“GSP” – Good Submission Practices!

I’d like to introduce Lisa D’Attanasio, part of our McCormick LifeScience family for the last 3 years!  Lisa has over 20 years of experience working in the pharmaceutical industry.  Her career started in Quality Assurance before moving into Regulatory Affairs.  For the last 15 years she’s worked in Regulatory Project/Submission Management for both small and large companies in the Cambridge area.  To date she’s notched 1 eNDA, 2 NDAs, 1 BLA, and 1 MAA on her CTD Submission Tool Belt.

Take it away Lisa!

Throughout our careers we attend countless training and re-training sessions on GCP (Good Clinical Practices), GMP (Good Manufacturing Practices) and GLP (Good Laboratory Practices) . . . well, she has created another (stop laughing!) — Good Submission Practices!  Regulatory submissions are our proof-of-concept communication with the FDA and other Regulatory agencies that help us put beneficial products on the market for patients.  As submission managers, there’s a lot to handle.  Here are her words of advice . . .

Know the Ropes.  Understand the details.  Like, ALL THE DETAILS.  You should commit every task of the NDA Project Plan and every item on the Content Plan to memory and be able to recall at a heartbeat’s notice, i.e., when the Regulatory Affairs Lead asks you in front of the CEO at a very contentious meeting.  Make flash cards and have your family quiz you!  It’s great that your family will miss you at dinner time because you’re working late, but the cherry on the sundae is when you finally get quality time with them you can involve them in your madness!  Winner, winner chicken dinner!

change management$h*t Happens.  Yes, I used a naughty word, but there’s no nice way of saying it.  Always reserve a buffer in your timeline for the <ahem> “stuff” you never dreamed could have happened, but did.  It’s never the “stuff” the Team has discussed ad nauseam (a serious, but not unexpected adverse event during marketing application development [statistical significance >95% confidence]) and is not nicely represented in fabulous green, yellow and red colors in a Risk/Probability Heat Map.  Maintain your super-secret time buffer in the NDA Project Plan, labeled as something important sounding like “Alignment” that so when the Team really needs extra time because “stuff” happened, lo and behold you found the Holy Grail of time out of nowhere!  You go, Submission Manager extraordinaire!  You’re like the Timeline Whisperer!

Never Let Them See You Sweat.  You are the Submission Manager for the SuperDrug RX NDA co-leading the NDA Team with Regulatory Affairs and are charged with developing the timeline, managing the team to the timeline, and at all times, defending the timeline.  You’ll be challenged by Mr. I am So Overwhelmed that I Don’t Know it Yet or by Ms. I’ll be Taking a Month Long African Safari during the Busiest Time, but don’t let any of it unnerve you.  People have lives that go on outside of the workplace and people react differently to stressful situations.  Listen attentively.  React logically and professionally when obstacles arise.  Your Team is expecting you to lead them through and work around difficulties.  Remember you can always Primal Scream as loud as you want while you commute—that’s the blessing of being in traffic for 2 hours a day!

During a short period of time the Team will have worked the graveyard shift, gone for broke, got on the same page (finally), crossed their fingers, at times wanted to throw in the towel, left no stone unturned, reviewed everything but the kitchen sink and run it up the flagpole, then, down to the wire, and at last SuperDrug RX leaves the building with Elvis!

In these few stressful months leading up to the marketing application submission date, I always remind myself “I’m thankful that I’m healthy”.  I knock on wood every day that I don’t need SuperDrug RX, but there are many patients suffering day to day with illness and I can certainly miss a few meals, stay up past my bedtime, or work a couple of Saturdays without hesitation.

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  • You manage and track many activities performed by many people all at one time.  Be organized, detail-oriented and prepared.
  • Always expect the unexpected.  Be a proactive planner.  It’s never a waste of time.  You’ll be ready to implement a solution when the time comes.
  • Always expect the unexpected.  Be a proactive planner.  It’s never a waste of time.  You’ll be ready to implement a solution when the time comes.