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Are You Ready To Be a Medical Writer?
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 Dan II Yeah, I'm actually just of interest anybody. My in terms of history and pedigree. My dissertation adviser Charles Turner himself had been a graduate student of Sir Hans Krebs, as in the Krebs cycle. Wow. And I met that guy a couple of times. Darshan That's kind of cool. I remember Matt trying to memorize the Krebs cycle.
31 minutes | 24 days ago
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, 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.
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Global Privacy Considerations for Healthcare IT & FDA Regulated Startups
Darshan Hey everyone, welcome to another episode of Darshan talks. My name is Darshan Kulkarni. As you all know, the goal of this podcast has always been to talk about the life sciences to talk about things that impact the life sciences. And one of the things that keep popping up is the idea of privacy, the evolving and emerging role of privacy and the discussions around it, and how that impacts the life sciences. And if you're in clinical research, if you are in marketing, if you are in PR, if you have if you are a medical device that has patient data, every single one of you are probably impacted by the discussion around privacy. Along the way, I, I follow a lot of really interesting people on LinkedIn. And one of the most interesting people I follow is an Amish shy Austrian. And Avishai is the head of privacy at axon. He is both a qualified privacy solicitor in England and Wales and also in Israel with a strong background in corporate commercial law. And, and what we're discussing is really how this all comes together and have a shot. Before I jump into some questions. Is there anything I missed? Would you like to answer any questions? clarify something I said or didn't mention? No, I think that was, first of all, thank you very much Darshan, for having me having me on the podcast, the chat always, always great to chat to friends all around the world. And that's what's amazing about this, this time that we're in now is that it's so easy just to hop on virtual chat and just Avishai have a conversation. So I love it. Darshan You never he never quite got this chance before. I'm gonna try. Let me ask you, oh, let's put some things out of the way. Because as lawyers, we kind of have to worry about this. This isn't legal advice. So if you're interested, I need legal advice. I wish I Why should they contact you? Avishai LinkedIn is a great place to find me. I'm very, very active there. So just drop me a line. And we'll we'll get the conversation started from there. Darshan Perfect. Um, so let's start with a couple of different questions. So we had a very brief conversation, as you know, started before the, this this starting the interview, and you talk to me about how you were born in Harrisburg. And, and yet here you are a solicitor in in Wales and the UK and and well, in England, Wales, and also in Israel. How does that all come together? Why Why did you come Bring these pieces together from a global perspective? And Yet, You're both not only an expert in, in privacy, but also corporate and commercial. So how do you bring that all together? Avishai Yeah, so a bit of a you highlighted a bit of my split personality there. But yeah, born in the US grew up in Israel, trained as a corporate and commercial lawyer went to law school here in Israel, trained as a corporate and commercial lawyer worked at one of the big firms and like every good young corporate lawyer, I did really everything I did, you know, high tech mergers and acquisitions, bit of antitrust even which was fascinating, and really fell in love with the area with privacy and data protection, and how basically how technology and the law, interact and sometimes clash with each other. And realize I wanted to develop my to have a career in this fascinating field, looked around at the Israeli privacy regulations and realized they weren't really the gold standard of privacy around the world. And they were talking about this new emerging regulation called GDPR. your listeners may be familiar with it, which is the privacy regulation that applies in the EU, that was supposed to be this new gold standard of privacy. And I said, great, you know, let's let's do that. And so I found the, you know, I knew of a UK firm that was actually based here in Israel. So I applied to work there and got my English qualification got my privacy knowledge up to date, and I really founded the privacy practice at esterson, which I had today. So that's, that's my journey.
32 minutes | a month ago
Consultant Pharmacy: An Important Role
Darshan Hey everyone, we have as you guys know, my podcast really deals with life sciences and pharmacy, and things that impact the engagement between the two, and things that impact just the care of patients. This specific podcast I thought was really interesting because I think groups like ascp come out and actually connect with a unique set of patients, patients who, whose needs are often not being met. So if you are in the pharmacy in this pharmacy, if you are a pharmacist or pharmacy, you want to be talking to someone like Chad, because you might want to find out Well, can I learn from lessons that that ascp has, if you're in the pharmaceutical industry, you may want to talk to Chad because these are pharmacists were frontline workers who are actually learning from patients and they need education. They need to know what your drugs are doing, what your devices are doing. So that's why I thought today's podcast makes sense. My name is Darshan Kulkarni, this is Darshan talks, and we have Chad Morris. So Chad, welcome. Chad Happy to be here. A little bit about yourself and escp. Sure. Well, first of all, thanks for having me on. Just from the audience perspective, I think the first time we met was a, a live stage podcasts. We were on stage in front of a group being recorded for a podcast and we had met I think, at lunch like 20 minutes before, and it's still one of the I had the best time. You know, obviously your personality lends to that. But just thanks for thanks for inviting me. Your show is fun. That's going to be a lot of fun today, you'll be good. Yeah. So um, yeah, to your point. asep is a is a unique organization. In pharmacy, we represent pharmacists, and pharmacies that take care of people in older adults setting. So traditionally, that's been skilled nursing facilities, assisted living facilities. Some states have intermediate care facilities, our pharmacists take care of a lot of individuals that live in group home setting, so developmentally disabled individual, so generally patients with complex medical needs. And it started, you know, 50 years ago, probably because a corner drugstore pharmacist said, How can I better serve these nursing homes that are popping up in the community? And ultimately, what what happened was the pharmacist figured out that there's a lot of things that those kinds of buildings need from efficiencies, like, how do you package medications and nurses can pass them better to how do you manage patients clinically when they start to accumulate medications. So the last 50 years has been this sort of growth and experience in how to take care of older adults that are complex from a medication standpoint. And now we sit at this intersection of sort of the Golden Age of pharmaceutical companies where we've got a lot of options to treat patients. So you've got a lot of demand for medications, and a lot of use of medications. Plus, you've got a population that over the age of 65 is growing faster than any other segment of our population. And even within that the over 85 population is growing the fastest within that over 65 population. So you've got older adults, they're living longer, they're healthier, primarily because of medications, but they're also dealing with the fact that they're they have to take a lot of those medications. So how do we do that safely? And how do we do that with an eye on the fact that they're a very different person than a younger, healthier population? So our pharmacists do that. You'll see them again, in nursing homes, assisted living facilities, and in the community. A lot of them are being embedded in in physicians, clinics and doctor's offices that take care of generally older adults. So let's start with the basics. Because when I talk to pharmacists, the big question I get asked is, how do I stop being a retail pharmacist? How do I stop licking, sticking, counting pouring? Generally speaking, if the big box retailers, I'm not knocking them.
