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. So I'm not sure if I liked him or hate him. But
Dan
we had to be able to do it. If we were In our sleep, we had to be able to wake up and go through the whole thing. Don't ask me now please just
Darshan
give me glucose six phosphate gives you fructose six phosphate because you fructose one, six that desperate
Dan
causes
Darshan
is that that causes holy crap.
Dan
That's been so far. Good trade isocitrate
Darshan
Oh, God.
Dan
Let's not bore the audience with this
Darshan
worthy audience. Sorry about that, guys. So let's talk a little bit, Danny, when we're talking about Sorry, I can't believe I got glycolysis and Krebs cycle mixed up. But so so you were talking about your history, you're talking about how you're coming? You started with why if you went to Santa Fe, you started doing a little bit freelancing, what happened that,
Unknown Speaker
um,
Dan
somebody actually was kind of funny, I went to a drug information Association annual meeting, something I hadn't been able to do, because why if at the time and cut down on where we were allowed to go, and Santa Fe T, for the time I was there, we were only allowed to go locally. So I treated myself when I went freelance. And I happened to run into the booth in the exhibit hall, the University of the sciences at booth. And I just started talking. So while we are medical writers, yeah, you know, we have a master's in medical writing program. And it really is it Yeah, so give me your resume. So I did, and turned out the director at the time. And I had postdoc in, she'd been the outgoing postdoc when I was the incoming postdoc, ah, and so she kind of looked at us as I know, this idiot and the next thing I knew I was an adjunct. Then one of the full timers left, and she said, Well, you know, what, how would you like to become a full time faculty and I said, you know, what, make a nice change. I'd already lost track. 14, MDS is an awful lot of effort. I, to this day, have no idea how many clinical study reports I wrote. I was doing at least five or six, phase three or four a year wioth. Other Phase One, two clinical study reports, of course, the 14 nbas that included all kinds of regulatory documentation, overseas responses, and as I just got tired of producing documents, at the same time, it's it's lucrative it was still is. And I felt like giving back to the industry, it gave me a chance to do something else I had already gotten tired. I had 18 years at the bench now as a bench scientist before I became a medical writer. And so I transitioned into teaching medical writing. The director there left, now a year and a half after I joined you sciences. And first I was interim director of the program, then I was confirmed as the director. I'm the fourth director in the program. I've been there. This is now my 13th year, which means that I have been director longer than my three predecessors combined. All also just just to know, I'm one of the few people who has been a full time online professor. I even I even gave a talk about that in 2006. At one of the Lilly conferences on college teaching, because it was really unusual at the time to have anybody teaching anything online. And full time at the time, I was teaching 45 credits a year online, which was too much I ultimately EDSAC can't do this anymore. I would get the week between between Christmas New Year a crash which is unsustainable. But I'm really happy with the way our program myself I've been able to affect people's lives. We have we did a survey back in 2017. This was part of the university survey, not just me, not just a personal thing. And as it turned out, 80% of our graduates were still in the business at the time. And and over half of those were either senior writers are above including at the time for who were directors or senior directors. And we had most of the others were successful freelance writers, either individually or they were they had their own business with people working under them as well. So we really we really did have an effect on people's lives. Yeah, and we're out there, we're well known program, I get plenty of calls, I get recruiter calls, I get requests for evidence to see if we have students who are interested in experiential work. So that's the question Danny,
Darshan
who is the right student to become a right person to become a medical writer?
