Submission Sagas

I thought a good place to start would be introductions. Hi, my name is Leah Kleylein and I work for Octagon Research Solutions, Inc. My role here is Product Strategist for the ViewPoint team. In other words, I am a lonely SME surrounded by oodles of techie people who use incomprehensible acronyms and made-up words. I’m pretty sure they talk about me while I’m in the room, but I just can’t understand them.

I’m allowed to say that because I’ve spent most of my adult life in jobs that also abounded with incomprehensible acronyms and made-up words. And that would be Regulatory Operations. Ahhh, Regulatory Operations.

Of course, I didn’t aim to be in regulatory when I emerged from college, armed and ready with my little B.A. in Liberal Arts. But don’t laugh techie people, my courseload focused on Industrial/Organizational Psychology which means I know ALL about you and how you interact with others, and how your team interacts with other teams. Why don’t you just sit back and relax, and tell me all about it?

Anyway, I ended up temping after college, and found myself one day whiting out dots on published literature for an imaging agent while locked up in what the company called a “submissions room”. Also, I would spend long hours standing at a copier making crooked copies of published literature into straight and beautiful copies of published literature with 1-inch margins at the minimum, preferably more on the binding edge.

Something must have appealed to me about the whole process because here I am today. I never said there wasn’t anything wrong with me…

Around about 1998 I began learning about the concept of electronic publishing, even though it ended in paper output. That was when I began understanding all too well the idea of what you start with is not always what you end up with, especially when it comes to symbols in a word document turning into other completely inappropriate symbols in the PDF rendition.

eBLAs and eINDs were next for me, and I loved the concept of cutting out the paper. What a great idea!! No more paper cuts, no more plastic binders, but most of all…most of all….No More Tabs. Tabs are the biggest waste of time on earth because Regulatory Affairs people always want More Tabs. It’s like asking for more cowbell because you can never have too much cowbell. Well, Regulatory Affairs people, you know you had a problem, and at least I didn’t have to keep being the bad guy. Tabs just went away. But don’t worry Regulatory Affairs people, I still like you and appreciate all I’ve learned from you. Especially stuff like when I learned what the word exsanguination means.

eCTD was the scariest thing I had ever encountered though. I dreamt of the easy paper days, the hand-paginating, the QCing of copied volumes. But you know what, I got over it pretty quick. eCTD is not that evil, it turns out it’s pretty easy after all. I swear!! I worked for someone at the time that basically told me, just do it (meaning do an eCTD), and wonder of wonders, I did! But I still felt like Calvin being literally kicked outside by his mom to play….

Just make sure you have the right tools…..don’t try hand-coding using notepad or something.

And now, with RPS looming on the horizon, I finally decided it was a good idea to leave Pharma and come to Octagon. No, no, I’m just kidding. I promise RPS won’t be bad. I will help you.

But anyway, so now my role is to be an expert on regulatory operations stuff and guidances and stuff like that for the development group here at Octagon. What I’ll be doing in this blog is discussing topics around publishing, guidances, what’s happening in the world of submissions, and so on. I look forward to the opportunity, who knew that part of my job one day would be to blog?