Newsletters

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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PreClinical CROs – Why, When, Who, and How?

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?

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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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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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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.

DRUMROLL PLEASE……..

Take it Away Diane!

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Talking Templates

Once again I welcome back one of my favorite members of the McCormick LifeScience Consultants, LLC team, Jacob Cooper, Quality Systems, Writer and Regulatory Operations Consultant.  He just keeps coming back for more writing!

It’s all you Jake!!

Do you ever feel like all you ever produce is … documents? You might be right!

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Friedreich’s Ataxia (FA)… there’s hope, but NOW is the time!

I joined CrossFit EXP (crossfitexp.com) (one of the best decisions of my life BTW) almost 2 years ago and have met some great people. One person has stood out for me, her name is Brenda Mullaney, and she’s my definition of a Supermom! She’s physically and mentally strong; she’s got a great positive and supportive personality, not to mention a perfect sense of humor. Little did I know, until about two months ago, what she was going through. Of her four children (twins Joey and Sean are 20, Kaela is 25, and Ryan is 26), Joey and Kaela (also amazingly awesome and strong if I do say so myself!) are affected with a rare, degenerative neuro-muscular disorder known as Friedreich’s Ataxia (FA). My already-positive opinion of Brenda sky-rocketed as I learned this.

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