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Patient-Centric Medical Writing

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Darshan

Hey everyone, welcome to the Darshan talks Podcast. I am your host Darshan Kulkarni. As some of you know, I'm an attorney, I'm a pharmacist, I advise companies with FDA regulated products. So if you work for or have an interest in an FDA regulated company or its products, this is the podcast for you. Today's guest is the president of witzel innovations, Inc, she refers to it as wi because she's cool and I'm not

and has a background in clinical development. So if you are in regulatory, if you're in clinical, if you're in statistics, you might be someone who, who's working with medical writers and you'd care about this because someone like Robin or Robin herself, might be working on your next NDA. If you if you think this is interesting to you, please like leave a comment, subscribe. Um, one of the things I do want to also point out is today's guest, which is Robin has, has a extensive background in clinical development. So she's not just a medical writer, not the just associate with it, but she has a wide range of experiences. And you can actually reach her

where can Where can they reach you again, Robin,

Robin

so they can reach out to me on LinkedIn or email me at Robin dot witsel at Mattel innovations calm. I recognize it's like the world's longest email address. And I apologize.

Darshan

Very cool. And ladies and gentlemen, our guest for today, Robin Woodall. So thank you for coming on Robin.

Robin

Hey, starsan Thanks for inviting me, of course.

Darshan

So um, Robin talked to me a little bit about just some oil with the we had a conversation right before we started. And actually, before we started should probably introduce what innovations actually is. It is a full service medical scientific writing company focused on pharmaceutical, biotech and device clients, your employees write regulatory documents from the preclinical stage, all the way through the clinical stages, including your ind protocols, IBS, clinical study reports, narratives, etc, etc, etc. You also go into manuscript writing, slide and abstract, abstract presentations, sales, AIDS, and module compilations, and also performed literature reviews, you write and edit continuing medical education, and book chapters for accredited institutions and firms. So that seemed like a mouthful.

Robin

It is well, and we acquired electronic regulatory publishing company back in 2019. So now we can push through the electronic submission gateway for the FDA with electronic regulatory submissions. Okay, so you very exciting soup to

Darshan

literally the nuts.

Robin

I guess. So.

Darshan

Apparently, I did discover recently that soup to nuts is not a thing most normal because

Robin

it kind of has like a, I don't know, I would go with end to end.

Darshan

Way better than soup to nuts. Right. So let's focus on the basics. Rob, you obviously have a background in clinical development. When you started with Wi Fi, why did you start wi with with your background? That was slightly different, if you will?

Robin

Sure. So my background was clinical development. And my my last job before I started WI, I was an assistant director of preclinical and clinical programs at a startup. And because it was a startup, and I was literally like the 20 somethings employee, like I would just come into work. And pretty much everything would be my job, like, oh, who's gonna write that protocol that we, you know, who's gonna work on that master manuscripts still you so and then I worked on one compound from ind through NDA. And I've written plenty of work on plenty of imds throughout that period, as well. So after that experience, after my second daughter was born, I thought, okay, I'll just hang out a shingle, I'll consult. And right away I had a ton of work and with this small startup company here in the Research Triangle Park, where I'm located, and they discovered that they really needed help with the writing piece like that was their big gap. And I looked around and I started seeing more and more companies where the big gap was the writing. And because I had worked for a big pharma worked for a Ciro worked for a startup, I had seen sort of the sensibilities of each of these companies and what they needed. And so it was easy for me to kind of get more and more work to the point where I thought, I'm in trouble. I either have to clone myself or hire so that was never really the intent. But once it started, it was like, Okay, and now that was 2006 and Now 54 employees later, there we are. So yeah, I mean, it was kind of a crazy journey. But it's been an exciting one. So,

okay for it.

Darshan

So so you, you talk about 54 employees, which means that farmers growing how has last year been for you, by the way?

