DarshanTalks Podcast

Darshan

Hey everyone, my name is Darshan Kulkarni and I'm your host for the Darshan talks podcast. As some of you know, I'm an attorney, I'm a pharmacist, and advise companies with FDA regulated products. So if you work or have an interest in FDA regulated companies or their products, this is a podcast for you. If you are working in an FDA regulated, regulated company or are interested in the products associated with it, you're probably dealing with with something that has had medical writers fingers all over it. And if the fingers have been all over it is because they've probably been through a lot of school. And to get there, they may have been THROUGH THROUGH THROUGH Danny's guidance. So you should care about today's podcast because our guest is someone who has spent a lot of time educating students. I believe it's over 22 years of distance learning 16 years of online teaching. But we'll talk about that more. Please leave a comment and subscribe. If you find this interesting. We'd love to have you listened to the next podcast. But Danny himself is currently the Director of biomedical writing programs. He's the professor of biomedical writing. He has a PhD in biology and has a decade at Wyatt where he worked on 14 MBAs. He redesigned he's now at the University of the sciences, where he redesigned the curriculum for the biomedical writing program significantly contributed to the creation of a graduate program in regulatory sciences and created or revised 12 courses. He's been the instructor for 10 regularly occurring courses and seven Special Topics courses, many of which have been taught multiple times. He's the author, co author of 14 manuscripts, two book chapters and numerous clinical reports. He's been on nine professionals, society, society meeting program committees, Danny, what did I miss?

Dan

Actually, it's now for book chapters because we

have a second

edition and significantly revised those two. So they really aren't the same thing anymore, since quite a bit happened between version one and version two. I have other manuscripts in the hopper. We'll see what happens. But that's part of Of course, being a professor. It's not just publish or perish. It's published because that's what we're supposed to do.

Darshan

Yeah. Ladies and gentlemen, our guest for the day, then Ben now, then you can thank you for coming on. I appreciate it.

Dan

Thanks for having me.

Darshan

It's so so let's, let's ask some basic questions. Right. Why did you decide to go from being in Wyatt working on NDA to being a professor? Well,

Dan

actually, I worked at y for a decade. I moved on from there. I was at Santa Fe, cinta labo for a bit over a year and then decided to go freelance.

Darshan

Okay.

Dan

So I freelanced. We kind of set an industry record before I left freelancing. I was hired in at the beginning of October, and we submitted an NDA in the middle of December.

Darshan

Wow. Then two months, right?

Dan

Yeah, two and a half months, and that product ultimately went to market,

Darshan

which was a dino, excuse me, which product was it?

Dan

Um, it was called ventes. It was it was a treatment for advanced prostate cancer used history colon, which was an off patent drug that was originally used to treat precocious puberty, but they wrapped it up in a the material that was so as a combo product, it was wrapped up in a tube made out of material from gas permeable contact lenses and was then implanted under the skin. So it was good for a year in creating in treating metastatic prostate cancer.

Darshan

Okay, so so your your biology knowledge is not skin deep, if you will, a PhD

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,