All right. Good to know.
In our last few minutes, I want to talk about golf.
There it is. And I want to talk about how last year when I saw you in Indianapolis at the AOPT meeting, you said, are you going to women in ophthalmology? And I said, yes.
And have you signed up for the golf tournament? And I said, absolutely not, because I haven't touched a golf club in ten years. And even when I used to golf nine holes on occasion with my lab mates, we were all terrible. And we mostly just did it for fun and to get some fresh air. And you said, that's perfect. That's exactly who we're looking for. And you better sign up. And I did, and I was terrified. But it ended up being so much fun, and I'm so glad I did it. So why is golf important, and why do you organize golf tournaments like that?
[00:58:36] Speaker C: I started playing golf when the men in my group would go off on the weekends without me, starting on Friday at about 04:00 to play golf. And they would talk about work and make decisions about work without me. And when Monday came, these guys would literally gang up on me. They had all figured out the rest of the world and all the world's problems on the golf course, and I wasn't there to put in my two cent. And if you're going to be part of these decisions, you got to be at the table. You got to be in the room where it happens. The room where it happens happened to be, at this point, a golf course in Princeton, New Jersey.
So I took golf lessons over the wintertime inside. And by spring, I was ready to go out and play golf with these guys, and I could hit the ball. And I realized very quickly that that was not the reason that these guys were going out to play golf. None of them could hit ball.
None of them could play golf. And someone took me aside and quietly explained to me that it's not about playing this game. It's about spending the time with these people and getting to know them in a way that was not obstacated by our roles, titles in science, so that we could speak freely.
Japanese word for this is called nomi no mi. And the americanized way of this is called no communication.
It's communicating without those roles, without those things that obfuscate the way that you can speak to one another.
So that introduced me to a subculture that I didn't know about. And since none of these guys could really play golf, and I loved the game, eventually took many, many more lessons, joined golf leagues and things like that, I realized that I could take this same kind of thing and move it over to my professional organizations, like my women in ophthalmology, like the association of ocular Pharmacology, like Orovo.
I belong to seven different golf leagues now, living down here in North Carolina, I can probably find a golf game on any day.
The idea is that golf was a great character builder for me because that part of my character had not yet been developed. I did not know how to communicate with someone who was outside of my level. I did not know how to listen empathically and understand what were the reasons behind why a particular boss was making types of decisions. I might have thought a person was an awful person until I learned to play golf with him. Or I might have thought a person was a great person until I learned that he cheated at golf. Those things tell you a lot about what you need to know to navigate the world with those people in your sphere. So along with that, and along with the idea of playing against the golf course and not against another person, just in nature, playing against the golf course, understanding your craft, learning the physics of golf, all of that appeals to the scientific end of me.
The engineering part of my golf clubs.
It had me 100% hooked.
It's now part of my household budget that I have money for golf balls because I'm going to lose them.
Part of the game, I'm going to lose them.
And I invested in my first real set of golf clubs only about six years ago, and I've been playing since 2011. So this is something that I have found has opened so many doors at Princeton. I went back and I joined their golf club. For this reason, I was speaking with an alum, soon to be an alum, a young girl who was part of Navy ROTC and her commanding officer had asked all of the graduating class to come out and play golf with them. It's a black woman, and she was frightened because she says, I don't know how to play golf, and my entire cohort is going to be there, and I'm behind the eight ball already. What should I do? And I said, come with me. I'll teach you.
And that was such an aha moment for me, that this young woman was going to experience what I had already experienced, that her cohort was going to go off on this golf course. They're going to make decisions without her, and she was never going to be in a room where it happened.
So she needed to learn and to enjoy, and she's a wonderful woman, and she plays still. And at the annual Princeton alumni Friends of Princeton golf event, I always look for her because that was a beginning, truly a teachable moment, just to make sure that she was in the room where it happened.
[01:04:46] Speaker B: Wow.
It's interesting. And I think, especially for women, we always have this perception when we're in a new area, we're an uncertain territory. We assume that everyone knows what they're doing. And I did it to you.
When you asked me to play golf, I said, oh, God, are you joking?
Absolutely not. And you said, no, you don't get it. And you explained to me, it's not about the golf, first of all. Second of all, we're going to have good people, but we're also going to have total newbies, and we're just out to have fun, and we're going to play best ball or scramble. So wherever the best ball lands, the closest ball, that's where you play from. So thank God, if you hit into the water, you hit into the rough. You don't have to go into the trees to look for it. It's okay.
But that's another reason why I wanted to start this podcast, is because trainees can look at a woman like you, and you have your own consulting firm. And you're very careful with what you say and you just totally seem like you have it together. And I feel like every single person I've interviewed, you can get that perception like, oh, she's got it together. And what I love sharing are those stories like what you talked about with your graduation gown or we all started in the same place.
We all had the moments where we snuck food home from a buffet because we were broke or the first time we ever stayed in a really nice hotel and we were like, oh my God, I don't belong here.
They're going to figure out that I don't make any money at all and they're going to kick me out.
We all have those moments. And so you follow your passions as you get older and then you end up in this space. But it's not that we start knowing that this is where we're going to end up. We all start in the same place. And I think how you describe golf is a perfect example of exactly that.
So the last question I'm going to ask you because I didn't get to it in the beginning, but my other big equalizer question that I ask everybody when you were studying and you had your NSF grant in your graduate work, the days that were really rough, what was your. Forget this. I'm giving this up and I'm going to run away and this is what I'm going to do.
[01:07:33] Speaker C: I have a classmate who is a musician. His name is Stanley Jordan and very unusual jazz musician. And I thought I was going to run away and I was going to be his.
Wasn't. There was no amorous thing there at all. I just thought the guy was so cool that I was going to be the person who would go in and go to those nightclubs, make those arrangements and be his roadie. When we were in college, Stanley Jordan was playing at a nightclub in New York called Dangerfields. Like Rodney Dangerfields, we were too young to go in.
So we stood with our noses pressed up against the window at Dangerfield while Stanley played.
And it was right there went, I'm going to be in there.
[01:08:39] Speaker B: I'm going to do this for him. That's how I'm going to get into the club. I'm going to carry an amp and that's how I'm going to get.
[01:08:45] Speaker C: Yeah, I thought that was what I was going to do.
[01:08:48] Speaker B: That's awesome.
I could honestly talk to you all day, Cheryl, but I know you have a lot to do today. S do I? But this was just wonderful. Thank you so much for coming on and sharing your story and just giving us a really fantastic way to kick off this new year with this.
[01:09:07] Speaker C: I genuinely appreciate honor to be able to kick off the new year with your viewers. Thank you so much.
[01:09:13] Speaker B: Thank you, Cheryl. And if people want to learn more about the Omar consulting group, where can they find you?
[01:09:20] Speaker C: Sure. So I have a website. It's ww omarconsultantsultants.com. And on that website, you can find a little button where you can push ask me a question info at Omar Consulting, and I will respond.
[01:09:39] Speaker B: Wonderful. They can also find you on LinkedIn, right?
[01:09:43] Speaker C: Oh, my goodness. Of course you can find me on LinkedIn. I have a full profile there. Cheryl L. Row rundleman on LinkedIn. Yeah.
[01:09:52] Speaker B: Cheryl, thank you so was just, it was a joy. We have to have you come back at some point.
[01:09:58] Speaker C: Thank you. Thank you so much.
[01:10:01] Speaker A: Thank you so much again to Dr. Cheryl Rowe Rendelman for her time today, some of the fabulous advice that she gave. And thank you all so much for listening, and we'll see you next time.