Robin

Last year was insane. So, at the beginning of the year, it's like what is going to happen? Right, I think I think pretty much no one had a playbook for what was going to be 2020. Right? Yeah. And I thought, Okay, this could go either way, like, all of all of clinical development could screech to a halt. And specifically, some of the areas that we work on work in have very fragile patients. I mean, they have cancer, they have heart conditions. And, and, you know, there's, in some of them, it's maybe the thought is that they can can delay treatment, or they can, and it was, it was kind of a scary time, like what is going to happen with those clinical trials. Yeah. And from an ethical perspective, when you think about somebody who's on chemo, it's really not super ethical to instantly withdraw them from a clinical trial. But many companies were saying, Hey, we're not going to start new protocols, we're going to put that on pause so that we can either address COVID, or just take care of the people that we have. And I think that was of concern that that we would be in this place where there'd be this huge gap. And so what we ended up doing is the opposite, we thought we'd have less work. And we ended up having more, it turned out that people needed more help with how they communicate with the FDA, how they structured their clinical trials, thinking more strategically about some of the global regulatory communications, some of our clients who are in Europe had some very different, I guess, challenges associated with their lockdowns than we did. So it was, it was a strange and dynamic time. But I thought a time where we really were able to have a great impact. And my personal passion is the patients and being able to apply what I know, to advocate for them. And I think all of us have been a patient or have been have loved someone or cared for someone who is a patient. So it gives us a great chance as medical writers to beat bring both that kind of scientific acumen. But that also that advocacy. So it was a cool year and the terrible year all at the same time.

Darshan

So you raise a couple of interesting things that I want to delve a little bit more in. Let's Let's start with the first one, which is you grew from you 50 for over 15 years. So impressive kudos for sure. But, but I'm sort of coming at it as not, there's no but actually the question I'm, I'm a, I'm a pharmacist, and one of the things that always talk about is how pharmacists are getting burnt out with their jobs. One of the things they always talk about is how they should consider medical writing as a profession. What have you worked with pharmacists, and what is your take been? Oh,

Robin

we have pharmacists on staff and they're amazing. So they bring an amazing kind of clinical sensibility to what they're working on. I think pharmacists that have worked for wi have enjoyed some of the pharma pharmacovigilance documents we work on because it really is that that clinical knowledge is really helpful. So I'd say it's it's I'd say that medical writing is a great job for pharmacists. I think two pharmacists have a great scientific background and a great understanding of these therapeutic areas and the challenges of them. And they probably have a greater understanding of the kind of medications that are already out there. So when they're when they're working documents, they can be very collaborative with team so we love pharmacists.

Darshan

But let me ask you, I'll tell you my experience with farm, okay. This is a great clinicians, my experience with them as they need to be trained how to write?

Robin

Sure. So you've touched on a very delicate subject, which is that, um, you know, just because you're an awesome scientist, and a great clinician, doesn't mean you're a great writer. And then there's this other huge factor to our job, which has to do with kind of herding cats. Part of being a medical writer is it's it's definitely a team sport. You know, you have to get the clinicians you have to get the statisticians if you're have a kineticist on your team. Everyone's got to kind of row the boat in the same direction. And they have competing priorities. And some of them don't understand that you are a valued member of the team as opposed to the typist. So you've kind of got to bring them along and help them understand how to come together to work on any of the documents you're working on. So, just being a great scientist, or just being a great clinician, or even a great clinician, and a great writer, might not get you all the way there to being a great medical writer.

Darshan

Thank you. The other thing I have seen with pharmacists, and again, I'm sure a lot of them are listening, a lot of them are friends. Being a pharmacist for 20 years, we get spoiled with a really high salaries as we start. Have you had to deal with that? How do you manage expectations?

Robin

So I think I think there's a there's a, there's a challenge with that, like pharmacists do expect really high salaries. I think the other thing is that, for some pharmacists, it's about a different life and a different mission. So yeah, I mean, I mean, you know, I don't know what the pharmacists salaries are right now. So I don't know how competitive we could be. But I think that if part of what you want to do is a different different impact if you want to make a different impact. And then a big value of, of my company, is how well we support our people and how well we support them in the totality of their lives. I mean, you can't bring your best work to the table if you are exhausted and frayed all the time. So we have pretty, pretty strict kind of thoughts around how much time we will commit a writer to a project. And our availability metric is much lower than the standard of the industry like we we try to have our people be at around 75% billable. So the rest of their time they can devote to things like scholarship inside of our industry, and submissions of abstracts and papers. And, and then the parts that are building a youngish company, like I guess we're not so young anymore, but building our company building our culture. We do a lot of internal training. So people develop training for us internally. So it gives them a chance to sort of be fuller people. So I think that's like something that perhaps a standard pharmacists job can offer.