Dan
You know, it's funny because there are really three genres of medical writing, okay, I came out, if I had 14 MBAs and clinical study reports that I no longer know how many that makes me a regulatory writer. That's one of the three major genres. The second genre is promotional. Now, when you say promotional people immediately think of medical advertising. And that is part of promotional, actually, a small part in terms of medical writing, much greater as manuscript writing the regulatory agencies consider any manuscript about an identifiable drug product is indeed, promotional. So this is not legal advice. This is just a fact of life. And then finally, there's education, and that's branded and unbranded brand, would be continuing medical education can any of the accredited continuing clinical type education. And then other than that, there is patient education, as monographs, instructions on how to do stuff, and for the patient, what to take how to take it. And these take somewhat different personalities. Regulatory writing is possibly in terms of actual writing the most boring tasks writing task on earth is very formulaic. What makes it interesting is that you're taking input from a number of different people, or a number of different specialties, and putting it all into one single document that has to look like it's had one author. So it's the mediation, negotiation, occasional psychiatric practice, in order to do that, then there's, um, emotional stuff, and education. Really, these are the people who have the more creative writing tasks. Okay, they still have to adhere to drug label. In order, you can't go and just sort of write anything you want. It has to be stuff that's, you know, stuff is sorry about the dog dog barking in the background, he always seems to have to join
Unknown Speaker
in but,
Dan
you know, it still has to conform to clinical research results, and what's on the drug label, in some way, shape or form, they can't just go out and say, Okay, this and this happened, then a miracle occurs by the drug doesn't work that way. And in fact, even medical advertisement is far more highly regulated than people realize. There are TVs ads that have created billion with the B dollar fines because they did stuff that that really the FDA didn't want done or other regulatory, or other regulatory agencies, actually, the United States and New Zealand are the only two countries that allow direct to consumer advertising of drugs and devices. So at any rate, um, you know, those are the three genres and they take different kinds of people who are willing to do it, probably the promotion area is the most creative, okay, especially when you get to the advertising stuff. In terms of in between that would be the education you're putting together. educational content, but it's usually agency work, you may freelance, but you work for an agency and the stuff that you're doing there cannot be branded if it's continuing it. It has to meet accrediting specifications in order to be useful for getting credit. And so takes a little bit of from each side, you know, understanding the regulations and what those are about. And at the same time, creating engaging content frequently under the direction of higher level course developers, patient dead stuff, it can be. Again, now a big thing is medication guides. That was never really given a formal format. But now they're kind of falling into place.
And
going back to where there is a certain amount of creativity in the regulatory field, the original target audience for regular to any regulatory documentation were prescribers and regulators. But increasingly, the patient themselves are the target audiences. Well, there's a market for people who can translate clinical into English that's understandable or language, that's understandable. In Europe, they call it lay language, because that's international English, it doesn't have the religious connotation does doesn't the US here, we tend to call it more plain language summaries, and whatever. So it takes different kind of head for each of those, you have to be willing to leave from below as a regulatory writer. But you still have to know your stuff. And you have to be able to deal with timelines, people who don't necessarily want to meet their deadlines, and will take a bite out of yours. And other stuff. In terms of promotion. Again, deadlines, we're all medical writing is deadline driven. Okay, it's not a it's not a leisure activity. It's always been quite stressful. The stress comes bigger and smaller as time goes on. But there's always that stress, the clock is always ticking. There was one of the metrics, getting kind of old now, but it came out of the tufts Development Center, which basically said that every last day of bringing a drug to market is a million dollars in opportunity cost out the window. So you know, having a writer fumble, that deadline can be damn expensive.
Darshan
Yeah. I think the number is not like two and a half million or something. Probably,
Dan
as I said, that's the one I can actually put a, you know, put a reference to if I had to go scrambling for it.
Darshan
So So here's the next question. So you've done a bunch of stuff around tele learning over the last year, that's obviously become extremely important. What are some tips that you'd give to, to companies as they become more remote on how they can train their staff, including the medical writers, but via medical writers?
Dan
Okay, I mean, a lot of it, you just sort of learned by doing. So you have people who may shadow and get and give minor contributions at the beginning. And as they gain confidence and experience, they move on. But now, and these were not available when I started back in 1990. There are certificate programs all over the place, some of them, given by universities, a lot of them are not part of the accredited area of universities, but they're still valid certificates with good training. There are professional society certificates. By the way, be aware that there's a big difference between a certificate and certification. For instance, the only real true certification in medical writing, there are others and medical editing and so forth. But medical writing is the NW C, which is an independent medical writer certification which is given by an independent group, but is administered generally through American Medical Writers Association and partly through Drug Information Association. So and that's a credential you can't even take the test unless you've had at least a year been an active medical writer for a year. Whereas if I'm to take any of the certificates, some have more assessment than others, the ones that have no real assessment I always call in I was there certificate. Okay, cuz you was there and you have a certificate but nobody knows how much you slept.
Darshan
Fair enough. Fair enough.
Dan
One of the things About degrees. And stuff that comes out of universities is we have to do is we have to have outside assessment. You know, if it's an accredited university, then somebody is watching what they're teaching how they're teaching it, and how they're assessing student progress. There's less so from a professional society and from some of these private organizations, maybe none, unless it's something like continuing ed, where there is an accrediting agency
Unknown Speaker
testing.
Dan
So that's quality control, and education and training.
