2016 Newsletters

Yes, Virginia, you ARE ready for eCTD!

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!

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GLPs… Assuring Data Quality

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.

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Don’t Forget the Value of Facetime

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).

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2016 Look Ahead

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.

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Orphan Drugs—Are They Worth It?

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.

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Preparing for Meetings with the Food and Drug Administration (FDA)

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?

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Deciding Which Compound is the Best

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.

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Building & Maintaining a Relationship with Regulatory Authorities

(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.”

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Tools for Successfully Managing a Clinical Trial

16A 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!

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