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.
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’d like to introduce a member of our McCormick LifeScience team, David Kroon! Dave brings us 18 years of experience in the pharmaceutical industry, in roles ranging from validation to manufacturing to clinical supply. Most recently, Dave developed and managed a complex clinical supply program requiring 25 CMOs in six countries, delivering drug product from 23 production sites to more than 80 clinical sites in US, Canada, and Europe (ok, I’m done bragging about him now).
I am pleased to introduce to you, one of our newest MLC, LLC team members, Claire Walsh, MS, RAC. Claire holds a Bachelor in Biology and Master of Science in Health Product Regulation & Health Policy from Regis College. She also maintains her Regulatory Affairs Certification (RAC). Claire has 20 years industry experience. She started her career in In Vitro Diagnostics at Bayer Diagnostics, and more recently comes to us from Braintree Laboratories, Inc., where she was the Director of Regulatory Affairs primarily supporting Non-Clinical, cGMP and Pharmacovigilance activities. Claire also recently completed a Clinical Project Management certification program.
Nearly 2 years 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.
When I started my company 10 years ago, I knew I would eventually need HR support and capabilities. I didn’t want to do it myself for a couple reasons . . . I didn’t have the experience or knowledge in HR (Nor do I want it, no offense to any HR friends!), and I didn’t have the set-up/capabilities to be able to do it. I ended up choosing an outside company and outsourced all of my HR needs/functions to them. Easy right? Nope! I had to consider . . . Do I really need them? When do I engage them? Who should I choose? How do I initiate and oversee them?
So really, how do you prepare for meetings with the FDA? They can be quite intimidating, especially for new companies developing a relationship with the FDA for the first time. Who knows what they need to hear? Who knows what they will ask? Do we wing it or do we prepare? Can we prepare? How would we prepare?
It is my pleasure to introduce to you, a member of the MLC team, Chris Town, PhD. Chris is a consultant in Drug Metabolism and Pharmacokintietics (PK). He has spent over 30 years in the Pharmaceutical industry designing, executing and interpreting PK studies and conducting research in support of pre-clinical development, ultimately moving compounds from research projects into human studies.
(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.”
A few days ago, I was trying to finish my work, keep my 1½ year old happy, put away the dishes in the sink, fold the laundry, get my 7-year-old a snack, pack our suitcases for our family trip to Maine, empty the garbage cans, pay a couple bills, paint my toenails (you can’t go to the beach without painted toenails!), make dinner, and water the flowers before we left. Oh-and make sure the cat had enough food and water. While I was going about my fairly NORMAL day, I thought to myself “life is sort of like managing a clinical trial.” There are numerous pieces … all of which must be completed (although, my husband would probably tell me I can skip feeding the cat … haha), and a strict timeframe in which it has to be done!