Darshan

So not short. So let me ask you this question. If let's say there's a pharmacist coming out of pharmacy school right now, she's very, very confident being a pharmacist, he trained them to be better, better writers? Is that something you can pick up? Or do you recommend they go learn writing first and then come to you.

Robin

So your questions exceptionally well timed? We, and I don't know if you know this, so we have an internship program. And we actually are accepting applications through Oh, tomorrow. So um, if she is a phenomenal clinician, and she has a passion for medical writing, which, if she isn't aware, it's the telling the story of a drug or a patient throughout the clinical development process and beyond. If she's passionate for that, then she should look into our internship, get her resume and a fabulous cover letter together and send it in. And our internship program lasts about it. Well, it depends on the person. So we say 18 months. But again, there's opportunities to accelerate that. And it's about a 10 hour week commitment or more if the person wishes. But by the end of that we've taught them all about the regulations, we've taught them about kind of how to structure the way that you write something in a way that I mean, I'm a big fan of less is more, we have some very wordy clients that we have to try to lead away from lecturing Health Authority. But um, but like we try to teach them that stuff. And then of course, there's like the mundane stuff, like how great Are you with word? mundane but necessary? So

Darshan

yeah, here's an easy question. Where do they where do they sign up for the internship?

Robin

Ah, right. Um, they look online with innovations calm, and it's our careers, and they can click through there. So I think, or they can just send it to careers at whistle innovations calm.

Darshan

So that's the bottom is that right? whistle

Robin

is right careers at whistle innovations calm or on our website there. Absolutely.

Darshan

We will change that to say careers at

Robin

that's where they can submit a resume and a cover letter. So our internship program is in its 11th. Year and, gosh, we get a lot of applicants, so we get I don't know last year, like maybe 80 something. Wow, take about four. So

probably

Darshan

Harvard has the same acceptance rate then.

Robin

I guess so.

Um, I guess, but i think i think it's it's interesting how applicants they find out We've had people that have applied more than once. And and you know, it's might be the second time that we take them. So I think it's it just depends on the person. And if that's the right fit for them if this is the right path. I know medical writing, it's tough to get into it. Because the expectations are so high. And you have all these different components like do you understand the regulations? Do you understand the science? How well do you write? And can you lead a team of grumpy people? Not always grumpy sometimes.

Darshan

So can you lead a team of grumpy people? That's, that should be. That should be part of the mantra for sure.

Robin

Hey, maybe just busy. Let's just go with busy rather than grumpy.

Darshan

Absolutely. So the other element you kind of raised is this idea of patience and meeting the needs of patients. So let's let's sort of take a step back there. What is the purpose of whistle innovations.

Robin

So we are a medical writing firm, which means that we support life science companies, so pharmaceutical biotech medical device. And with those companies, as we're in a regulated industry, they have to perform investigations of their new products prior to selling them. So they conduct clinical trials, as we've been hearing about with COVID for the past year. And those clinical trials start out with a protocol. Well, actually, they start out with what's called an investigational new drug application. As you know, it's basically asking permission from the FDA to conduct a clinical trial. And health authorities around the world have their same version of that document or those series of documents. And we start out there usually, or sometimes before, they're supporting companies with the documents they need. So non clinical documents where they've been looking at animals, chemistry, manufacturing, and controls if it's a biologic or a chemical entity, where they've been looking at how the stability of this thing or the forced degradation of it. So we help them with the structuring any of those documents, the writing piece, like I said, team sport. So it's kind of pulling together these different sources to create a sustaining story for a health authority. So the protocol is the study design. And then when the study is over, our best friends, aka the statisticians perform the statistical analyses, which will include include descriptive statistics, so things like demographics, the range, the age ranges, and things like that. And then in for inferential statistics, things that would give us a signal about, Hey, is this a safety concern? Or Hey, is this what does this say about efficacy and effectiveness? So it's, it's kind of all of that, I love it. It's great. purposes, whatever communication, which I was long, but beautiful communication

Darshan

was incredible. I would say, this is how I would describe you.

Robin

I need to like, hang out with you, Robin darsana. Get a glass of wine. Come back. have a chat. It.

