To learn more about clinical trials in diabetes, I invited Dr. Stayce Beck, Global Vice President of Clinical Affairs at Dexcom Inc. on the podcast.  Dr. Beck currently oversees clinical operations, clinical strategy and science, biometrics and human factors at Dexcom Inc, a leading manufacturer of continuous glucose monitors (CGMs) Prior to joining Dexcom, Dr. Beck worked at Food and Drug Administration for over ten years, spending time as a scientific and regulatory reviewer, a chief of...

Providing patients access to novel medical products can be challenging to navigate for sponsors and trial participants alike.  To learn more about expanded access, compassionate use, Right to Try laws, I invited Dr. Alison​ ​Bateman​-​House​, ​PhD​, ​MPH, MA​, ​an​ ​Assistant​ ​Professor​ ​in​ ​the​ ​Division​ ​of​ ​Medical Ethics​ ​at​ ​NYU​ ​Grossman​ ​School​ ​of​ ​Medicine​.  Dr. ​Bateman​-​House​ ​is​ ​co​-​chair ​of​ ​the​ ​Working​ ​Group​ ​on Compassionate​ ​Use​ ​and​ ​Preapproval​...

Unlike an electrical engineer or a plumber, clinical research roles are not explicitly defined or categorized as such, in government employment databases. There are no certification or degree requirements to work as a clinical research professional either. To explore the topic of clinical research as a profession, I invited Erike Stevens on the podcast. Erika advises life sciences, academic medical centers, hospitals, cancer centers, foundations and health systems process improvement...

To learn about community engagement in clinical trials, what it means, recent regulations and guidance documents, I invited Chris Komelasky, CEO and Co-founder of SiteBridge Research, on the podcast.  SiteBridge Research is an Integrated Research Organization (IRO). Chris and his team help connect physicians and their patients to clinical trials and facilitate the process by reducing barriers for sites and participants. Prior to the launch of SiteBridge, Chris has held various leadership...

Community health system-based research continues to become an important focus area for pharmaceutical and medical device sponsors given the recent FDA guidance on diversity in clinical trials.  Our guest for this episode is JoAnne Levy, Vice President at Mercy Research, a part of Mercyhealth.  Mercy Research is one of the largest fully integrated, community health system-based research organizations in the United States with more than 40 acute care, managed, and specialty hospitals,...

In this episode, we’re going to talk about Postmarket Surveillance Studies.  In light of the EU Medical Device Regulation (MDR), medical device manufacturers are required to implement a Postmarket Surveillance (PMS) plan, which in turn may require them to conduct Postmarket Surveillance Studies.  The importance of such studies has grown in recent years as regulators want to know about the safety and effectiveness during the lifetime of a medical device.  To learn about Postmarket...

There are advantages and disadvantages when it comes to being a standalone clinical trial site.  Standalone clinical trial sites enjoy the freedom of running their own operations. But they may face challenges with executing some parts of a clinical trial.  This is where site networks come in.  For example, a site can run more efficient marketing campaigns, be more systematic in its clinical trial operations, or share patient recruitment and retention resources by being part of a site...

In this episode, I’m excited for you to learn about Heart Failure Clinical Trials for medical devices. Our guest today is Sonna Patel-Raman. Sonna is currently the President at NuPulse Inc, an early stage medical device company responsible for developing the first minimally invasive, long-term, ambulatory counterpulsation device that works in sync with the heart. At NuPulse, Sonna is responsible for developing and executing on strategic initiatives for the company, building a diverse and...

To learn more about site reads and the role of medical imaging software, I invited Kelie Williams Luby, Vice President of Clinical Trials at Mint Medical.  Kelie has 24 years of experience as a clinical trial researcher, first as a medicinal chemist, and for the past 19 years as a clinical trialist in medical imaging-based endpoints. She is passionate about optimizing clinical trial designs while reducing the cognitive burden placed on healthcare providers treating patients in those clinical...

