Patient-Centric Medical Writing

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,