Darshan

But But let me ask you a different version of the question. I did badly the first time around. Okay. What does whittle innovation do?

Robin

Sure,

Darshan

what is the mission of Whitson? Oh, gosh,

Robin

so that's a better question. So, you know, I think in terms of our industry, we could do better, you know, we can, we could think about how we interact with patients better and how we design clinical trials and how burdensome they can be for the people that carry them out the clinical investigators and their staff, and the patients who participate. So if I had a mission, if I had like one thing I get to pick, it would be sort of a more mindful approach to clinical development. And I think that the health authorities have signaled they want that, you know, the, the guidances that have come out about patient centric clinical development are out there. But there's still this sense, in our industry of we do things the way we've done them, because we've always done them. So there's this fear, like if you don't have this extremely dense clinical trial and everything in the kitchen sink, that you might miss something and so you create something like overly burdensome can be created. So I think I've had a mission to be like, hey, let's think about how to do this just a little better. A little smarter, a little kinder.

Darshan

So your your mission words, if you will, just starting from this and just playing better. Sure.

Robin

So let's look at patient centric. And there are two though.

Darshan

So let's talk about patient centricity. When you talk, what what do those words mean to you? And And how has that? How have? How has that word been interpreted for you differently in say 2020 versus 2015? versus 2010?

Robin

Sure, um, well, 2020 is its own year, and let's hope it stays that way. Um, but really, for 2021

Darshan

already has it? Right,

Robin

right. Well, the extension of 25, part two, um, I mean, 2020 kind of introduced the whole world to the concept of clinical trials, right, for the most part, it was fairly invisible, like, drugs just show up at Walgreens, you know, it's not, hey, you do something, you get the idea, okay, you get to sell them, maybe the FDA just kind of figures it out. And, like me, I had actual conversations with people like, wait, what do you do? That's a thing. Um, and then 2020 came along, and everybody's an expert, so yay, for that. Um, but but really, so patient centricity is this idea of, you know, pharmaceutical companies, ultimately, your your customers a patient. And so unnecessarily when you go to develop a medication, the way that you have to think about that might differ than the way it would be actually applied in clinical practice, right, like, because clinical trials have to answer specific questions. So they have to structure everything, as similarly as possible. Yeah, to get to the answer of that question. And so I think patient centricity is kind of thinking about what that impact is for the person that's a hero, it's participating in your clinical trial, you know, they're showing up with something that's their health. I mean, you don't get anything more precious than that. Yeah. And in some cases, there, when you think about the COVID, clinical trials, those were healthy people saying, okay, sign me up, I want to do something, you know, and that's pretty amazing when you think about it. Like I, my, myself, my husband, and my eldest kid all signed up, didn't pick us. But we all were, like, you know, what we've seen, we've seen what has been written about the compounds that are there, the vaccines are developing the sound safe. And if we can all get together behind this and get this thing. So I was willing to be in the clinical trials. I wasn't selected. But I was willing to do it. And I've been in a clinical trial before.

So so there's that

Darshan

your participation in a clinical trial change how you operate now?

Robin

You know, I would say it just reinforced. So it was all the stuff I thought like how a foreign informed consent form was written, you know, there is this sense, kind of, yeah, we're in there is this really direct and clear and straightforward, and it's a struggle, you know, it's a struggle between how much information you need to convey and how to convey it. But I'd say that was influential to me. The, this was like a silly dermatological clinical trial. So it wasn't like I was oncology or something deep. But I mean, it was one of those things where I had been on the development side for at least, like at that point, like, more than 15 years, I'm like, I've never actually been in a clinical trial. Right, you know, and, and so when my dermatologist was like, Oh, do you want to do this? I'm like, Oh, okay. So, you know, and it, it was interesting to me to sort of be on that side of it, because she had no idea what I did for a living. And that was something like to her it was like, so this is what a clinical trial is going to do. And you just sign this form, that's 22 pages.

Darshan

But it tells you what they actually talked to you about it. Um, so you as you know, we usually aim for these to be about 1520 minutes. Oh, gosh, we've gone over already. But I'm, you're the second person. I'm going to do this with.

Robin

Okay,

Darshan

I have a six rapid fire questions for you.

Robin

Oh, ouch. Okay, so Pisa thanks. So you're telling me

Darshan

it's just whatever comes to mind quickly.

