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.
I am pleased to introduce to you, one of our MLC, LLC team members, Lawrence Yarmaloff! Larry is a veteran of 23 years in the clinical research industry. As a consultant for the past 13 years, he provides quality assurance and clinical operations management support to small-midsize pharmaceutical and medical device companies. He holds professional certifications from the Society of Quality Assurance and the Association of Clinical Research Professionals.
I joined CrossFit EXP (crossfitexp.com) (one of the best decisions of my life BTW) about 8 months 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.
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).
When face-to-face with the FDA:
- Get the CRITICAL discussions and questions taken care of first, in case meeting time runs out.
- Seek agreement: “Do you agree?” (shows confidence, avoids open-ended questions)
- Support questions with data/info: Be sure to know all of the possible answers, so there are no surprises; research first if needed.
I’d like to introduce a member of our McCormick LifeScience team, Elizabeth Preisinger, MD trained in pathology at Brigham and Women’s Hospital, Harvard Medical School, and in molecular biology and genetics at Massachusetts Institute of Technology. She has clinical experience in community pathology at Lowell General Hospital and at the Veterans Administration.
I’d like to introduce Lisa D’Attanasio, part of our McCormick LifeScience family for the last 3 years! Lisa has over 20 years of experience working in the pharmaceutical industry. Her career started in Quality Assurance before moving into Regulatory Affairs. For the last 15 years she’s worked in Regulatory Project/Submission Management for both small and large companies in the Cambridge area. To date she’s notched 1 eNDA, 2 NDAs, 1 BLA, and 1 MAA on her CTD Submission Tool Belt.
I’d like to introduce Donna Keith, part of our McCormick LifeScience family! Donna has twelve years’ experience in the pharmaceutical industry with hands on training in GMP manufacturing since 2001 and seven years in Program management branching out and leading a CMC team delivering quality APIs and sterile drug products. She’s been consulting since 2013 in the areas of CMC and Quality Assurance.
I’d like to welcome back an integral part of the McCormick LifeScience Team, Mark Goodsell, a Quality professional with over 20 years GXP experience.
Your turn Mark!
Bringing up three boys in a busy household was always filled with challenges. Nothing brought about more tension at home than when my wife would tell the kids to “clean” and rarely was the end result close to Mom’s expectations. I told her that just saying “clean” was not enough, and that the boys needed her instructions to be interpreted based upon what needed to be cleaned. Setting out to reestablish peace and quiet, I broke each cleaning chore down to individual steps. Instructions to clean the kitchen became a detailed list, i.e., empty the dishwasher, reload the dirty dishes, put the silverware away, empty the recycling, sweep the floor . . .