Complexity in Early Phase Clinical Trials with Dr. Oren Cohen
Clinical Trial Podcast | Conversations with Clinical Research Experts
Release Date: 09/26/2022
Cardiology Clinical Trials with Dr. Gregg Stone
Clinical Trial Podcast | Conversations with Clinical Research Experts
To learn more about this important field of cardiovascular clinical research, I invited Dr. Gregg Stone on the podcast. Dr. Stone is an Interventional Cardiologist and Director of Academic Affairs for the Mount Sinai Heart Health System and Professor of Medicine (Cardiology) and Professor of Population Health Sciences and Policy at the Icahn School of Medicine at Mount Sinai in New York, NY. He has served as the national or international principal investigator for more than 150 national and international multicenter randomized trials and studies (many of which have led to new device...
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Clinical Trial Insurance with Dan Fuld
Clinical Trial Podcast | Conversations with Clinical Research Experts
In this episode, you will learn about what type of insurance (if any) is needed to conduct a clinical trial. We also discuss different insurance provisions, choosing the right insurance partner, regulatory requirements that dictate insurance and much more. Dan is a seasoned insurance professional with 10+ years of underwriting and broking experience. Dan and his team also assist in the implementation of alternative risk mitigation strategies, and see themselves as strategic partners to those in the life science space. Dan graduated from the Katie School of Insurance at Illinois State...
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Diabetes Clinical Trials with Dr. Stayce Beck
Clinical Trial Podcast | Conversations with Clinical Research Experts
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 the Diabetes Diagnostic Devices Branch, and Deputy Office Director of Personalized Medicine and...
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Access to Novel Medical Products with Dr. Alison Bateman-House
Clinical Trial Podcast | Conversations with Clinical Research Experts
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...
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Clinical Research as a Profession with Erika Stevens
Clinical Trial Podcast | Conversations with Clinical Research Experts
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 initiatives for productivity, quality and efficiency in operations, cross-functional relationships,...
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Community Engagement in Clinical Trials with Chris Komelasky
Clinical Trial Podcast | Conversations with Clinical Research Experts
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 roles at PPD, GlaxoSmithKline, Accenture and ZS Associates. Chris holds a B.S. in Systems Engineering...
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Community health system-based research with JoAnne Levy
Clinical Trial Podcast | Conversations with Clinical Research Experts
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, convenient urgent care locations, imaging centers and pharmacies. In 2022, over 38,000 Mercy patients...
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Postmarket Surveillance Studies with David Rutledge
Clinical Trial Podcast | Conversations with Clinical Research Experts
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 Surveillance Studies regulatory requirements, process for collecting clinical data for such...
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Human-centered design role in clinical trials with Bruce Hellman and Ben James
Clinical Trial Podcast | Conversations with Clinical Research Experts
In this episode, we explore the role of design in clinical trials. Most clinical research professionals are so focused on protocol design, data collection, and analysis that it’s easy to overlook the importance of well-designed technology that supports clinical trials. One such technology product is electronic Patient Reported Outcomes or ePROs. ePROs are surveys that are presented to and completed by clinical trial participants as part of the study requirements. To learn more about ePROs and the role of design in clinical trials, I invited Bruce Hellman and Ben James on the Clinical...
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Clinical Trial Site Networks with Christian Burns
Clinical Trial Podcast | Conversations with Clinical Research Experts
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 network. To learn more about site networks, I invited Christian Burns, President of Elligo...
info_outlineWhen 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 Pharmacology Services and Chief Medical Officer at Labcorp Drug Development on the show.
Dr. Cohen has more than 30 years of healthcare experience which includes his work on clinical development.
I hope you enjoy this conversation with Dr. Oren Cohen.
Podcast Sponsor:
This podcast episode is brought to you by Calyx. Calyx is a trusted name in medical imaging, having delivered imaging services to meet the needs of global biopharmaceutical sponsors and clinical research organizations for over 25 years. To learn more, visit calyx.ai