Robin

Okay, cool.

Darshan

What is it accomplishment you're most proud of?

Robin

Oh, being the mom of four kids, four amazing kids, and growing a company while being the mom of four amazing kids.

Darshan

There you go. Who is your your heroine or hero and why?

Robin

Oh, wow. That's a tough one. Um, let's Go with Marie Curie because she was an iconoclast, two Nobel prizes in two distinctive disciplines. And in a world that probably did not believe in her one bit, so she had to believe utterly in herself.

Darshan

I love it. I always find that the, the answers I get reflect something or the person on the on the person. Well, what is your favorite way to give back to your community?

Robin

I'm huge on volunteerism. So I wish we weren't having a pandemic. So when typical year why we do an annual retreat, we fly everybody in because we're all remote across the United States. And one of the things we do is a service project, and we get together and we partner with a local organization that we're showing up to actually do some good and do something that they need. And I think it's it's critical to give back. I also serve as a volunteer in different organizations like the diversity Alliance for science. I love their mission. I love what they're doing, and I'm happy to step up. And that's how we met actually, exactly. So what was it D? I can't remember which one?

Darshan

I honestly don't know. Here's a how I asked you this question. How has COVID changed how you balance your work and personal life?

Robin

Not well.

So those those fabulous

kids are like home schooling here. And it's like, Rock Paper, Scissors who's doing homework? Like, am I gonna? Am I doing calculus tonight? Or is that you honey? And I always get Japanese. So um, yeah, it's, it's tough. But you know, I think I have to give myself kind of a little bit more grace. You can't do it all. You can't have it all. And sleep. So that's probably how it's changed

Darshan

the school there. I did. I did not go to Jefferson Medical College only popped up a little bit. Okay, Lydia green says thanks, Robin for your comments.

Robin

Thanks, Lydia. My pleasure.

Darshan

Now, here's another one. How do you define success? Wow,

Robin

these are tough. You're supposed to warn me. I'm so success. So I think success has to do with the person you are every day the person you show up to me. So for me, that's how I define it. Like, am I living in the light? am I showing up and showing up positively for the people around me? Am I calming, more chaos that I'm creating for my employees and co workers and in the lives of my kids? Are they? Are they navigating their journey in a way that makes sense for them? Am I able to help them with that?

That's success.

Darshan

That's a lot of things you've got to accomplish be successful?

Robin

You know, I agreed on a curve.

Darshan

I love it. Last question, what challenges you owe?

Robin

What doesn't challenge me? My goodness. So I'm a young soul, I have a lot to learn. Each challenge is that kind of a gift. It's like this thing that's wrapped in a package for me to open up and figure out what I need to learn now. So and I do love it a good challenge, I think, you know, I I think learning new stuff is always cool and great. So when that when our company takes on something new, that's exciting, like going through an acquisition was definitely a learning curve for me.

So I think these are all like kind of the, the challenges I've tried to sit to face. So that's awesome.

Darshan

I'm gonna do a quick recap. Give me a sec. Okay. So I believe we started off with talking about why you actually started with cell solutions with cell innovations. And then we actually got into what actually is your purpose and your mission behind it. We then got into patient centricity. We talked about what that means to you. We talked about pharmacists, and the the actual internship program that you had. And then we did a little bit of a rapid fire round. Did I miss anything?

Robin

I think you got it all.

Darshan

So again, nothing in this podcast should be construed as any kind of legal or clinical advice. It was only to educate. For those of you who missed it. Robin, where can you be reached again,

Robin

I can very smoothly link LinkedIn on LinkedIn. So I'm Robin witsel. And the President of whistle innovations, I'm on LinkedIn. And please include a little note so I don't think you're a crazy stalker. But and then our company where it would sell innovations calm if you're a fabulous medical writer who's in search of a house Your home please come visit us are always hiring or if you purchase our services, we'd love to hear from you.

Darshan

Perfect. If you like this podcast, please leave a comment and subscribe. You can find me at Darshan talks on Twitter or go to our website at Darshan talks.com

Robin

oh I'm I'm at Robin with on Twitter so feel free to tweet me to

Darshan

add Robin with Twitter guys.

Robin

Thanks so much on fun fun

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