33 minutes | a month ago
How To Rule the World – Twice Over
Darshan Hey, everyone. So we, as you guys know, on this podcast, we land up talking a lot about the life sciences. And we talk about things that impact on life sciences, including clinical trials. today's podcast is going to be talking about what is what are clinical trials, like, from the perspective of a site, who is doing oncology? It's a multi multi location site, if you will. And we have with us, Kathleen ritardo. Kathy, I believe I know you're a pharmacist, but is it PharmD or is it RPh? Kathleen RPh. Darshan Okay. So we have Kathleen with us and Kathleen is unusually a pharmacist, which I know for me at least that for something when I was going to pharmacy school, I always wanted to ask to talk to people who've done the goi ng down that pathway of being a pharmacist and clinical research. I've never found one. And the ones that I did find really ended up being more people who mix up the drugs as opposed to people who actually administer the site. So a Kathleen is what I think of as a unicorn. So welcome, thank you. And this is my name is Darshan Kulkarni, this is Darshan talks. This is Kathleen Hurtado. Happy to introduce yourself, please. Kathleen So thank you, Darshan. Really nice to be here with you today. So you kind of already did it. My name is Kathleen Hurtado, and I am the VP of research administration for Cancer Treatment Centers of America. And I've had a very, you know, blessed career very varied career, but started started out as a oncology pharmacist at MD Anderson, my first job out of pharmacy school. So, and I've had lots of different things all the way around and kind of ended up serendipitously here. So Darshan I'm not gonna let you go that or that easily. Okay, go from pharmacy school to run your clinical research site. Because, personally, like I said, You're the unicorn. How did you even think, did you think you'd land up here? Kathleen Oh, no, never. I love being a pharmacist and thought that's what you know, I would, I would, you know, do for the rest of my life, but it was just very serendipitous. So I am working at MD Anderson, we, I was worked in pediatrics, and we had a lot of, you know, sales reps come and call on us. And so one of them was we I got to be, you know, friends with her. And she kept saying, Oh, you should come into sales, you should come to sales. And I was like, no way. So I'm, I'm really pretty much an introvert by nature. And so it was something I could just never see myself doing. And so at the time, they were starting, that company was starting in oncology, Salesforce. And so they were looking for people that knew oncology, oncology, pharmacist, psychology nurses, because they knew that to go out to doctors, you had to be able to speak the science speak to the science. So I thought, Well, you know what, I'm going to go interview because what's the worst possible thing that can happen? The worst possible thing that can happen is I go, I tried to do it. I don't like it. I go back to being a pharmacist. You know, I knew I could I love that. I could always go back and do that. And as it turns out, I was actually good at it. Yeah, I wish I would never ever, ever have expected. And I think I was I started out as a surprise, I started out carrying the bag. So yeah, in fact, I had a five state territory. So I had Minnesota, Iowa, Wisconsin, North and South Dakota and the Upper Peninsula of Michigan. And so yeah, and so for somebody who had never driven in snow in their entire life, it was kind of a rude awakening. And I used to scare my district manager half to death. Because I was a little bit crazy, it was like, as a company car, let's, you know, spin it and see what happens. So but, um, but it was great, because it got me out of my comfort zone. So what I learned from that was that, you know, sometimes you have to, you know, you take a risk and do something different. And I always encourage people to, you know, try try something new, like, you know,
25 minutes | 2 months ago
Are You Losing Your Voice?
Your voice helps to define your personality, mood, and health. In this episode, speech-language pathologist Jessica Schwartz explains what can impact your voice (and how you can take care of it!).
44 minutes | 2 months ago
How Are Global Transparency Laws Affecting Your Clinical Trials?
Join me as I talk with Jordan Fischer, CIPP-E, CIPP-US, CIPM about the role of #privacy in the #lifesciences. Discussions included the EU privacy shield, US Surveillance laws and why they matter for data privacy, the #Brexit Adequacy decisions, and #biometricdata privacy laws - and how all of these affect #clinicaltrials, clinical trial #transparency and life science #marketing.
23 minutes | 2 months ago
Sales & Marketing Oversight
Sales and marketing representatives in the life science industry must comply with state and federal regulations. What are these regulations and how should you navigate them? Join Darshan Kulkarni as he talks with Marc Banjak, General Counsel at Dova Pharmaceuticals, about sales compliance in the life sciences. We’ll also discuss some problems that arise with patient ambassadors.
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