2015 Newsletters

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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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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Oversight of Clinical Investigations – a Risk-Based Approach to Monitoring

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.

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Teamwork and the Ticking Clock

I am pleased to introduce to you, one of our favorite MLC, LLC team members (well, aren’t they all favorites!?!), Alisia Collett! She’s spent nearly 11 years in the biotech/ pharmaceutical industry and worked her way up from Animal Care Technician to Senior Research Associate. She always seemed to be the person on her team who would end up writing SOPs, protocols, and reports, so it was only natural that she would eventually find her way to her current position of Scientific Editor for McCormick LifeScience Consultants, LLC.

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

When I started my company 7 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)

Remember back to college (only a ‘couple’ years ago, right?!) . . . big presentation coming up!  Did you prepare?   Research your topic?  Take notes?  Make a power point presentation?  Practice it a few times?  My guess is that you did. If not, I can’t imagine things turned out too well!  Which leads me to our topic for today . . . how do you prepare for meetings with the FDA?

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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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