Clinical Trial Podcast | Conversations with Clinical Research Experts

Conversation with Clinical Development Veteran Marshall Cool "There are a lot of things we can do, but we want to make sure we're doing what we want to do" - Marshall Cool In this interview, I talk to one of my dear friends Marshall Cool, who also turns out to be a clinical research veteran. Marshall brings to us his over two decades of clinical development experience, including his time at Abbott Vascular, leading one of the most exciting post-approval medical device studies, XIENCE V USA. Marshall also has significant experience managing Investigator Sponsored Studies (ISS) and clinical research organizations, details of which he shares with us during this interview. In addition, Marshall is an avid reader and loves books. Please enjoy my conversation with Marshall Cool. Listen to it on iTunes.Stream by clicking here.Download as an MP3 by right-clicking here and choosing "save as." Selected Links from the Episode: Connect with Marshall Cool LinkedIn CSU Annual Biotechnology Symposium Bristol-Myers Squibb Abbott Seth Godin Blog Center for Disease Control National Institute of Health Office of Inspector General Medical Affairs Strategic Summit (West) Medical Affairs Strategic Summit (East) ACRP Investigator Initiated and Sponsored Research Interest Group Books Mentioned: The Road to Character by David Brooks Chronicles of Narnia by C.S. Lewis and Pauline Baynes Linchpin: Are You Indispensable by Seth Godin The Checklist Manifesto: How to Get Things Right by Atul Gawande Show Notes: Description of what a clinical researcher does [02:10] Early days in clinical research [04:23] Roles and responsibilities of a clinical research associate (CRA) [08:55] You don't need an M.D. or Ph.D. to be in clinical research [10:55] Relocating for jobs [13:20] Transition from pharma to medical device clinical trials [15:55] What to do when you lose your job [19:46] Getting into the habit of reading and how it can help your clinical research job [26:31] Getting to First Patient In (FPI) for a post-approval medical device study [31:50] Onboarding a clinical research organization (CRO) [39:15] Investigator sponsored studies (non-company sponsored research) [41:30] Starting your career in Phase I-III research [45:45] Marshall's #1 advice to listeners [56:30] My motivations for starting the Clinical Trial Podcast [1:01:33] QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.

"Life is an adventure" - Gary Thompson In this interview, I had the pleasure to speak with one of the most optimistic individuals on the planet, Gary Thompson. Gary is the Vice President of Clinical Research at Abbott Vascular. In this interview, Gary shares a ton of valuable information on career choices, his #1 advice for all managers, and the relationship between money and happiness. In his free time, Gary loves to sail and is a proud owner of two sailboats. We discuss how sailing and clinical research are related in more ways than you can imagine. Enjoy my interview with Gary! Selected Links from the Episode Dr. Melvin P. Judkins Japan Ministry of Health Hobart "Hobie" Alter Show Notes: Advice on how to get into clinical research [1:20] Working in Japan [7:33] In-direct career paths [11:10] How to decide when considering a new clinical role [13:12] What it takes to work in a new geography [19:22] Most valuable lesson for all managers [23:26] Succeeding in the absence of a typical American childhood [25:56] Importance of work life balance [28:38] On sailing and how it applies to clinical research [32:46] Why you should take time off [41:44] Being present and meditation [43:30] Calling friends and family during the daily commute [47:20] Taking advantage of the right opportunities [57:30] QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.

Download Episode "It's important to make things clear and also look at it from the lens of public health not just from the lens of business." - David Rutledge "Don't let the place you begin dictate the place you end up" - David Rutledge My guest on today's podcast is David Rutledge. David is a Regulatory Affairs Director at Abbott Vascular. David is an expert in Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) which form the foundation of medical product approvals and license renewals worldwide. In his previous role as a Clinical Research Director, David has led publications strategy for Abbott's medical products including the blockbuster XIENCE V drug eluting stent. David has also served on the FDA advisory committee for four years prior his industry experience. David is my go-to person for advice on interpretation of Meddev regulations and the Medical Device Regulation (MDR). He is also a regulatory and quality expert presenting at many conferences and providing input on draft regulatory guidance documents. Enjoy my interview with David! Selected Links from the Episode: Connect with David Rutledge LinkedIn Six Sigma CFDA demonstrates the wisdom of Confucius. He said, "By three methods we may learn wisdom: First, by reflection, which is noblest; Second, by imitation, which is easiest; and third by experience, which is the hardest." Food and Drug Administration Harvard Business Review Books Mentioned: Simple: Conquering the Crisis of Complexity by Alan Siegel and Irene Etzkorn Steve Jobs by Walter Isaacson Chess Not Checkers: Elevate Your Leadership Game by Mark Miller The Art of Asking: How I Learned to Stop Worrying and Let People Help by Amanda Palmer Kiss, Bow, Or Shake Hands: The Bestselling Guide to Doing Business in More Than 60 Countries by Terri Morrison and Wayne A. Conaway Show Notes: How to pierce through clinical study reports and making insightful comments [09:45] About Six Sigma certification [17:05] Three basic skills that will make you a better CRO or medical writer [21:59] Developing competency in quality systems [31:05] Paying for certifications and training [34:40] Guidance for productive one-on-one meetings with managers [37:00] Learning from the mistakes of others [40:18] Keeping current with latest developments in clinical research industry [42:41] Working in China and the CFDA [52:20] Taking ownership of your career [1:02:45] QUESTION: What was your favorite lesson from this episode? Leave me a comment below and thanks for listening.