Darshan
Fair enough. Danny, as you know, we usually just aim for 15 to 20 minutes we're already over because you're just interested in your wealth of information. But we're going to do a new segment we're doing now, which is rapid fire questions. I'm gonna ask you 10 questions, and you just answered it very quickly. Okay, what is an accomplishment? you're most proud of?
Dan
14 MBAs,
Darshan
okay? Who is your hero or heroine? And why?
Dan
My hero actually have a lot. My true ultimate hero is George Washington. Why? Why the man who could have been King and said, No, thank you.
Darshan
Very cool. What is your favorite way to give back to your community?
Dan
teaching? I love teaching. Sometimes you get poor doing it, but it's worth it.
Darshan
How do you define success?
Dan
Success is when you say to me, success is defined by when you affect other people's lives positively. I think that's important. It might be part of my religious background. I'm not sure but if you have boosted other people in the world, you can consider yourself a success.
Unknown Speaker
There you go.
Darshan
What challenges you
Dan
what challenges me keeping the edge being able to, you know, being able to say I'm up to date, and I know what's going on. By the way, part of that was like and has been as director, I went to five professional meetings a year just to stay abreast of what was going on. Four out of those five I paid for out of my own pocket.
Darshan
Oh my god, Really? Wow. Okay, what is your favorite movie?
Dan
My favorite movie? Oh, boy. My favorite all time movie, the original? Magnificent Seven.
Darshan
Okay,
Dan
the farmer always wins.
Darshan
If you were a superhero, what would your power be?
Dan
If I were to be a superhero? What would my power be? knowledge. Knowledge, there's a character in one of my and forgive me. There's a character in one of the novel series that did he knew everything. And he also had a hole through the space time continuum in his knapsack that at the other end was in a fruit warehouse. But the reason he had super knowledge was he found the scroll of ultimate knowledge. It had the answer to every question in the universe. And as he pointed out to when he finally admitted to having that two things could happen, you go crazy and kill yourself or you learn how to deal with it. Or you have to learn how to deal with it. He learned how to deal with it. He has other thing was he was a wizard. But he said there's no such thing as magic just tricks.
Darshan
If you want a million dollars, what would you buy?
Dan
What million lottery tickets?
Darshan
I don't know. Owing some money on that one. If you could add a person to Mount Rushmore, who would it be? And why?
Dan
person to Mount Rushmore? Wow. Um, no. They're all presidents. So
Darshan
I don't think
Dan
at all, but probably Franklin Roosevelt.
Darshan
Okay.
Dan
Why? Because he took he took office in incredible different difficult time that got increasingly difficult as he went along and dealt with it was able to deal far longer than any other president partly because of it was permitted. And partly because despite the fact that he was in a wheelchair, he had the stamina, the guts and the willingness to do it.
Darshan
Okay, last question. Would you rather lead an easy life or an interesting life
Dan
Let's see, would you rather be in the link or suffer from a Chinese curse? Interesting. I've had an interesting life. I've never regretted getting my doctorate. Because I have used it now in four separate career directions. That would not have been nearly as possible if I didn't have it. I'm ever grateful. My real true hero, ultimate hero, actually was my dissertation advisor. He taught me so much. And I think of him every day of my life. And I use stuff that he taught me every day of my life. My father taught me a lot, too. And he's, he was to me, he was my best friend.
Darshan
Now, I'm going to call it my legal card. You did not answer the question. Would you rather an easy life or an interesting life? Interesting.
Dan
There you go. Okay. And I had the interesting life to back it up.
Darshan
If you do, yes, you do. Okay, so during this podcast, we talked a little bit about your history about how you came to teaching how you went from, you know, basically bumped into university of Sciences at di, you talk about three types of medical writing, the types of people are right for them. You talked about the right student to become a good medical writer. We then did our rapid fire questions. And I thought that again, while we didn't discuss anything that's legal or clinical advice, we had a good time doing it. But for those of you who missed it, Danny, where can you be reached? And well, where can you be reached first?
Dan
I can be reached mainly still at the university. Okay. I have a university email address. And you want me to give it online or? Yeah, sure. Okay. d dot. B isn't boy, he is in northern au at U sciences.edu.
Darshan
There you go. And if you liked this podcast, please leave a like or comment or subscribe. You can find me at Darshan talks on Twitter, or just go to our website at Darshan talks.com. Thanks, everyone. Thanks for being a part of this. Danny.
Dan
Thank you so much, again, for having me.