This is a special episode on risk management. It is important to understand what dictates the work we do as clinical research professionals and how our work fits into the bigger picture of medical product development. This episode serves exactly that purpose. You’ll be introduced to ISO 14971 Application of risk management to medical devices and learn about its relationship to ISO 14155 Clinical investigation of medical devices for human subjects — Good clinical practice. You’ll also...

In this episode, I’m excited to share with you 5 Strategies for planning and conducting investigator and steering committee meetings.  Now that the world is starting to re-open after the COVID-19 pandemic, more sponsors are conducting in-person meetings with key opinion leaders (KOLs).  These meetings are exceptionally critical to the success of any medical product development. The purpose of these meetings is to discuss the clinical trial strategy, clinical investigational plan, patient...

When a new drug or device undergoes “first in human” experience, the primary focus is on participant safety. How will the drug or device interact with the human body? And will this interaction be safe? To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early phase clinical trials. To learn more about the complexities in early phase clinical trials, I invited Dr. Oren Cohen, President of Clinical...

Phase I trials are generally conducted in healthy participants or in patients with no treatment options such as oncology patients. Unlike late phase trials, Phase I (also known as early phase) studies have different patient recruitment challenges. To learn more, I invited Dr. Graham Wood, Executive Vice President, USA at Nucleus Network. Dr. Wood is a leader in the conduct and design of clinical pharmacology studies having held senior executive roles in a number of the top clinical...

Medical Imaging in Clinical Trials with Elizabeth Dalton In this episode, I’m excited to talk about medical imaging in clinical trials.  We’ll discuss the role of a medical imaging CRO, imaging endpoints in clinical trials, expensive mistakes to avoid as a trial Sponsor/ CRO, saving money on medical imaging services, imaging data collection process, and more. The guest for today’s show is a long time friend of mine, Elizabeth Hartunian Dalton, Vice President at Calyx.   Liz is a seasoned...

Who owns the clinical trial data generated in industry sponsored or investigator initiated clinical trials? What responsibilities do Sponsors, CROs, or Sites have when it comes to sharing clinical trial results with patients? Should a Sponsor get access to patient data collected outside a clinical trial setting? To answer these questions and more, I invited Darshan Kulkarni to the show. Darshan is a regulatory attorney specializing in FDA law, professor, author, and speaker. He is...

In the fiscal year 2021, the National Institute of Health (NIH) funded only 16,959 out of 80,878 research project grants.  In other words, the success rate was 21%. And the total funding amount was $8,827,444,624. The question I had was, “What does it take to get grant approval and launch an NIH funded research project?” To answer this question, I invited Dr. Manish Shah,  Professor of Pediatrics at Baylor College of Medicine and Attending Physician in the Texas Children’s Hospital...

A big part of managing clinical research at any site is managing clinical research billing. If you don’t keep track of your research finances, it can end up costing you a lot of money in the long run.  To understand clinical research billing, how to manage billing activities, the role of a clinical trial management system (CTMS), differences between cash and accrual based accounting, and more,  I invited our guest, Kristi Etchberger, on the show.   Kristi founded Clinical Research Billing in...

As the clinical research ecosystem becomes more site and patient centric, I was curious about what an ideal software stack looks like for clinical research sites. It goes without saying you need a laptop and stable internet connection to do business in this day and age. But what else do you need to keep yourself organized as a clinical research site?  How can a clinical trial site bring most value to their research participants, run a profitable research operation, and not overwork...

Dr. Bierer is the Director of the Regulatory Foundations, Ethics and the Law Program of the Harvard Clinical and Translational Science Center and the Director of Regulatory Policy, SMART IRB.  Previously she served as senior vice president, research, at the Brigham and Women’s Hospital for 11 years, and was the institutional official for human and animal research, for biosafety, and for research integrity.  She initiated the Brigham Research Institute and the Innovation Hub (iHub), a focus...