Nearly a year ago, I was scrolling through my news feed on Facebook (yes, one of my guilty pleasures!) and came across a very disturbing picture of a newborn with horrible blisters and open sores all over his body. With immediate heart ache, I had to know his story . . . I found out he was suffering from Epidermolysis Bullosa (EB), a rare genetic disorder that causes the skin to be so fragile that the slightest touch or friction can cause severe and painful blistering—internally and externally.
Think waaaaaaaaaaaaay (haha) back…growing up, did you ever try and take shortcuts when doing your homework? Perhaps reading the cliff notes for a book instead of the actual book you were assigned?!? Sound familiar? Eh…hem…we all took shortcuts at some point! The problem was…those shortcuts typically didn’t work…we probably ended up in a situation where our developing minds were missing important information that was needed for question number 1 on a final exam! Sweaty palms for the rest of the exam…
SO…… who do you feel like during the holidays?!?! Although I’d love to say “Miss Cheery” on the left, I think I’m more often “Mrs. Stress Ball” on the right!
You have to work through the “wrong” ones to get to the “right” one. What does that make you think of? It makes me think of 2 things: 1) Relationships, and 2) Drug Development. I know, you’re thinking, “huh?”
I am pleased to introduce to you Lori Muir, one of our fabulous MLC, LLC team members! Lori holds a BS in Chemical Engineering from Syracuse University. She has 22+ years industry experience and maintains professional certification from ACRP as a CCRA. She started her career in product/process development and processing engineering in the Biotech and Pharmaceutical Industries. She then moved onto clinical research and gained experience as a CRC, CRA, CPM, and most recently held the position of Director of Clinical / Regulatory Affairs for a life sciences CRO that managed clinical studies for the In Vitro Diagnostic Industry.
Yes, Virginia, you ARE ready for eCTD!
It is my pleasure to introduce you to one of our “newest” members of the McCormick LifeScience team! Nannette Hayes, RAC, has 12 years of Regulatory experience and holds her RAC certification. She has operations and strategy experience working on trials conducted in the US and OUS (Canada, UK, Bulgaria, Czech Republic, Australia, Brazil, Colombia, Argentina, etc.) in Phases 1-3 with a special interest in working with controlled substances in clinical studies. Nannette also has experience with the preparation of several NDAs and post-market requirements. Always a team player, Nannette possesses a great work ethic, sense of humor and dynamic personality!
Can you remember back in our good ole’ school days (no, I’m not implying you’re old!) doing those long, drawn out math problems where we had to show every step prior to getting the answer?! The pain, the pain, the pain.
Please allow me to introduce one of the newest members of our McCormick LifeScience crew who has simply added levels of experience (and humor!) to our great team! Lauren Agnotti, is a medical writer with over 10 years of experience, spanning trade journal articles and NDA submissions. She does not LARP (live action role play), and last wrote poetry in middle school. 😉
I’d like to introduce a member of our McCormick LifeScience team, Elizabeth Preisinger, MD trained in pathology at Brigham and Women’s Hospital, Harvard Medical School, and in molecular biology and genetics at Massachusetts Institute of Technology. She has clinical experience in community pathology at Lowell General Hospital and at the Veterans Administration.
(or any Regulatory Agency for that matter!)
I once learned from a very awesome colleague of mine (not to mention any names, but Michael Katz of Blue Penguin Development, small business marketing guru!), to “Stay in front of the people you know, over and over again, in a way that positions you as a likeable expert.”