2012 Newsletters

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

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!

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The New Alphabet Soup of Market Access and Reimbursement: Part 3 of 3

As I have been glued to the television over the past many days watching the devastating Sandy coverage, I realize how each person and town has been affected so differently. I highly respect the efforts and jobs of the National Guard, FEMA and local police/fire fighters . . . each response required is unique based on what each person/town is dealing with from a recovery perspective.

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The New Alphabet Soup of Market Access and Reimbursement: Part 2

22Let’s welcome back, Jamie Banks, PhD! As a “refresher” (for those who DID NOT read the last issue, ‘eh hem!’), Jamie is part of our team here at McCormick LifeScience Consultants as a health care consultant and strategist with experience in health economics, outcomes research, health policy, value assessment, trial design, technology valuation, and communications/publications.

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The New Alphabet Soup of Market Access and Reimbursement: Part 1

Although I have never been a patient in a Clinical trial, a personal medical experience got me thinking about today’s newsletter topic. Years ago (when I was oh-so-young and naïve), while working in the lab during my early years in the industry, I was hit with an unbearable abdominal pain . . . one so bad I was rushed to the Doctor for a look. After a few palpations of my abdomen and questions posed by the Doc, he claimed it’s “probably just a kidney stone” that will take care of itself, and I was sent on my way. In hours the pain completely subsided, so I assumed he was right and I passed the stone (TMI?!). HURRAY, what an accomplishment!! Three months later the pain returned with a vengeance.

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Foundation for Product Development: Stability & Solubility Fingerprinting

OK…who knows what this molecule is?! Come on … you know it … you can do it … YES! That’s right! It’s 5-ethylene-glycol!!! Well, so … maybe only the Chemists got that one.


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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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Pathology Peer Review of GLP Nonclinical Safety Studies

… And without wasting any more time, please let me introduce to you, a member of the McCormick LifeScience Consultants, LLC team, Roger E. Wells, DVM, MS, DACVP, Professor Emeritus, University of New Hampshire!

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Which Came First, the Regulatory Chicken or the Egg?

Please…without further ado, let me introduce to you a member of the McCormick LifeScience Consultants Team, Diane C. Tiernan, M.S., RAC, a Device Regulatory professional possessing >25 years industry experience. Diane has worked in large and small device companies, and is currently a private medical device consultant.


Take it Away Diane!

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Biostats for the Non-Biostatistician

Why Do We Compute p-values?

SO—I know you think I know EVERYTHING and that I’m the SMARTEST person you have EVER known…BUT…I’m here to break some sad news: I do not know everything and my consultants are really the ones that know everything and are the smartest people you will ever know (except for yourself of course)!

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Shortcuts to Receiving Market Approval

13Think 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…

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