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CTP 018: Genetic Testing in Clinical Trials with Karmen Trzupek

Karmen Trzupek, MS, CGC, is part of the leadership team at Informed DNA where she is responsible for ocular and rare disease genetics services. In this phenomenal interview, Karmen shares with us the world of genetic testing and the role it plays in clinical trials. Karmen is a certified genetic counselor since 2005. She earned her masters in Genetic Counseling from Northwestern University and a bachelor’s in Microbiology from University of Illinois Prior to joining Informed DNA, Karmen...


CTP 017: The Ultimate Roadmap for Patient Recruitment

In this episode, I share with you strategies and tactical advice on patient recruitment. Patient recruitment is the foundation of any clinical study. If your trial doesn’t enroll the minimum number of patients required per protocol, you or your company cannot get the data you need to prove your trial hypothesis, determine product safety and effectiveness. More importantly, you cannot bring the medical product to the market on time (or possibly never!). This means loss of revenue and...


CTP 016: Bioethics in Clinical Research with Dr. Lindsay McNair

Our guest on the show is Dr. Lindsay McNair, Chief Medical Officer for the WIRB-Copernicus Group, a central Institutional Review Board (IRB) overseeing more than 200,000 clinical research protocols and more than 2,700 institutions and 700 local Institutional Biosafety Committees. In her current role, Dr. McNair develops strategic partnerships with pharma/biotech companies for comprehensive ethical and clinical services. She oversees a consulting group which provides consultation on human...


CTP 015: Real-World Insights and Epidemiology with Dr. Christina Mack

Christina Mack, Ph.D., MSPH is Sr. Director of Epidemiology and Clinical Evidence in the IQVIA Real-World Insights division. She is a recognized expert in effectiveness studies for medical devices and pharmaceutical products, sports injury research, and pharmacoepidemiology methods including the use of external comparators, propensity scores, instrumental variables, and missing data. Her work focuses on the use of electronic health record systems and claims data for research, with a focus...


CTP 014: The World of Program Management with Stephen Smith

In this interview, I had the pleasure of speaking with Stephen Smith. Stephen has several years of project management experience in the healthcare industry. His experience isn’t limited to clinical project management. Stephen has served as senior program management director where was the glue between R&D, marketing, clinical and manufacturing teams for rare disease and oncology drugs. Stephen shares his experience working for top-notch organizations such as Genentech, Gilead Sciences,...


CTP 013: Become an Outstanding Clinical Researcher with Dr. Jeff Kingsley

In this interview with Dr. Jeffrey Kingsley, we talk about what it takes to start and manage a clinical trial site, the world of site networks, how an investigator can decide whether or not a clinical study is worth their time, volunteering for Association of Clinical Research Professionals (ACRP), Food and Drug Administration (FDA) audits, books and a lot more. Dr. Kingsley is the President and CEO; Institute for the Advancement of Clinical Trials DBA IACT Health and an owner of 11 clinical...


CTP 012: Solving Clinical Research Problems Using Technology with Ryan Jones

“Just create output. You don't start riding a bike until you take both feet off the ground and push off” - Ryan Jones, CEO, Florence Healthcare Technology is disrupting the clinical research industry. Globally sites, sponsors and CROs are adopting technology to manage risks, to stay competitive, to build a culture that embraces change, to fail fast and to move forward with speed. In this interview with Ryan Jones, the CEO and Co-founder of Florence Healthcare, we discuss a wide range of...


CTP 011: From Disney to Drugs with Melissa Easy, Founder of DrugDev

“Technology makes our lives easier, but it doesn’t replace people” - Melissa “Liss” Easy The dynamic, engaging Melissa “Liss” Easy is the Founder of clinical operations technology provider DrugDev, which is now part of IQVIA. Early in her career Liss was consulting to a Contract Research Organization and became frustrated by inefficiencies in matching investigators to pharma protocols. She started DrugDev to bring sponsors and investigators together by focusing on the needs of the doctors,...


CTP 010: Effective Clinical Research Sites with Gabriel D'Amico-Mazza

“I enjoy conversations. It takes you somewhere different” - Gabriel D'Amico-Mazza Gabriel is one of the most positive and enthusiastic individuals I know in clinical research. This was one of the main reasons I wanted him to be on this show. He is an expert in business development at a clinical trial site, GCP Research, in Quebec, Canada. Since joining GCP Research in 2010, Gabriel has led recruitment and advertising for Phase 2 and Phase 3 clinical studies. He has been involved in over 40...


CTP 009: Real World Data in Clinical Trials with Manuel Prado

“We’re at the threshold of an astounding period in medical discovery” - Manuel Prado Manuel Prado is an amazing individual who has founded three companies in the clinical space. He spent much of his youth in Peru and worked in investment banking before transitioning into medical transcription and real-world data. Manuel and I had an amazing conversation about how we’re missing a lot of eligible patients in clinical trials by only focusing on EMR and claims data and his solution to address...


CTP 008: Exceptional Clinical Research Insights with Norman Goldfarb

In this interview, Norm and I dig deep into the business of clinical research. You’ll hear us talking about what it takes to run a clinical trial site, the importance of clinical research training and certifications, negotiation strategies, remote monitoring, challenges of being a research coordinator, our love for Ben Franklin and much, much more. Hope you enjoy my interview with the all amazing Norman Goldfarb. About Norman Goldfarb Norman Goldfarb is a seasoned executive and leading...


CTP 007: The Future with EMR with Dr. Manfred Stapff

“It is important that you start with the big picture” - Dr. Manfred Stapff This is episode Dr. Manfred Stapff, Chief Medical Officer at TriNetX shares with us the use and application of real-world data in clinical trial. Manfred Stapff is a physician and board-certified clinical pharmacologist with an extensive career in clinical and pharmaceutical medicine. He was formerly an Executive Director at Actavis, Forest Laboratories, and Merck and also served as a Medical Officer in the German Air...


CTP 006: Journey from Engineer to Clinical Director with Robin Eckert

“You have to forgive yourself and not expect perfection” - Robin Eckert In this episode, I had the privilege to talk to Robin Eckert. Robin is an engineer by training who later transitioned into clinical safety and clinical trial management. She is a very accomplished individual who has led complex structural heart medical device trials. Robin is also one of the most creative individuals in the clinical research space. If you’re a gal (or a guy) wanting to transition into clinical research...


CTP 005: Health Economics and Outcomes Research with James Hasegawa

“Don’t be afraid to try new things” - James Hasegawa This is a special episode in Health Economics and Outcomes Research (HEOR) with James Hasegawa. James is a director at Abbott and is responsible for HEOR projects. In this episode, James shares insights on how healthcare reimbursement works as it related to clinical trials. We also dig into the world of Health Technology Assessment (HTA) groups and what it takes to model reimbursement for a medical product. If you’re interested in breaking...


CTP 004: 13 Suggestions for Becoming a Great Clinical Project Manager

This is a solo episode where I share with you “13 Suggestions for Becoming a Great Clinical Project Manager.” If you are currently clinical project manager or desire to transition into the clinical project manager role, this episode is for you. This episode will also serve well for those interested in learning about what are the roles and responsibilities of a clinical project manager. In this episode, I’ll share with you the fundamentals, tactics and soft skills that turn a good project...


CTP 003: Conversation with Clinical Development Veteran Marshall Cool

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....


CTP 002: Hidden Opportunities in Clinical Research with Gary Thompson

“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...


CTP 001: Becoming an Intelligent Clinical Researcher with David Rutledge

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...